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RF_DIS_8_SUDHA
ALMEIDA AND CHACKO—M. LEPRAE POPULATION DYNAMICS IN MDT
Vol. 57 No. 4
Indian journal of leprosy
Oct-Dec 1985
COMPUTERIZED MATHEMATICAL MODEL OF M. LEPRAE PO
PULATION DYNAMICS DURING MULTIPLE DRUG THERAPY
*
J.G. Almeida1 and C.J.G. Chacko2
t _ is the time elapsed between time 0 and time t.
Abstract : .-1 computerized mathematical model of M. leprae populations
during multiple drug therapy (MDT) was constructed. Relevant published
information available to (tale was fed into it, and reasoned assumptions were
made. From the mode!, it seems likely that .MDT steadily selects bacteria re
sistant to the most powerful of the three drugs used: unless the individual bacteri
cidal potencies of the drugs balance one another. If the drugs used have differ
ing potencies, cure probably hinges on treatment being continued until all metabolically active bacteria are killed Withdrawal of treatment before that could
lead to relapse with bacteria resistant to the most powerful of the drugs used.
INTRODUCTION
Mathematical models of human populations allow theoretical predic
tions that are more accurate than rough guesses. Bacterial populations
can be similarly analysed. Simplistic guesses about the outcome of che
motherapy are often misleading.
This model is offered as a beginning. As more information becomes
available from investigations, the model should expand to incorporate it.
Computer programs have been written to solve the mathematical equa
tions involved. The mode) should help explain observations, indicate areas
deserving research, and give clues to the results of long-term trials of MDT.
METHODS
Population dynamics of bacteria
Bacterial population growth (and death) can be described by the equa
tion :
Pt~Poe"'
where Po - is the initial number of siablc bacteria, at time O;
(1)
•Working paper for the Workshop on Experimental Chemotherapy of the XII
International Leprosy Congress, New Delhi. February 16-17, 1984.
1.
Dr. J.G. Almeida, MBBS. Dip. Comp. Prog., Dip. H. Stat., Research Fel
low,
2.
Prof. C.J.G. Chacko. M.D., Ph.D., Head, Radda Bamen Research Laboratories,
Schieffelin Leprosy Research and Training Cenlre, Karigiri 632106, Tamil Nadu,
India. ■
780
Pt — is the number of viable bacteria at time t;
e — is the base of natural logarithms;
R — is a constant for a given set of conditions affecting growth;
This equation should adequately describe increases or decreases in vi
able bacteria (except near the asymptotic limits).
R, the growth constant for a given set of conditions
The most important factors affecting the population dynamics of M.
leprae are :
(1)
Bacterial doubling.
(2)
Killing/clearance by host responses.
(3)
KJUing/inhibition by drugs.
(4)
Mutation of bacteria to drug resistance.
Appropriate rates were assigned to these factors, based on published
data wherever available. The following data were used:
(1) Bacterial doubling : The “doubling time” of M. leprae in the mouse
foot pad is 11.1 days (Levy, 1976). That is, one viable M. leprae at the end
of 11.1 days gives two viable M. leprae.
Hastings and Morales (1982) have pointed out that if a change in bac
terial staining (from “solid” to non-“solid") indicates death of A/. leprae,
the bacterial life-span must be very short. This in turn would mean that
M. leprae need to divide approximately once a day, to maintain a doubling
time of about 10 days. As soon as a consensus is reached on this question,
it will be possible for this model to include bacterial generation time, rather
than doubling time, in calculations. Until that time, we choose to abstain
from the controversy by using the doubling time of viable bacteria — the
net result of generation time and bacterial life-span.
(2) Killing!clearance by host responses : Lepromatous patients on
dapsone monotherapy show a steady decline in numbers of M. leprae :
0.58 log10 units per year, measured by the logarithmic biopsy index.
In
lepromatous patients with borderline features, the decrease was 2.51 log10
units per year, (Ridley, 1967).
781
ALMEIDA AND CHACKO—M. LEPRAE POPULATION DYNAMICS IN MDT
INDIAN JOURNAL OF LEPROSY
Vol. 57 No. 4
Oct-Dec 1985
(3) Killing!inhibition of growth, by drugs : The ideal bactericidal drug
may be arbitrarily delined as one that kills 99.9% of drug-sensitive bacteria
during the time taken for one doubling of viable bacteria. The ideal bac
teriostatic drug prevents all drug sensitive bacteria from multiplying, with
out altering the action of a bactericidal drug. The effect of drugs given
simultaneously is presumed to be additive.
teria in skin smears includes the many dead bacteria that accumulaie dur
ing bactericidal treatment. Dead bacteria presumably do not contribute
to the population equations and therefore do not appear in the computer
printouts.
Computer programs
(4) Mutation to drug-resistance : Most mutants in nature occur with
a frequency of about one in 106 (one in 103 to one in 1010). Apparently,
direct measurements of the spontaneous mutation rate of M. leprae to
resistance against various drugs have not been made. The frequency of
any mutants is presumed to be one in !06.
Programs were written in BASIC, for the PDP-11 and PC 350 compu
ters manufactured by Digital Equipment Corporation. Sample problems
were run through the computer program and independently verified on
calculators. Table 1 is taken from a computer print-out, indicating the
variables for which any desired values can be entered. Any imaginable
combination of the listed factors can be followed in the computer program.
Table 1 shows the actual values used for MDT in an LL patient.
Drug-resistance may be denned for the present purpose as resistance
to the highest attainable concentration of drug in the host.
Table 1 : Sample text of computer printout
Also for the present purpose, all drug-susceptible and drug-resistant
M. leprae are considered to have identical rates of multiplication, and backmutation from drug-resistance to drug-susceptibility is excluded.
R = r, ~ r, + r,............................................... (2)
where R - is the growth constant for a given set of conditions;
VIABLE BACTERIA ALONE are considered.
Assumed : LL(. IE+ 11 bact.)/bact. gen. time — I Id./mutants— 10E-6
Enter (n) if you prefer other assumptions : ?n
The generation time (DAYS) of bacteria is not 11 but? 11
The initial no. of VIABLE bacteria is not 0.1E 4- 11 but? 0.1EI1
The frequency of mutants is ONE IN not 0.1E7 but? 0.1E7
tj — constant for bacterial doubling;
The clearance constant is MINUS not 0.042 but? 0.042
r2 — constant for host response;
The bacterial growth constant is not 0.69 but? 0.69
r3 — constant for bactericidal action of drug.
The bactericide constant is MINUS not 6.91 but? 6.91
The constants r,. r2 and r> can each be derived from the observations,
in an easy calculation. For example, if each unit of time is taken as 11
days (one doubling of viable bacteria) and if a bactericidal drug kills 99.9%
of bacilli in one unit of time, then:
Symbols used in the log scale display of VIABLE bacteria:
.............. = sensitive bacteria = ‘sens’.
xxxxxxxx = resistant to (bacterio) static drug = ‘ res. (stat)’
*•••»•• = resistant to cidal drug = ‘res. (-.ide)'
r-
iogn P, /Po = logn 0.001
—6.91
Number of viable bacteria before treatment
Lepromatous (LL) patients are presumed to harbour 1010 viable M.
leprae before treatment. Borderline lepromatous (BL) patients are presum
ed to harbour IO7 viable bacteria.
Viable bacteria alone are considered in the mathematical model and
computer display'. It must be emphasized that the total number of bac782
Do you want to print the present screen display (y/n)? y
Treatment option no. 6
Bacteria : res. (stat) = .584291E-04 sens. = 58.429
res. (cide) — 8917.82
total = 8976.25
Display bacterial population (y/n)? n
Time elapsed till now is Oy. Im. Ow. Od.
Total VIABLE bacteria = 8976.25
Vol. 57 No. 4
INDIAN JOURNAL OF
LEPROSY
Oct-Dec 1985
The total number of viable bacteria, and the sub-populations of drugsusceptible an<l drug-resistant bacteria, can be monitored during treatment—
daily, weekly, monthly or yearly, as desired (interchangeably). Table 2
shows the interchangeable options available for treatment. Only options
4 and 6 were used, being considered closest to currently popular forms of
MDT.
“Option 4” -2 bacteriostatic drugs;
“Option 6”
2 bacteriostatic 4- 1 bactericidal drug.
Table 2 : Treatment options
Monitor bacteria at : d)aily w)eekly mkmthly yjearly intervals.
En er selected letter? d
En'.cr the no. of your treatment option :
No treatment
1
I static drug only
2
1 cidal drug only
3
2 static drugs
4
1 static — 1 cidal drug
5
2 static
6
1 cidal drug
Selected option no.? 6
Therapeutic situations
Changes in viable bacteria have been followed during MDT of — “LL”
and “BL” patients
—with 1 bactericidal (cidal) and 2 bacteriostatic (static) drugs, given as
follows:
Treatment 1 — “Intermittent" : Cidal —once monthly-}- 2 static — daily.
Treatment 2—“Continuous” ; Cidal — daily + 2 static — daily.
Treatment 3
“Initial”: Cidal — daily, for 3 weeks only4-2 static — daily, conti
nuously.
Limitations of model
The poorly explained phenomenon of drug-sensitive “persistor” bacteria
cannot be incorporated until a reasonable theoretical basis for it is formu
lated. Only metabolically active viable bacteria are considered here.
784
ALMEIDA AND CHACKO—M. LEPRAE POPULATION DYNAMICS IN MDT
Patients in a hyper-endemic area may be at constant risk of fresh infec
tion from external sources. The literature seems silent on this important
question, and for present purposes, the risk is considered to be negligible.
The assumption that bacteriostatic drugs do not attenuate the potency
of bactericidal drugs against M. leprae seems precarious, but it is made in
the absence of definite evidence to the contrary.
The same assumption
seems to be made by advocates of MDT combining bacteriostatic and bac
tericidal drugs.
The constants used in the equations are based on the published evidence
available. Future findings may modify the values assigned For example,
it may be found that drug-resistant M. leprae multiply less quickly than
drug-susceptible M. leprae.
Nevertheless, comparison between the three regimens should remain
unaltered. The relative differences between the regimens should not be
prejudiced by a change in mathematical constants that are common to the
regimens. Interpretation of the results should therefore focus on the re
lative, rather than the absolute, durations of the three treatments.
RESULTS
The figure presents the results in graphs, based on the computer prin
touts. The four lines in each graph of the figure represent (from top to bot
tom) : bacterial index (BI), total number of viable bacteria, bacteria resis
tant to the bactericidal drug, bacteria resistant to either one of the bacterio
static drugs.
Many interesting features can be spotted in the graphs.
prominent ones are listed here.
Only a few
(I) Viable organisms are killed much more rapidly than the bacterial
index (BI) suggests.
(2) Initial killing of M. leprae (during the first few weeks of treatment)
is remarkably better with the “continuous” treatment 2, than with the “in
termittent” treatment 1.
(3) In an LL patient on MDT, bacteria resistant to the most powerful
of the three drugs used, do attain a majority. However, if treatment is
continued without interruption, the two weaker drugs ensure that bacteria
resistant to the strongest drug do not multiply. These dru? red..™
‘vMbiani. bac-
Vol. 57 No. 4
Indian journal of
leprosy
ALMEIDA AND CHACKO—M. LEPRAE POPULATION DYNAMICS IN MDT
Oct-Dec 1985
teria are then slowly removed over a period of years, by the host responses
provided the two weaker drugs are not prematurely w’ithdraWn.
(4) In LL patients, the three MDT regimens (intermittent, continuous
and initial) take equally long to kill all viable M. leprae.
I
i
(5) In BL patients, killing of bacteria is so much quicker than in LL
patients, that the lines representing viable bacteria in the Figure, are scarcely
distinguishable from the y axis: particularly for treatments 2 and 3. One
point of interest in the BL graphs is that drug-resistant bacteria do not attain
a majority at any stage of treatment. Also, in BL patients, “continuous”
three-drug treatment 2 kills all viable bacteria in less than half the time
taken by “intermittent” treatment.
(6) Within weeks of starting treatment, viable bacteria arc no more than
a minute population scattered among vast numbers of dead bacteria.
DISCUSSION
,
MDT (multiple drug therapy) kills M. leprae more quickly than the fall
in BI suggests. However, from the graphs in the figure, it is evident that
the initial rate of killing is not sustained. This is apparently due to selection of mutant bacteria resistant to the most powerful of the three drugs
used.
The model only underlines what common sense might have predicted.
Bacteria resistant to the powerful bactericidal drug are acted on relatively
slowly, by the two weaker drugs. The remainder of bacteria are rapidly
killed by the bactericidal drug. Thus bacteria resistant to the most power
ful drug are relatively favoured, and attain a majority among the surviving
bacteria. Fortunately, if treatment is not prematurely withdrawn, these
resistant bacteria are contained by the weaker drugs — to be removed slowly
by the immune responses of the host. Eventually, no viable bacteria re
main.
Bacteria resistant to the most powerful drug can only be contained if
the Weaker drugs are ingested regularly, until no metabolically active bac
teria remain.
Fi8' ’■
786
^tee^p0puJati0nsdurin« Multiple drug therapy of LL and BL leprosy
MDT kills bacteria so rapidly at first, even when given “intermittent! ”
that viable bacteria are soon masked by huge numbers of accumulated dead
bacteria. The remarkably slower killing of bacteria by “intermittent”
compared to “continuous” or “initial” schedules of MDT. is unlikelv to b*
demonstrable by currently used methods. Neither mouse foot pad inocula
787
Vol. 57 No. 4
Indian journal of leprosy
Oct-Dec 1985
ALMEIDA AND CHACKO—M. LEPRAE POPULATION DYNAMICS IN MDT
tion of bacteria from skin biopsies, nor Bl or morphologic index (MI) mea
surements are likely to uncover this important difference. This is probably
because the enormous numbers of dead bacteria obscure the difference. How
ever, the model suggests that the “intermittent” schedule of MDT lags well
behind “continuous” MDT in the initial killing of bacteria.
9
Bacteria resistant to the most powerful drug are steadily selected, and
therefore the initial rate of bacterial killing is not maintained. A slower
phase of bacterial clearance by host immune responses follows, during
which the weaker drugs inhibit bacteria resistant to the most powerful drug.
This “slow phase” in LL patients lasts so much longer than the rapid initial
killing, that all three schedules of MDT achieve “cure” (no metabolically
active bacteria) within approximately the same interval after starting treat
ment.
The “initial” schedule of MDT, employing the bactericidal drug daily
for a limited initial period, achieves rapid initial killing of M. leprae. It
also avoids wastage of the powerful bactericidal drug after the surviving
bacterial population has become predominantly resistant to that drug.
MDT with the few drugs available emerges as a calculated risk. The
benefits of rapid initial killing by the bactericidal drug Will be useless unless
the Weaker drugs are ingested regularly, for long enough. Otherwise, bac
teria resistant to the most powerful of the drugs might multiply again to
produce drug-resistant relapse. Only when the imbalance in potency bet
ween the single powerful bactericidal drug and the other drugs is remedied,
will MDT be free of the risk of selecting drug-resistant M. leprae. This
emphasizes the need to find new potent drugs, if only to balance the potency
of the one strong drug now available.
This picture of bacterial population dynamics during MDT is less naive
than many popular guesses. It provides food for thought, and suggests
areas deserving more research.
ACKNOWLEDGEMENTS
We thank the computer section of the Christian Medical College,
Vellore, for computer time, and Mr. K. Hall for expert criticism. We are
grateful to the Department of Epidemiology, SLR & TC, Karigiri, for com
puter time; and to Mrs. Doris Kore for secretarial assistance.
788
REFERENCES
1. Hastings, R.C. Morales, M.J. (1982). Observations, calculations, and spe
culations on the growth and death of M. leprae in vivo. hit. J. Lepr., 50 : 579-82(abstract).
2- Levy, (1976). Studies of the mouse foot pad technique for cultivation of
Mycobacterium leprae. 2. Doubling time during logarithmic multiplication. Lepr. Rev.,
3. Ridley, D.S. (1967). A logarithmic index of bacilli in biopsies. 2. Evaluation.
bit. J. Lepr., 35 : 187-193.
Volume 54, Number I
Printed in the U.S.A.
International Journal of Leprosy
Relapse Rates in Lepromatous Leprosy
According to Treatment Regularity1
Joel Gerald Almeida, Kumar Jesudasan, Melville Christian,
and Chinoy John George Chacko2
Patients with lepromatous leprosy may
now hope for a limited period of treatment
instead of life-long therapy (u). The study
of relapses after skin smears become “neg
ative for Mycobacterium leprae" will help
determine the optimal duration of treat
ment. We therefore continued our previous
analysis of relapses among smear-negative
lepromatous (LL) and borderline leproma
tous (BL) patients on dapsone (DDS) mono
therapy (2) to find out whether continued
treatment during smear negativity has as
much influence on relapse rates as previous
treatment during smear positivity.
Much data is available on the magnitude
of relapse rates among treated “multibacillary” leprosy patients (4-6’13), including that
from our own previous report (2). However,
none of these studies considered the regu
larity of treatment during smear positivity
separately from that during smear negativ
ity.
MATERIALS AND METHODS
The well-documented leprosy control
program of the Schieflelin Leprosy Re
search and Training Centre (SLR&TC), Karigiri, India, among the 450,000 inhabitants
of Gudiyatham Taluk in South India, has
previously been described in detail ('). The
most relevant points alone are repeated here.
The whole population in the area is regu
larly examined for leprosy. All known pa
1 Received for publication on 12 July 1985; accepted
for publication in revised form on 4 November 1985.
:J. G. Almeida, M.B., B.S.. Research Fellow, Di
vision of Laboratories. Schienclin Leprosy Research
and Training Centre (SLR&TC); K. Jesudasan. M.B.,
B.S.. D.T.P.H., Ph.D., Associate Epidemiologist; M.
Christian. MB.. B.S., D.T.M.&H . D.E.C.D., Head.
Department of Epidemiology and Leprosy Control,
SLR&TC, Karigiri 632106, Tamil Nadu, India. C. J. G.
Chacko. M.D.. Ph.D.. Head. Division of Laboratories,
SLR&TC. and Professor of Pathology, Christian Med
ical College Hospital. Vellore, India.
Reprint requests to Dr. Chacko.
16
tients arc registered for treatment, which
they collect at monthly village clinics near
their homes. Details on each patient are
carefully maintained in an individual pa
tient record.
All 1580 LL and BL patients residing in
Gudiyatham Taluk (area = 1320 km2) were
listed on 31 December 1977 from the treat
ment register of SLR&TC, Karigiri. Data
were assembled for each patient, from the
date of registration up to 28 February 1981,
from individual patient records; 157 of 1580
patients had insufficient data. Of the re
maining 1423 patients (90.1%), all were in
cluded who had been smear positive and
had had at least two consecutive negative
skin smears at any lime after registration;
1008 patients satisfied these criteria.
DDS monotherapy was used throughout
the study period, and smear-negative pa
tients continued on treatment. Smears were
taken annually from a minimum of four
skin sites: earlobe and chin on the right,
forehead and buttock or thigh on the left.
“Relapse” is taken to mean the re-ap
pearance of M. leprae in the skin smears of
a smear-negative patient, excluding those
cases where a single bacillus was found at
only one skin site on an isolated occasion.
The “period of smear negativity” for a pa
tient is defined as the single longest period
after registration which started with, ended
with, and included only negative skin
smears. The sum of the periods of smear
negativity for a group of patients yields their
“person-years of smear negativity.” “Reg
ularity of treatment'.’ during a stated period
is defined as the percentage of months
throughout the period during which the pa
tient attended a monthly village clinic to
collect tablets. Those who collected fewer
tablets were assumed to have ingested fewer
tablets, on the average, than those who col
lected tablets regularly. In the interest of
clarity, it was decided before analysis that
treatment regularity during smear negativ-
£>15 s- x54, 1
Almeida, cl al.: Relapse Rates in LL
ity should not have class intervals identical
to those for regularity during smear positiv
ity.
“DDS-resistant infection” (') had been
diagnosed among patients whose annual skin
smears showed a continuing increase in the
number of bacilli, despite >50% regular
treatment overall. Some patients with
enough bacilli [bacterial index (BI) > 2 + ]
for successful inoculation of the mouse foot
pad were also tested for the presence of DDSresistant bacilli (3).
The chi-squared test with correction for
continuity was used to determine the sta
tistical significance of observed differences.
A
RESULTS
17
The Table. Relapses among smear-neg
ative LL and BL patients by regularity of
treatment during smear negativity and reg
ularity of treatment during smear positivity.
Treat
Dura ment
tion of regu
smear larity
nega during
tivity smear
(yrs)
nega
tivity
1-3
4-6
>7
s75%
>75%
<75%
>75%
<75%
>75%
Treatment regularity during
smear positivity
*
<66.7%
>66.7%
17/279 (6.1%)
11/288 (3.8%)
10/209 (4.8%)
1/206 (0.5%)b
13/557 (2.3%)
4/551 (0.7%)
9/191 (4.7%)
17/755 (2.3%)
6/123 (4.9%)
9/521 (1.7%)
8/297 (2.7%)
16/1378 (1.2%)
The lowest relapse rate during the initial
* Number of patients relapsed/person-years smear
three years of smear negativity was found negativity.
5 Significantly less than <75% treatment regularity
among the patients with the better treat
ment regularities during both past smear during 4-6 years of smear negativity; p < 0.005, chipositivity and smear negativity (The Table). squared test.
For example, until the third year of follow
up. patients with a history of less regular
(<66.7%) treatment during past smear pos and, hence, was diagnosed to have DDSitivity had 4.9% relapses per year (17 + 11 = resistant infection (').
28 relapses during 279 + 288 = 567 personDISCUSSION
years of smear negativity); whereas those
with more regular (>66.7%) treatment had
“Relapses” in lepromatous leprosy can
only 2.8% relapses per year (26 relapses dur occur due to “endogenous” M. leprae from
ing 946 person-years). The difference is sta within the patient, or “exogenous” M. lep
rae from external sources, or both. During
tistically significant (p < 0.05).
A striking finding, however, is that from the initial three-year period of follow up,
the fourth year of follow up onward, pa more regular treatment during past smear
tients treated more regularly during past positivity was associated with lower relapse
smear positivity did not have lower relapse rates. Perhaps inadequately treated M. lep
^ates than those treated less regularly. On rae resume multiplication and manifest as
0ie other hand, more regular (>75%) treat a relapse within this initial period of smear
ment during smear negativity was consis negativity. Beyond this period, relapse rates
tently accompanied by lower relapse rates are no lower for the patients treated more
than less regular (£75%) treatment even regularly in the past than for those with less
seven or more years after the attainment of regular past treatment.
Relatively regular treatment during smear
smear negativity (The Figure).
Patients with >75% regular treatment positivity seems to have no salutary effect
from the seventh year of smear negativity on the risk of relapse after the third year of
■ I he Table) had 1919(551 + 1378)person- smear negativity. Perhaps this is because
>ears of observation. Twenty patients re "endogenous” M. leprae (from within the
lapsed. giving a relapse rate of 1.0% per year; patient) do not pose as great a threat as “ex
16 of these patients eventually became smear ogenous” bacilli after the third year of smear
negative again while continuing on DDS negativity.
Beyond the initial period of smear neg
monotherapy. Two of the remaining pa
tients were demonstrated to harbor DDS- ativity, the risk of “endogenous” M. leprae
resistant bacilli by the mouse foot pad test multiplying should tail off. and relapse rates
■ l. one of whom showed a continuing in similarly tail off, unless "exogenous" sources
case in bacilli in successive skin smears of M. leprae (outside the patient) are avail-
18
International Journal of Leprosy
1986
The Figure. Relapses among smear-negative LL and BL patients by regularity of treatment during smear
negativity and smear positivity.
able. In the one non-endemic area where
treatment was stopped after using four drugs
for a period (’), none of 80 LL and BL pa
tients with negative smears had relapsed.
The risk of relapse from “endogenous” M.
leprae may have been minimized in that
study by the use of four drugs. However,
the low (possibly zero) relapse rates are con
sistent with the view that few “exogenous”
M. leprae were available in that non-endemic area.
The frequency with which “exogenous”
sources of M. leprae may lead to detectable
bacilli in the skin of an individual was partly
measured by a total population study of ap
parently noninfected persons in a leprosy
endemic area (5); 5.8% of about 7000 per
sons with no sign of leprosy were found to
harbor acid-fast bacilli in the skin of one
earlobe. The corresponding figure among
patients with apparently “resolved” leprosy
was 13.33%. That these bacilli were M. lep
rae was suggested not only by their failure
to grow on routine mycobacterial media but,
more strongly, by the higher-than-avcragc
incidence of subsequent clinical leprosy
among the apparently noninfected persons
harboring the bacilli.
One interesting group in the present study
is the 20 patients who “relapsed” after hav
ing been smear negative for seven or more
years, despite >75% regular treatment dur
ing smear negativity (The Table). Although
bacilli reappeared in their skin smears, 16
of them went on to become smear negative
again while on DDS monotherapy. DDSresistant infection, therefore, seems an un
likely explanation of their transient smear
positivity. If “endogenous” M. leprae had
multiplied to give the positive smears, those
patients treated more regularly during past
smear positivity should have a lower “re
lapse” rate than those less regularly treated.
Instead, their relapse rate is at least as high:
1.2% per year for those with more regular
(>66.7%) treatment during smear positivity
compared to 0.7% per year for those with
less regular (<66.7%) treatment. This is
consistent with the explanation that the ba
cilli could have come from “exogenous”
sources and were, therefore, unaffected by
previous treatment during smear positivity.
54. 1
Almeida, ct al.: Relapse Rates in LL
The rarity of DDS-rcsisiani infection, or
even of sufficient bacilli to inoculate the
mouse foot pad, among the patients who
“relapsed” after years of smear negativity
is in keeping with our earlier studies (*)• We
had found that smear negativity indicated
a significantly reduced risk of DDS-resistant
infection.
SUMMARY
In Gudiyatham Taluk, South India, 1008
lepromatous (LL) and borderline lepromatous (BL) patients were studied. They had
previously been smear positive, had at
tained smear negativity, and continued on
DDS monotherapy. “Relapse” was defined
^as the reappearance of Mycobacterium lepVrae in skin smears. The area is endemic for
leprosy.
The lower relapse rates in the first three
years of smear negativity alone were asso
ciated with more-regular treatment during
both past smear positivity and smear neg
ativity. From the fourth year of smear neg
ativity onward, only the more-regular treat
ment during smear negativity was associated
with lower relapse rates; whereas patients
with more-regular treatment during past
smear positivity had no lower risk of relapse
than those with less-regular treatment.
The finding that regularity of treatment
during smear positivity seems to have no
effect on relapse rates beyond the third year
of smear negativity is discussed. In a lep
rosy-endemic area, it is argued that beyond
the first three years of smear negativity in
an LL or BL patient, sources of M. leprae
Outside the patient may be more responsible
nor relapse than the patient’s own bacilli.
RESUMEN
Sc estudiaron 1008 pacientcs lepromatosos (LL) y
lepromatosos intermedios (BL) cn Gudiyatham Taluk,
al sur de la India. Los pacientcs que previamente habian sido baciloscopicamente positives, alcanzaron la
negatividad baciloscopica y continuaron con mono•apia a base de dapsona (DDS). Sc considcro que
nubieron rccaidas cuando rcaparccieron bacilos cn los
e.xtendidos de linfa cutanea. En cl area cstudiada la
lepra es cndemica.
Las bajas frecuencias de rccaida en los primeros 3
anos de negatividad baciloscopica sc pudicron asociar
con un tratamiento muy regular tanto durante la posilividad baciloscopica previa como durante la ctapa
de negatividad. A partirdcl cuarto ano de negatividad.
las bajas frecuencias de rccaida solo sc pudicron asociar
19
con un tratamiento muy regular durante la etapa de
negatividad baciloscopica. Los pacientcs con un tra
tamiento muy regular durante la positividad bacilo
scopica previa luvicron igual riesgo de rccaida que
aqucllos pacientcs con tratamiento menos regular.
La regularidad del tratamiento durante la positivi
dad baciloscopica no parcce tener efecto sobre la frecucncia de rccaidas despues del tcrcer ano de negati
vidad. Sc argumenia que en un area con lepra cndemica,
las fuentes de Mycobacterium leprae extemas son mas
importantcs que los bacilos del propio individuo como
causa de rccaida cn un paciente LL o BL despues del
tcrcer ano de negatividad baciloscopica.
RESUME
On a etudie 1008 maladcs lepromaicux (LL) ct lepromateux dimorphes (BL), dans 1c Gudiyatham Ta
luk, en Indc du Sud. Ccs maladcs avaient etc antcneurement bactcnologiquement positifs; ils ctaienl
negatifs au frottis cutane. ils ctaienl toujours sous
monothcrapie par la DDS. Les “rccidives” ont ele definics commc la reapparition de Mycobacterium leprae
dans les frottis cutancs. Cette region csl endemique
pour la lepre.
Un taux reduil de rccidives au cours des trois pre
mieres annecs a bactcriologie negative etail associc avec
un trailemenl plus regulier avant la negativation, tant
au cours de la penodc precedcnte de bactcriologie po
sitive, qu’au cours de la periodo caraclerisec par une
bactcriologie negative. A partir de la quaindme annee
a bactcriologie negative, el au cours des annecs suivantes, 1’abaissemcnl du taux de rccidivc n’elait associee qu’avec un traitement plus regulier au cours de
la periode negative. Les malades ayant poursuivi leur
traitement de manidre plus regulidre au cours de la
periode d bactcriologie positive, ne presentaient pas un
taux de recidive plus faible quo ceux qui avaicnl cu un
traitement moins regulier au cours de celte periode.
On discute ccttc observation que tend d montrer que
la regularite du traitement au cours de la periode de
bactcriologie positive semble n’avoir aucun effet sur
les taux de rccidives au-deld de la troisidme annee de
bactcriologie negative. Dans une region endemique pour
la Idprc, on peut defendre 1’hypothdsc qu’au-dela des
trois premieres annecs de bactcriologie negative chez
des malades LL ou BL, les sources de M. leprae extericures au malade peuvent etre davantagc responsablcs pour les rccidives que les bacillcs du malade luimcmc.
Acknowledgments. We thank all of the staff of the
Department of Epidemiology and Leprosy Control and
the Division of Laboratories, particularly Mr. J. Sam
uel. Mrs. Recny S. Charles typed the manuscript.
REFERENCES
1 Almeida, J. G., Chacko, C. J. G., Christian, M..
Taylor. P. M. and Fritsch i. E. P. DDS-resistant
infection among leprosy patients in the population
20
International Journal of Leprosy
of Gudiyatham Taluk, South India. Part 3. Prev
alence, incidence, risk factors, and interpretation
of mouse fool pad test results. Ini. J. Lepr. 51
(1983) 366-373.
2. Almeida, J. G., Christian, M. and Chacko, C.
J. G. Follow up of lepromatous (LL and BL) pa
tients on dapsone (DDS) monotherapy after at
tainment of smear negativity in Gudiyatham Ta
luk, South India. Im. J. Lepr. 51 (1983) 382-384.
3. Almeida, J. G., Joseph, P. S., Sarangapani, G.
and Chacko, C. J. G. The mouse foot pad test
sensitive to small proportions of drug-resistant ba
cilli in a sample of M. leprae. Indian J. Lepr. 56
(1984) 10-14.
4. Browne, S. G. Relapses in leprosy. Ini J. Lepr.
33 (1965) 273-279.
5. Chatterjee, B. R., Taylor, C. E., Thomas, J. and
Naidu, G. N. Acid-fast bacillary positivity in
asymptomatic individuals in leprosy endemic vil
lages around Jhalda in West Bengal. Lepr. India
48 (1976) 1 19-131.
6. Erickson, P. T. Relapse rates following apparent
arrest of leprosy. Int. J. Lepr. 19 (1951) 63-66.
7.
1986
Jopling, W. H., Ridley, M. J., Bonnici, E. and
Depasquale, G. A follow-up investigation of the
Malta Project. Lepr. Rev. 55 (1984) 247-253.
8. Lowe, J. The late results of sulphone treatment
of leprosy in E. Nigeria. Lepr. Rev. 25 (1954) 113124.
9. Noordeen, S. K. Relapse in lepromatous lep
rosy. Lepr. Rev. 42 (1971) 43-48.
10. Quagliato, R., Bechelli, L. M. and Marques,
R. M. Bacteriological negativity and reactivation
of lepromatous patients under sulphone treatment
Abstract in Int. J. Lepr. 36 (1968) 655.
11. Ramu, G. and Ramanujam, K. Relapses in bor
derline leprosy. Lepr. India 46 (1974) 21-25.
12. Rodriguez, J. N. Relapses after sulfone therapy
in leprosy of lepromatous type. Int. J. Lepr. 26
(1958) 305-312.
13. Touw-Langendijk, E. M. J. and Naafs. B. Re
lapses in leprosy after release from control. Lepr.
Rev. 50 (1979) 123-128.
14. WHO Study Group. Chemotherapy of leprosy
for control programmes. Who Tech. Rep. Ser. 675.
Geneva: World Health Organization, 1982.
International Journal oe Leprosy
Volume 54. Number 1
Printed in the U.S.A.
Spot Test for Detection of Dapsone in Urine:
An Assessment of Its Validity and Interpretation in
Monitoring Dapsone Self-administration1
Han Huikeshoven and Monina G. Madarang2
In 1965, de Castro, el al. (:) described a
simple spot test for the detection of dapsonc
in urine, employing filter paper impregnat
ed with a modified Ehrlich’s reagent. Spots
of urine on the impregnated paper show a
yellow ring at the periphery caused by urea
an inner spot of orange when the drug
resent. Noordeen and Balakrishnan (6)
reported the test to be reliably positive in
urine collected before 48 hours following
the administration of 10 to 75 mg of dap
sone to children. Ellard, el al. (3) could not
affirm this high degree of sensitivity. In their
hands, one day after giving single doses of
200 mg of dapsone to 34 patients only 23
(68%) urine samples were positive. Recent
ly. however, Irudaya Raj, el al. (5) reported
positive spot tests in the urine of 13 (59%)
out of 22 patients six days after a last daily
dose of 100 mg dapsone, while all urines
were positive one day after the last dose.
The present study aims to clarify the sen
sitivity and, hence, the validity and inter
pretation of this simple test for monitoring
dapsone self-administration.
treatment urine samples of the volunteers
to final concentrations of 1, 2, 3, 4, 5, 7.5,
10, 12.5, 15, and 20 /rg/ml, respectively, to
serve as internal standards. The specimens
were preserved by thimerosal in a final con
centration of 0.02%; they were coded and
randomized prior to testing.
Spot tests. The method of de Castro, et
al. (2) was employed with the following
modifications. Chemicals for the impreg
nation of the paper were dissolved com
pletely in 70% ethanol, thus giving brighter
spots than before when very little nacconol
was dissolved in absolute ethanol. The color
intensities of 50 m1 urine spots on the im
pregnated paper were compared with that
of a standard spot using acidified urine con
taining 5 Mg dapsone per ml (final HC1 con
centration = 0.1 N) both before and after
the addition of 50 pl drops of 1 N HC1 to
the spots. Portions of the urine specimens
were sent to Cebu City, Philippines, where
a second observer (MGM) repeated the tests.
Both observers repeated the tests once again
on duplicate portions of the specimens.
D:C ratios and T‘/z values. The dapsone:
MATERIALS AND METHODS
creatinine (D:C) ratios in urine specimens
^Krine samples. After giving their in- were determined as described by Ellard, et
fanned consent, 20 volunteers (15 men and al. (3). Individual values for the half-time
5 women) ingested four consecutive daily (T'Zz) of dapsone elimination were derived
doses of 100 mg dapsone. Urine samples from the linear regression of the logarithm
were collected at 9 a.m., immediately before of the D:C ratios in the first six urines ob
the dapsonc doses were taken, and at the tained after the last dapsonc intake with de
same hour on each of ten days following the duction of the blank “D:C ratio” found in
last dapsone intake; the urine used was nev the pretreatment urine sample of each vol
er the first morning specimen. Dapsone was unteer.
added to pairs of randomly selected, pre-
«
■ Received for publication on 6 February 1985; ac
cepted for publication in revised form on 5 August
1985.
-’ll Huikeshoven, Ph.D,, Research Officer. Royal
Tropical Institute, 1092 AD Amsterdam. The Neth
erlands. M. G. Madarang. M.T. (ASCP). B.S. (Pharm ),
M B.A . Chief. Technical Services, Leonard Wood Me
morial Center for Leprosy Research. Cebu City, The
Philippines.
RESULTS
Results obtained with the 20 internal
standards indicate that generally assess
ments were correct. However, in standards
containing dapsonc concentrations of (or
near) the reference value of 5 pg/ml, the first
observer was more inclined to positive as
sessments than the second observer. Table
21
DISCUSSION ON DAPSONE MONOTHERAPY
There is no reason to delay or avoid the declaration of “Cure” for
these patients.
(4) The impact of dapsone therapy on transmission judged by
the case detection rate is slow. For the last 20 years, this rate remains
between 1 and 2% per year but shows a definite decline.
These facts on dapsone therapy are just reminded because Centres
or Institutions who can not assure a good level of treatment, df supervi
sion and follow up could continue to use Dapsone alone except in cases
clinically suspect of dapsone resistance. There is a fresh danger in using
Rifampicin and Clofazimine in an indiscriminate manner.
EFFICACY OF DAPSONE MONOTHFRAPY IN NON-LEPROMATOUS
LEPROSY: K. Jesudasan, D. Bradley, M. Christian
1,701 non-lepromatous patients treated with dapsone monotherapy
for at least four and a half years and released from control, were followed
up and examined, for evidence of relapse. They contributed a total of
5,254 person years of risk, there were 51 relapses (3%), giving an overall
relapse rate 9.7 per 1000 person years of risk. This paper examined the
effect of various factors, on the risk of relapses, such as age, sex and
classification of the disease; duration and regularity of treatment; percent
age of attendance; deformity grade; number of patches and lepromin
status. Some of the factors studied such as age, sex classification, percent
age of attendance and the number of patches in association with the
lepromin status were found to significantly influence the risk of relapse
in these patients. Therapy in non-lepromatous leprosy was discussed in
the light of these findings.
Resume of Discussions
P.N. Neelan (to K. Jesudasan): (a) Regarding the ten cases of relapse with
bacteriopositivity, were attempts made to identify drug-resistant organisms by the
mouse foot pad test in these ? (b) Did the lepromin reaction change in these cases at
the time of relapse?
K. Jesudasan : (a) No attempt was made to identify drug resistant organisms by
the mouse foot pad test in the ten cases of bacteriologically positive relapses. But all
of them have responded well to dapsone monotherapy, (b) There was no evidence
of change in lepromin status at the time of relapse.
P.D. Samson :
in your study ?
Did different doses of Dapsone have any relation to relapse rate
K. Jesudasan : There was no evidence that different dosage or of treatment had
anything to do with.
Vol. 56
No. 2 (Suppl)
Indian journal of leprosy
Apr-Jun 1984
DISCUSSION ON ‘EVALUATION OF DAPSONE MONOTHERAPY
IN THE FIELD”
Date : Friday, the 18th
November 1983
Leader
Rapporteur
Participants
P
Time : 4.15 P.M. to
5.00 PM.
Dr. C.J.G. Chacko
Dr. G.Y. Joshi
Dr. J.G. Almeida
Dr. C. Vellut
Dr. K. Jesudasan
Dr. A. Thomas
Shri S.S. Naik
Dr. P.N. Neelan
ABSTRACTS AND RESUME OF DISCUSSIONS
C.J.G. Chacko : I am honoured to be asked to organise this sympo
sium on “Evaluation of Dapsone Monotherapy in the Field”. Data from
five well known leprosy control programmes in India known for their high
quality of work and maintenance of good records will be presented at
this Symposium.
Some of you may wonder as to why should this topic be discussed
at the present juncture when new regimens are being tried out in different
parts of the country. Evaluation is a well recognised principle in manage
ment and we should analyse the data from well known control programmes
to see what has been achieved and this will form the baseline data against
wh ch results of the newer drug regimens can be compared;
EVALUATION
OF DAPSONE
MONOTHERAPY FOR LEPROMATOUS
LEPROSY IN GUDIYATHAM TALUK : J.G. ALMEIDA, C.J.G. CHACKO
The paper reports results upto 1981, obtained in Gudiyatham Taluk,
the leprosy control area of the Schitffelin Leprosy Research and Training
Centre, Karigiri. Some relevant features of the leprosy control programme
frcm 1963 have been : house-to-house surveys in the entire population of
about 450000, health education, and careful maintenance of individual
patient records. DDS (dapsone) monotherapy was used during the period
under review. Smear negative patients continued on DDS.
1423 LL (lepromatous) and BL (borderline lepromatous) patients
were studied. 90.9% had attained smear negative status (Figure 1). Smear
negativity was found to be an important prognostic sign. Firstly, the
454
“B-B
DISCUSSION ON DAPSONE MONOTHERAPY
risk that M. leprae would reappear in skin smears decreased progressively
after the attainment of smear negativity. During- the.finitial two years of
smear negativity, M. leprae reappeared in 2.8% of patients per year. In
contrast, from the ninth year of smear negativity onwards, M. leprae
reappeared in only 0.9% of patients per year. 77.7% of the 1423 patients
had been smear negative for 3 or more years, and from the third year of
smear negativity, M. leprae reappeared in 1.1% of patients per year.
Oopsone monotherapy of LL/8L patients in Gudiyatham Taluk
(SLR & TC.Karigiri 1981) --i,
Fig. 1. Dapsone monotherapy of LL/BL patients in Gudiyatham Taluk.
W
'
'-.'I? ■
'
'
Secondly, smear negativity was found to indicate a significantly
reduced risk of the subsequent appearance of DDS-resistant infection. A
continuing increase in the number pf M. leprae in successive annual skin
smears despite DDS treatment was taken to indicate- DDS-resistant infec
tion. 1224 LL and BL patients who were not absentees were studied for
DDS-resistant infection. 93.8%ipf:the 1224 . patients had attained smear
negative status. The prevalence of DDS-resistant infection among the
1000 patients who had at some point in treatment been smear negative
" for 3 years or more was only .T.2%. In contrast, the prevalence among
the 76 patients who remained continuously smear positive was significantly
higher, 23.7% (Figure 2);
• p.
455
Vol. 56
No. 2 (Suppl)
INDIAN JOURNAL OF LEPROSY
Apr-Jun 1984
Duration of smear negativity among LL-BL patients :
Prevalence of DPS-resistant Infection
(Gudiyatham Taluk DDS-resistance survey ;
Schleffelln Leprosy Research & Training Centre, Karigirl.)
> 3 yrs I <3 yrs (Positive I Combined
Fig. 2.
Duration of smear negativity among LL-BL patients : prevalence
of DDS-resistant infection.
Smear negativity, an important prognostic, sign, was found among
the vast majority of LL and BL patients treated with DDS monotherapy
in Gudiyatham Taluk.
A search was also made for evidence that treated LL and BL patients
with DDS-resistant infection were infecting others with DDS-resistant
M. leprae. M leprae with “low grade resistance” (to small but not large
doses of DDS) were much less common than M. leprae with “high grade
resistance”, among treated patients. Newly diagnosed patients infected
by those with DDS-resistant infection should show a failure of response
to DDS-monotherapy. Not a single one of the several hundred newly
diagnosed LL and BL patients seen over the years in Gudiyatham Taluk
showed such failure of response at the start of treatment.
Secondly, as the prevalence of DDS-resistant infection among
treated patients increased each year, the proportion of newly diagnosed
patietts infected with DDS-resistant M. leprae should correspondingly have
increased. Patients starting treatment relatively long ago should show a
better response to DDS-monotherapy than those starting more recently.
The observation, on the contrary, is that 148 LL and BL patients
registered in the years 1971 to 1973 responded as well to DDS-monothe456
DISCUSSION ON DAPSONE MONOTHERAPY
rapy as 391 patients registered in 1964 to 1966. In fact, at the 5th, 6th
and 7th years after the start of treatment, a significantly higher proportion
of smear negative patients was found among those registered in f971 to
1973 (Figure 3). Interestingly, only 15.1% of those starting in 1964-66
had an initial BI of 3+ or more, whereas 46.9% of those starting in
1971-73 did so.
Period ot treatment (years)
Fig. 3.
Attainment . of smear negativity among 2 groups
of LL/BL patients or. DBS monotherapy.
This evidence does not support the hypothesis that treated patients
with DDS-resistant infection commonly transmit DDS-resistant infection
to others.
.jj
The status of all 58 surviving patients with lepromatous leprosy on
DDS-monotherapy for 20 years or more was examined. 51 of 58 (88%)
could be pronounced “smear negative” and “clinically inactive”.
457
'ol. 56
No. 2 (Suppl)
INDIAN JOURNAL OF LEPROSY
Apr-Jun 1984
In summary :
(1)
DDS monotherapy renders over 90% of LL and BL patients
srnear negative.
(2)
Smear negative patients have a reduced risk of developing
DDS-resistant infection.
(3)
The evidence available does not support the hypothesis that
treated patients with DDS-resistant infection commonly trans
mit DDS-resistant infection to others.
(4)
After 20 years or more of DDS monotherapy, 51 of 58 survi
ving patients with lepromatous leprosy are “smear negative" and
“inactive".
Resume of Discussions
J. Prakash and N.K. Jain : How can we rely on Dapsone monotherapy when
we do not know the actual blood level of Dapsonc required for its bacteriostatic
action?
J.G. Almeida : I think we do know the blood level of dapsone required for its
bacteriostatic action. I can’t remember the exact figure, but I'm sure that the infor
mation is available in the literature.
G. Ramu : Primary Dapsonc resistance has been shown as 35% in Chingleput
and 51% in Ethiopia. Have you any observation to make ?
J.G. Almeida : The figures of 35% and 51% refers, I think to DDS resistant
\f. leprae delected in the mouse lest. This is not the same as a failure to response to
DDS monotherapy in the patient.
:e FACTS ABOUT 25
•
YEARS
AMBAKKAM : C. Vellut
of dapsone
monotherapy at
This is not a study but a reminder about results of dapsone
monotherapy.
(I) Out of 937 lepromatous patients treated for 25 years 228
cases (25%) were regular for tieatment. 97.8% cases were and remained
negative for AFB in skin smears.
(2) Dapsone treatment shows slow results. It takes 4 years to make
50% of the I-T-BT group to become inactive and 7 years to make 50%
of the lepromatous become inactive.
(3) The relapses in the non-lepromatous and borderline group
ire rare ±4 to 5%,year (without relation to the time of observation).
158
DIS
£c/>r 7?et> (1983) 54, 185-191
jU).
’i
Studies on dapsone-resistant Mycobacterium
leprae in leprosy patients of Gudiyatham
Taluk, the leprosy control area of the
Schieffelin Leprosy Research and Training
Centre, Karigiri. 2. A progress report
J G ALMEIDA, M CHRISTIAN, C J G CHACKO,
P M TAYLOR & E P FRITSCHI
Schieffelin Leprosy Research and Training Centre. Kangiri632 106, South India
Summary The 1580 LL and BL leprosy patients in a community of 480,000
persons in South India were studied for the occurrence of dapsone-resistant
Mycobacterium leprae, between March 1978 and February 1981 Patients with a
BI >2 + were biopsied for mouse inoculation, even if they were improving on
dapsone monotherapy. Between 89 and 116 patients per 1000 patients screened
were estimated to harbour dapsone-resistant M leprae.
Taluk of North Arcot District in Tamil Nadu, the leprosy control
itairftte Schieffelin Leprosy Research and Training Centre, covers an area of
tonwately 1320 sq km with a population of 480,000 (1981 Census). The
hyperendemic for leprosy, and in December 1977, 6880 patients were on
Sjannent register at 44 peripheral clinics within the control area. Dapsone
■Zmterapv has been extensively used in this area since 1963. and fairly accurate
jjpnfcafpatients have been maintained systematically throughout this period.
^objectives of the study were: 1, to determine the number of registered
who harbour dapsone-resistant Mycobacterium leprae', and 2. to identify
jjs associated with the occurrence of dapsone-resistant M. leprae.
B
and methods
B?
/^BSninator chosen for the study was all LL and BL cases on the treatment
186
J G Almeida et al.
Dapsone-resistant M. leprae
this institution at the end of December 1977, who resided within the control area.
Every patient in the denominator was clinically examined by a medical officer,
and skin smears were taken from 4 routine sites as well as from other sites at which
there w'as evidence of activity.
Patients with a BI >2+ at any one site were biopsied, preferably from the site
with the highest index (avoiding the face). In order not to underestimate the
number of patients harbouring dapsone-resistant M. leprae, biopsy was per
formed on all patients with a BI > 2 +. and not only on those showing evidence of
active disease, as in the studies reported to date.1'13 It must be emphasized that
those biopsied included patients improving on dapsone monotherapy, who
would not ordinarily be suspected of harbouring dapsone-resistant M. leprae.
Biopsies were usually taken in the field and transferred to the base laboratory on
wet ice for mouse foot-pad studies, which were performed by methods already
described.14-15
The patients whose M. leprae failed to grow even in untreated mice, and those
in whom the test did not detect resistant M. leprae, were rescreened and biopsied
again if eligible.
Results and interpretation
All 1580 registered LL and BL patients residing within the area were enumerated
in December 1977. The screening began in March 1978, and the activities
undertaken during the next 3 years are summarized in Table 1. Of the total, 1431
patients were screened in the first year, forming a cohort that was subjected to
annual screening, and biopsied when eligible.
In the first year 149 patients evaded screening. A 10% random sample of these
patients were subsequently screened, and none was found eligible for biopsy. The
Table 1. Numbers of patients screened annually
149 patients were therefore not included in any subsequent procedures or
analysis.
As shown in Table 2, 9 patients among the 1431 screened had been shown
earlier by mouse inoculation to harbour dapsone-resistant M. leprae. Table 2 also
shows the number of patients found eligible for biopsy (Bl >2+) during each
year of the study, and the number of patients subjected to biopsy. The large
proportion of biopsies done during the third year of survey did not reflect an
increase in the number of patients attaining eligibility for biopsy during that year,
but resulted from an improved operational capacity for handling biopsy
specimens. A total of 188 patients were found eligible for biopsy, of whom 142
have thus far been subjected to the procedure.
The results of biopsy and mouse inoculation are presented in Table 3. Of the
188 patients eligible, 46 escaped biopsy for a variety of reasons. Of the 142 mouse
foot-pad studies carried out, the results of 17 are still not available. In 26 studies
rhe inoculated M. leprae failed to multiply in both control and dapsone-treated
mice. Dapsone-resistant M. leprae were detected in 89 studies. The resistant M.
leprae in 81 of these studies manifested resistance to the highest concentration of
dapsone used (0-01 g%). 10 studies did not detect any dapsone-resistant M. leprae.
It is of great interest to note that an eleventh study, which on one occasion did not
detect dapsone-resistant M. leprae, was repealed on the same patient after a
period of 12 months. On the second occasion, dapsone-resistant M. leprae were
detected, that manifested resistance to the highest concentration of dapsone used.
Thus, of the 188 patients eligible for biopsy and mouse inoculation, the results
of mouse foot-pad studies have so far been obtained for only 99. Because 89
patients for whom no results are available comprise so large a fraction of the total.
it is necessary to make some assumptions regarding them, in order to estimate the
number of patients harbouring dapsone-resistant M. leprae. It appears reason
able to assume that among the 46 patients not subjected to biopsy and the 17 for
Table 2. Numbers of patients with positive smears and numbers biopsied annually
Year of survey
Year of survey
1978-79 1979-80 1980-81
Enumerated
Migrated or died during the
previous year
Resistant bacilli demonstrated
in previous year
Eligible for screening
Acutally screened
1580
1431
1320
—
56
48
—
1580
1431
(90-6%)
33
1342
1320
(98 4%)
27
1245
1208
(971%)
187
No. of patients
Pre-1978
*
1978-79
Smear positive
BI>2 +
BI ^2 +with clinical relapse
Biopsied for mouse inoculation
—
9
9
9
336
114
46
26
1979-80 1980-81
330
86
49
28
179
82
34
80
Cumulative!
—
188
87
142
* 9 patients among the 1431 screened had already been shown by mouse inoculation
to harbour dapsone-resistant M. leprae.
t A patient who appears to more than I year is counted only once in the cumulative
total.
188
Dapsone-resistant M. leprae
J G Almeida et al.
189
Table 4- Estimation of total number of patients harbouring dapsone-resislant M.
Table 3. Results of biopsies and mouse inoculation
leprae
Number of specimens
Number of patients
Year of survey
Successive
smears show
increasing BI
Pre-1978 1978-79 1979-80 1980-81
Biopsied
No growth of Af. leprae
No DDS-resistant A/. leprae detected
DDS-resistant M. leprae detected
Resistant to DDS. at mouse
diet concentration of:
00001 g°0
0-001 g°/0
0-01 g%
Study in progress
9
—
—
9
26
—
2*
24
28
—
1
27
80
26
8
29
—
—
9
—
—
2
22
—
—
2
25
—
1
3
25
17
»
'■3
n
n
5
* One of these patients was later biopsied again and shown at that time to iar
resistant organisms; he is included only once in the cumulative totals.
whom results are awaited, the proportion who harbour dapsone-resaamt |J} '
leprae is the same as among those for whom results are available. The26pKSm» '
whose organisms failed to multiply in control mice are problematic, hoawfttj;
could be argued that these patients harbour no dapsone-resistant A/. 4^.
because such a large proportion of the organisms from these patients
killed during dapsone treatment that no organisms grew even in untreated
However, it is possible that viable dapsone-resistant M. leprae were
'although the inoculum contained too few to produce growth in the mni
.'
*
foot-pad. To allow for this uncertainty, a separate estimate of the total nuaAe<’i
patients harbouring dapsone-resistant M. leprae has been made for each::
alternative possibilities.
SSmB
It has already been pointed out that some patients who showed impre»«ia<;
on dapsone monotherapy were biopsied only because they had a BI^2~:ia^ 7
patients would not ordinarily have been suspected of harbouring dapsoacMns
*y
‘
tant M. leprae. They differ markedly from the rest of the patients biojMjaj^-c
showing a decrease in BI in successive smears at the time of biopsy. UseJ^significance of this difference is more fully understood, it appears importa#^+
maintain the distinction between this group of patients and the rest. Tbasjfe^.-i
the 188 patients eligible for biopsy have been divided in 2 groups: 142 whortiw^ ;;
an increase in BI in successive smears at the time of biopsy; and 46 whosl»»a£
*
:
decrease in BI.
•
Table 4 shows the estimation of the total numbers of patients harhtaa^i
142
Eligible for biopsy
27
No results available*
22
No growth of M. leprae
84
Resistant M. leprae detected
9
No resistant M. leprae detected
Predicted additional number
with resistant M. leprae:
——---- x27 = 20
(93 + 22)
alternative no. It
84
— x 49 = 44
alternative no. 2J
93
Total number with resistant
.If. leprae:
alternative no. 1
alternative no. 2
84 + 20=104
84 + 44= 128
Successive
smears show
decreasing BI
Total
46
36
4
5
1
188
63
26
89
10
(6 + 4)
38
- x 40 = 33
6
77
5+18 = 23
5 + 33 = 38
127
166
• Includes patients not biopsied. and those whose results are pending.
t M. leprae that failed to grow in mice assumed not resistant.
J M. leprae that failed to grow in mice assumed susceptible and resistant in
same proportions as those that multiplied in mice.
.^cos-resistant M. leprae in each of the 2 groups. The assumption has been
none of the 26 patients whose M. leprae failed to multiply in mice
altars dapsone-resistant organisms, whereas, among the remaining 63
i«lisais for whom no results are available, the proportion who harbour resistant
.^tuans is the same as among the 99 patients for whom results are available.
•folk these assumptions, a total of 104 patients from the first group and 23
■;|Ulint!s from the second group, altogether 127 patients, were estimated to
Sjcor dapsone-resistant M. leprae.
P&tead, if among the 26 patients whose M. leprae failed to grow in control
the proportion who harbour resistant bacilli is considered to be the same as
:i*»jjoportion among the 99 patients whose results are available, then, by similar
alalions, an alternative estimate is obtained. According to this alternative
SBjte, 128 patients from the first group and 38 patients from the second group.
Hjether 166 patients, were estimated to harbour dapsone-resistant M. leprae.
fie number of registered LL and BL patients residing in Gudiyatham Taluk.
190
J G Almeida et al.
Dapsone-resistant M. leprae
191
who harbour dapsone-resistant M. leprae, is therefore estimated lotat
i: C.-ni'-liH g«»|UW. Ridley DS. Studies on sulfone resistance in leprosy. I. Detection of cases.
127 and 166 patients, of a total of 1431 patients screened annuaUi.
1
19661 341375'90'
. .
KWH. Rees RJW. Walers MFR. Sulphone resistance in leprosy—a review of one
these figures as fractions, between 89 and 116 per 1000 patienu Kp»nzei'
c,'nicai cascs Lu"cci-i975;69 72
estimated to harbour dapsone-resistant M. leprae. It appears
3
s’
•’■Jmuiiis'i SB. Desikan KV. Sulphone resistance tn leprosy: a report of three cases, l.epr
assume that the true figure must fall somewhere between these twoatiinkHfc i
SR- Sulphone resistance in Hansen's disease. J Christian Med Assoc India. 1974: 49:
S'- hairt B
*
CC, Gordon GR. Rojas AV. Elizondo DS. The incidence of DDS resistance
H ^.’i^rcn>u;:aus patients in Costa Rica: their metabolic disposition of DDS. Ini ./ Lcpr. 1976;
Discussion
As reported earlier,15 the crude estimate of the prevalence of dapfctUMt^t
g<
Jltyf CtrackoCJG. Job CK. Study of sulphone resistance in leprosy patients m India. Lepr
leprosy in Gudiyatham Taluk after the first year of this study
'& ■ jfcLlinfc^TrS-l1.aifMH Ross WF. Rees RJW. DDS-resislance in Ethiopia—a progress report Ini J l.epr.
This may be explained partly by our earlier inability to test in tnioe shr-M
I M
of all the patients eligible for biopsy during a given year, and puth ft-.,
>
>/..
', ggbtn GS. Sheskin J. The prevalence of dapsone-resistant leprosy in Israel. Lcpr Rcr.
that biopsy during the first year was done only on patier.y. wan,
V
48e EO7-12deteriorating, by smear and clinical criteria.
38
ihlVH Cap JA Haile GS. Dapsone-resistant leprosy and ns implications lor control
ri
The unexpected finding that patients who were improving wi
i
i977:48:83-94Haile GS. Barnetson RSlC. Rees RJW. Dapsone-resistant leprosy in Ethiopia.
monotherapy were also shown by the mouse foot-pad test to hartwwiit^,
1979; 50: 183-99.
resistant M. leprae raises problems of interpretation. It would appcwjsren^^, j
|jaganath C. Garg BR. Paneerselvam R. Secondary sulphone resistance in
to make a decision on this until a detailed analysis of our data can be«itm&ta£ i
of a case. Lepr India. 1980; 52 (2): 299-301.
Analysis of risk factors has also been deferred. However, carefdraamft:,^
lfe.'.^it»n,G Ferracci C, Saint Andre R. Patlyn SR. Dapsone-resistant leprosy in a population
“i'. ^Jwiu.'iolMali). Lepr Rev. 1980; 51: 315-19.
been kept of the treatment and progress of all the patients screened,
it'’*' Drug resistance of M. leprae—particularly to DDS. Ini J Lepr. 1967: 35: 625.
date of diagnosis. An analysis of the prevalence of dapsone resewaast.io^J
fcsodasan K. Chacko CJG. Christian M. Taylor PM. Fritschi EP. JobCK. Prevalence
causation and consequences in the individual and in the comxanafc,
dapsonc resistance in Gudiyatham Taluk, the leprosy control area of the
undertaken in subsequent publications.
<
1
aW
Acknowledgements
'
We wish to thank Mr Samuel Joseph and Mr G Sarangapani forexzwga^^B
assistance; Mr J Samuel for help in the field work; Mr N
secretarial services; and all the staff of SLR & TC, Karigiri.
Department of Epidemiology and Leprosy Control, without whaje-^the study could not have succeeded.
This investigation received support from the Chemotherapy
(TH ELEP) component of the UNDP/World Bank/WHO Special Pftj
Research and Training in Tropical Diseases.
References
> Pettit JHS. Rees RJW. Sulphone resistance in leprosy: an experiment,I
Lancet, 1964; ii, 673-4.
|v'.
Leprosy Research and Training Centre. Karigiri. I Preliminary report, hit J Lcpr.
397-401.
114
International Journal of Leprosy
1985
munosiimulant therapy with Icvamisole for rheu
5. Tripodi, D., Parks, L. C. and Brugmans, J.
matoid arthritis. Lancet 1 (1976) 393-395.
induced restoration of cutaneous delayed hypejj^
*
2. Meyers, W. M., Kvernes, S. and Staple, E. M.
sitivity in anergic patients with cancer. N. Em] i
Med. 289 (1973) 354-357.
Failure of levamisole to alter the lepromin reaction.
6. Turk, J. L. and Waters, M. F. R. Immunologfc^
Am. J. Trop. Med. Hyg. 24 (1975) 857-859.
3. Ramu, G. and Sengupta, U. Preliminary Inal of
basis for depression of cellular immunity and
intervention. Levamisole therapy in persistently
delayed allergic response in patients with lepi^,
bactenologically positive lepromatous leprosy. Lepr.
matous leprosy. Lancet 2 (1968) 436-438.
India 55 (1983) 64-67.
7. Yagnik, C. S., Jogaikar, D. G. and Mehta, j.U
4. Sher, R., Wadee, A. A., Joffe, M., Kok, S. H.,
Effect of levamisole on clinical outcome and DNCfi
Imkamp, F. M. J. H. and Simson, I W. The in vivo
conversion in leprosy patients. Lepr. India 55 (19gji
and in vitro effects of Icvamisole in patients with
68-70.
lepromatous leprosy. Int. J Lepr. 49 (1981) 159—
166.
Persistence of Langhans’ Giant Cells in Rapidly
Downgrading Leprosy Lesions
To the Editor:
Inflammatory giant cell formation occurs
in many diseases and is usually associated
with granulomatous infiltration. Langhans’
giant cells are a feature of the histopatho
logical cell types found in lesions of tuber
culoid and, to a lesser extent, borderline
tuberculoid leprosy. They are not a feature
in mid-borderline or lepromatous leprosy.
Cell-mediated immunity in borderline
leprosy is unstable and, in a review of the
outcome of reactions in 12 patients, it was
shown that Langhans’ giant cells were pro
duced and persisted following upgrading re
versal reactions but were not conspicuous
in downgrading reactions (').
We have recently observed Langhans’
giant cells in the histopathology of rapidly
downgrading leprosy.
Case A presented one month after the
emergence of hypopigmented macules on
his thigh and upper arm. A biopsy showed
mid-borderline leprosy. Six weeks later he
returned with an increase in the number of
lesions, some of which were slightly ery
thematous. A biopsy of the left radial cu
taneous nerve showed a cellular infiltration
containing a few epithelioid cells, foamy
macrophages, lymphocytes, and Langhans’
giant cells. Acid-fast bacilli were also seen.
With the exception of the Langhans’ giant
cells, the histological picture was that of
borderline lepromatous leprosy (The Fig
ure).
Case 13 was seen four months after the
appearance of multiple hypopigmented lesions with poorly defined edges. The lesions
had rapidly increased in number; some were
marginally elevated but all had near normal
sensation. Histopathology showed border-
The Figure. Langhans’ giant cell in an othcr»v
borderline lepromatous histological field from Case*1
Correspondence
115
line lepromatous to subpolar lepromatous similar histopathology who were also con
leprosy with acid-fast bacilli. Langhans’ sidered as downgrading.
The presence of Langhans’ giant cells in
■ i.ant cells were also present.
b Case C was a patient who had been seen rapidly downgrading leprosy suggests that
three times over a period of ten months. On either these cells arc capable of remarkable
her first presentation, she had typical hy- longevity or that the factors stimulating their
popigmented anesthetic lesions of border formation remain present despite a dimi
line .uberculoid leprosy. She was seen again nution of cell-mediated immunity. Their
i'olll r >nths later. During this period she persistance, together with the cellular types
had not taken her treatment, and the lesions expected at the lepromatous end of the spec
were more inflamed and obvious nerve in trum, may be a useful histopathological sign
volvement was present. A biopsy showed of rapidly downgrading leprosy.
borderline tuberculoid leprosy in reversal
— N. F. Lyons, M.Phil.
reaction. She was subsequently seen six
— B. P. B. Ellis
months later. The disease had progressed
University
of
Zimbabwe
ai^the lesions, which were more plconWphic, were clinically borderline lepro- Godfrey Huggins School of
Medicine
nia .’i A biopsy confirmed this diagnosis
— B. Naafs, M.D., D.Sc.
but. m addition to the expected histological
appearance, Langhans’ giant cells were also Ministry of Health
Harare, Zimbabwe
The histopathology and the history in
REFERENCE
these three patients were quite similar, and
all had borderline lepromatous or subpolar
Ridley, D. S. and Radix, K. B. The histological
course of reactions in borderline leprosy and their
lepromatous leprosy. In addition, all had
outcome. Int. J. Lcpr. 49 (1981) 383-392.
rapidly downgraded. Since these observa
tion-,. - c have seen two other patients with
DDS-resistant Leprosy
To the Editor:
With reference to the paper by Almeida,
i't^± on "DDS-resistant Infection Among
^Lsy Patients . . .” appearing in the Sep
I.
tember 1983 issue of the Journal (pp. 366373). the following comments are offered:
Firstly, exclusion of 149 “not screened
cases.” 198 “absentees,” and cases with less
Ilian 80% treatment from analysis intro
duces a bias in estimation. Taking overall
ire.!'." .-nt regularity as criteria for compar
ts
>es not appear to be correct since it
does not discriminate the treatment rega
lari t y in the crucial initial period of treat
nient in a patient.
in their paper, "prevalence” is worked
nut as a percentage of the total number of
cases "fully studied” over an unspecified
period of time: whereas "incidence" is cxp:
: as the average annual percentage of
t“
rson-years of treatment experience.
It is like cutting the cake to suit the needs
of the situation. If we cut a lamb into a
certain number of pieces, we do not get that
number of lambkins, only lamb chops con
sidered to be a culinary delicacy. Use of
person-years to work out rates in Tables 2
and 3 seems unnecessary' and makes it dif
ficult to apply statistical tests for compari
son, in the way they arc presented. “Prev
alence” and “incidence” figures are projected
in many papers on studies on DDS-rcsistancc. Can someone elucidate the appro
priate methodology for a study to find out
prevalence and especially incidence rates of
DDS resistance? We are in total disagree
ment with the interpretation of the findings
in Table 3. Cases with less than 50% treat
ment as well as those with 50-79% treat
ment should have been included. If, after
their inclusion, the results were found to be
similar to what is projected in the table, the
1 16
International Journal of Leprosy
198j
one way it could be interpreted is that in
With reference to Almeida, el al “Rt
cases on low initial doses of DDS, the oc sponse to Dapsonc (DDS) ... 196(0
currence of DDS-resistant infection seems 1970s”:
The statement in their discussion:
to be postponed or delayed; it appears to be
quicker in cases on higher initial doses.
“although negative findings cannot be useg
In their discussion, the following state to disprove hypotheses, these data do ne)
ments are made which invite comments:
support the claim that DDS-resistant infer,
a) “attainment of smear negativity ap tions have been increasing in frequency since
pears to be a favorable prognostic sign, in- the introduction of DDS monotherapy”:^
dicatinga significantly reduced risk ofDDS- grossly misleading and irrelevant to the
resistant infection” —Risk of DDS-resistant findings presented in the paper. Wegotshn,.
infection cannot be assessed by comparing ilar findings on the analysis of data on cases
the “prevalence” figures given earlier.
treated in the 1960s and 1970s in ouf&g
b) “Patients deteriorating on DDS treat area at C.L.T. & R.I. which are being
ment are likely to harbor a greater propor fished in another journal. These findings Only
tion of DDS-resistant Mycobacterium lep show that the overall level of efficacy ofDDS
rae than those improving on DDS in the treatment of leprosy in either period
treatment”—This is not supported by any was not very high, and this might stillIk
finding presented in the paper. It could be reduced if the relapses among them areijj.
stated the other way also. Carryingout more eluded in the computation. However, the
frequent serial harvests using more animals efficacy does not appear to have diminish^
in each MFP experiment, to find out how over the years. This finding only support!
soon DDS-resistant infection is identified the case for inclusion of DDS in the muf.
in patients and also noting the multiplica tidrug regimens recommended and accepttion factor in such positive test harvests, ed for treatment of leprosy in the presiffl
may perhaps give an indication of the rel context.
'-'W'
ative proportions of resistant and sensitive
With reference to Almeida, et al. “ResvhiS
organisms in such patients.
of Long-term Domiciliary DDS Monoc) “the demonstration of DDS-resistant therapy for Lepromatous Leprosy ..
M. leprae by the mouse test (Ref) should
The use of surviving LL cases only in ftt
not be regarded as synonymous with failure analysis in this paper introduces bias ani
of response to DDS monotherapy” —It de hence limits the value of the findings.^
pends on what one accepts as response to better method would be cohort analysis.,!!
treatment. This statement could be coun is known that mortality is higher amof.«
tered by stating that the (apparent) response lepromatous cases who do not respond W
to DDS monotherapy should not be regard treatment and worsen clinically.
ed as insurance against subsequent devel
-P. N. Neelan, D.P.H., M.P.K
opment of DDS-resistant disease on con
— B. N. Reddy, D.P.H.,M &
tinued DDS monotherapy, using the same
Central
Leprosy
Teaching
argument put forth by the authors in the
and Research Institute
first part of the paragraph on page 371.
Chingleput 603001, India
The criteria for growth in mouse experi
ments in their study do not seem to conform
to the accepted standards established by the
WHO Workshop held in 1979.
Response to Drs. Neelan and Reddy
To the Editor:
We welcome this letter with its painstaking critical approach. All the points raised
can be answered.
We staiccj fully in our paper why the el
elusion” of some patients probably did®®
alter the findings. We repeat the most
**
portant points.
Correspondence
117
Ol the patients enumerated 77.5% were ularity of treatment and, within a regularity
ijillv studied. Of the remainder, 149 who “slab,” to compare various initial dosages.
had earlier escaped screening were not ig This ensured that any differences found were
nored but were pursued in 1981; 122 were not due to differing regularity of treatment.
screened, and the prevalence of DDS-resis- We would also want to consider tests for the
|;int infection among them was no higher statistical significance of differences before
than among the fully studied patients. The making declarations like the one suggested
I os absentees” were excluded from both by the correspondents, about initial dosage
the numerator and denominator of the es of DDS and DDS resistance.
In our discussion, the inference that “at
timates because methods had not yet been
developed to distinguish between relapses tainment of smear negativity in a patient
due to a simple lack of treatment and those appears to be a favorable prognostic sign
due to drug resistance. The “drug-resistant indicating a significantly reduced risk of
proportion test” using the mouse foot pad DDS-resistant infection” seems inescap
has been described only recently ('), and will able. The prevalence of DDS-resistant in
□ v<^ the former problems of interpreting fection among the group of 76 patients who
•
c footpad drug resistance” (2). More never attained smear negativity was 12.4
over "c found no association between reg- times that among the group of 1148 who
ulaniv of treatment and incidence of drug did attain smear negativity. Only if the group
resistance. The wisdom of our approach has that remained smear positive had been
subsequently been confirmed by the find treated on the average 12.4 times longer than
ings of Wamdorff-van Diepen, et al. (4), who the smear negative group, would the risk of
showed that reliance on mouse foot pad test DDS-resistant infection be equal in the two
irsults leads to inflated estimates of drug groups. On the contrary, we found that the
resistance. The third group of patients said 76 patients had a shorter average duration
io base been excluded, those with a treat of treatment than the rest. Since our point
ment regularity of less than 80%, were in was already made beyond reasonable doubt
fact included among the 1224 patients fully by the figures for prevalence, this supporting
finding was judged superfluous.
studied.
1 reatment regularity in the initial period
We have investigated, with some success,
is claimed to be crucial to drug resistance. the problem of obtaining quantitative rath
So reference or evidence is offered for this er than merely qualitative results from the
hspothesis. Until this claim is substantiat mouse foot pad test for drug-resistant My
ed treatment regularity following the “ini cobacterium leprae. We have demonstrated
tial pci md” must be considered equally cru- that the mouse test can classify strains with
i nil
only 1 in 1000 drug-resistant M. leprae as
Hoarding the prevalence, contrary to the drug resistant. Further, we have described
alORion we stated clearly the period con the “drug-resistant proportion test” to
joined was 31 December 1977 to 28 Feb- quantify the proportion of M. leprae in a
ruars 1981. The use of person-years to work sample that are resistant to a drug. The cor
"ul rates in Tables 2 and 3 was considered respondents’ speculation on “multiplica
<>> us to be quite necessary, to allow for tion factor” in positive harvests is not likely
tumlardization by duration of treatment. to be useful; no accurate estimate of the
I he dill.cully said to be experienced by them number of viable M. leprae inoculated can
m apt- m; statistical tests for comparison be made at the time of inoculation, and the
n. : shared by us. Many parametric as final plateau of growth is not known to be
•rll as nonparametric techniques are ap different for drug-resistant M. /eprae or drug
propriate to the data presented.
sensitive M. leprae.
We arc in total disagreement with their
The third part of their response to our
ratesimn regarding Table 3, that cases with discussion has been rendered an academic
'littering regularity of treatment should be exercise by the paper of Wamdorff-van Die
: •"■led together in analyzing for association pen, et at. (4). That study demonstrated that
'• I"-. ’ ri initial dosage of DDS- and drug- 7 out of a sample of 18 patients who yielded
'•ast..
.lion. The alternative pre- DDS-resistant M. leprae in mouse foot pad
■ rred
ii-. ... as to standardize first for reg tests subsequently responded to DDS
118
International Journal of Leprosy
monotherapy for the entire duration of ob respond to treatment and worsen clinic^.
servation—5 to 9 years. When one consid ly,” is not supported by any evidence in ft..
ers that a single high-grade DDS-resistant letter or by a reference.
M. leprae bacillus dividing once in 12 days
We hope that previous papers by oft;,
should yield 1012 M. lepraein only I1/? years, workers on DDS resistance will receive a
the observed response to DDS monother similar critical evaluation by the correspog.
apy seems spectacular. Previous assump dents.
tions that mouse test drug resistance was,
—J. G. Almeida, M.B., fie
in the long run, equivalent to clinical drug
-C. J. G. Chacko, M.D., Ph,D.
resistance in patients seem contrary to ac
Schieffelin Leprosy Research
cumulating evidence.
and Training Center
Our criteria for growth in mouse experi
Karigiri 632106, South India
ments require a sixfold or greater increase
in the number of M. leprae remaining in the
foot pad 24 hr after inoculation (3). In fact,
REFERENCES
we observed a 12-fold or greater increase in
1.
A
lmeida
,
J.
G., Joseph, P. S., Sarangapani, G. and
every experiment. This is unlikely to be due
Chacko, C. J. G. “Drug-resistant proportion test"
to chance.
for M. leprae to quantify the proportion of drug.
We are glad to know that the correspon
resistant M. lepraein a sample using the mouse foot
dents will publish findings similar to ours
pad. Int. J. Lepr. 52 (1984) 468-470.
on the response to DDS monotherapy com
2. Almeida, J. G., Joseph, P. S., Sarangapani, G.anii
pared between the 1960s and 1970s. They
Chacko, C. J. G. The mouse foot-pad test—sen
agree that the efficacy of DDS monotherapy
sitive to small proportions of drug-resistant bacilli
has not diminished over the years. We are
in a sample of M. leprae. Indian J. Lepr. 56 (1984)
content with the corroboration afforded by
10-14.
their observations. Our own inferences have 3. Evans, M. J., Newton, H. E. and Levy, L. Early
response of the mouse footpad to Mycobacterium
been fully spelled out in the paper, and will
leprae. Infect. Immun. 7 (1973) 76-85.
be judged by the readers. We obviously do
not oppose the use of DDS suggested by the 4. Warndorft-van Diepen, T., Aredath, S. P. and
Mengistu, G. Dapsone-resistant leprosy in Addis
correspondents.
Ababa: A progress report. Lepr. Rev. 55 (1984) 149The interesting claim that “mortality is
157.
higher among lepromatous cases who do not
Drug Sensitivity Testing of M. leprae
To the Editor:
We have been surprised by the content of
the discussion and the conclusions reached
by the authors in the Almeida, et al. paper
that appeared in the 1983 September issue
ofIJL(1983 51 366-379); namely, a) that
patients may respond to dapsone (DDS)
monotherapy despite a high degree of dap
sone resistance, and consequently b) that
results of mouse foot pad sensitivity tests
do not indicate whether patients will re
spond to DDS monotherapy.
Concerning the first point, the conclusion
of the authors is not fully supported by the
data they present. Actually, their whole rea
soning is based upon the results of bacterial
smears under routine DDS monotherapy.
When the BI decreases, patients are consid
ered as having DDS-sensitive infection, and
when the BI is reported to increase, patients
are considered as having DDS-resistant in
fection. When the authors biopsied 128 pa
tients treated with DDS for at least three
years with increasing BI and inoculated the
specimens into the foot pads of mice for
sensitivity testing, they observed 26 failures
to grow Mycobacterium leprae (20%).
Among the 102 M. leprae strains that grew,
90 were DDS resistant (77 with high-degree
DDS resistance). When the authors biop-
Correspondence
,
jetj 1 . patients treated with DDS for at probability for a drug-resistant mutant to
least three years with decreasing BI and in have been inoculated is very low, as thus is
oculated the specimens for sensitivity test the probability for a fully sensitive strain to
ing. they observed 8 failures to grow (57%); be considered as resistant. Secondly, the
imong the 6 strains that grew, 1 was DDS sensitivity to DDS is judged by the growth
sensitive and 5 resistant to DDS (high de of AFB in the foot pads of mice that have
gree). It >s well known that all steps in the been fed with three different concentrations
preparation, staining, and reading of skin of DDS in the diet. The highest concentra
srn t- are difficult to standardize. Thus we
tion, 0.01% in the diet, is selected to give
would conclude that, in the published data, blood levels in the mouse as high as those
there is a good correlation between the as obtained in patients treated with a full daily
sessment of clinical deterioration by skin dose of DDS (100 mg or 1.6 mg/kg). When
smears and the mouse foot pad assessment. M. leprae is able to grow in the foot pads
The five observed discrepancies would form of mice fed with 0.01% DDS in the diet, it
the few exceptions that confirm the rule. is also able to grow in man despite treatment
Therefore, we would certainly not support with a full dose of DDS. Twenty years’ ex
tl^^nclusion of the authors that the mouse perience has shown this in a number of stud
te< c mnot discriminate between patients ies. Therefore, correlation between mouse
deter; rating and patients improving, es- foot pad data and clinical data under che
peciaily when there is no evaluation of the motherapy should be excellent. When ex
accuracy and adequacy of their method used ceptions are now found, the accuracy of the
to diagnose deterioration or improvement. newly collected data should be considered.
For mouse foot pad sensitivity testing,
Moreover, one would not support the au
thors' implicit conclusion that the mouse accuracy means not only a low inoculum
food pad sensitivity tests are unreliable. It but also adequate concentrations of the drug
is true that it is by analogy with M. tuber- in the mouse diet and an assessment of M.
cidosd that wild strains of M. leprae are leprae growth in the drug-treated mice as
as-.ui.cd to contain about one drug-resis soon as the control mice are positive. The
tant mutant in 106 sensitive organisms. Such first condition has already been mentioned.
a proportion has practical implications in The second condition is self-evident. The
the performance of drug sensitivity testing third condition is important because a strain
tn tuberculosis. If the inoculum used for the which would have been considered as par
sensitivity test contains as many as 10’ vi tially resistant might well be interpreted as
able units, a situation which is easily real fully resistant. It is because every specialist
ized. a fully sensitive wild strain of M. tu is aware of such risks that mouse sensitivity
berculosis will give confluent growth of testing is done everywhere with great care
:es on drug containing medium, and and in a strictly standardized manner.
t^^may be considered as drug resistant.
Concerning the accurate assessment of
To prevent false conclusions due to the use whether a patient is deteriorating or im
of heavy inocula, Canetti, et al. (') strongly proving under chemotherapy, we would like
recommended the use of defined and low to point out two essential ideas.
1. For routine assessment of multibacilinocula (about 102 and 104 viable units) for
sensitivity testing, a recommendation now lary patients under chemotherapy, the use
widely understood and accepted by those of a standardized BI technique is certainly
uhe work in the field of tuberculosis che- commendable. However, there is ample
evidence of the limitations of this tech
i. > erapy.
Let us now consider the conditions under nique.
2. In view of these limitations, when the
which drug sensitivity tests are done in lep
rosy. First of all, the inoculum used for M. purpose is to demonstrate a possible need
leprae drug sensitivity testing has always to reconsider the whole concept of drug sen
been low, about 5 x 10’AFB (ofwhich per sitivity testing of M. leprae then compre
haps 10-20% are usually viable). Given the hensive data, including clinical, bacterio
assumed proportion of IO6 drug-resistant logical, and histopathological findings, arc
mmant in a wild strain of M. leprae, the needed, as well as the accurate assessment
I
i
'■
|
1 19
120
International Journal of Leprosy
of the drug intake. What has been necessary
to establish the present concept itself should
be used to challenge it.
—J. Grosset, M.D.
— L. Levy, M.D., Ph.D.
— R. J. W. Rees, M.D.
—C. C. Shepard, M.D.
Geneva, Switzerland
19jj
REFERENCE
1.
Canetti, G., Fox, W„ Khomenko, A., Mar&
H. T., Menon, N. K„ Mitchison, D. A., Risr^
and Smelev, N. A. Advances in techniques oftej,
ing mycobacterial drug sensitivity, and the use^
sensitivity tests in tuberculosis control pro.
grammes. Bull. WHO 41 (1969) 21-43.
|
Response to Dr. Grosset, et al.
To the Editor:
We thank the correspondents for their in
terest in our papers, and are happy to note
that they do not dispute those of our find
ings of most practical importance. Our pop
ulation-based study in an established lep
rosy control program directly observed
dapsone resistance in a leprosy-endemic
area. Previous estimates had relied on clin
ic- or hospital-based studies.
One thousand out of 1224 lepromatous
and borderline lepromatous patients on
dapsone monotherapy in the 1320 km2 area
ofGudiyatham Taluk, India, were found to
have been smear negative for three years or
more. Smear negativity was found to indi
cate a markedly reduced risk of dapsone
(DDS)-resistant infection. Seventy-six pa
tients, a very small group, remained con
tinuously smear positive despite treatment,
and only this group had a high prevalence
of DDS-resistant infection.
This small “high-risk” group that emerges
during dapsone monotherapy deserves the
fullest possible concentration of efforts and
resources. Theoretical predictions that dap
sone-resistant infections would threaten
every “multibacillary” patient are not sup
ported by evidence from leprosy control
programs in endemic areas. On the con
trary, data showing the continuing efficacy
of dapsone monotherapy, after two decades,
were presented by independent investi
gators from Polambakkam, Chinglcput, and
Salur (all in South India) at the biennial
conference of the Indian Association of
Leprologists in November 1983.
The correspondents seem to feel that
mouse test drug resistance is equivalent to
clinical drug resistance in patients. In out
view this is not supported by the evidence
which, in fact, comes from several sources,
Pearson, et al. (4) found patients who responded for over 53 months (4'Zz years) to
DDS monotherapy, after the mouse footpad
test had grown high-grade DDS-resistant
Mycobacterium leprae. Jacobson (3) observed that patients diagnosed by the mouse
foot pad test to harbor primary dapsone
resistant M. leprae, and treated initially with
DDS monotherapy, showed a response that
was “completely normal as measured by al:
the usual criteria.” Wamdorff-van Diepet
(6) showed that after even “high-grade” dap
sone-resistant M. leprae grew in mice, pa'
tients yielding such organisms attained
smear negativity and clinical inactivity de
spite continuing on dapsone monotherapy
It seems to us that the mouse foot pac
test for drug resistance has suffered from the
omission of a control group of patients
While patients deteriorating on DDS mono
therapy invariably yielded dapsone-resistant M. leprae in mice, it was assumed tha'
patients responding favorably to DD.
monotherapy would not do so. No “con
trol” group of responding patients was eve,
tested. Such a control group has now be
come available from our study, and 5 ou
of 6 responding patients yielded M. lepra
*
resistant to high-dosage dapsone (0.019
*
w/w) in the mouse diet.
The mouse foot pad test for drug resis
tance, as described by Pettit and Rees (f)
seems exquisitely sensitive to the presence
of a few drug-resistant M. leprae in predont
inantly drug-sensitive strains. We have sub
sequently demonstrated that strains of M
Correspondence
leprae with only 1 in 1000 bacilli drug re
sistant can grow drug-resistant M. leprae in
the mouse foot pad test ('). It is likely that
the more carefully and expertly the mouse
test is performed, the more exquisitely sen
sitive will it prove to minute proportions of
drug-resistant M. leprae. In order that a dis
tinction be made between predominantly
jru, resistant and predominantly drug-sensitise strains, the “drug-resistant propor
tion” test (2) has now been described. The
technique previously described by Pettit and
Rees (5) required that harvests be done “at
intervals of six to ten months from the day
of inoculation.” The reliability of that techn io lie is likely to be enhanced by the “drugi^Bltant proportion” test (2), where harvests
are performed before the plateau of bacil
lar- growth is reached in untreated mice.
1 heoretical predictions are often contra
dicted by practical experience. However, the
evidence in this case comes over a long pe
riod. and from several independent sources.
We feel that a more realistic view of dapsone
resistance in leprosy is required.
—J. G. Almeida, M.B., B.S.
-C. J. G. Chacko, M.D., Ph.D.
,S\ hud'elin Leprosy Research
and Training Center
Karigiri 632106, South India
121
REFERENCES
Almeida, J. G., Joseph, P. S., Sarangapani, G. and
Chacko, C. J. G The mouse fool-pad lest—sen
sitive io small proportions of drug-resistant bacilli
in a sample of M. leprae. Indian J. Lepr. 56 (1984)
10-14.
2. Almeida, J. G.. Joseph, P. S., Sarangapani, G. and
Chacko, C. J. G. “Drug-resistant proportion test"
for M. leprae to quantify the proportion of drugresistant M. leprae in a sample using the mouse fool
pad. Int. J. Lcpr. 52 (1984) 468-470.
3. Jacobson, R. R. The effectiveness of dapsone in
patients with primary dapsone-rcsislant leprosy. In
dian J. Lcpr. 56 Suppl. (1984) abstract no. III/162
(A).
4. Pearson, J. M. H., Haile, G. S., Barnetson, R.
St. C. and Rees, R. J. W. Dapsonc-rcsislant leprosy
in Ethiopia. luipr. Rev. 51 (1980) 315-319.
5, Pettit, J. H. S. and Rees, R. J. W. Sulphone re
sistance in leprosy. An experimental and clinical
study. Lancet 2 (1964) 673-674.
6. Warndorff-van Diepen, T., Aredath, S. P. and
Mengistu, G. Dapsonc resistant leprosy in Addis
Ababa: A progress report. Lcpr. Rev, 55 (1984) 143—
147.
1.
Volume 51, Number 3
Printed in the U.S.A.
International Journal of Leprosy
Follow-up of Lepromatous (LL and BL) Patients on
Dapsone (DDS) Monotherapy After Attainment of
Smear Negativity in Gudiyatham
Taluk, South India1
Joel G. Almeida, Melville Christian, and Chinoy J. G. Chacko1
2
Patients with lepromatous leprosy appear
to show no improvement in their specific
immune response to Mycobacterium leprae
even five years after their Bacterial Index
(BI) (-) has fallen to zero (3). This could
mean that smear negative lepromatous pa
tients remain susceptible to reinfection even
if chemotherapy can rid them of all per
sisting M. leprae. The risk of reinfection is
likely to be most prominent in areas where
leprosy is endemic. It appears important to
measure the frequency with which lepro
matous patients “relapse” once they have
attained smear negative status.
The objectives of this study were: 1) to
determine the frequency with which M. lep
rae reappear in skin smears among smear
negative lepromatous (LL) and borderline
lepromatous (BL) patients on dapsone
monotherapy, and 2) to determine whether
the duration of smear negative status in such
patients influences the risk of M. leprae
reappearing in skin smears.
Gudiyatham Taluk is the leprosy control
area of the Schieffelin Leprosy Research and
Training Centre, Karigiri. The prevalence
of leprosy in the area has been over 15 per
1000, and about a fifth of all registered pa
tients are clinically diagnosed to have LL or
BL leprosy. Fairly accurate records are
available of the treatment and progress of
each patient from the start of treatment.
DDS monotherapy was widely used until
1 Received for publication on 8 March 1983; ac
cepted for publication in revised form on 25 April
1983.
2 J. G. Almeida, M.B.B.S., Research Medical Officer;
M. Christian, M.B.B.S., D.T.M. & H., D.Epid., Head,
Department of Epidemiology and Leprosy Control; C.
J. G. Chacko, M.D., Ph.D., Professor of Pathology,
CMC Hospital, Vellore, India, and Head, Division of
Laboratories, Schieffelin Leprosy Research and Train
ing Centre, Karigiri 632106, N.A. Dt., Tamil Nadu,
India. Reprint requests to Dr. C. J. G. Chacko.
382
1981, and DDS tablets were delivered to
the patients at village clinics for domiciliary
treatment. Intensive case detection is ef
fected by repeated house-to-house surveys
and health education. A well-equipped base
hospital supports the program.
PATIENTS AND METHODS
All known LL and BL patients resident
in Gudiyatham Taluk were enumerated
from the village clinic register maintained
by the institution. Data on these patients
were compiled from the individual records
of each patient. Smears had been taken from
four routine sites (earlobe and chin on the
right side, forehead and buttock/thigh on
the left side) as well as apparently active
sites, generally at one-year intervals. Read
ing of smears was done by trained personnel
at the base hospital, who were given no in
formation about the patient. Techniques and
criteria for smears remained unchanged
throughout the period under study.
The period of smear negativity in a pa
tient is defined as the single longest period
during which the patient was continuously
smear negative while under treatment. The
sum of the periods of smear negativity for
a group of patients yields the “person-years”
of smear negativity for that group of pa
tients. “Relapse” is taken to mean the reap
pearance of M. leprae in skin smears after
smear negativity. This could be due to rein
fection from other patients, or to the pa
tient’s own persisting organisms, or both.
RESULTS
A total of 1580 LL and BL patients were
on the treatment register on 31 December
1977. Information was available from the
start of treatment in each patient up to 28
February 1981 for 1423 (90%) of these pa
tients. Of those 1423 patients 131 had re-
51.3
Almeida, et al.: Follow-up on DDS Monotherapy
The Table. Annual "relapse” rate by pe
riod of smear negativity among LL and BL
patients on DDS monotherapy.
383
the eighth year it has fallen to 0.9% per year.
This means that if 100 LL and BL patients
who have been smear negative for two years
are observed for a further period while on
No.
Annual
Period of
No.
DDS monotherapy, only one of them on the
personNo.
patients “relapse”
smear
average is found to “relapse” each year.
years
of
patients
negativity
rate
with
Further, among smear negative LL and BL
observed smear
"relapse” (%/yr)
(yrs)
negativity
patients who collect 2:80% of their pre
scribed DDS tablets, the relapse rate from
2494
Initial 2
70
2.8%
1293
>2
1.1%
92
1106
8299
the third year of smear negativity onwards
>8
620
2945
26
0.9%
is only 0.7% per year. Over half of the smear
negative LL and BL patients were found to
collect 2:80% of their tablets.
mained continuously smear positive up to
The low rates of relapse found in this study
28 February 1981. The 1293 (90.9%) out of are in keeping with a previous report by
the 1423 patients who had at some time Noordeen (') on 125 South Indian leprobeen smear negative are included in the matous patients on DDS monotherapy. The
analysis.
suggestion made in that paper that “prob
Of the 1293 patients, 1106 had been smear ably 6 years of treatment, after a case of
negative for >2 years. These 1106 patients lepromatous leprosy becomes smear nega
had 8299 person-years of smear negativity tive, may be adequate,” deserves consid
from the third year onwards, with 92 “re eration. Over half of the lepromatous pa
lapses"; yielding an annual relapse rate of tients on DDS monotherapy in Gudiyatham
1.1% per year in this group. Similarly, 620 Taluk were found to have been smear neg
of the 1293 patients had been smear nega ative for more than six years. Noordeen
tive for >8 years. These 620 patients had pointed out that after six years of smear
2945 person-years of smear negativity from negativity, the risk of relapse “was not af
the ninth year onwards, with 26 relapses; fected by whether the patients took treat
the annual relapse rate in this group is thus ment regularly or irregularly” ('). Therefore,
0.9% per year.
cessation of DDS monotherapy after six
In contrast, during the initial two years years of smear negativity may not increase
of smear negativity, the 1293 patients had the risk of relapse in a patient. Concurrent
a total of 2494 person-years of smear neg comparison of relapses following limited
ativity with 70 relapses; a relapse rate of periods of either DDS monotherapy or
2.8% per year. The Table lists the relapse combination drug therapy in smear nega
rates in these different groups of patients.
tive LL and BL patients should yield valu
Of the 1293 patients, 694 (53.7%) had able information.
collected 2:80% of their prescribed DDS
tablets during the period in which they had
SUMMARY
had negative smears. Six hundred six (606)
At the Schieffelin Leprosy Research and
of these 694 patients had been smear neg
ative for >2 years. These 606 patients had Training Centre, Karigiri, India, an analysis
4553 person-years of negativity from the of “relapse” rates was undertaken on all the
third year onwards with 31 relapses, yield 1293 residents of Guidyatham Taluk who
ing an annual relapse rate of 0.7% per year. were known to have lepromatous (LL) or
borderline lepromatous (BL) leprosy and had
DISCUSSION
attained “smear negative” status. “Re
The “relapse” rate for smear negative LL lapse” was defined as the reappearance of
and BL patients on DDS monotherapy is acid-fast bacilli (AFB) in skin smears,
found to show a progressive decrease as the whether by reinfection from other patients
duration after the attainment of smear neg or from the patient’s own persisting organ
ativity increases. During the first two years isms. The “relapse” rate decreased steadily
of smear negativity, the relapse rate is 2.8% with the time elapsed after the attainment
per year. From the third year onwards, the of smear negativity: 2.8% (2.8 per 100 pa
“relapse” rate is only 1.1% per year, and by tients per year) in the initial two years; 1.1%
International Journal of Leprosy
384
from the third year onwards; and 0.9% from
the ninth year onwards. Of the 1293 pa
tients, 694 (53.7%) had taken >80% regular
dapsone (DDS) treatment during smear
negativity. In this group, the “relapse” rate
from the third year onwards was only 0.7%
per year.
The vast majority (90.9%) of LL and BL
patients on DDS monotherapy in the area
had at some point attained smear negative
status. It appears important to study wheth
er a limited period of DDS monotherapy
after the attainment of negative skin smears
would be an effective alternative to life-long
DDS treatment in LL and BL patients.
RESUMEN
En el Centro SchiefTclin de Investigacion y Adiestramiento de la Lepra, Karigiri, India, se hizo un es
tudio sobre cl grado de rccafdas en 1293 jesidentes de
Gudiyalham Taluk que habian lenido lepra lepromatosa (LL) o intermedia (BL) y que habian alcanzado cl
estado de negatives segun los rcsultados de las preparaciones de linfa cutanea. La “recaida” se definio
como la reaparicibn de bacilos dcido resistentes (BAAR)
en las preparacioncs de linfa cutanea por reinfcccion a
partir de otros pacientes o de los microorganismos pcrsistentes on el propio paciente. El grado de “recaidas”
disminuyo soslenidamente con cl tiempo transcurndo
despues de alcanzar la negatividad en las preparaciones
de linfa cutanea: 2.8% (por ano) en los dos anos iniciales; 1.1% del tercer afio en adelante, y 0.9% despues
del noveno afio. De los 1293 pacientes, 694 (53.7%)
habian seguido un tratamiento con una rcgularidad del
80% o mayor a base de DDS y en este grupo, el grado
de recaidas del tercer ano on adelante fue solo del 0.7%
por ano.
La gran mayoria (90.0%) de los pacientes LL y BL
bajo tratamiento solo con DDS alcanzaron en algun
momento el estado de negatives segun las preparacio
nes de linfa cutanea. Parece importantc estudiar si un
periodo limitado de monoterapia con DDS despues de
alcanzar la negatividad en las preparacioncs de linfa
cutanea, podria scr una altcmaliva al tratamiento de
por vida con DDS en los pacientes LL y BL.
RESUME
Au SchiefTclin Leprosy Research and Training Centre,
de Karigiri, en Inde meridionalc, on a procede a 1’analysc des laux de rScidive dans I'enscmble des 1293
1983
residents du Guidyatham Taluk connus pour etre atteints de lepre lepromatcuse (LL) ou dimorphe 16promateuse (BL), ayant atteint le stadc de negativation
bacteriologique dans les frottis. Une “rccidive” a etc
definie comme la reapparition de bacilles acido-resistants dans des frottis cutanes, soil a la suite de rein
fection a partir d’autres malades, ou par reinfection
endogene par des organismes persistant chez le meme
malade. Le taux de recidive a dccru regulierement avec
le temps, apres qu’un etat de negati vitc bacteriologique
ait ete obtenu. Cc taux etait de 2.8% (2.8 pour 100
malades par an), au cours des deux premieres annees;
1.1% a partir de la troisieme annee el ensuite: de 0.9%
a partir de la neuvieme annee. Parmi les 1293 malades.
694 (53.7%) avaienl continue a suivre un traitement
regulier par la dapsone (DDS), a raison de >80% de
la dose presente. au cours de la periode de negativite
des frottis. Dans ce groupe, le laux de recidive a partir
de la premiere annee et au-dela n’a ete que de 0.7%
par an.
La grande majorite (90.9%) des malades LL el BL,
soumis a la monotherapie par la DDS, dans celte re
gion, a, a un moment ou 1’autre, presenie des frottis
negatifs. Il apparait important d’etudier si une periode
limitee de monotherapie par la DDS. apres que les
frottis cutanes soienl devenus negatifs, pourrail constituer un moyen efficace de substitution au traitement a
la DDS prolonge pour toute la vic, chez les malades
LL et BL.
Acknowledgments. We thank the staff of the depart
ments of Epidemiology and Leprosy Control, and Lab
oratories; particularly Mr. J. Samuel. Mr. Raja Rao
typed the manuscript.
REFERENCES
1. Noordeen, S. IG. Jjtelapse in lepromatous leprosy.
Lepr. Rev. 42 (4-94-1-) 43-48.
2. Ridley, D. S. Bacterial indices. In: Leprosy m The
ory and Practice. Cochrane, R. G. and Davey. T.
F., eds. Bristol: John Wright & Sons, Ltd.. 1964,
2nd ed. pp. 620-622.
3. Smelt, A. H. M., Liew, F. W. and Rees. R. J. W.
Attempts to induce delayed type hypersensitivity
(DTH) to M. leprae in healthy individuals and in
“buml-out” lepromatous patients. In: LeprosyProceedings of the XI International Leprosy Con
gress, Mexico City. Mexico. November 1978. Latapi. F., Saul, A.. Rodriguez, O.. Malacara. M. and
Browne, S. G.. eds. Amsterdam: Excerpia Medica.
1980. p. 159. Abstract in Im. J. Lepr. 42 (1979) 377.
J?1S S. -7
International Journal of Leprosy
Volume 51, Number 3
Printed tn the U.S.A
DDS-resistant Infection Among Leprosy Patients in the
Population of Gudiyatham Taluk, South India. Part 3.
Prevalence, Incidence, Risk Factors, and
Interpretation of Mouse Foot Pad Test Results1
Joel G. Almeida, Chinoy J. G. Chacko, Melville Christian,
Phyllis M. Taylor, and Ernest P. Fritsch!1
2
“The wide variation among estimates of
the prevalence of secondary dapsone resis
tance” among leprosy patients was pointed
out in October 1980, by the Scientific Work
ing Group of the World Health Organiza
tion’s THELEP program (14). The present
study assesses the problem ofdapsone (DDS)
resistance in the Gudiyatham Taluk of South
India. Gudiyatham Taluk, in Tamil Nadu,
South India, with an area of about 1320 km2
and a population of about 480,000 (1981
census), is the leprosy control area of the
Schieffelin Leprosy Research and Training
Centre, Karigiri, India. Most of the popu
lation is engaged in agriculture, and migra
tions in or out of the area are not common.
The area is hyperendemic for leprosy and
in December 1977, 6880 patients were on
the treatment register at 44 village clinics.
DDS monotherapy given as domiciliary oral
treatment was introduced in 1955, and has
been used throughout the area since 1963.
Intensive case detection by repeated houseto-house surveys and health education, and
careful maintenance of individual patient
1 Received for publication on 8 March 1983; ac
cepted for publication in revised form on 25 April
1983.
2 J. G. Almeida, M.B.B.S., Research Medical Officer;
C. J. G. Chacko, M.D., Ph.D., Head, Division of Lab
oratories, SLR&TC, and Professor of Pathology, CMC
Hospital, Vellore, India; M. Christian, M.B.B.S.,
D.T.M.&H.. D.Epid., Head, Department of Epide
miology and Leprosy Control; P. M. Taylor, M.R.C.P.,
D.Phys.Med., Head, Department of Medicine; E. P.
Fritschi, M.B., F.R.C.S., D.Orth.. Director and Con
sultant Surgeon, Schieffelin Leprosy Research and
Training Centre (SLR&TC), Karigiri 632106, N.A. Dl.,
Tamil Nadu, India. Reprint requests to: Dr. C. J. G.
Chacko, SLR&TC, Karigin, Vellore N.A. Dl., Tamil
Nadu 632106, South India.
366
records, are features of the program launched
in 1963.
The objectives of the present study were:
a) to determine the prevalence and inci
dence of DDS resistance among treated pa
tients in the area, and b) to identify the risk
factors associated with the occurrence of
DDS resistance.
PATIENTS AND METHODS
All known lepromatous (LL) and border
line lepromatous (BL) patients resident in
the area were enumerated on 31 December
1977, from the treatment register main
tained by the institution; excluding patients
who had previously died or emigrated. Pa
tients had been seen by a physician at the
village clinic every three months, if not more
often. Individual patient records allowed
access to information dating back to the start
of treatment for each patient. Data on the
patients continued to be assembled up to
28 February 1981. Every patient included
had been treated for a minimum of three
years by 1981.
Annual skin smears had been taken from
apparently active sites as well as four rou
tine sites (earlobe and chin on the right;
forehead and buttock or thigh on the left).
Reading of smears was done.by trained staff
who were given no information regarding
the patient. In comparing successive smears
to decide whether the number of bacilli was
rising or falling, the average Bacterial Index
(BI) C3) of the routine sites was considered,
except when this was contradicted by the
change in the highest single reading. In the
event of such conflict, the comparison was
based on successive highest readings.
“Regularity of treatment” is defined as
the percentage of months throughout treat
51,3
Almeida, et al.: DDS-resistant Leprosy
ment in which the patient collected DDS
tablets. This is based on the assumption that
those who collect fewer tablets also ingest
fewer tablets, on the average, than those who
collect tablets regularly. The “initial dos
age” of DDS in a patient is defined as the
average dosage of DDS during the first 26
weeks in which tablets were collected by the
patient.
Lepromatous (LL) and borderline lepromatous (BL) patients can deteriorate solely
through failure to take DDS. Therefore pa
tients who had been absent for > 50% of the
entire period of treatment (“absentees”) were
excluded from both the denominator and
the numerator in the calculations of prev
alence and incidence.
In the remaining patients, DDS-resistant
infection was diagnosed when review of
skin smear results showed a continuing
increase in the number of bacilli in succes
sive smears. Smear results from the start of
treatment were reviewed in each patient. It
was thus possible to identify the point at
which DDS-resistant infection first mani
fested itself in skin smear readings. This cri
terion was used to calculate the prevalence
and incidence of DDS-resistant infection.
The “duration of smear negativity” in a
patient isdefined as the single longest period
during which the patient remained contin
uously smear negative at any time from the
start of treatment up to 28 February 1981.
For example, in a patient who had been
smear negative from 1971 to 1975, smear
positive from 1976 to 1979, and again smear
negative in 1980, only the single period of
smear negativity from 1971 to 1975 would
be considered, since that was the longest
period for which the patient remained con
tinuously smear negative.
The “person-years” of treatment for a pa
tient is the sum of the years of treatment
undergone by that patient up to 28 February
1981. In the person-years of treatment for
a particular period of treatment, only those
years of treatment within the specified pe
riod are included.
In addition, a separate approach was used
to estimate the frequency with which DDSresistant Mycobacterium leprae occurred in
patients, regardless of whether or not the
patients responded to DDS monotherapy.
Between March 1978 and February 1981,
patients with a Bl >2+ were biopsied for
367
the mouse foot pad test. All other clinical
and historical criteria were disregarded in
selecting patients for biopsy. (Not all pa
tients with a BI >2+ could be biopsied,
however, since some refused biopsy, others
died or migrated before they had been biop
sied and, in some, the BI subsided to <2+
before the biopsy could be taken.) The mouse
foot pad test was performed by methods
already published ('•l2). The detection of
>2 X IO4 M. leprae per foot pad >6 months
after inoculation with 1 X 104 M. leprae per
foot pad, in mice continuously treated with
DDS from the day of inoculation, indicated
the presence of DDS-resistant M. leprae (5).
Samples of mouse feed were tested for DDS
content to ensure that the required concen
tration of DDS was achieved in the feed (4).
Some mouse tests were unsuccessful, failing
to grow M. leprae in even untreated control
mice and, therefore, allowing no conclusion
about the drug sensitivity of the M. leprae
inoculated.
RESULTS
A total of 1580 patients with lepromatous
(LL) or borderline lepromatous (BL) leprosy
were enumerated from the treatment reg
ister. Of these, 1224 patients (77.5%) were
fully studied. One hundred forty-nine
patients were not screened from 1978 on
wards. Another 198 patients were “absen
tees,” having missed >50% of their treat
ment. The records of the remaining nine
patients were not available.
The 1224 fully studied patients were di
vided into three groups according to their
“duration of smear negativity” during treat
ment. The prevalence of DDS-resistant in
fection in each of the three groups is shown
in Table 1. Among the 76 patients who had
remained smear positive throughout treat
ment, DDS-resistant infection was diag
nosed in 18 patients (23.7%). Among the
148 patients who had been smear negative
for <3 years during treatment, DDS-resis
tant infection was diagnosed in ten pa
tients (6.8%). Among the 1000 patients who
had been smear negative for £3 years dur
ing treatment, DDS-resistant infection was
diagnosed in 12 patients (1.2%). DDS-resislant infections were significantly more
frequent among the patients who remained
smear positive throughout treatment than
369
Almeida, et al.: DDS-resistant Leprosy
51. 3
Table 3. Incidence of DDS-resistant infection among patients with ez80% regular
treatment, by “initial DDS dosage" and period of treatment.
Patients with initial DDS dosage
Penod
after
start of
treatment
(yrs)
<70 mg/week
71-200 mg/weck
>200 mg/week
PersonPersonPersonyears of No. with
years of No. with
years of No. with
Incidence
Incidence
Incidence
treat
treat
resistant
resistant
treat resistant
(%/yr)
(%/yr)
(%/yr) ment (no.
ment (no. infection
infection
ment (no. infection
persons)
persons)
persons)
0-2
188
(94)
0
0.00
368
(184)
0
0.00
654
(327)
0
0.00
3-5
282
(94)
0
0.00
545
(184)
0
0.00
913
(327)
5
0.55
6-10
447
(93)
0
0.00
768
(176)
2
0.26
992
(241)
0
0.00
11-15
332
(84)
1
0.30
415
(HO)
1
0.24
592
(153)
3
0.51
16-26
15
(6)
0
0.00
9
(4)
0
0.00
141
(39)
2
1.42
108 successful tests detected DDS-resistant
M. leprae. It is interesting to compare the
proportion of successful tests which detect
ed DDS-resistant M. leprae in the different
groups of patients tested. Patients in the first
column showed an increase in the number
of M. leprae in successive skin smears pre
ceding biopsy, even though they had not
been absent from treatment. In contrast, pa
tients in the third column showed a definite
response to DDS as manifested by a de
crease in the number of M. leprae in suc
cessive smears preceding biopsy. Among
those in the first column, 26 (100%) out of
26 successful tests detected DDS-resistant
M. leprae, however, among those in the third
column, 5 (83.3%) out of 6 tests also de
tected resistant M. leprae. The difference is
not statistically significant (p > 0.10, Fish
er’s exact test).
The occurrence of tests failing to grow M.
leprae in untreated mice is significantly more
Table 4. Results of all mouse tests performed.
Number of patients
Successive smears show number of bacilli
Increasing
Decreasing
Total
Not absentees
Absentees0
BI >2+b
Biopsicd
Failure to grow M. leprae
31
29
3
111
99
23
46
14
8
188
142
34
Test successful0
Only DDS-scnsilivc bacilli grown
DDS-resistant bacilli detected
Highest concentration al which
bacilli grew (g% DDS in
mouse diet)
0.0001
0.001
0.01
26
0
26
76
12
64
6
1
5
108
13
95
3
3
20
1
6
57
0
0
5
4
9
82
• Patients absent from >50% of their treatment.
b Bacterial index >2+ at any time during the period 1 March 1978 to 28 February' 1981.
c M. leprae grew in untreated control mice.
51, 3
Almeida, et al.: DDS-resistant Leprosy
corresponding failure of response to DDS
monotherapy. Pearson, et al. (9) reported
uninterrupted response to DDS mono
therapy in patients who yielded DDS-resistant M. leprae in the mouse test, even when
patients were observed for a further 4'Z>
years. It appears difficult to maintain that
every patient who yields DDS-resistant M.
leprae in the mouse test will fail to respond
to DDS monotherapy. The explanation is
likely to be as follows.
The frequency of DDS-resistant M. lep
rae in an untreated population of M. leprae
is believed to be about 1 in IO6. Since every
untreated LL or BL patient is likely to have
> 106 M. leprae, every such patient proba
bly harbors DDS-resistant organisms. Dur
ing treatment with DDS, approximately
99.9% of the M. leprae are “killed” within
four months (15). Only 103 out of 106 M.
leprae survive, including all of the DDSresistant M. leprae. The frequency of DDSresistant M. leprae among the surviving ba
cilli would have now reached 2:1 in 1000.
With the continuation of DDS monother
apy, the frequency of DDS-resistant M. lep
rae in the steadily diminishing total bacil
lary population can only increase. It appears,
therefore, that the “threshold proportion”
above which the mouse test can detect re
sistant bacilli may be exceeded at some stage
of DDS monotherapy in every LL and BL
patient. Yet no more than 3.3% of such pa
tients failed to respond to DDS mono
therapy. In the remaining 96.7% of patients,
unknown factors must have operated to
avert DDS-resistant infection. The dem
onstration of DDS-resistant M. leprae by
the mouse test (Almeida, et al., Leprosy Re
view, in press) should not be regarded as
synonymous with failure of response to DDS
monotherapy. Estimates of DDS resistance
based on the mouse test are likely to indicate
the frequency of DDS-resistant M. leprae,
rather than the frequency with which pa
tients fail to respond to DDS monotherapy.
Because the mouse test has a low “thresh
old” for the detection of DDS-resistant M.
leprae, areas where relatively many mouse
tests were done are likely to report higher
estimates of resistance than areas where rel
atively fewer tests were done. This is re
flected in the estimated prevalence of 2.5%
(25 per 1000) in Malaysia, the lowest of all
371
available estimates (8). A carefully super
vised trial of DDS monotherapy had been
used in that study to exclude from the mouse
test patients who responded to DDS. In con
trast, one study in Ethiopia reported a prev
alence of 19% (190 per 1000) and an inci
dence of 3% per year (8). Patients with
predominantly DDS-sensitive AL leprae can
deteriorate solely through failure to take
DDS. It appears difficult to avoid the infla
tion of DDS-resistance estimates with such
patients unless they are given a well-super
vised trial of DDS treatment before being
subjected to the mouse test.
These findings merely confirm what has
long been known in the related field of tu
berculosis chemotherapy. In a report on the
Geneva international consultation of spe
cialists, Canetti, et al. (3) stated that “all
strains of tuberculosis contain some bacilli
that are resistant to anti-bacillary drugs.
However, in resistant strains, the proportion
[italics added] of such bacilli is considerably
higher than in sensitive strains.” They
pointed out that sensitivity tests that do not
discriminate between a predominantly sen
sitive strain and a predominantly resistant
strain may misclassify sensitive strains as
resistant. They remarked that, “Paradoxi
cally, sensitivity testing might even result
in actual harm by leading to unnecessary
changes of chemotherapy from effective and
acceptable regimens.” (3) Smear examina
tion “to assess the progress of therapy at
intervals” was accorded priority over sen
sitivity tests in tuberculosis control pro
grams (3). It might prove prudent to recon
sider the interpretation of sensitivity tests
in leprosy. Regular skin smear examination
retains its value in monitoring the response
to treatment as well as the occurrence of
drug-resistant infection, in both individual
leprosy patients and in epidemiological
studies.
SUMMARY
At the Schieflelin Leprosy Research and
Training Centre, Karigiri, India, a study of
the population of Gudiyatham Taluk re
vealed that the prevalence of dapsone
(DDS)-resistant infection among lepromatous (LL) and borderline lepromatous (BL)
leprosy patients treated for a minimum of
three years was 3.3% (33 per 1000), with an
51, 3
Almeida, el al.: DDS-resistant Leprosy
REFERENCES
1.
Balraj, V., Jesudasan, K., Chacko, C. J. G.,
Christian, M., Taylor, P. M., Fritschi, E. P.
and Job, C. K. Prevalence of secondary dapsone
resistance in Gudiyatham Taluk, the leprosy con
trol area of the Schieflelin Leprosy Research and
Training Centre, Karigiri. 1. Preliminary report.
Int. J. Lepr. 48 (1980) 397-401.
2. Baquillon, G., Ferracci, C., Saint Andre, R.
and Pattyn, S. R. Dapsone-resistanl leprosy in
a population of Bamako (Mali). Lepr. Rev. 51
(1980) 315-319.
3. Canetti, G., Fox, W., Khomenko, A., Mahler,
H. T., Menon, N. K., Mitchison, D. A., Rist, N.
and Smelev, N. A. Advances in techniques of
testing mycobacterial drug sensitivity, and the use
of sensitivity tests in tuberculosis control pro
grammes. Bull. WHO 41 (1969) 21-43.
4. Ellard, G. A. Assaying dapsone in mouse diets.
Lepr. Rev. 51 (1980) 321-323.
5. Evans, M. J., Newton. H. E. and Levy, L. Early
response of the mouse footpad to Mycobacterium
leprae. Infect. Immun. 7 (1973) 76-85.
6. Levy, L. Studies of the mouse foot pad technique
for cultivation of Mycobacterium leprae. 3. Dou
bling time during logarithmic multiplication. Lepr.
Rev. 47 (1976) 103-106.
7. Levy, L., Rubin, G. S. and Sheskin, J. The prev
alence of dapsone-resistanl leprosy in Israel. Lepr.
Rev. 48 (1977) 107-112.
373
Pearson, J. M. H. The problem of dapsone-re
sistant leprosy. Int. J. Lepr. 49 (1981) 417^420.
9. Pearson, J. M. H., Haile, G. S., Barnetson, R.
St. C. and Rees, R. J. W. Dapsone-resistant lep
rosy in Ethiopia. Lepr. Rev. 51 (1980) 315-319.
10. Pearson, J. M. H., Rees, R. J. W. and Waters,
M. F. R. Sulphone resistance in leprosy. A review
of one hundred proven clinical cases. Lancet 2
(1975) 69-72.
11. Peters, J. H., Shepard, C. C., Gordon, C. R.,
Rojas, A. V. and Elizondo, D. S. The incidence
of DDS resistance in lepromatous patients in Cos
ta Rica: Their metabolic disposition of DDS. Int.
J. Lepr. 44 (1976) 143-151.
12. Rees, R. J. W. Drug resistance of Mycobacterium
leprae, particularly to DDS. Int. J. Lepr. 35 (1967)
625-636.
13. Ridley, D. S. Bacterial indices. In: Leprosy in
Theory and Practice. Cochrane, R. G. and Davey,
T. F., eds. Bristol: John Wright & Sons, Ltd., 1964,
2nd ed. pp. 620-622.
14. Scientific Working Group of THELEP. Dapsonc-resistant leprosy—the THELEP approach. Int.
J. Lepr. 49 (1981) 421-422.
15. Shepard, C. C., Levy, L. and Fasal, P. The death
of Mycobacterium leprae during treatment with
4,4'diaminodiphenylsulfone (DDS). Initial rate in
patients. Am. J. Trop. Med. 17 (1968) 769-775.
8.
r> s
International Journal of Leprosy
Volume 51, Number 3
Printed in the U.S.A.
Results of Long-term Domiciliary Dapsone (DDS)
Monotherapy for Lepromatous Leprosy in
Gudiyatham Taluk, South India1
Joel G. Almeida, Melville Christian, and Chinoy J. G. Chacko1
23
The Schieffelin Leprosy Research and been registered in 1960 or earlier, and were
Training Centre, Karigiri, has used dapsone still alive in March 1981.
(DDS) monotherapy in the treatment of lep
Only seven of these 58 patients remained
rosy patients for over 20 years. Formerly, smear positive in 1981. Four of these seven
patients attended the center to be examined patients were subjected to the mouse foot
and to collect a month’s supply ofDDS tab pad test for the detection of DDS-resistant
lets. Beginning in 1963, however, the lep Mycobacterium leprae. All 4 yielded M. lep
rosy control program extended these ser rae resistant to 0.01% w/w DDS in mouse
vices to the villages of Gudiyatham Taluk. diet but, during subsequent DDS mono
Fairly extensive records of treatment and therapy, the number of bacilli in successive
progress are available for each patient, and annual skin smears was found to be increas
a well-equipped base hospital serves the ing in only 2 of these patients and decreasing
in the other 2. Of the remaining 3 patients,
program.
This background made it convenient to 1 was absent from treatment, while 2 were
study the present status and past history of improving on DDS monotherapy.
lepromatous leprosy (LL) patients who had
Among these 58 patients, of 36 who had
been treated with DDS for >20 years.
at some point in treatment been continu
ously absent for >6 months, 6 (16.7%) were
PATIENTS AND METHODS
found to be smear positive in 1981. Of the
All surviving LL patients registered for 22 who had not been absent, only one (4.5%)
treatment in 1960 or earlier and resident in was found to be smear positive. This dif
Gudiyatham Taluk, India, were enumerat ference is not statistically significant.
ed in March 1981. Data on each of these
Among these 58 patients, 32 had at some
patients were assembled from the individ time a Bacterial Index (BI) >2+. Seven
ual patient record. Skin smears had been (21.9%) of the 32 were found to be smear
taken, generally at one-year intervals, and positive in 1981. Among the remaining 26
read by trained personnel. A record was kept patients who had had a maximum BI <2+,
of the amount of DDS collected by the pa none were found to be smear positive in
tient on each visit to the clinic.
1981 (p < 0.05).
RESULTS
DISCUSSION
Fifty-eight patients with the clinical di
agnosis of lepromatous leprosy (LL) at reg
istration have been included. They had all
DDS monotherapy is found to be effec
tive among LL patients, even when the re
sults 20 years after the start of treatment are
considered. Fifty-one of the 58 patients were
smear negative and clinically inactive in
1981. The findings of this community-based
study appear more favorable than the report
from a clinic-based study in the United
States ('), where only three out of 13 LL
patients who were alive 30 years after start
ing on sulfone therapy could be pronounced
inactive.
Patients whose BI had at some point been
>2+ were found smear positive in 1981
1 Received for publication on 8 March 1983, ac
cepted for publication in revised form on 25 April
1983.
3 J. G. Almeida, M.B.B.S., Research Medical Officer;
M. Christian, M.B.B.S., D.T.M. & H., D.Epid., Head.
Department of Epidemiology and Leprosy Control. C.
J. G. Chacko, M.D., Ph.D., Professor of Pathology,
CMC Hospital, Vellore, India, and Head, Division of
Laboratories, Schiclfclin Leprosy Research and Train
ing Centre, Karigiri 632106, N.A. Dt.. Tamil Nadu.
India. Reprint requests to Dr. C. J. G. Chacko.
385
3
r?is
International Journal of Leprosy
Volume 51, Number 3
Printed in the U.S.A.
The Significance of Dapsone (DDS)-resistant
Mycobacterium leprae in Untreated Patients1
Joel G. Almeida, Chinoy J. G . Chacko, and Melville Christian2
■t
; •
•
The finding that untreated leprosy pa
tients can harbor Mycobacterium leprae
which withstand the action of dapsone
(DDS) (7-l0- ,6"18) has caused alarm (5). We
report a study done in a stable rural popu
lation of South India, to find how many
previously untreated patients harbored such
resistant M. leprae.
The area studied, Gudiyatham Taluk, is
the leprosy control zone of the Schieffelin
Leprosy Research and Training Centre, Ka
rigiri, and has a population of 480,000 (1981
census). DDS monotherapy, given as do
miciliary treatment, has been extensively
used in the area since 1963. Intensive case
detection by regular surveys and health ed
ucation, careful maintenance of individual
patient records, and a continuing search for
treated patients harboring resistant M. lep
rae are features of the control program. A
total of 7157 patients were on the treatment
register of the institution on 31 December
1980. This background made it convenient
not only to study the occurrence of resistant
M. leprae in untreated patients, but also to
relate the findings to the picture of leprosy
in the community as a whole.
PATIENTS AND METHODS
Between 1 May 1980 and 10 August 1981,
all residents of Gudiyatham Taluk newly
discovered to have borderline lepromatous
(BL) or lepromatous (LL) leprosy had skin
1 Received for publication on 8 March 1983; ac
cepted for publication in revised form on 25 April
1983.
2 J. G. Almeida,
Research Medical Officer,
Schieffelin Leprosy Research and Training Centre
(SLR&TC), Karigiri 632106, N.A. Dt., Tamil Nadu.
India. C. J. G. Chacko, M.D., Ph.D., Head, Division
of Laboratories, SLR&TC, and Professor of Pathology,
CMC Hospital, Vellore, India. M. Christian, M.B.B.S.,
D.T.M. & H., D.Epid., Plead, Department of Epide
miology and Leprosy Control, Schieffelin Leprosy Re
search and Training Centre, Karigiri 632106, N.A. Dt.,
Tamil Nadu, India. Reprint requests to: Dr. C. J. G.
Chacko, SLR&TC, Karigiri, Vellore N.A. Dt., Tamil
Nadu 632106, South India.
374
biopsies taken. Those who could reasonably
be suspected of having previously taken
DDS and those with a Bacterial Index (BI)
<2+ were excluded from the mouse foot
pad test. The mouse foot pad test, to detect
M. leprae resistant to DDS, is usually not
successful on specimens with a BI <2+. Al
together, 18 subjects qualified for the test:
5 were clinically diagnosed to have LL lep
rosy; 13, to have BL leprosy.
Ethical considerations did not allow DDS
to be withheld from patients once they were
diagnosed to have leprosy. Biopsies could
sometimes only be taken after DDS therapy
had been started. In no case did the delay
exceed a month.
Biopsies were processed for the mouse
test by methods described previously (').
Growth of Af. leprae in mice treated with
DDS was taken to indicate the presence of
M. leprae resistant to DDS at the concen
tration used. If no growth occurred in even
the untreated control mice, the concerned
test was regarded as a failure, allowing no
decision about the occurrence of resistant
M. leprae.
A list was made of all treated patients in
the area who were already shown to harbor
DDS-resistant M. leprae by the mouse test.
The places of residence and of work during
the preceding ten years were noted for each
of these patients, as well as for each of the
18 subjects. Treated patients shown to har
bor resistant M. leprae were considered as
“contacts” who had possibly passed resis
tant M. leprae to a subject, if they had shared
a workplace, or even a village, with the sub
ject, during the preceding ten years. In ad
dition, a separate list was made for each of
the 18 subjects, of all leprosy patients who
had at some time in the preceding ten years.
actually lived in the same house as the sub
ject.
RESULTS
The Table indicates that 12 mouse tests
yielded a result; 5 tests detected M. leprae
51, 3
Almeida, et al.: DDS-resistant M. leprae
375
resistant to DDS, while 7 tests did not.
The Table. Results of the mouse test for
Among the 5 tests that detected resistant the detection ofM. leprae resistant to DDS.
bacilli, 3 detected bacilli resistant to the
Growth of M. leprae
highest concentration of DDS used (0.01% No. un
in mice fed
Delected
w/w DDS in mouse diet); while in 2 tests treated
(g% DDS in diet)
patients
M. leprae
the bacilli were found resistant to only a
tested
Nil 0.0001 0.001 0.01
lower concentration of DDS (0.001% w/w
+
+
+
+
Resistant
3
DDS in mouse diet). It is not possible to
to 0.01
decide whether any resistant bacilli were
2
+
+
+
Resistant
present in the six patients who failed to yield
to 0.001
growth of M. leprae.
+
7
Sensitive
Among the 12 subjects successfully tested,
to 0.0001
4 had shared the house of at least 1 treated
(Failure
6
leprosy patient, and none of the 4 yielded
of test)
resistant M. leprae, whereas of the 8 who
had not shared the house of a leprosy pa
tient, 5 (62.5%) yielded resistant M. leprae. of the spread of leprosy, and involve small
The difference however, is not statistically numbers of patients; however, no other data
significant (p > 0.10, Fisher’s exact test).
of this nature appear to be available.
A comparison was made among the 12
The findings are easily explained by anal
subjects successfully tested, between those ogy with tuberculosis. Tubercle bacilli re
who did have identifiable contact with a sistant to isoniazid (INH) were isolated in
treated patient shown to harbor resistant M. 1948 (9), several years before INH was first
leprae, and those who did not. Of 9 subjects used for the treatment of tuberculosis. This
with contact, only 3 yielded resistant M. is consistent with the bulk of evidence ac
leprae, whereas of 3 subjects without con cumulated in bacteriology, which indicates
tact, 2 yielded resistant M. leprae. However, that bacterial populations include mutants
the difference is not statistically significant that develop before exposure to a selective
(p > 0.10, Fisher’s exact test).
agent (3-4-6' l2). In the case of drug resis
Among the 9 subjects who did have iden tance, this means that resistant bacteria ex
tifiable contact with a treated patient shown ist in bacterial populations before any con
to harbor resistant M. leprae, the 3 who tact with the drug. The prevalent concept,
yielded resistant M. leprae had, on an av implying that all “strains” of M. leprae
erage, only 3.0 such “contact” patients each; which have not come into contact with DDS
whereas the 6 who yielded no resistant M. form homogeneous groups in which there
leprae had, on an average, 6.0 such “con is no real variation in sensitivity to DDS,
tact” patients each. The difference, how seems to ignore the bulk of evidence avail
ever, is not statistically significant (t test, able (2-> s. s. 9. H-13-l5-18).
There are at least two possible explana
p > 0.1).
tions for resistant bacilli in an untreated pa
DISCUSSION
tient: 1) the bacterial population in the pa
Leprosy patients treated with DDS may tient may contain naturally resistant mutants
possibly transmit M. leprae which are re or 2) the resistant bacilli may have been
sistant to DDS. If this happened commonly, acquired from a treated patient. The evi
it might be cause for alarm.
dence in tuberculosis indicates that the lat
The data presented do not support the ter “rarely happens” (” l5). Further, the
hypothesis that treated patients are likely to finding in untreated patients of tubercle ba
be the only source, or even the major source, cilli resistant to INH (sometimes called
of resistant M. leprae in untreated patients. “primary INH resistance”) ceased to cause
Known contact with a treated patient in the alarm when it was pointed out that the “pri
ten years preceding the diagnosis of leprosy mary resistance” showed no increase over
did not significantly increase the risk of several years (2,s-13).
DDS-resistant M. leprae occurring in an un
The limited evidence available in leprosy
treated, newly diagnosed patient. These data does not support the view that treated pa
share the limitations inherent in any study tients are the major source of resistant M.
1983
International Journal of Leprosy
376
leprae in untreated patients. It would seem
important to know whether the proportion
of untreated patients who harbor DDS-resistant M. leprae has been increasing. M.
leprae from untreated patients were report
ed to grow in mice treated with DDS as early
as 1965 (,6>1711S). In recent years there have
been more reports of DDS-resistant M. lep
rae in untreated patients (7> l0, ,4). It is not
clear whether these reflect an actual increase
in the occurrence of resistant M. leprae, or
merely an improved surveillance.
The monitoring of drug resistance among
untreated patients, especially before a drug
is pressed into general use in an area, is of
great aid to subsequent evaluation of drug
resistance in that area. It is hopefully not
too late to do this for rifampin and clofa
zimine, which are being used increasingly
in leprosy.
SUMMARY
In a stable rural population of South In
dia, 18 consecutive untreated persons newly
discovered to have leprosy with a Bacteri
al Index (BI) >24- were tested for My
cobacterium leprae resistant to dapsone
(DDS) by the mouse foot pad test. Of 12
successful tests, five detected resistant M.
leprae. Known contact with a treated pa
tient in the ten years preceding the diagnosis
of leprosy was not found to increase the risk
of DDS-resistant M. leprae occurring in an
untreated, newly diagnosed patient.
This data is consistent with the bulk of
evidence in the field of bacteriology, which
makes it seem unlikely that treated patients
are the only source, or even the major source,
of resistant M. leprae in untreated patients.
Bacterial mutants resistant to a drug have
been shown to precede initial use of the drug.
Tests for drug-resistant bacteria in untreat
ed patients before a drug is widely used in
a community are likely to be important for
subsequent evaluation of resistance to the
drug in that community.
RESUMEN
Usando el mdtodo del cojinetc plantar on cl ratdn,
se invesligo la prcscncia de M. leprae resistentes a la
dapsona (DDS) en 18 personas con lepra no tratada de
reciente diagnostico y con un Indice Bacterial de
2+ o mayor. El cstudio se realize cn una poblacidn
rural estable del sur de la India. En 5 de 12 pruebas
exitosas sc cncontraron M. leprae resistentes al DDS.
Las personas en contacto por 10 afios o mas con un
paciente tratado no aumcnlaron cl riesgo de que los
casos recientcs de lepra, no tratados, dcsarrollaran M.
leprae resistentes a la dapsona.
Este dato indica que es poco probable que los pacientes tratados scan la unica o la principal causa de
la aparicion de M. leprae resistentes al DDS en los
pacientes de reciente diagnostico aun no tratados. Se
ha demostrado que las mutantes resistentes a la droga
aparecen antes de que esla haya sido ulilizada. Las
pruebas para esiablecer la resistcncia a una droga de
las bacterias de pacientes no tratados, antes de administrar csa droga en una comunidad, podrian ser importantes para la evaluation subsecuentc de la resistencia a la droga en esa comunidad.
RESUME
On a precede a unc etude de la resistance de My
cobacterium leprae a la dapsone (DDS), au moyen de
1’eprcuve sur coussinct plantairc de la souris, chez 18
maladcs consecutifs non trailes, el recemmcnt decouverts portcurs d’unc lepre avcc Index Bactericn
(BI) >2+. Cette etude a ete menec dans une population
ruralc stable de 1’Indc meridionale. Parmi 12 tests pra
tiques avec succds, cinq ont permis de mettre en evi
dence des M. leprae rdsistants. Il est apparu qu’un
contact connu avec un malade traitc au cours des dix
annees ayanl precede le diagnostic de la lepre, n’entrainait pas une augmentation du risque de resistance
a la DDS de M. leprae, chez des malades non trailes
recemmcnt diagnostiques.
Ces donnees sont en accord avec tout cc quo nous
savons dans le domaine de la bacteriologic, dont il
ressort qu’il est peu probable que les maladcs trailes
soient la seulc source, ou meme la source principale,
de M. leprae resistant chez les malades non trailes. On
a montre quo des mutants bact6riens resistant a un
medicament pouvaient apparaitre avant 1’utilisalion
initiale du medicament. Avant qu’un medicament soil
largement utilise dans unc communaute, il parait im
portant de proccdcr a des epreuves portani sur la re
sistance mcdicamcntcuse des bactcries chez des ma
lades non trailes, ct ccci afin de permetlre une evaluation
ult6rieure de la resistance au medicament dans cette
communaute.
Acknowledgments. This study received support from
the Chemotherapy of Leprosy (THELEP) component
of the LJNDP/WORLD BANK/WHO Special Pro
gramme for Research and Training in Tropical Dis
eases. The views expressed do not necessarily reflect
official policy of the World Health Organization.
We thank Mr. S. Joseph and Mr. G. Sarangapani for
expert technical assistance; Mr. J. Samuel and all the
staff of the branch of leprosy control; and Mr. Raja
Rao and Mr. N. Christopher for secretarial assistance.
51, 3
Almeida, et al.: DDS-resistant M. leprae
REFERENCES
Balraj, V., Jesudasan, K., Chacko, C. J. G.,
Christian, M.. Taylor, P. M., Fritschi, E. P.
and Job, C. K. Prevalence of secondary dapsone
resistance in Gudiyatham Taluk, the leprosy con
trol area of the Schieffelin Leprosy Research and
Training Centre, Karigiri. 1. Preliminary report.
Int. J. Lepr. 48 (1980) 397-401.
2. Canetti, G., Fox, W.. Khomenko, A., Mahler,
H. T., Menon, N. K., Mitchison, D. A., Rist, N.
and Smelev, N. A. Advances in techniques of
testing mycobacterial drug sensitivity and the use
of sensitivity tests in tuberculosis control pro
grammes. Bull. WHO 41 (1969) 21-43.
3. Cavalli. L. L. Genetic analysis of drug-resis
tance. Bull. WHO 6 (1952) 185-206.
4. Cavalli-Sforza, L. L. and Lederberg, J. Iso
lation of preadaptive mutants in bacteria by sib
selection. Genetics 41 (1956) 367-381.
5. Chemotherapy of leprosy for control programmes.
WHO Tech. Rep. Ser. 675, 1982.
6. Demerec, M. Origin of bacterial resistance to an
tibiotics. J. Bacteriol. 56 (1948) 63-74.
7. Girdhar, B. K., Sreevastsa and Desikan, K. V.
Primary sulphone resistance, a preliminary report.
Lepr. India 50 (1978) 352-355.
8. Hobby, G. L., Johnson, P. M., Lenert, T. F.,
Crawford-Gagliardi, L., Greetham, L. and
Ivaska, T. A continuing study of primary drug
resistance in tuberculosis in a veteran population
within the United States. Am. Rev. Respir. Dis.
89 (1964) 337-349.
9. Hobby, G. L. and Lenert, T. F. Resistance to
isonicotinic acid hydrazide. Am. Rev. Tuberc. 65
(1952) 771-774.
1.
377
Jacobson, R. R. The present status of sulfone
therapy of leprosy. Proc. 1st Int. Workshop on
Chemotherapy of Leprosy in Asia, Manila, Phil
ippines. Tokyo: Sasakawa Memorial Health Foun
dation, 1977, pp. 25-36.
11. Lederberg, J. and Lederberg, E. M. Prelica plat
ing and indirect selection of bacterial mutants. J.
Bacteriol. 63 (1952) 399-406.
12. Luria, S. E. and Delbruck, M. Mutations of
bacteria from virus sensitivity to virus resistance.
Genetics 28 (1943) 491-51 1.
13. Miller, A. B., Tall, R., Fox, W., Lefford, M.
J. and Mitchison, D. A. Primary drug resistance
in pulmonary tuberculosis in Great Britain: Sec
ond national survey, 1963. Tubercle 47 (1966) 92107.
14. Pearson, J. M. H., Haile, G. S., Barnetson, R.
St. C. and Rees, R. J. W. Dapsone resistant lep
rosy in Ethiopia. Lepr. Rev. 50 (1979) 183-200.
15. Prevalence of drug resistance in previously un
treated patients. United Slates Public Health Ser
vice Cooperative Investigation. Am. Rev. Respir.
Dis. 89 (1964) 327-336.
16. Rees, R. J. W. A preliminary review of the ex
perimental evaluation of drugs for the treatment
of leprosy. Trans. R. Soc. Trop. Med. Hyg. 61
(1967) 581-595.
17. Rees, R. J. W. Recent bacteriologic, immunologic
and pathologic studies on experimental human
leprosy in the mouse foot pad. Int. J. Lepr. 33
(1965) 646-657.
18. Shepard, C. C., McRae, D. and Habas, J. A. Sen
sitivity of M. leprae to low levels of 4,4'-diaminodiphenylsulfone. Proc. Soc. Exp. Biol. Med. 122
(1966) 893-896.
10.
Dis 's-io
Volume 51, Number 3
Printed in the U.S.A.
International Journal of Leprosy
Response to Dapsone (DDS) Monotherapy in Leprosy
Patients of Gudiyatham Taluk, South India:
Comparison Between the 1960s and the 1970s1
Joel G. Almeida, Melville Christian, and Chinoy J. G. Chacko1
2*
Dapsone (DDS) has long been the cor
nerstone in the treatment of leprosy. The
low cost and relative rarity of toxic effects
are outstanding features of DDS therapy.
However, the efficacy of therapy must be
the prime consideration in the choice of
therapeutic agents. The recent reports of
Mycobacterium leprae which are resistant
to DDS C"6) suggest the need to determine
whether the efficacy of DDS has changed
over the years.
A direct measurement of the response to
DDS in a patient can be obtained by noting
the clearance of M. leprae from skin smears.
Patients infected relatively long ago can then
be compared with patients infected more
recently, for response to DDS.
Gudiyatham Taluk, with a population of
425,000 (1971 census), is hyperendemic for
leprosy. In 1963, the leprosy control pro
gram was launched by the Schieffelin Lep
rosy Research and Training Centre, Karigiri, employing DDS monotherapy given as
domiciliary treatment; backed by repeated
house-to-house surveys and health educa
tion, and careful maintenance of individual
patient records. DDS monotherapy re
mained in use until 1981.
The objective of this study was to deter
mine whether the efficacy of DDS in the
treatment of leprosy showed a change with
the passage of time.
PATIENTS AND METHODS
All residents of Gudiyatham Taluk reg
istered for the treatment of leprosy in the
years 1964 to 1966 or 1971 to 1973, with
a clinical diagnosis of lepromatous (LL) or
borderline lepromatous (BL) leprosy and
acid-fast bacilli in skin smears, were in
cluded in the analysis. Data for each of these
patients were obtained from the individual
patient record. Skin smears had been done
annually from four routine sites (ear and
chin on the right, forehead and buttock/thigh
on the left) as well as apparently active sites
and read by trained personnel at the base
hospital. Techniques and criteria for skin
smears remained unchanged throughout the
period under consideration. The attainment
of skin smear negativity in a patient during
the initial seven years of treatment was
compared in two groups of patients: 1) those
first registered in the years 1964 to 1966,
and 2) those first registered in 1971 to 1973.
For the purpose of this study, “maximal”
DDS treatment has been defined as the col
lection of > 80% of the prescribed DDS tab
lets, with no interruption of treatment ex
ceeding six months.
The standard error of a proportion was
determined by the formula V(p X q/ri)
where p is the number of n individuals in
one category and q the number in the other.
RESULTS
1 Received for publication on 8 March 1983; ac
cepted for publication in revised form on 25 April
1983.
2 J. G. Almeida, M.B.B.S., Research Medical Officer,
M. Christian. M.B.B.S., D.T.M. & H., D.Epid., Head,
Department of Epidemiology and Leprosy Control; C.
J. G. Chacko, M.D., Ph.D., Professor of Pathology,
CMC Hospital. Vellore, India, and Head, Division of
Laboratories, Schieffelin Leprosy Research and Train
ing Centre, Kangiri 632106, N.A. Dt., Tamil Nadu,
India. Reprint requests to Dr. C. J. G. Chacko.
378
A total of 391 patients registered in the
years 1964 to 1966 and 148 patients reg
istered in the years 1971 to 1973 were in
cluded in the analysis. The proportion of
patients in each group who were “smear
negative” after each year of treatment is
shown in Table 1 and Figure 1. Among pa
tients registered in 1964 to 1966, the pro
portion of patients smear negative rose from
0% at the start of treatment to 51.9% after
51.3
Almeida, et al.: Response to DDS 1960s vs 1970s
379
Table 1. Attainment of smear negative
status by period of treatment in two groups
of patients on DDS monotherapy.
Period
of treatment
(yrs)
0
1
7
3
4
5
6
7
No. (°/o ± standard error) of patients
smear negative registered
during the years
1964-1966“
1971—1973b
0
48 (12.3 ± 1.66)
98 (25.1 ± 2.19)
143 (36.6 + 2.46)
165 (42.2 ± 2.50)
165 (42.2 ± 2.50)
179 (45.8 ± 2.52)
203 (51.9 ± 2.53)
0
23 (15.5 ± 2.97)
43 (29.1 ± 3.73)
56 (37.8 ± 3.99)
66 (44.6 + 4.09)
81 (54.7 ± 4.09)
98 (66.2 ± 3.89)
114 (77.0 ± 3.46)
• A total of 391 patients were registered in 1964 to
1966.
b A total of 148 patients were registered in 1971 to
1973.
seven years of treatment. Among patients
registered in 1971 to 1973, the correspond
ing figures were 0% at the start of treatment
and 77.0% after seven years of treatment.
After 5, 6 and 7 years of treatment, respec
tively, the occurrence of smear negative sta
tus was significantly more frequent among
patients registered in 1971 to 1973 than
among those registered in 1964 to 1966 (p
in each case <0.05).
However, only 135 (34.5%) of 391 pa
tients registered in 1964 to 1966 had re
ceived “maximal” DDS treatment; whereas
69 (46.6%) of 148 patients registered in 1971
to 1973 had done so (p < 0.05).
Table 2 and Figure 2 show the attainment
ofsmear negative status among patients with
“maximal” DDS treatment. Among such
patients registered in 1964 to 1966, the pro
portion with negative smears rose from 0%
at the start of treatment to 74.8% after seven
years of treatment. The corresponding pro
portions among patients registered in 1971
to 1973 were 0% and 85.5%. The differences
between the two groups do not attain sta
tistical significance at any stage of treatment
(p > 0.05).
The Bacterial Index (BI) (7) at the time
of registration was analyzed in each group.
Only 59 (15.1%) of 391 patients registered
in 1964 to 1966 had a BI >3+, as against
69 (46.9%) of 148 patients registered in 1971
to 1973 (p < 0.002).
Period of treatment (years)
Fig. 1. Attainment of smear negative status by pe
riod of treatment in two groups of patients on DDS
monotherapy. Percentages are shown ± standard error
of the percentage: 100 X V(p X q/n).
DISCUSSION
Patients registered in 1971 to 1973 were
found to respond as well to DDS mono
therapy as patients registered in 1964 to
1966, as indicated by clearance of M. leprae
from skin smears during the initial seven
years of treatment. A significantly higher
proportion of patients registered in 1971 to
1973 received “maximal” DDS therapy,
when compared to patients registered in
1964 to 1966. This could be explained by
the steadily improving rapport between the
institution and the inhabitants of Gudiyatham Taluk. This seems to explain why a
larger proportion of those registered in 1971
to 1973 than those registered in 1964 to
1966 were smear negative after 5, 6 and 7
years of DDS treatment. Despite the dis
advantage of including a higher proportion
with an initial BI >3 + , patients registered
in 1971 to 1973 did not attain smear neg
ative status any more slowly than those reg
istered in 1964 to 1966.
The exact date of infection in a patient is
380
1983
/nternational Journal of Leprosy
Table 2. Attainment of smear negative
status by period of treatment in two groups
of patients on “maximal” DDS monother
apy.
Period
of treat
ment
(yrs)
0
1
2
3
4
5
6
7
No. (% ± standard error) of patients
smear negative registered
during the years
1964-1966“
1971—1973"’
0
27 (20.0 ± 3.44)
44 (32.6 ± 4.03)
66 (48.9 ± 4.30)
79 (58.5 ± 4.24)
89 (65.9 ± 4.08)
95 (70.4 ± 3.93)
101 (74.8 ± 3.74)
0
11 (15.9 ± 4.40)
21 (30.4 ± 5.54)
27 (39.1 ± 5.87)
32 (46.4 ± 6.00)
41 (59.4 + 5.91)
51 (73.9 ± 5.29)
59 (85.5 ± 4.24)
“ A total of 135 patients registered in 1964 to 1966
received “maximal” DDS monotherapy.
b A total of 69 patients registered in 1971 to 1973
received “maximal” DDS monotherapy.
difficult to pinpoint. It appears reasonable,
however, to assume that patients registered
in 1971 to 1973 were infected more recently
than those registered in 1964 to 1966. In
the interval of lime between the two groups,
the responsiveness of M. leprae to DDS ap
pears to have shown no marked change.
Although negative findings cannot be used
to disprove hypotheses, these data do not
support the claim that DDS-resistant infec
tions have been increasing in frequency since
the introduction of DDS monotherapy.
SUMMARY
Al the Schieffelin Leprosy Research and
Training Centre, Karagiri, India, 148 lepromatous (LL) and borderline lepromatous
(BL) leprosy patients registered for treat
ment in the years 1971 to 1973 were found
to respond as well to dapsone (DDS) mono
therapy as 391 LL and BL patients regis
tered in 1964 to 1966, as indicated by clear
ance of Mycobacterium leprae from skin
smears during the initial seven years of ther
apy in each patient. Apparently, the efficacy
of DDS monotherapy has not been pro
gressively diminishing since the introduc
tion of DDS monotherapy into the area.
RESUMEN
En un estudio realizado on el Centro Schieffelin de
Invesligacion y Adiestramiento de la lepra, Karigiri,
India, se cnconlro quo 148 pacientcs lepromatosos (LL)
e intermedios (BL) registrados para tratamiento en los
Period of treatment (years)
Fig. 2. Attainment of smear negative status by pe
riod of treatment in two groups of patients on “max
imal” DDS monotherapy. Percentages are shown ±
standard error of the percentage: 100 X \/(p X q/ri).
anos de 1971 a 1973 respondicron a la monoterapia
con dapsona (DDS) tan bien como 391 pacientcs LL
y BL registrados de 1964 a 1966. Esto se concluyo en
base a la ehminaci6n de M. leprae observada en las
prcparaciones de piel de cada pacicnte durante los 7
anos iniciales de lerapia. Aparentemenic, la eficacia de
la monoterapia con DDS desdc su introduction, no ha
disminuido con el tiempo on el area estudiada.
RESUME
Au Schieffelin Leprosy Research and Training Centre,
a Karigiri, en Inde mdridionale, on a observe que 148
maladcs attcints de lepre Idpromateusc (LL) ou dimorphe (BL) cnregislres au traiicmcnt au cours des
anndcs 1971 a 1973, repondaient aussi bien a la monothcrapic par la dapsone (DDS), quo 391 patients LL et
BL cnregistres entre 1964 et 1966. Cette observation
a etc basec sur des etudes de 1’immunisation de My
cobacterium leprae dans des frottis cutanes au cours
des sept premieres annees du traitemenl chez chaque
malade. Il apparail dds lors que 1’efTicacite de la monotherapic par la dapsone n’a pas diminue progress! vcmenl dans cello region, depuis 1'introduction de la
monotherapic par la DDS.
Acknowledgments. We thank the stall'of the depart
ments of Epidemiology and Leprosy Control, and Lab
oratories, particularly Mr. J. Samuel. Mr. Raja Rao
typed the manuscript.
51,3
Almeida, el al.: Response to DDS 1960s vs 1970s
381
4. Pearson, J. M. H., Haile, G. S., Barnetson, R.
REFERENCES
St. C. and Rees, R. J. W. Dapsone-resistant leprosy
Balraj, V., Jesudasan, K., Chacko, C. J. G.,
in Ethiopia Lepr. Rev. 50 (1979) 183-199.
Christian, M., Taylor, P. M„ Fritschi, E. P. and
5. Pearson, J. M. H., Rees, R. J. W. and Waters, M.
Job, C. K. Prevalence of secondary dapsone resis
F. R. Sulphone resistance in leprosy. A review of
tance in Gudiyatham Taluk, the leprosy control area
one hundred proven clinical cases. Lancet 2 (1975)
of the Schieffelin Leprosy Research and Training
69-72.
Centre, Karigiri. 1. Preliminary report. Int. J. Lepr.
6. Peters, J. H., Shepard, C. C., Gordon, G. R.,
48 (1980) 397-401.
Rojas, A. V. and Elizondo, D. S. The incidence
2. Baquillon, G., Ferracci, C., Saint Andre, R. and
of DDS resistance in lepromatous patients in Costa
Pattyn, S. R. Dapsone-rcsistant leprosy in a pop
Rica: Their metabolic disposition of DDS. Int. J.
ulation of Bamako (Mali). Lepr. Rev. 51 (1980)
Lepr. 44 (1976) 143-151.
315-319.
7. Ridley, D.S. Bacterial indices. In: Leprosy in The
3. Levy, L., Rubin, G. S. and Sheskin, J. The prev
ory and Practice. Cochrane, R. E., ed. Bristol: John
alence of dapsone-resistant leprosy in Israel. Lepr.
Wright & Sons, Ltd., 1959, pp. 371-372.
Rev. 48 (1977) 107-112.
1.
COMMON.TY KV'.LTH CELL
47/1.(Firstl-<v^.iu.. M-rksRo«d
BANG—<.G..c Lu-001
'A
“Zb
SILVER JUBILEE
OF
Leprosy Relief Rural Centre
CHETTIPaVtY
1956 — 1981
Report of Activities.
(Dr. E VOMSTEIN)
It is a pleasing task for me, to present-in the name of the
Staff this report of the activities of the Centre from its inception 25
years ago.
The joy is heightened by the fact, that a good number of Staff
members and friends of the "first hour" are still with us.
The Centre came into existence through the single-hearted
devotion of Marie Denis to the cause of Leprosy and the understand
ing assistance of Mgr. Dr. V. Selvanather, the then Bishop of Salem.
During the first few years the work of the Centre was localised
and confined to Chettipatty village and its surroundings. It was
recognised within the scheme of N. L. C. P. (National Leprosy Con
trol Programmejin 1960 and has then been allotted a Project area,
within which its activities are carried out in alignment with the
directives of N. L. C. P.
The Project Area comprises Omalur Taluk and two thirds of
Mettur Taluk, about 1200 sq. kms., with a population of 4,09,646
lakhs (Census 1971)
The first mobile Clinic was functioning at Pusaripatty at a
distance of 10 km. To date 23 Clinics are run regularily at selected
suitable spots at the road-side or in the premises of Govt. Hospitals
or Health Centres.
Mass-treatment in Clinics became possible with the advent of a
cheap effective Drug-DAPSONE.
4
Paramedical Assistants are posted permanently in villages.
From there they go about their important tasks: House to house Survey,
case detection and upkeep of personal records of the patients. In
this way the patients are linked with the Clinic and with the Head
quarter-Hospital, and regular treatment can be secured.
We are reaching out in a radius of rough'y 25 kms. Since the
start 25,599 Patients have gone through our Clinics. They were
examined, recorded and taken under treatment. 11,817 patientshave
left the area permanently
Migration here is much above average.
This can be attributed, among other reasons, to progressive Industria
lisation in the adjacent Taluks, ("for instance Salem Steel Plant,
which made the shifting of entire villages necessary; then Mettur
industries attract workers ) A notable migrant Group characteristic
for Salem Dt. are the professional stone-breakers, who are sought
after throughout India. Regular Control and follow-up of these
people is impossible.
1281 patients died; in most of the cases not directly due to
Leprosy.
5252 Persons are cured
7249 Patients are on rolls.
2796 are "inactive", denoting that the progress of the disease
is contained.
4453 are still ‘active", indicating the current combat between
the invading Bacilli and the defence-mechanism of the
host.
The number of cases detected and registered every year remained '
for 15 years fairly constant around 1200. Since 1979 we notices
considerable drop to between 600 to 700. The greatest part of the
patients (51%; are voluntarily reporting for examination and treat
ment- Evidently a considerable awareness has been created among
Population.
As a result of School Survey, covering a great number of
schools, the number of newly detected Patients will show an increase.
But as these are children with early mild signs of the infection, we
can be sure, that they will be cured in the foreseeab e future and shall
not be subjected to the stigmatising symptoms and their dreadful
consequences.
As part of our endeavours to bring to all Leprosy patients
under treatment in the early stages, we have made arrangements to
treat the school-going children in the school itself. An everage of 600
children per year are treated under this scheme. Luckily we have met
with the sympathetic ready co-operation of the school-authorities
and teachers. A hearty "thank you" to them.
A somewhat similar scheme is the ''Factory-treatment” in 3
factories in Mettur under which 50 workers are taken care of.
For teachers, factory-workers of other areas (Magnesite Ltd.) etc;
treatment is given at "Sunday-Clinics" in Chettipatty itself. A total
of 100 persons are benefiting from this arrangement.
We have to concentrate our efforts on the multibacillary cases,
who are peihtps .he sole agent for effective propagation of the
infection. 15",, of the known patients in our area are of this type.
Of these 44% have become bacteriogically negative-thus no longer
spreading the disease. Among the new cases we register yearly
the rate of "positive" cases is down to 5% only.
The Deformity-rate presents the same tendency. Overall there
are 12.43% cases with some deformity (0.2% not visible). This
rate wi'l remain more or less constant with the present generation
of patients Many of them had already severe deformities when
they first reported for treatment.
Since several years now among the newly registered cases per
year there have been 4-5% of persons with some type of deformity.
In 1981 only 2"., of the newly registered caseshave a defor
mity.
These definite remarkable reductions in the portion of Infecti
ousness and in Deformties in newly registered cases, is interpreted,
I hope justly so-as an indication that our struggle has brought us
nearer the ultimate goal.
The above given datas refer to persons from our Project area
only. Added to these we have an average of 300 patients from out
side the Project area under regular treatment with us.
HOSPITAL OR IN-PATIENTS' DEPARTMENT :
The Hospital with a capacity of 90 beds was inaugurated on
1st January 1970.
Since then an average of 639 patients were admitted every
year. Invariably 25% of these patients have been referred from
neighbouring Control Units or came voluntarily.
The great majority of Patients need hospitalisation for treat
ment of Trophic Ulcers and Reaction (a severe medical complica
tion in Leprosy/
A sequel to the destruction of peripheral nervs and one of the
most serious complications is the occurrence of Ulcers in the feet.
70% of the patients, hospitalised for this kind of ulcers are
more than 40 years old. Their number is increasing in direct
relation to increase of age. Admissions for more than once-upto 10
times and more - are also characteristic for the patients in the
advanced age group. These peoples too, when reporting for treat
ment 15—20 years ago, had already ulcers. It is evident, that long
standing anesthesia, contractures, and injuries of the soft tissues,
break down of the bony structures combined with the natural
regressions of the normal functions of th} body, make the foot
extremely vulnerable.
All sorts of protective footwear cannot
prevent the occurence of ulcers. Therefore, it must be our endevour to prevent the first ulcer.
In 1981, 117 patients were admitted for ulcers of the
49 of them only were from our project area.
An average of 250 operations for simple and
ulcers are performed per year.
feet
complicated
Since 1967, 434 operations for the correction of
paralysed hands and feet have been performed.
partially
REACTION :
This is a cemplicatian significant for and direcfly related to
Leprosy. It occurs almost exclusively in the multibacillary type of the
disease.
In 1973 the multi-drug regimen, namely RIFAMPYCIN.
ISOPRODIAN or Rifampycin combined with other antileprotic drugs,
was introduced. Upto now 296 patients have been treated with this
drug-combinations. The results are gratifying. Besides attaining nonmfectivity more speedily - or per haps because of it-ever since we can
note a steady decrease in admissions for reaction ; from 162 in 1973
to 54 in 1981 (21 of these came from onside our area). Average
i
stay at the Hospital equally shortened from former 49 days to the
present 28 days. We are deeply indebted to Prof. Dr. Freerksen and
German Leprosy Relief Assn, for the introduction of this treatment,
which by now is the internationally recognised expedient, to attain
negativity in multibacillary cases or at least bring the bacillary load
drastically down and reduce their pathogenic capacity to nil.’
All newly detected multibacillary cases are now treated with
this comb, drug regimen.
LABORATORY :
At least 2600 skin smears are examined every year. Besides
kthese about 7000 other tests; Blood, Urin Stool, Sputum are carried out,
*of 110 blood smears (1981) 37 were confirmed Malaria PI; positive.
SPUTUM ;
41 were found AFB-positive (Tuberculosis).
PHYSIOTHERAPY-ORTHOPEDIC DEPARTMENT COBBLER'S
WORKSHOP :
Physiotherapy is a most important component and indispenable for the treatment of deformities in Leprosy or in any other
ohysically disabling diseases
Our Physiotherapists are busy with hundreds of various appli
cations during the year.
502 pairs of special chappals and sandals for the
of feet are yearly made and supplied to the patients.
protection
"Prevention of u’cers is better than any subsequent cure"
In 1976 we could announce the opening of our Orthopedic Work|jJKop. Salem District has been sore’y lacking an Orthopedic and
Prosthetic Centre. We knew, we would be faced with innumerable
difficulties and problems by taking up this project. But a deep con
cern for the handicapped peoples impelled us to go ahead and tackle
the problems when and as they cropped up. The then Collector of
Salem.
Mr. V. Karuppan, declared the workshop 'open'. In his
inaugural address he expressed his pride about the fact that Salem
now had one more amenity for the public. He was p'eased to note
that it was a Leprosy Control Unit, that was offering such vital
facility to the people, a most valuable contribution to the Health
Services. This Orthopedic Centre was not meant only for Leprosy
patients, but for all the physically handicapped persons, to whom it
could render competent service.
The appliances manufactured are :
a) MAJOR ones, such as long and short leg braces. Patella
tendon bearing brace (PTBJ, fixed ankle brace walker
fFAB), artificial limbs
bj
MINOR, Elbow crutches, moulded shoes, metal insoles’
foot-drop springs, alkathene splints etc.
250 major and 244 minor appliances have been supplied since the
opening of the workshop.
213 major appliances were made for children, victims of
Poliomyelitis and a few with congenital deformities All the children
were admitted in the Hospital for not less than 3 weeks upto several^)
months - depending on the extent of the deformity and the severity
of their disability.
OUT-PATIENTS--DEPARTMENT :
Th s facility offered for ambulatory medical services builds a
bridge between persons afflicted by Leprosy and those with general
complaints and ailments. It is thus a place and opportunity of inte
gration. as all are treated together in the same locality.
Most of the peoples who attend OPD suffer from skin disorders.
Many of them are given medicines for weeks together to spare them
travelling problems and expenses.
About 450 persons who called on the OPD with dermatological
complaints, are each year found suffering from Leprosy. Usually they
are not living in our project area. We direct them for treatment to
the respective Control Units.
Some 80 persons are seen daily in the OPD-total consultation?^®)
in 1981 — 18,000.
HEALTH EDUCATION :
This always played an integral part along with the other activi
ties. Educative Public meetings, slide shows in schools, addresses
to teachers, various Clubs, and in all Clinics to patients and by
standers. We are most fortunate that the generosity of G. L. R.
Assn, made the acquisition of a 16 mm Photophone Film-Projector
possible.
A number of patients and former patients
settled with the Centre :
are vocationally
i
Shoemakers,
Gardeners,
Poultry farm attendee Weavers,
Attenders in Wards and OPD.
7 severely disabled Persons have feund a permanen home with us.
ADMINISTRATION :
The administrative and clerical staff has been kept very limited
in number throughout the years. We have not yet succumbed to the
Law of Parkinson.' This position is being taken as a testing challenge
which we faced and handled bravely enough, I presume.
The assets of the Centre are assets of the Diocese of Salem.
■phe Bishop of Salem is the Patron of the Centre, which is a branch
of Salem Diocese Society.
Financially we are dependent entirely on Grants and contribu
tions from abroad and Benefactors from India.; We are most indebted
to German Leprosy Relief Assn,, which over all these years has borne
the largest part of our financial requirements. Its uninterrupted help
and deep understanding have assured the increasing extension and
improvement of our activities, without causing us too much worries.
Patients and staff join me in expressing our grateful thanks and wishes
for God's blessings on this organisation and the peoples, who make
its admirable performance possible.
With Grants from MISEREOR / Germany we have constructed
the Hospital. For many years no .v substantial contributions to our
Budget have come from the Belg an organisation Amis du Pere Damien
from Foundation Raoul Follereau France, from LEPRA and ORDER of
CHARITY ENGLAND, from LEPRAHILFE EMMAUS SCHWEIZ - not
to forget PAX CHRISTI Movement and CARITAS VERBAND
GERMANY. To all of them our heartfelt thanks. Last but not least
our hearts go out in thanksgiving to ail the personal friends in India
and abroad, who make our task easier by their moral and material
support.
To the Government of India, we owe thanks for the first vehicle
a Willy's station wagon and for intermittend supplies of DAPSONE
in appreciable quantities. We are equally grateful for the approval
and appreciation and guidance we always received from the State and
Centre Authorities.
All'.his said I can not omit to express my heartfelt personal
gratitude and appreciation to the patients and to the Staff, whose
trust and reliance were and are imperturbable, whatever problems and
difficulties we
worse”!
had to takle.
They are
faithful “for
better, for
The future will find us together in the same Team spirit, pursuing
the same objectives. We certainly will do our very best to improve
our performance, to overcome shortcomings, to eliminate any lacunae
and in this effort contribute effectively to the N. L. C. P.
The Patient will remain our principal commitment. He, our
fellow-man who is attacked by a pathegenic organism, that can and
often does, devastate his body. He has to carry the Cross of suffering,
for which instead of being respected by fellow humans, he all too
often is despised and removed from their midst, helplessly left to a
merciless fate.
If Leprosy Control should be successful, the co-operation of
the sufferer himself is needed above all else. This cardinal require
ment seems at times forgotten in otherwise very intelligently and
meticulously worked out eradication schemes.
The Honourable Prime Minister has given new impetus to
N. L. C. P. by her urgent request and wish, that Leprosy must be
wiped out by the year 2000. Let us hope, that N. L. C. P. in co
operation with dedicated VOLUNTARY INSTITUTIONS is able to
create an attitude and social and spiritual climate, that inspires
confidence and gives the patient security and peace of mind on his
extremely trying route to final cure. Only with his unreserved con
sent will India eventually overcome this serious Public Health
Problem.
MAY GOD GIVE HIS BLESSINGS I
P)|5 *5.17-
Cotti si r y i t -.:
«7/i. /First Floor) S'. /W?rks Road,
health technology
dinections
PATH
Program for Appropriate Technology in Health
Leprosy
Leprosy is a chronic, infectious,
mycobacterial disease that
affects about 10 million people,
mainly in developing countries.
The World Health Organization
(WHO) estimates that approxi
mately 1.6 billion people currently
live in regions where the preva
lence of the disease exceeds one
case per 1,000 persons.
Leprosy, also known as Han
sen's Disease, primarily affects
peripheral nerves, skin, and
mucous membranes. The dis
ease exacts a high social as well
as physical toll. If left untreated,
leprosy can result in deformity
and disability, causing those
afflicted to be needlessly
Volume 9, Number 3
shunned and feared in many
parts of the world because of
myths and prejudices associated
with the disease. Although effec
tive drugs to cure leprosy have
been available for several dec
ades, many sufferers are reluc
tant to identify themselves by
seeking treatment. This is partly
because they fear that families,
friends, community members, and
employers may reject or ostracize
them. Yet leprosy is curable, and
if it is diagnosed and treated
early, deformity and disability can
be prevented.
in the treatment and control of
leprosy. The most important of
these is multidrug therapy (MDT),
which uses a combination of
drugs to treat the disease and
was developed to address the
problem of drug resistance asso
ciated with single drug therapy.
Other technologies related to pro
gram management, service deli
very, patient and community edu
cation, and the prevention and
correction of disabilities also have
led to more effective leprosy con
trol activities worldwide.
During the 1980s, several new
technologies were developed that
have led to major improvements
This issue of DIRECTIONS
describes leprosy and reviews the
technologies used in its diag
nosis, treatment, and prevention.
Treatment and Prevention
Program Management
ISSN: 0730-8620
1989
2
Description and Diagnosis
Description
Mycobacterium Leprae, the bacil
lus (rod-shaped bacteria) that
causes leprosy, is a slow-growing
organism closely resembling the
tuberculosis bacillus. Because
M. Leprae has never been culti
vated successfully in vitro, know
ledge about it is limited.
Leprosy generally is more com
mon among males than females.
This difference, which is less pro
nounced in children, may exist
because adult males in many
societies have greater mobility
than their female counterparts
and thus more opportunities for
exposure to the bacillus. Lep
rosy’s average incubation period
ranges from two to seven years
and sometimes longer.
Transmission: The exact mode
of leprosy transmission is still
unclear. For many years, leprosy
was believed to be transmitted
through direct skin-to-skin con
tact. Because leprosy bacilli usu
ally are not found on the skin's
surface, however, experts now
consider this mode unlikely.
Instead, they believe that M. Lep
rae is transmitted primarily via the
directions/9:3 1989
Susceptibility: The incidence
and distribution of leprosy varies
widely and irregularly within
endemic regions, suggesting that
the risk of acquiring the disease
varies among individuals. Thus,
while leprosy bacilli may be trans
mitted easily, perhaps 95 percent
of people who are infected with
the bacilli never develop the dis
ease. Cell-mediated immunity
(CMl), or the ability of individual
cells to resist infection, is the
mechanism that protects against
leprosy. CMl also influences the
type of leprosy that develops.
Factors influencing the strength
of the CMl response in individuals
include prior exposure to other
mycobacteria, pregnancy, the
presence of other diseases, and
genetics. For instance, experts
have known for years that a rela
tionship exists between leprosy
and tuberculosis (TB), which is
also caused by a mycobacterium.
Where TB is widespread,
declines in leprosy incidence
have been observed, possibly
due to a cross-immunological
effect between the two diseases.
(For more information on TB, see
DIRECTIONS, 6(1), 1986.)
Pregnancy may lead to the devel
opment of active disease in
women already infected with the
bacillus or to exacerbation and
relapse in untreated or inade
quately treated existing cases.
This may occur because elevated
estrogen levels associated with
pregnancy lower CML WHO rec
ommends that women with active
leprosy postpone pregnancy until
completion of treatment.
Some experts fear that the
increased incidence of human
immunodeficiency virus (HIV)
infection, which causes acquired
immune deficiency syndrome
(AIDS) and is associated with
depressed CMl, may lead to ah
increase in leprosy incidence or
deterioration in existing cases.
More research is needed, how
ever, to confirm such a relation
ship.
Diagnosis
Because individual resistance to
leprosy varies, the disease
appears in many different forms
and exhibits a wide range of
signs and symptoms. This some
times makes diagnosis difficult,
yet early diagnosis is critical to
prevent disability and deformity.
CIBA-GEIGY, Limited
upper respiratory tract, which
may harbor millions of leprosy
bacilli. With each cough or
sneeze, the bacilli are discharged
on droplets or dust particles that
healthy individuals then inhale.
Prolonged, close contact with
infectious persons is likely to
increase the risk of transmission.
3
Slit-Skin Smears
Skin smear examination is important for accurately diagnosing, classi
fying, and treating leprosy. High standards are vital when performing
the procedure; smears that are mishandled or interpreted incorrectly
after they are stained yield misleading results. Selection of smear sites
should be made by an experienced leprosy clinician. Smears usually
are taken from at least one ear lobe and from the most active edges of
two to four typical skin lesions. They should be taken in good light so
that lesions can be seen easily. After the samples are fixed to slides,
they are stained using the Ziehl-Neelsen technique. The density of the
stained bacilli in smears is called the bacterial index (Bl). The morpho
Lesion and smear sites should be
logical index (Ml) indicates the percentage of uniformly stained bacilli in
documented on a body diagram.
the slide. Taking good smears requires clean microscope slides and a
slide box; slide labels or a grease pencil for marking slides; a sharp,
sterile scalpel; matches, spirit, and a spirit lamp (if possible); cotton wool swabs; and surgical gloves.
After taking a smear, all materials contaminated with blood should be sterilized, if possible, or disposed
of safely. To reduce risk of infection, especially with HIV, health workers should use scalpels with
sterile, detachable blades that are discarded after a single use. Reusable scalpels or blades require
steam sterilization or high-level disinfection by boiling between uses. Chemical disinfection is much
less reliable and should be avoided. Where possible, workers should wear surgical gloves when taking
smears and handling slides to prevent contact with blood or smear material. For information on
resources regarding smear collection and interpretation, see Materials Available, page 12.
The three definitive diagnostic
signs of leprosy are: (1) reduc
tion or loss of feeling in skin
lesions, (2) enlargement and
tenderness of one or more peri
pheral nerves, and (3) the pres
ence of acid-fast bacilli in a skin
smear. Diagnosis is made when
one or more of these signs is
present. Technologies for diag
nosis are limited, but health wor
kers at all levels of the health
care system can use basic clini
cal and laboratory techniques to
improve diagnostic accuracy.
Skin lesions often are among the
first signs of leprosy. While other
diseases may cause lesions, only
leprosy lesions have impaired
sensation. A wisp of cotton wool,
a nylon thread, thin paper, or a
feather can be used to test for
sensory loss. After asking the
patient to close both eyes, the
examiner touches normal and
affected skin with one of these
items. With eyes still closed, the
patient points to the spot where
sensation is felt. This test is
repeated in affected and unaf
fected areas. Sensitivity to tem
perature is tested the same way
with two test tubes, one filled with
hot water and the other with cold.
WHO recently field tested a new,
inexpensive, battery-powered
thermal sensibility tester. About
the size of a pen, it provides a
quick and easy way to test ther
mosensitivity. Pain sensitivity is
tested by pin-prick.
Peripheral nerves may be tender
and enlarged due to leprosy
infection. (See diagram, page 2.)
Nerve damage symptoms include
sensory loss, muscle weakness,
paralysis, and tingling sensations,
especially in the face, hands, and
feet. Impaired eyelid function,
corneal anesthesia, and inflam
mation of the iris can lead to eye
damage. Since nerve damage
often results in painless injuries
and burns, potentially leading to
ulceration and disability, early
identification of nerve involve
ment is crucial.
Slit-skin smear results are used
to confirm leprosy diagnosis,
classify the disease, and monitor
the efficacy of chemotherapy.
Accurate interpretation of smears
depends on effective training and
supervision of health workers and
laboratory personnel and on the
condition of laboratory equipment
such as microscopes, glassware,
and reagent supplies. (See box
above.)
When clinical and bacteriological
examinations are inconclusive,
skin biopsies can provide needed
information. Nerve biopsies are
recommended in exceptional
directions / 9:3 1989
Paucibacillary leprosy lesion.
cases where peripheral nerves
are enlarged, but skin lesions are
absent. Major sensory and motor
nerve trunks should not be biopsied.
Skin and serological tests to
detect subclinical leprosy infec
tion currently are under develop
ment. If adequately sensitive and
specific, such tests could facilitate
early identification and treatment
and enhance understanding of
risk factors relating to leprosy
infection and disease.
Leprosy classification helps to
determine treatment strategies
and identify patients who are
highly infectious or at risk of dis
ease complications. The different
forms of leprosy are classified
along a continuous spectrum of
disease. Three different classifi
cation systems are in use: the
Madrid system, the Ridley and
Jopling system, and the WHO
system.
The Madrid system divides lep
rosy into three forms: (1) the
lepromatous form, which is the
most severe and indicates that
the patient’s CMI is extremely
weak or nonexistent; (2) the
tuberculoid form, which is the
least severe; and (3) the border
directions/9:3 1989
The Ridley and Jopling classifi
cation system is somewhat more
precise and divides leprosy into
five groups from least to most
severe: (1) polar tuberculoid,
(2) borderline tuberculoid,
(3) mid-borderline, (4) borderline
lepromatous, and (5) polar lepro
matous.
Both of these classification sys
tems also recognize an indeter
minate form of leprosy in which
patients have one or a few illdefined skin lesions. Peripheral
nerves usually are unaffected,
and skin smears are negative.
Sensory impairment, however, is
always present. These cases
may develop into more serious
forms of the disease or may
resolve without treatment.
The WHO classification system
divides leprosy into two groups:
paucibacillary and multibacillary.
Paucibacillary leprosy is usually
noninfectious. It includes all
smear-negative polar tuberculoid,
borderline tuberculoid, and inde
terminate forms. Multibacillary
leprosy includes all smear
positive mid-borderline, border
line lepromatous, and polar lepro
matous cases. The multibacillary
CLASSIFICATION
SYSTEMS
Ridley &
Jopling
Madrid
WHO
patient has little or no resistance
to leprosy bacilli and may be very
infectious until treated.
Of these systems, the Ridley and
Jopling system places the dis
ease most precisely on the immu
nological spectrum, while WHO’s
classification is simplest and most
applicable to developing country
control programs. The WHO sys
tem's primary goal is to ensure
that leprosy patients receive the
appropriate MDT regimen. The
relationship among the three
systems is illustrated below.
The lepromin test, which consists
of an intradermal injection of
autoclaved M. Leprae into the
patient's forearm, sometimes is
used to classify the disease after
diagnosis by indicating the
strength of a patient's CMI
response. Paucibacillary patients
will have a positive test result,
indicating a strong immune
response. Multibacillary patients
will have a negative test result,
indicating that there is little or no
resistance to infection. In mid
borderline and indeterminate
cases, the results vary. The long
waiting time (three to four weeks)
between administration and inter
pretation of the test, however,
makes follow-up difficult, espe
cially in rural areas. Obtaining
lepromin and training health wor
kers to use the test add to the
logistical difficulty.
SPECTRUM OF LEPROSY
Polar
Borderline
Tuberculoid Tuberculoid
Tuberculoid
Paucibacillary
Polar
Mid
Borderline
borderline Lepromatous Lepromatous
Borderline
Lepromatous
Multibacillary
ALERT/German Leprosy
Relief Fund
line form, in which the patient
shows some resistance but may
have a variety of symptoms,
depending on the strength of
resistance.
I reatment and Prevention
three years to a lifetime, which
often results in poor patient com
pliance. Compliance problems,
as well as exclusive reliance on a
single drug administered in low
doses over a long period of time,
have led to the emergence of
dapsone-resistant strains of M.
Leprae in over 40 countries.
Resistance causes frequent
relapse or failure to improve with
treatment, and patients resume
infectiousness. (For details on
drug resistance, see DIREC
TIONS,^), 1983.)
After diagnosis and classification,
appropriate treatment is selected.
Chemotherapy is the most impor
tant technology for treating lep
rosy and managing complications
such as changes in immunologi
cal status (reactions) and relapse.
If chemotherapy is started early,
recovery from leprosy usually is
complete, and disability can be
prevented. New treatment and
prevention technologies, such as
vaccines, also are under develop
ment. Technologies to control
disabilities include tools and tech
niques to facilitate physical func
tioning and protective devices to
prevent further damage.
Chemotherapy: For nearly 40
years, leprosy has been treated
with a single sulfone drug called
dapsone. Dapsone revolution
ized leprosy control. Isolation of
leprosy patients no longer was
considered necessary, and
patients could treat themselves
with daily doses at home. Dap
sone is inexpensive, has few side
effects at recommended dosage
levels, and is very effective in
arresting leprosy and its trans
mission. Complete cure, how
ever, may require treatment for
Treatment failure due to resis
tance can be avoided by com
bining drugs to treat leprosy. In
1981 WHO recommended that
multidrug therapy (MDT) replace
dapsone monotherapy for treat
ing leprosy. The goals of MDT
are to eliminate patients' infec
tiousness, interrupt disease trans
mission, shorten the duration of
treatment, and prevent or over
come further development of
drug resistance. WHO defined
specific drug regimens for paucibacillary and muItibacillary
patients that are effective and
feasible under a variety of field
conditions. (See box, page 6.)
MDT uses three anti-leprosy
drugs: dapsone, rifampicin, and
clofazimine. Multibacillary
patients receive all three, while
paucibacillary patients receive
only dapsone and rifampicin.
Rifampicin is well-tolerated and
very effective; a single 600 milli
gram dose kills almost all bacilli
within several days, leaving the
patient noninfectious. Multibacil
lary and paucibacillary patients
both receive monthly, supervised
doses of rifampicin.
In addition to dapsone and rifam
picin, multibacillary patients take
daily and monthly doses of clofa
zimine. Though very effective,
clofazimine side effects can
include reddening of skin lesions
and darkening of skin exposed to
sun, which causes some patients
to object to its use. If a patient
refuses clofazimine, a thiomide
(ethionamide or protionamide)
may be considered. Thiomides,
however, are much more toxic
than clofazimine, possibly caus
ing liver damage when taken with
rifampicin, and generally are not
advisable.
MDT is a major development in
leprosy treatment and control.
Sustained use of MDT may
reduce leprosy prevalence by 75
percent in five years, making pos
sible the eventual eradication of
A. Multibacillary patient before MDT. B. The same patient
after one year of MD T.
i(Sl Flo
Bangalore
Roaa,
/ 9:3 1989
6
leprosy. Patients can be com
pletely cured in six months to two
years (depending on the form of
leprosy), and those who receive
MDT early in the course of the
disease are much less likely to
develop permanent disabilities.
Vaccines: Research on leprosy
vaccines has been under way for
many years. Progress has been
slow mainly because M. Leprae
cannot be cultivated in vitro, and
large quantities of the bacillus
can be obtained only from experi
mentally infected, nonhuman
sources such as the armadillo.
The Bacillus of Calmette and
Guerin (BCG) vaccine, which pro
tects against tuberculosis, was
the first vaccine considered for
leprosy because of possible
cross-immunological benefits.
BCG's protective effect against
leprosy has been tested in four
field trials. Because results
ranged from 20 percent protec
tion in Burma to over 80 percent
in Uganda, BCG is not recom
mended for use against leprosy.
Current research is focusing on a
vaccine combining heat-killed M.
Leprae (HKML) with BCG to
induce strong CM I responses in
leprosy patients who previously
had little or no response. Com
bining these mycobacteria may
prevent infection as well as gen
erate immune responses in
patients already infected. Field
trials of HKML alone and in com
bination with BCG began in
Malawi and Venezuela several
years ago. Study results will not
be available for almost ten years.
Treatment of reactions: Reac
tions are acute episodes associ
ated with changes in the patient's
immunological status. They can
occur in all forms of leprosy
except indeterminate leprosy,
regardless of whether or not the
patient is on chemotherapy.
Unless reactions are treated
promptly and adequately, they
can lead to severe and perma
nent neural and tissue damage.
Two basic reactions occur in lep
rosy patients. Type One lepra
reactions, also known as reversal
reactions, primarily occur in
borderline cases and involve a
sudden strengthening of the CM1
response. Of greatest concern
are the changes in peripheral
nerves, which swell rapidly,
become painful, and impair nerve
function. If untreated, severe and
permanent nerve damage may
result, causing loss of sensation,
muscle contractures, and perma
nent paralysis. Corticosteroids
should be given to treat inflam
mation, and analgesics may be
administered to relieve pain.
Type Two lepra reactions occur in
lepromatous patients. They are
caused by changes in humoral
(systemic) immunity response
and also are called erythema
nodosum leprosum (ENL)
reactions, which means red
nodes of leprosy, because of
their clinical features. Like Type
One reactions, ENL reactions
often affect nerve functioning.
Unlike Type One reactions, how
ever, they also may involve eyes,
kidneys, spleen, testes, joints,
and muscles. Corticosteroids
and thalidomide or clofazimine
are used to treat ENL reactions.
Women of childbearing age
should be given clofazimine
instead of thalidomide, which can
cause serious birth defects.
MULTIDRUG THERAPY FOR LEPROSY
PAUCIBACILLARY
LEPROSY
MULTIBACILLARY
LEPROSY
Rifamoicin-soo mg oncemonthly, supervised
RltamPlC'n-600 mg oncemonthly, supervised
WHO Recommended
Regimen
Dapsone--100 mg (1-2 mg/kg
body weight) daily, self
administered
DaES2ll2--100 mg (1-2 mg/kg
body weight) daily, self
administered
*-Clofazimine
aoo
mg oncemonthly, supervised, and 50
mg daily, self-administered
Duration of Treatment
Six months
At least two years or, when
possible, until skin smears are
negative
Surveillance after
Completion of Treatment
Annual exams for at least two
years
Annual exams for at least five
years
‘If patients refuse clofazimine, substitute ethionamide or protionamide In dally, self-administered
doses of 5-10 mg/kg body weight.
directions/9:3 1989
For either reaction, patients on
MDT should continue the pre
scribed regimen, rest affected
limbs, and limit activity until the
reaction has passed. Severe
reactions may require hospitali
zation.
Disabilities: Approximately30
percent of registered leprosy
patients suffer from deformities
and disabilities. Damage to peri
pheral nerves, which maintain
skin sensation and muscle move
ment, causes the majority of dis
abilities. Complications such as
blindness, paralysis, and loss of
7
skin sensation are preventable
with early diagnosis, treatment,
and patient education. If disabili
ties develop, prompt measures to
control them and prevent further
damage are critical.
Although all areas of sensory loss
are at risk of injury, the feet and
hands are most susceptible.
Infected wounds leading to ulcer
ation of the foot is one of the
most common problems of lep
rosy. Almost all ulcers heal with
rest over time. If the patient does
not detect the wound due to sen
sory loss and continues to walk
without protection, however,
severe tissue damage and even
tually bone loss may result.
Untreated hand injuries lead to
similar problems including loss of
fingers. Leprosy also may impair
skin secretions, such as the abil
ity to sweat, and affected areas
often become dry, cracked, and
therefore susceptible to infection.
Protective devices help prevent
injury to hands, feet, and eyes.
For example, gloves should be
worn to avoid hand burns when
cooking or tending fires, and
shoes or sandals should be worn
at all times. Deformed feet
require specially designed shoes
to fit abnormal contours and
distribute weight evenly. Foot
wear with stiff soles and insoles
of microcellular rubber or plastazote (a soft, heat-moldable foam
plastic) are ideal. Extra high arch
supports relieve pressure on
toes, and soft, cotton sandal
strap lining protects against
chafing and blistering. Nails
never should be used in shoes
for leprosy patients.
About 250,000 people may be
blind due to leprosy, yet leprosyrelated blindness is preventable
ment, and flush eyes with spe
cially formulated disinfectant or
tear substitute, or for iris inflam
mation, with steroid drops.
in most cases. Blindness may
occur for several reasons. Mus
cles in the eyelid may be para
lyzed due to peripheral nerve
damage, thereby preventing
blinking; the cornea may lose
sensitivity (corneal anesthesia),
making the patient unaware of
eye damage or infection; or the
iris may become inflamed during
a Type Two reaction, potentially
causing permanent damage.
Dark glasses can protect eyes
from dust and dirt. A low-cost
eye shield made of transparent
plastic and adhesive also can be
worn for protection.
Self-care techniques: Patients
suffering from sensory loss must
conduct regular, daily exams of
hands, feet, and eyes to check
for minor infections and injuries.
To prevent infection and mois
turize the skin, leprosy patients
should soak affected hands and
feet in water for 20 to 30 minutes
every day. After soaking and
patting the skin dry, the patient
should apply petroleum jelly or a
vegetable oil over the skin to help
retain moisture. If eyelid muscle
weakness is evident, patients
should close eyes regularly as
tightly as possible (“think and
blink”), apply antibiotic eye oint
Clinical care: If ulcers develop,
they should be cleaned thor
oughly with soap and water.
Adhesive zinc tape or other
dressings or in severe cases, a
plaster cast for about five weeks
to rest the limb also may be nec
essary. A cast should not be
used, however, until the ulcer is
clean and the infection is con
trolled.
Physical therapy: Simple, daily
exercises such as repeatedly
extending paralyzed fingers can
prevent muscle wasting and con
tractures and increase muscle
strength. Conditions such as
dropped foot or claw hand may
require splints or braces to pre
vent further damage. Plaster or
molded plastic splints also stabi
lize affected limbs during reac
tions, reducing pain and prevent
ing contractures. To facilitate the
use of small objects, gripping aids
made of epoxy putty can be
molded to items such as tools,
pens and pencils, and eating
utensils.
Surgery: Common surgical pro
cedures include removing dead
bone, draining abscesses, and
debriding ulcers. Tendon transfer
to straighten clawed fingers and
toes and correct dropped feet, as
well as reconstructive surgery to
rebuild collapsed noses or
replace lost eyebrows, also are
possible. Severe deformity or
infection may warrant amputation.
Surgery also may be required to
treat eyelid paralysis. Unfortu
nately, most leprosy control pro
grams are not equipped to pro
vide such specialized care.
directions/9:3 1989
Program Management
used. Case-finding activities,
however, are valuable only if effi
cient, reliable treatment services
are available for every case iden
tified. Essential service compo
nents include well-trained per
sonnel; well-organized, fullystocked clinics; accessible labo
ratory facilities for smear and
biopsy analysis; and referral faci
lities for patients with reactions,
drug side effects, or deformities
requiring surgical corrections.
The essential components of
successful leprosy control pro
grams are: (1) early case-finding
and treatment; (2) effective mon
itoring and follow-up of patients
under treatment; (3) education of
the patient, family, and commu
nity; (4) training and supervision
of health care personnel at all
levels of the system in leprosy
diagnosis, case management,
and referral; (5) program moni
toring and evaluation; and (6)
social integration and rehabilita
tion of persons with leprosy.
Early case-finding and treat
ment: Early case identification
and registration allows prompt
administration of chemotherapy
to prevent disabilities and elimi
nate infectiousness. WHO
defines a leprosy case as “a per
son having clinical signs of lep
rosy with or without bacteriologi
cal confirmation of the diagnosis,
and requiring chemotherapy."
WHO recommends that this
definition be adopted worldwide
so that data may be compared
among different countries.
Active case-finding methods
include contact surveillance and
screening of schoolchildren. In
contact surveillance, health wor
kers obtain smears and conduct
clinical examinations on all previ
ously identified patients and their
household contacts to confirm
diagnosis. It is most useful in
areas of low to moderate endemicity and in urban slum areas,
where cases often are clustered.
Screening schoolchildren is use
ful in highly endemic areas. In
Bombay, India, school surveys
have been conducted since 1970.
Active methods with more limited
use include total population sur
veys, job site screening, and
rapid surveys. Total population
surveys are useful only in highly
Both active and passive case
finding methods commonly are
screening schoolchildren.
directions / 9:3 1989
endemic areas. Job site screen
ing can be effective but may
result in job loss for workers iden
tified as having leprosy. Rapid
surveys, usually organized at
centrally located screening sites,
are particularly effective when
combined with general health
examinations.
Despite these efforts, most cases
are identified through self
reporting, referral, and notifica
tion. These passive methods
absolutely require effective health
education to dispel myths about
leprosy, teach people to recog
nize early signs of the disease,
and inform people about avail
able treatment services.
Once cases are identified, MDT
should be initiated immediately.
Unfortunately, the pace of MDT
implementation has been slow.
Of the estimated 10 million lep
rosy cases worldwide, about 5
million cases are officially regis
tered, and of this number only
about 2.1 million cases, or less
than half, have been put on MDT.
In Africa, less than 20 percent of
leprosy cases are receiving MDT.
Several factors contribute to this
problem. First, initial costs of
MDT are higher than dapsone
therapy. The duration of MDT,
however, is much shorter, espe
cially for paucibacillary leprosy
(six months instead of three to
five years), making the long term
cost-effectiveness of MDT much
greater than dapsone therapy. In
addition, drug costs are dropping
steadily, as are total expenditures
for treating disabilities, since
disabilities occur less frequently
among patients receiving MDT.
9
Blister Calendar Packs
Blister calendar packs provide a one-month supply of all necessary
drugs for M DT. The upper portion of the pack contains the drugs to
be taken monthly under supervision. The clinic worker tears off and
retains this portion when the drugs are dispensed. The lower por
tion contains the daily doses of dapsone, organized by weeks into
four rows. Different packs are available for both paucibacillary and
multibacillary adult patients as well as for paucibacillary child
patients. Multibacillary leprosy in children is rare, making blister
calendar packs less cost-effective for this group. Study results from
India, the Philippines, and Thailand indicate that patient compliance
improves when these packs are used. In addition, non-medical per
sonnel can be trained to dispense the packs, and time previously
spent counting out pills and instructing the patient can be devoted to
other control activities. Blister calendar packs appear to facilitate
drug planning and supply, improve delivery of proper treatment from
peripheral health posts to rural populations, reduce drug wastage
and misuse, and improve clinic attendance. They are more expen
sive than “loose” drugs, however, and although it appears that using
blister calendar packs is cost-effective, further studies are needed to
confirm this.
Experience over the last seven
years has shown that effective
MDT programs need adequate
resources and well-trained per
sonnel to carry out support activ
ities related to MDT. Prior to
implementing MDT in an area, all
registered cases must be
reviewed and those patients no
longer requiring treatment should
be released from the registers. In
areas where resources are lim
ited, MDT should be introduced
on a small scale in one area or
district and then slowly expanded
to other areas as resources
become available. A systematic
method of tracing patients who
have dropped out of treatment
also should be established.
Follow-up: Monitoring and
follow-up of patients on MDT is
crucial to promote compliance
and minimize interruption of treat
ment. Drug intake can be moni
tored by consulting with the
patient and counting remaining
tablets or capsules or by taking
urine samples to test for the pres
ence of anti-leprosy drugs. Dap
sone is easily detected in urine
using a spot test on filter paper
treated with Ehrlich’s reagent; a
yellow ring immediately appears if
the urine contains sulfones. Sim
ply checking the urine for a red
dish color will indicate if rifampicin
has been taken in the last six to
ten hours. Health workers also
should make home visits to
remind patients of appointments.
recommends that, if possible,
paucibacillary patients and their
household contacts be kept
under surveillance for at least two
years, with annual clinical exam
inations. Multibacillary patients
and their household contacts
require five years of surveillance.
Patients who have completed
treatment should be instructed to
return to the clinic at the first sign
of relapse.
Health education: Because
leprosy inspires such fear and
misunderstanding, programs to
control the disease require inten
sive health education for patients,
families, and the community to
dispel myths and reduce preju
dice. Training people to recog
nize leprosy signs and symptoms
also is important. Health educa
tion campaigns must take into
account local attitudes and
beliefs about leprosy. Cam
paigns are most effective when
respected community members
such as village chiefs, traditional
healers, religious leaders, and
school teachers are involved.
Existing leprosy education mate
rials can be adapted to specific
settings to support effective lep
rosy education campaigns. (See
Materials Available, page 12.)
Because MDT regimens require
coordinating the supply of differ
ent drugs and taking a mixture of
daily and monthly dosages both
at home and under supervision,
assuring timely and correct drug
intake can be difficult. One inno
vation to improve treatment com
pliance is the development of
blister calendar packs to facilitate
the delivery of drugs. (See box
above.)
Once the prescribed course of
treatment is completed, WHO
Health worker explains importance of
foot care to leprosy patient.
COMMUNITY HP-
~:,' C£LL_____________ —
47/1. (First Floor; St. n?ar;;s Road
Bangalore - 560 001.
directions/9:3 1989
10
Patient education begins at diag
nosis. To improve compliance,
patients must understand what
chemotherapy can accomplish
and how long treatment is
required. They also must
develop a personal sense of
responsibility for preventing
disabilities and deformities and
have a clear understanding of
appropriate self-care techniques.
The patient’s family also must be
educated about the disease so
that they do not reject or ostra
cize the patient. If family mem
bers understand the disease and
the need for regular treatment,
they can play an important role in
achieving patient compliance with
MDT and self-care.
Mass media can help educate the
general public about leprosy. For
example, in India, posters and
billboards with simple phrases
such as “leprosy is curable" and
“leprosy is not hereditary" have
been posted throughout the rail
way and bus systems in certain
provinces. Similar messages are
printed on railway timetables.
Exhibitions and check-up stations
allow waiting passengers to see
videos, read pamphlets, and be
screened for leprosy, if desired.
Keeping accurate records is an essen
tialcomponent of effective leprosy
control programs.
directions / 9:3 1989
Radio and film presentations,
pamphlets, community education
campaigns, and school-based
health education also can reduce
the social stigma and prejudice
often associated with leprosy. In
Sierra Leone, a local theater
staged several performances
about a person with leprosy to
raise community awareness.
Training and supervision:
MDT implementation and other
new control activities make train
ing of health care personnel at all
levels very important. Clearly
defined tasks accompanied by
good supervision increase effi
ciency, develop skills, and pro
mote positive work attitudes. A
manual with all essential informa
tion on leprosy diagnosis, treat
ment, management, and pre
vention must be developed for
health workers. Adequate train
ing in leprosy must be included in
the curricula of medical and para
medical training institutions,
especially in countries where the
disease is endemic.
Monitoring and evaluation:
Simple, standardized information
systems should be established to
monitor and evaluate the opera
tional, clinical, and epidemiologi
cal aspects of leprosy control.
Ideally, the following data should
be collected: number of regis
tered cases, case detection rates,
disability rates among new cases,
MDT coverage and drop-out sta
tistics, and relapse rates. At a
minimum, leprosy control pro
grams should maintain patient
record cards or a treatment regis
ter for active patients. Patient
record cards should contain
demographic information, diag
nosis, treatment initiation and
completion dates, and follow-up
examination results.
To ensure accurate statistics,
program managers should estab
lish routine quality control sys
tems. The nature and extent of
random quality control checks
depends on the availability of
supervisory staff and laboratories.
Activities that should be reviewed
routinely include leprosy diag
noses and classification, smear
results, record-keeping systems,
and statistical calculations.
To determine the effectiveness of
leprosy control activities, WHO
has helped develop the OMSLEP
Recording and Reporting System,
which is used in many countries.
The system can be adapted to
the specific information system
used in each country, and its
standardized format facilitates the
comparison of data among dif
ferent countries. Information can
be compiled and interpreted with
or without the use of microcom
puters.
Social integration: The social
isolation of leprosy patients,
though less prevalent than in the
past, is one of the last remaining
barriers to the eradication of
leprosy. Social isolation is
unnecessary and inflicts untold
suffering on patients and their
families. Community programs
help encourage social integration
of leprosy patients. For example,
community-based rehabilitation
(CBR) for the disabled integrates
leprosy patients by treating disa
bilities through existing health
services within the community.
CBR promotes awareness and
responsibility for care among
community members, increases
self-reliance, and encourages the
use of simple, affordable, and
culturally acceptable methods
and technologies for physical
therapy and rehabilitation.
11
NATIONAL PROGRAM STRATEGIES
When establishing a national leprosy control program, important considerations include whether or not it
will be integrated into general health services and how MDT will be introduced. In most countries, sepa
rate, vertical, leprosy control programs have been established, it is generally agreed, however, that leprosy
care should be integrated into primary health care where possible. Although specialized care for leprosy
patients still is needed, integration helps to reduce the stigmatization of leprosy patients, to improve access
to comprehensive and continuous care, to prevent duplication of services, and to minimize dependence on
donor agencies.
Integration requires extensive planning, a well-supported primary health care system, and effective super
vision of staff. In highly endemic areas (more than 5 cases per 1,000 persons) a vertical program may be
necessary to avoid overloading the system until additional resources are available. In India, which has an
estimated four million leprosy cases, integration is occurring in phases. In highly endemic districts, leprosy
control is organized vertically. In remaining districts, the program is managed through the general health
care system.
MDT introduction has been a national policy in India since 1983, with the goal of curing all known cases by
2000. As of March, 1989, MDT had been introduced in phases into 112 of 201 highly endemic districts,
with 2.3 million people receiving MDT. These phases are outlined below. In ten districts where MDT has
been available for five years or more, overall prevalence rates for all districts have dropped from 20.7
cases per 1,000 to 2.4 cases per 1,000. The incidence and disability rates also are declining.
PHASES OF MDT IMPLEMENTATION
Planning and
Preparation
Intensive
• organize positioning of
infrastructure
• perform rapid surveys to
detect remaining cases
• deliver MDT to eligible
patients
• monitor patients com
pleting MDT
• provide basic training to
staff
• conduct sample surveys
to validate existing data
and obtain baseline
figures
• screen all cases to verify
classification and MDT
eligibility
• follow-up on MDT drop
outs
• conduct ongoing case
detection: screen house
hold contacts, school
children
• general health care staff
assume more responsibility
Mobilization
• conduct active case
finding surveys to detect
at least 80% of cases
• monitor drug intake
• conduct intensive public
awareness campaigns
Conclusions
Leprosy is a serious public health
problem affecting millions of
people worldwide. In addition to
physical suffering, leprosy
patients often endure social
ostracism and prejudice because
of myths and misconceptions
surrounding the disease.
Yet never before have the pros
pects been better for controlling
and eradicating leprosy. New
diagnostic, treatment, and pro
gram management technologies
are being developed that may
revolutionize the control of the
disease. The most important of
these is MDT, which represents a
crucial breakthrough in the treat
ment of leprosy. Where chemo
therapy has been introduced and
sustained, marked reductions in
leprosy prevalence have occurred.
The future development of tech
nologies such as vaccines to
prevent and treat leprosy also
promise to have profound effects
on the control of the disease. In
addition, health education and
program management techniques
to encourage public support of
leprosy patients are receiving
greater attention. For patients
Maintenance
• phase out vertical program
as prevalence declines
who have developed disabilities
and deformities, rehabilitation
tools and techniques now exist to
improve functioning and prevent
further physical deterioration.
All of these technologies can
reduce the needless physical and
psychological suffering of leprosy.
Concerted efforts to improve
health care delivery to leprosy
patients and educate the public
about the disease must continue,
however, so that people with
leprosy will seek and receive the
treatment they need without fear
of social reprisal.
directions/9:3 1989
12
Materials Available
WHO has produced several
excellent publications on leprosy.
They include: A Guide to Lep
rosy Control, Second Edition;
Epidemiology of Leprosy in
Relation to Control; Chemo
therapy of Leprosy for Control
Programmes; and WHO Expert
Committee on Leprosy. All
publications are available from
WHO, Leprosy Unit, Division of
Communicable Diseases, 1211
Geneva 27, Switzerland, or from
WHO regional offices.
□
Implementing Multidrug Ther
apy for Leprosy, by Dr. A. Colin
McDougall, covers all essential
issues related to MDT introduc
tion. It is available for US$7.95
per copy (includes shipping
costs). Write to: OXFAM, 274
Banbury Road, Oxford, 0X2
7DZ, U.K.
□
Many resources are available
from The Leprosy Mission Inter
national (TLMI). For example,
Preventing Disability in Lep
rosy Patients, by Jean M.
Watson, contains basic informa
tion and illustrations on care and
prevention of disabilities. Health
Education in Leprosy Work is
an excellent manual fortraining
health care workers. For details
on taking smears, consult the
Technical Guide for Smear
Examination for Leprosy by
Direct Microscopy. TLMI also
produces a magazine every six
months called Partners. It is
available at no charge to leprosy
health workers. For a complete
list of English language teaching
and learning materials and order
ing information, contact: The
Leprosy Mission International, 80
Windmill Road, Brentford,
Middlesex, TW8 OQH, U.K.
directions / 9:3 1989
Two comprehensive and wellillustrated guides entitled Lep
rosy: Basic Information and
Management and Leprosy for
Medical Practitioners are avail
able in limited quantities free of
charge from CIBA-GEIGY, Ltd.,
CH-4002, Basle, Switzerland.
□
Teaching Aids at Low Cost
(T.A.L.C.) produces a wide range
of training materials, slide sets,
and guides on leprosy for training
medical and paramedical person
nel. For more information, write
to: T.A.L.C., Box 49, St. Albans,
Hertfordshire, AL1 4AX, U.K.
□
David Werner’s books, Where
There Is No Doctor and Disabled
Village Children, contain excel
lent sections on the diagnosis and
treatment of leprosy and on the
care and prevention of disabilities
resulting from leprosy. For
ordering information, write to:
Hesperian Foundation, P.O. Box
1692, Palo Alto, CA 94302, U.S.A.
□
A bibliography on leprosy is avail
able from PATH.
CORRECTIONS
In the last issue of DIRECTIONS
(“Immunization," 9(2), 1989), the
sentence at the bottom of the
Vaccine Storage Temperature
chart on page seven should have
stated that DPT, IPV, and TT
vaccines freeze at temperatures
below -3° C, not -30° C.
On page ten, STERitimer’s™
color change due to heat expo
sure was described as being irre
versible. In fact, it reverts back to
the original color as it cools.
Published by Program for
Appropriate Technology in Health
(PATH)
Editor:
Vivien Davis Tsu
Managing Editor:
Suzanne Janzen
Research and Writing:
Arnie Bishop
Production Assistance:
Nancy Legener
PATH
4 Nickerson Street
Seattle, WA 98109-1699 USA
Tel: (206) 285-3500
Tlx: 4740049 PATHUI
Fax:(206)285-6619
President:
Gordon W. Perkin, M.D.
The following people reviewed all or
part of this issue of DIRECTIONS:
Pieter Feenstra, Royal Tropical
Institute, Amsterdam, The Nether
lands; Robert Jacobson, G.W. Long
Hansen’s Disease Center, Carville,
Louisiana; A.C. McDougall, former
editor of Leprosy Review and con
sultant to LEPRA, Oxford, U.K.;
S.K. Noordeen, WHO, Geneva,
Switzerland; W.F. Ross, American
Leprosy Missions, Inc., Elmwood
Park, New Jersey; and Teera
Ramasoota, Ministry of Public
Health, Bangkok, Thailand. We
thank them for their valuable com
ments. Contents or opinions
expressed in DIRECTIONS, how
ever, remain the responsibility of
PATH.
DIRECTIONS is published three
times a year at irregular intervals.
Single copies are free to health
program managers in developing
countries and others interested in
primary health care programs.
PATH is a nonprofit, international
organization devoted to the devel
opment and application of appro
priate health technologies for pri
mary health care programs in devel
oping countries. PATH is pleased
to acknowledge support from the
Sasakawa Memorial Health Foun
dation for this issue.
£)i 8 <t> 13
LEPROSY IS CURABLE
LEPROSY has been shrouded in mystery since ancient times.
There are many misconceptions, false beliefs and supersitions
about this disease.
Leprosy is an infectious disease caused by a germ
known as Mycobacterium Leprae.
All leprosy cases are, however,
not infectious. Only 25 per cent of the leprosy cases in
India are infectious and they can transmit the disease to
healthy people by close contract.
Leprosy is neither herediatry
nor veneral in origin.
Nor is leprosy a curse of God or
supernatural forces.
It is a problem of prolonged sickness
and. deformity and sometimes destitution arising out of social
stigma and ostracism people often wrbngly associate with the
disease.
Leprosy is now curable by modern methods of treatment.
Regular treatment from the early stages of the disease cures the
patient without deformity.
Early signs:
Most of the- leorosy cases start with a discoloured
skin patch, accompanied by loss of sensation or with numbness
in one or more fingers and toes. Leprosy may also begin with a f
reddish patch or discolouration of the face often associated with
small nodules in the face or in the margin of the ears.
These patches usually tend to persisit and do not
itch or sweat, and hence dry. Sometimes the patches many look
smooth, glistening with ill-defined margins but without definite
loss or sensation in patch. But then the smears from the patch
will show leprosy bacilli as a sign of infectivity of the case.
Some other symptoms of leprosy are thickening of nerves in
exposed parts of the body, flattening of nose, nasal dis-charge,
clawing of fingers, recurrent chronic ulcer in the sole of the
feet.
Treatment:
Anybody showing these signs should consult a medical
practitioner or a doctor of the Primary Health Centre or Leprosy
Control Unit ano take treatment regularly. The treatment should
be continued as long as advised by the doctor.
Patients can stay
in their own homes and continue their normal occupations alongwith
regular outcoor treatment.
The patients should not be ostracized or
treated as social outcastes but must be persuaded to come forward
for early and regular treatment. A sympathetic attitude towards the
patient will greatly alleviate the discomfort of leprosy patients
and promote the programme of early detection and timely treatment
of new cases.
patients.
It will also help in rehabilitation of the cured
... .2
2
Only infectious patients should be kept in separate rooms
with separate arrangements till they become non-infectious.
Child contacts of infectious patients should be given regular
preventive treatment-oral CDS tablets.
>bn-infectious child
patients should not be refused admission in schools not should
they be discriminated against in any manner.
Rehabilitation is possible:
With the introduction of sulphone drugs, emphasis in
leprosy treatment has now shifted from isolation in colonies to
outdoor treatment on domiciliary abmulatory pattern which helps
the patient to remain with his own family, thereby preventing him
to become either a permanent colony patient or a beggar and
continue his occupation. One of the specific achievements of
progress of medical sciences over the years is the advancement
in physiotherapy, occupational therapy and reconstructive
surgery which help rehabilitate even a deformed leprosy patient
by correcting largely the physical deformities.
It is possible to use the results of modern advancements
only if leprosy is detected early and the patient put on regular
treatment. Thus deformities, if any, may not go to the
incorrigible stage. While regular and proper treatment is an
important requirement for cure and rehabilitation, a congenial
atmosphere in the patient's home and a sympathetic attitude is also
called for to boost up his morale.
These help in early cure.
A cured or non-infectious leprosy patient can work in any field,
according to his abilities. He is no danger to others. A medical
certificate as to the non-infectivity or cured status of the patient
can be taken as a criterion for accepting him in any job as any
other healthy person.
Voluntary organizations engaged in leprosy control work
have been encouraged and schemes for leprosy control work, training
of personnel and social wel£-are schemes for rehabilitation of
leprosy patients,, alongwith other handicaps have also been provided
respectively by the Health and Social Welfare Departments of the
Government, df India.
Leprosy is curable and preventable.
People should accept
it as a disease just like any other communicable disease.
They
shoulc, or course take necessary precautions for cure and prevention.
And, the patients should be shown the Same compassion as is shown to
any sick person.
3
3
Control and Preventive measures;
Leprosy is preventable by avoiding contact with infectious
patients and controllable by the use of "Dapsone" (DDS) tablets).
Administration of "Dapsone" is particularly effective and is
advised for children below 15 years who are living with or are in
contact with infectious cases of leprosy.
The National Leprosy Control Programme was launched by the
JYosjEaxitnsxwas Government of India in 1955 with these objectives in
view. Leprosy Control Units, Survey, Education and Treatment
Centres, etc., have been established in different parts of the
country to provide early diagnostic, regular follow up and
treatment services for all leprosy patients through outdoor and
indoor services.
SCU RCE: SWASTH HIND —
March/April 1979.
-o-o-o-
LeprRev (1982) 53, 205-209
COMMUNITY HEALTH CELL
326, V Main, I block
Koram»ng - la
Bangalore-560034 -/
India
Leprosy and Primary Health Care:
the Mandwa Project, India
N H ANTIA
The Foundation of Medical Research, 84-A R. G. Thadani Marg,
Worli, Bombay 400 018, India
Received for publication 23 April 1981
No disease can be controlled, however effective the remedy, if there is failure
in detection and regularity of treatment is not assured.
Leprosy control programmes were commenced in most endemic countries
of the world about a quarter of a century ago based on the availability, for the
first time, of a drug against the disease which was not only highly effective but
also safe, cheap and orally dispensable. A separate service was started for
leprosy as for many other major health problems like malaria, tuberculosis
and smallpox. These were the days of euphoria when we believed science had
the answers to most human problems. Twenty-five years later we remain sadder
but wiser.
Even in diseases like those which are sexually transmitted and where a
single injection can ensure cure, we have failed in achieving success in countries
where knowledge is widespread and facilities for treatment are freely available
to all. This sad tale has repeated itself for all the diseases where hopes of
control were high because of availability of cheap and effective drugs, vaccines
or insecticides. Smallpox was the only exception. The blame for such failure
has been attributed to many causes such as inadequate funds, nonavailability
of drugs, suitable personnel, transport; ignorance and apathy of the people
and their rulers, and finally the development of resistance to drugs and insecti
cides and the nonavailability or the exhorbitant cost of alternative treatment.
Yet we know that most of these diseases were eliminated from the
developed countries long before dings or vaccines were available for their
control. Education combined with improvement of the social and economic
conditions therefore remains the only certain way of controlling communicable
diseases. They are therefore more amenable to social and political action rather
than purely medical measures.
0305-7518/82/053205 + 06 $01.00
© British Leprosy Relief Association
205
206
N H Antia
Failure to achieve results despite vast inputs of men and money could have
been condoned in the early phases as a genuine lack of appreciation of these
factors, but the continuation and expansion of services which have proved to
be inadequate or ineffective can only be attributed to the vested interest
of professionals, bureaucracy, pharmaceutical industry and politicians in
propagating the empires built by them on various diseases. Any new approach,
however well based on scientific and/or social reality, is firmly resisted on
administrative or technical grounds. Unfortunately, those who have a vested
interest in maintaining the status quo are also generally the persons in
whom society has vested responsibility for bringing about the necessary
changes. In such a system it is also unfortunately true that those whose
interests are primarily at stake are seldom involved in making decisions for their
own welfare and are treated as passive recipients of health or illness care. In the
poor and chiefly rural societies of developing countries this implies that
decisions are made by a small coterie of the urban elite, who even if well intentioned, have little concept of the actual problems of the majority of the people
with whom they have little physical or cultural affinity.
In the case of leprosy, where the problem of stigma far overrides the
problem of technology, our whole approach has been of an almost entirely
technical nature. While we have a vast number of medical and paramedical
personnel there are hardly any social scientists in the field; by which I do not
mean social workers. While we spend increasingly more on research of the
scientific aspects of leprosy, including the vaccine, we almost totally ignore
research into the equally important social aspects of the disease. Even if an
effective vaccine was available, which is problematic, why do we think it will
not go the way of all the other vaccines and immunizations? For millions still
suffer and die of infectious diseases like tuberculosis, tetanus, poliomyelitis
and diphtheria. The failure has been in the delivery of the drugs and vaccines
and not in their potency.
Why is it then that despite the availability of drugs and vast investment in
manpower and other resources leprosy continues to remain a major health
hazard? This is not to say that no benefits have accrued; the problem may have
been worse without such programmes. But it is also clearly evident that mere
detection and distribution of pills cannot succeed. The answer lies in the fact
that the techno-bureaucratic approach has failed to understand or has ignored
the significance of stigma which plays a predominant role in this disease and
without whose appreciation no programme for leprosy control can ever
succeed.
Should we then not try to study the real causes of the stigma as it affects
the various segments of our population and how they perceive the disease and
its sufferers? Should we not find out why the medical profession itself has such
an unscientific fear of the disease as it has of no other? Can we expect health
education of the public to succeed when the medical profession which is
Leprosy and PHC: Mandwa, India
207
looked to for guidance on medical problems refuses to handle leprosy patients
an admit them to hospitals? In actual fact the stigma is most marked in the
educated and not so great among the less educated masses. Yet being the
decision makers, whether in medicine or employment they play a major
negative role.
The approach of the patient to this disease also affects early detection,
regularity of treatment and his rehabilitation for without his co-operation little
can be achieved. A better understanding and appreciation of the human aspects
of this disease is essential in devising any programme for its control, the lack of
which has been the major cause of our failure. While a special leprosy pro
gramme has some advantages it has several disadvantages, such as too large an
area of coverage per worker, the attachment of stigma to him with resultant
lowered acceptability by the people and inability to get motivated doctors to
provide leadership A vertical programme also suffers from all the other disad
vantages of a government service such as lack of supervision and accountability,
repeated transfers which prevent build up of rapport with patients and the
community, and lack of administrative and technical support. Though few
in-depth evaluations of such services are available it is generally accepted that
except in a few states the performance is poor, especially when compared with
the voluntary agencies. A considerable percentage of the cases are not detected
and the regularity of treatment is generally less than 50% as judged by the
WHO criteria.
Recently attempts have been made at integrating the leprosy service with
the other health programmes at the paramedical level in the hope that this will
eliminate the stigma attached to the workers, reduce the area of coverage and
help establish greater rapport with the people. Unfortunately, such integration
has been firmly resisted on the basis that there is a danger of losing whatever
has been gained over the years.
It should be realized that many of these problems afflict the whole health
delivery system of which leprosy is only a small segment. A recent joint report
of the Indian Council of Social Science Research and Indian Council of Medical
Research has highlighted these problems and has recommended an integrated
‘bottom up’ rather than a ‘top down’ approach which should be firmly based
within the local community which should assume responsibility for its own
health and for which it should be assigned both administrative and financial
powers. Wherever possible the staff should be recruited from the local
community and answerable to them, and the pernicious system of transfers be
eliminated. Only thus can there be peoples’ involvement in their own problems
and ensured rapport and accountability in the persons who are employed to
help them.
The report further analyses the actual problems of health and its care on
the basis of the experience of several microstudies. It states that about 90% of
all health care including its most important components, whether preventive,
promotive or even curative is of a relatively simple nature requiring a low level
208
N H Antia
of technical knowhow, but close cultural affinity with the people with whom
it should be in close proximity. Hence it can be best carried out by the people
themselves with some training and support. If any outside agency like the
government tries to undertake or appropriate these tasks there results not only
an increase in cost but also a failure to deliver the goods. Worse still, it generates
a feeling of dependency among the community, with resultant loss of interest
and absence of participation in activities for the improvement of their own
health and welfare.
Leprosy fits this proposed model admirably like most other communicable
diseases such as gastroenteritis, tuberculosis and malaria. In an experimental
field project covering a rural population of 30,000 in north Alibag Taluka
popularly known as the Mandwa project, we have trained local women as parttime health workers — one for each village of approximately 1,000 population.
They are taught to undertake all forms of health care practices with special
emphasis on the problems of women and children. They have also been taught
the basic signs and symptoms of leprosy, namely, anaesthetic patches, thickening
of the skin and ear lobules, loss of eyebrows, and palpation of the ulnar and
greater auricular nerves; as also of other diseases like malaria and tuberculosis.
Prior to the commencement of the project the full-time 2-year trained
government leprosy technicians working for over 10 years in the area had
detected 63 cases of leprosy in this population. In a period of 3 years from
1977 to 1979, 90 other cases have been detected by this system, most of them
(59) by our village workers and confirmed by the supervisory staff. It is inter
esting to note that most of these were early cases including those of the lepromatous variety, prior to the development of major deformities. Much more
important, the regularity of dapsone treatment, as measured by the WHO
criteria has increased from less than 50 to more than 90%. Since the workers
are local women dealing with all types of health problems and visit each house
in the village at least once a month (and the at-risk cases more frequently) there
arise no problems of regularity, accessibility, rapport or communication. The
women mix freely with the patients and invite them to their homes thus
eliminating fear and stigma in the minds not only of the patients but also of the
community. It is not surprising that such constant contact ensures early
detection and regularity of treatment. The stigma of leprosy does not get
attached to such a local worker who looks after all health activities of the
village and her word often carries more weight within her community than that
of an outsider.
While a detailed study of the project is in the process of being undertaken
there is ample evidence to demonstrate the higher effective nature of such an
approach to leprosy, at what turns out to be a much reduced cost.
This approach has proved equally effective for other diseases such as tuber
culosis, malaria, and gastroenteritis and the immunization rate has increased
from 15 to over 70%.
Leprosy and PHC: Mandwa, India
209
Unfortunately, the Government Community Health Worker Scheme based
on such a model has failed to achieve similar results. This is because the
concept of educating the community to look after its own health problems and
providing only supportive service has not been acceptable either to the medical
profession or paramedical workers. They see these community health workers
as a threat to their practice and also as a means of ensuring accountability. The
community is hardly aware of the true nature of this scheme and are not
involved in the programme. Under these circumstances such a promising
avenue for health care can hardly be expected to thrive. The potential, never
theless, exists as revealed by our studies and other similar ones, and provides us
with one of the most potent weapons in our armamentarium for the control of
this disease at little, if any, increase in cost.
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STRATEGY JiOR A VOLUNTARY AGENCY ACTION
IN LEPROSY CONTROL IN A TALUK
Contents
1.
Preamble
2« Evolving a Process
3« Components of a future Strategy
<1, Additional Information
(Reading, Resources in Karnataka,
Projects in India)
5
The overall strategy for leprosy control has been
outlined in the preamble. The programme as it has
evolved in the governmental sector has been primarily
i. a top-down programmer
ii. a medicalised programmer
ill
*
a programme emphasising physical aspects
at the cost of social/cgltural/economic
aspects)
iv. a programme concentrating on individual
patients not on groups or communitiesr
v. a programme in which most of the health
•
education is ’telling the patient’ a set of
dos and donts not making them aware and
evolving act ton with them.
The voluntary sector especially the missionary sector
on the other hand has evolved a more institutional
approach, caring for the patient and supplementing
the medical programme with physical rehabilitation,
corrective surgery, appliances for deformity end
, income generation activities. V.'hlle this has tackled
the problem in a relatively more holistic way, it
has created a lot of dependence, a charity consciousness,
inlands of charity cut off from the rest of society
and in many ways isolated the problem from the community.
While both the governmental and non-go-ernmental
response to date has its own particular relevance and
logic and has definitely been responsible for creating
a general awareness and some services for some patients,
there Is still need for a more community based, enabling
approach stressing awareness bullding/educatlon for health
so that the patient with leprosy is integrated with the
6
6
the rest of the community and is able to function
with hie family as part of the social set up and
contributing to the community according to his
capacity and does not get ostracised, marginalised
or forced into beggary.
The alternative approach will consist of many
preliminary actions and process.es through which
a more relevant strategy can be evolved. Such an
approach will necessarily require a group that will
be committed to explore
hat may be a challenging
and even difficult task, learning from existing
projects using more orthodox approaches but evolving
more creative and patient supportive? strategies which
are community based and non-formal education oriented.
Step
One
Learning about the problem and the methods evolved
by different groups to tackle it.
Assessing the strength and weaknesses of each
approach by discussion with project team
members.
Meeting people with experience and reflecting
with them on alternative approaches.
Step
Two
Making a situation analysis in the selected taluk:
a.
Extent of the problem and distribution
b.
Types of services available—
1, Government SET Centres/
PHC/Sub-centre etc.
11. Non—Governmental voluntary
agencies In the area
7
7
c.
Problems and prospects as assessed by the
team of the govemment/non-government
projects. Stress should be on seeking feed
back from the para-medics and field level
workers directly in contact with the patient.
d.
The leprosy patients points of view—interviews
with groups of patients exploring their
experience through focus group discussion.
e«
Assessing community awareness and preparedness
for participation in tackling the problem.
The groups in the community to be focussed on
specifically are village lenders—-formal and
Informal—school teachers, members of youth
groups or mahlla mandal.
f.
From all the discussions clearly identifying the
soclal/cultural/economic/religlous and other
factors that have a bearing on the problem.
It la Important that this step Is first informal
and thorough and not a formal questionnaire
survey to begin with.
Step
Three
Thia will evolve through a creative interaction with
the findings of Step one and Step Two. Among other
things it should consist of some of these components.
The exact nature, focus and type of activities in
each will be determined by local situation.
a.
Community awareness bulldlnq/hcalth education
at school level involving teachers, high school
students and reaching all sections of the
community and family through child to child
and child to family approaches.
Community awareness building through school
activity can be supplemented by involvement
Of youfch groups and mahlla mandal.
8
8
b.
Group process with leprosy patients.
A process to be evolved with groups of
patients with leprosy that improves
self-image, encourages collectivity
and mutual support and promotes individual
and group self-reliance. This process will
have no doubt an educational dimension but
the ‘enabling
*
component in the attitudes/
skills of the facilitator are crucial.
The emphasis is on with the’group of patients
*
not for a group of patients.3
' :
Continuing education and motivation of
existing para^medlcs and health workers' ‘
j--. .. be they government or non-government. >
Staff motivation and supportive supervision
c.
are important. Both are invariably absent. .
The field workers perceptions and problems
and ideas are seldom sought or built upon
for policy generation. A group discussion
'..................
'
'
:'”i
process can generate ideas and action.
------
I ■
3. Components of a future strategy—Step Four
As three components of Step Three evolve
the ’facilitating group
*
t^ill develop and promote
a new consciousness in the area about the problem
and the possibilities. Depending on the overall
assessment of the situation and the existing/ongoing
facilities/structures/servlces the group can
decide on whether it wants to«
9
9
a.
Provide some services—curatlve/rehabllltative
services of its own;
b.
Supplement existing services with some efforts
in survey or income generation activities or
community rehabilitation etc;
c.
Empower patients and groups of patients and
all those who are interested to do some work
in the area to demand/pressurise/promote
a better response from existing services.
In terms of phasing, Step one to Step three should be
allotted atleast 1^-2 years. Step four could evolve
within 2 years and depending on option a., b., or c»,
further servlces/project components could be finalised
10
If option a. or b. is chosen then some of the actions
would includei
a
GENERAL
a. find out SET or any other NLEP working
units working in this area and liaise
with them;
b. involve local leaders and organizations
Including school teachers etc;
c. look for persons cured of leprosy and
involve them;
d. try not to duplicate work of NLEP
CASE DETECTION
a. general survey of the entire population
with a view to detecting cases;
b. priorities to school health check up
and lower socio-economic strata;
c. locate all patients under treatment
from existing sources;
d. concentrate efforts on villages with
higher incidence and also the immediately
surrounding villages.
CHEMOTHERAPY
Cases to be handed over to nlep or any
other existing organisation for treatment.
FOLLOW UP
Regular follow up for all patients and
contacts.
11
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3
3.0
LEPROSY PROFILE AND PROGRESS OF NLEP IN THE COUNTRY
India has a population of 682 million as determined at the 1981 census; and of the
current prevalence of 12.0 million cases of leprosy in the world, one third is estimated to be
in this country. The estimated prevalence rate in India in 1981 was 5.7 per thousand
population. Up to March, 1987, 3.33 million cases had been recorded; 2.88 million brought
under treatment and up to the end of August 1987, 2.58 million discharged. Over 400
million people live in 196 leprosy endemic districts (prevalence rate 5 and over). Amongst
the 435 districts in the country as on 1 st September, 1987 in 80 the disease prevalence rate
is below 1 case per 1000 persons; in 159 it ranges from 1 to 5 and in another 196 the
prevalence rate exceeds 5. The multidrug treatment (MDT) programme, starting in two
districts in 1982 now extends to 49 endemic districts, with 1.34 million leprosy cases.
Additionally 5 leprosy low endemic districts were also brought under MDT on an
experimental basis during 1987-88. Provision for MDT of dapsone refractory cases exists in
even/ dapsone monotherapy district since 1987-88.
There are over 125 Voluntary Organisations sharing the activities under Leprosy
Eradication Programme.
For the first time during the current year, the number of leprosy cases cured was
higher than those detected and this trend is expected to increase consistently to achieve
the goal of inactivity in all the leprosy cases by the year 2000 AD. The proposed annual
targets for case detection and cure and the number of cases at the end of each year up to
the year 2000 have been worked out in consultation with Dr. S.K. Noordeen, Chief Medical
Officer, Leprosy Unit, WHO, Geneva and are given hereunder. The targets are subject to
the availability of adequate resources to create additional infrastructure and to extend MDT
to all the districts in a phased manner.
Year
No. of cases
at the
beginning of
the year
New
Cases
Discharges
due to death,
dapsone & self
healing
Discharges
due to MDT
No. of cases
at the end of
the year
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
3.160
2.860
2.460
2.060
1.660
1.260
1.060
0.760
0.560
0.360
0.210
0.110
0.055
+0.500
+0.500
+0.500
+0.400
+0.400
+0.400
+0.300
+0.300
+0.200
+ 0.100
+0.050
+0.025
+0.010
-0.300
-0.300
-0.300
-0.300
-0.300
-0.200
-0.200
-0.100
-0.100
-0.050
-0.050
-0.030
-0.030
-0.500
-0.600
-0.600
-0.500
-0.500
-0.400
-0.400
-0.400
-0.300
-0.200
-0.100
-0.050
-0.035
=2.860
=2.460
=2.060
= 1.660
= 1.260
= 1.060
=0.760
=0.560
=0.360
=0.210
=0.110
=0.055
=0.000
Statewise leprosy profile and the progress of NLEP is given in Table-1. The Districtwise
problem of leprosy and infrastructure in each State are given in alphabetical order followed
by the data in respect of Union Territories.
s.
No.
1.
2.
3.
4.
5.
6.
i
8
9.
11.
12.
13.
14.
15.
16.
17.
19
20
22
23
24.
25
26
27
28
29
30
31
.-'■S’:
STATEWISE LEPROSY PROFILE AND THE PROGRESS OF NLEP IN INDIA 1987
s.
No.
1.
2.
3.
4.
5.
6.
7.
8
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24
25.
26.
27.
28.
29.
30.
31
Name of State
Andhra Pradesh
Arunachal Pradesh
Assam
Bihar
Goa
Gujarat
Haryana
Himachal Pradesh
J. & K.
Karnataka
Kerala
Madhya Pradesh
Maharashtra
Manipur
Meghalaya
Mizoram
Nagaland
Orissa
Punjab
Rajasthan.
Sikkim
Tamil Nadu
Tripura
Uttar Pradesh
West Bengal
Andaman & Nicobar
Chandigarh
D&N Haveli
Delhi
Lakshadweep
Pondicherry
Popu
lation
1981 in
lakhs
Esti
mated
prev.
Rate
Regd.
Prev.
prev.
535.5
6.3
199.0
699.0
10.9
341 0
129.2
42.8
27.0
371.4
254.5
521.8
627.8
14.2
13.4
4.9
78
263.7
167.9
342.0
3.2
484.1
20.5
1108.6
545 8
1.9
4.5
1.0
62.2
0.4
6.0
11.8
3.6
1.5
5.4
5.0
29
0.08
1.6
2.2
6.0
5.8
2.3
6.2
4.5
4.6
1.0
3.9
12.1
0.1
1.6
7.8
12.9
4.9
3.7
6.9
4.9
NA
1.0
0.4
25.0
15.0
6818.3
5.7
No.
Total
<1
1-5
5+
8.6
2.3
0.9
6.2
1.9
1 9
0.1
1.1
1.2
3.9
3.0
3.9
5.5
3.8
1.2
1 3
2.3
7.9
0.2
0.5
1.1
11.3
2.7
4.3
5.2
4.9
1.3
1.1
1.6
10.1
11.7
__
_
3
22
4
1
16
__
5
—
__
__
6
10
22
19
3
__
—
1
13
—
1
6
13
15
3
2
__
6
5
10
4
23
11
5
2
1
2
—
__
19
——
__
3
21
2
1
1
1
1
—
1
1
3
23
10
17
31
3
19
12
12
14
20
14
45
30
8
5
3
7
13
12
27
4
20
3
58
17
2
1
1
1
1
4
4.9
80
159
196
435
__
12
12
6
9
4
__
__
....
—
3
2
4
__
12
8
—
—
__
5
__
__
__
—
_
—,
—
4
20
0
30
16
1
—
—
.
Cases
on re
cord
Casos
under
treat
ment.
Cases
disch
arged
Cases
under
MDT
461598
1466
17577
435337
2082
71201
1086
4751
5412
144718
76041
203496
342572
5402
__
1573
631
246
1767
1700
208229
149677
—
3183
6357
15648
__
338
545129
404109
NA
5617
48766
479452
88793
284766
—
940
—595
__
114
—
9936
404
404
—
7008
424159
1466
17577
395610
2082
68216
1086
4751
6412
116349
67338
199478
324028
3350
1573
631
1767
202901
3124
14140
338
451613
5617
443527
110321
940
595
99
8752
404
5350
723172
687
8545
168960
3090
54887
212
1878
1919
61302
49948
76838
322074
2408
1043
232
550
138284
2458
3679
98
653970
2617
206121
74255
1066
24
NA
NA
169
4306
78998
75
3861
12977
1639
22106
206
NA
Nil
23601
4055
4746
38482
153
Nil
246
143
60585
361
6357
. 237
58384
—
32092
33100
86
555
Nil
8752
404
336
1340749
2882594
2582252
392537
Distts, under MDT
Popula
Cases
tion
No. ofDistts with PR
10
__
Nil
1
3
1
1
__
2
1
2
9
—
—
1
1
3
—
1
_
10
1
3
2
—
__
1
—
251.54
__
__
10.80
—
47.47
13.41
3.03
59.25
1895
30.57
132.44
—
—
3 40
0.79
101.79
__
17.71
__
235.13
9.76
64.46
44.13
—
__
__
—.
0.40
—
53 ! 1045.03
358897
—
—
15760
__
32703
206
NA
—
31184
10042
20727
171178
3338069
22
4.6
GUJARAT
The Gujarat State has a population of 34.1 million with 67.5 per cent of the people living
in the rural areas. It is amongst the low endemic states for leprosy. The estimated
prevalence rate as in 1981 is 2.9. Of the 19 districts, in only 5 the prevalence rate exceeds 5
per 1000 persons. Three of the districts (Baroda, Valsad and Dangs) with an aggregate
population of 47.47 lakhs are covered by MDT. The estimated case load is 1.0 lakh and one
third of the patients are multibacillary.
O
U
C
L.
P
State data
34085799 lakhs
23004474 lakhs
11081325 lakhs
Total population (1981)
Rural
Urban
No. of districts by estimated prevalence rate
N
Prevalence/1000 population
Districts under MDT
Estimated case load
MB
PB
Total
Registered Prevalence Rate (1987)
Distribution of cases (1987)
Total
10+
5-10
< 5
19
3
0
0
5
3
14
0
30000
60000
90000
1.9
1
•
23
Total
On record
Under treatment
Monotherapy
MDT
Dapsone refractory
Cases discharged since inception of the programme
Leprosy voluntary organisations in the State
Physical infrastructure
SSAUs
1
RSUs
2
LRPUs
1
LTCs
1
Manpower deployed
41
Medical officers
Non-medical supervisors
161
Para-medical workers
629
Laboratory technicians
35
Physio-technicians
17
Health educators
14
71201
68216
46110
22106
611
54887
w
2 DISTRICTWISE PHYSICAL INFRASTRUCTURE UNDER NLEP
SI Name of
No. district
1 Valsad
2 Surat
3 Bharuch
4 Vadodara
5 Panchmahal
6 Dangs
7 Kheda
8 Ahmedabad
9 Gandhinagar
10 Mehsana
11 Banaskantha
12 Sabarkantha
13 Bhavnagar
14 Rajkot
15 Junagadh
16 Jamnagar
17 Amreli
18 Surendranagar
19 Kutchi
Total
Population
1981
census
Prev. rate
Estd
Regd
17,74,136
24,93,211
12,96,451
25,58,092
23,21,689
1,12,664
30,15,027
38,75,794
2,89,088
25,48,787
16,67,914
15,02,284
18,79,340
20,93,094
21,00,709
13,93,076
10,79,097
10,34,185
10,50,161
6.9
5.6
7.3
1.8
5.2
6.2
0.9
0.4
0.2
0.4
0.3
0.8
0.4
0.4
1.1
0.7
0.4
0.1
0.1
6.1
5.9
7.4
1.5
0.3
6.1
0.9
0.4
0.2
0.3
0.3
0.8
0.4
0.4
1.1
0.7
0.4
0.1
0.1
22,584
14,406
11,772
22,796
9,112
851
1,775
1,104
39
305
513
952
475
517
3,432
591
231
11
11
3,40,85,799
2.9
1.9
91,477-
No. of
No. of
cases cases on
dischar
record
ged
LCU/MCU
SET
ULC
3/86
3/87
3/86
3/87
3/86
3/87
10,784
14,753
9,595
3,850
12.240
691
2,607
1,483
64
783
432
1,261
774
786
2,287
974
473
89
84
3
4
2
2
3
1
1
—
—
1
—
—
1
—
1
—
—
—
—
4
4
2
2
3
1
1
—
—
1
—
—
1
—
1
—
—
—
—
6
3
3
3
2
—
—
2
—
—
—
—
—
—
2
—
—
—
—
6
3
3
3
2
—
2
—
—
—
—
—
—
—
2
—
—
—
45
21
53
49
22
—
—
6
1
—
—
16
—
6
3
14
—
2
3
49
21
53
49
22
—
—
6
1
—
—
16
—
6
3
14
—
2
3
64,010
19
20
21
21
241
245
34
4.10
Monothe
MDT
Dapsone
KARNATAKA
The Karnataka state has a population of 371.4 lakhs as per 1981 census of which 71.1
per cent belong to the rural areas. The State is of moderate endemicity to leprosy with 6 of
its 20 districts having an estimated prevalence rate of more than 5 and one of them more
than 10 per 1000 persons. The estimated prevalence rate for the state as a whole is 6.0.
The estimated case load is 2.42 lakhs. Two districts Belgaum and Dharwar, with the
population of 59.25 lakhs, are covered under MDT.
State data
371.4 lakhs
264.1 lakhs
107.3 lakhs
Total population (1981)
Rural
Urban
No. of districts by estimated prevalence rates (1987)
Prevelence/1 000 population
District under MDT
Total
10 +
5-10
20
2
1
0
5
2
14
0
Registered prevalence rate (1987) 3.9
Distribution of cases (1987)
On record
Under treatment
Total
MB
PB
144718
116349
35856
28116
108862
88233
Cases dischai
Leprosy volu
Physical infra
SSAUs
RSUs
LRPUs
LTCs
Manpower c
Medical
Non-me
Parame'
Laboratc
Physio-t
Health e
92748
23601
Monotherapy
MDT
Dapsone refractory
61302
32
Cases discharged since inception of the programme
Leprosy voluntary organisations in the State
Physical infrastructure:
SSAUs
RSUs
LRPUs
LTCs
Manpower deployed
75
Medical officers
243
Non-medical supervisors
1096
Paramedical workers
53
Laboratory technicians
49
Physio-technicians
Health educators
v
RfCcnni hurtivf
'
- - . . ,
73825
9783
17500
18923
8007
6101
iMvcje-xj
X Cl b i 11 H;< h <>v-,
< v\ ma
uxwi
Ptoi-v\ o I1 cm
DISTRICTWISE INFRASTRUTURE UNDEK NLEP
SI.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Name of
district
B'lore (U)
B'lore (R)
Chitradurga
Kolar
Shimoga
Tumkur
Belgaum
Bijapur
Dharwad
U. Kannada
Bellary
Bidar
Gulbarga
Raichur
Chickmagalur
D. Kannada
Kodagu
Popula
tion
(1981)
Regd
Prevrate
No. of
cases
dischar
ged
No. of
cases
on record.
3492771
1454839
1777499
1905492
1656731
1977854
2980440
2401782
2945487
1072034
1489225
995691
2080643
1783822
911769
2376724
461888
3.03
1.97
1.49
3.72
0.77
1.96
1.81
5.87
3.49
1.10
8.85
8.00
7.88
10.52
0.45
2.88.
0.20
2405
1187
845
2852
816
2040
11999
5250
12115
337
6285
11282
10689
7797
6
6414
23
10573
2869
2648
7085
1276
3883
5409
14089
10273
1180
13187
7970
16392
18765
411
6842
92
LCU/MCU
ULC
3/86 3/87
SET
3/86 3/87
SI.
No.
Nr
dir
3/86 3/87
1
__
2
2
—
1
3
3
4
__
4
3
3
4
__
1
—
1
__
2
2
—
1
4
4
4
__
4
3
4
4
__
2
—
7
7
21
42
1
1
2
2
50
3
48
3
1
1
21
1
31
1
2
4
53
3
3
49
4
4
48
1
1
144
4
25
20
2
2
3
50
3
2
2
29
__
__ 10
2
54
2
—
—
4
21
42
50
48
21
31
53
49
50
14
25
20
50
29
10
54
4
18. Ha
19. M
20. Mv
—
To
—
67
RAJASTHAN
According to 1981 census the population of Rajasthan is 34.3 million and 7.9 per cent
of the people reside in the rural areas. The state has a very low estimated leprosy
prevalence rate of 1.6 per thousand population. In all the 27 districts the prevalence is less
than 5. The estimated case load is 10,000 but approximately half the cases are
multibacillary. Alwar district is covered by Multidrug treatment with the assistance of
primary health care staff from 1987-88.
State data
Population (1981)
Rural
Urban
No. of districts by prevalence rates
34262000
27051000
7211000
Prevalence/1000 population
10+
5-10
<5
Districts under MDT
27
0
10
0
0
27
1
Registered Prevalence rate (March, 1987)
5
0.
Total
Registered case load (3/87)
MB
PB
Under treatment
15648
NA
NA
14140
68
Monotherapy
7783
MDT
6357
Dapsone refractory
Nil
Cases discharged since inception of
the programme
3679
Leprosy voluntary organisations in the State
17
Physical infrastructure:
SSAUs ■
RSUs
LRPUs
LTCs
1
Nil
Nil
Nil
Manpower deployed
Medical officers
Non-medical supervisors
Para-medical workers
Laboratory technicians
Physio-technicians
Health educators
—
—
—
—
—
—
2. DI
SI.
No.
Name of the
District
1.
2.
3.
4.
Alwar
Ajmer
Banswara
Barmer
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Bharatpur
Bhilwara
Bikaner
Bundi
Chittorgarh
Churu
Dholpur
Dungarpur
Ganganagar
Jaipur
Jaisalmer
Jalore
17.
18.
19.
20.
Jhalawar
Jhunjhunu
Jodhpur
Kotah
69
2. DISTRICTWISE PHYSICAL INFRASTRUCTURE UNDER NLEP
SI.
No.
Name of the
District
1.
2.
3.
4.
Alwar
Ajmer
Banswara
Barmer
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
LCU/LCU
ULC
SET
Estd.
Regd.
No. of
cases
discharged
1771173
1440366
886600
1118892
2.71
2.47
1.42
—
—
0.5
0.5
—
79
59
117
—
1364
687
397
—
1
—
—
—
—
1
—
—
2
2
5
—
Bharatpur
Bhilwara
Bikaner
Bundi
Chittorgarh
Churu
Dholpur
Dungarpur
Ganganagar
Jaipur
Jaisalmer
Jalore
1299073
1310379
848749
586982
1232494
1179466
585059
682845
2029968
3420574
243082
903073
2.62
—
1.83
1.19
1.51
0.72
1.08
1.73
2.55
2.04
1.01
—
1.0
0.1
0.7
0.3
0.1
0.1
0.4
0.6
0.1
1.2
0.2
—
113
—
12
34
44
18
258
73
4
482
4
—
1
—
—
—
—
—
—
—
—
1
_
—
_
—
1
—
—
—
—
—
—
2
—
—
Jhalawar
Jhunjhunu
Jodhpur
Kotah
784998
1211583
1667791
1559784
—
0.75
1.89
0.73
0.2
0.3
0.4
0.3
—
193
686
66
1311
79
526
166
172
107
210
402
141
4255
56
175
—
369
606
394
1980
1
1
1
2
2
1
3
4
1
4
1
4
1
—
Population
1981
Prev. rate
No. of
cases on
record..
—
—
—
1
—
—.
1
—
1
5
70
i
SI.
No.
Name of the
District
Population
1981
21.
22.
23.
24.
25.
26.
27.
Nagaur
Pali
S. Madhopur
Sikar
Sirohi
Took
Udaipur
1628669
1274504
1535870
1377245
542049
783635
356959
Estd.
Regd.
No. of
. cases
discharged
1.29
1.50
2.69
1.29
2.24
—
2.44
1.2
0.1
0.2
0.2
0.2
0.02
0.6
542
33
102
138
24
—
24
Prev- rate
No. of
cases on
record.,
126
362
270
108
14
1371
NA
LCU/LCU
ULC
SET
—
—
—
—
—
——
—
—
——1
2
3
5
1
4
1
2
4
Total
3,42,61,862
1.63
0.5
3105
15648
4
6
b
pf<
a
n
I
s
T
59
R
N
D
NATIONAL LEPROSY
,
-
'•<,/
-vV r
■;
PROGRAMME
independeoevaluation
1991
Hlftn ’ LEPR0SY DIVISI0N ■ '- ' ■
W&L directorate general of HEALTH SERVICES
ministry of health
new DELHI-110001
’
:
NATIONAL LEPROSY
ERADICATION
PROGRAMME
4th
INDEPENDENT EVALUATION
1991
LEPROSY DIVISION
DIRECTORATE GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH
NEW DELHI-110001
DR. G. K. VISHWAKARMA
director general of health services
Tal, .301MJ8 (0)
• '• • 3MS®3 (nJ
Rie«t for
ffofrl
10011
directorate general of health services
NIRMAN BHAWAN
NEW DELHI-110 011
190
Dated ........................ fgg
Sako
FOREWORD
The Indian Programme for Leprosy Control is one of the
largest of its kind in the world.
It witnessed phenomenal
expansion in the past one decade.
Starting with two
districts in 1983, today it provides Multi Drug coverage to
all of the 201 endemic districts.
Rapid programme expansion
often leads to dilution of the quality of services.
Even as
a system of day to day monitoring has been built into the
NLEP, its independent appraisal by internationally renowned
scientists will greatly contribute to its operational
effectiveness.
We are pleased to have the World Health Organisation as
our partners in this exercise.
I thank them for their
cooperation in providing the services of foreign experts to
guide this venture.
The success of any leprosy control ultimately depends
on men and women working for it, who must combine skills in
the field of diagnosis and of management, and a sense of
< devotion.
This evaluation reflects the present status of the
programme, the tasks that have been -fulfilled and others that
need attention.
It is my hope that this booklet will act as a spur to
the State Governments to redouble their efforts towards
seeing the end of leprosy from this country.
CONTENTS
Page No.
I INTRODUCTION
1
1. The national leprosy eradication programme
1
II
OBJECTIVES OF EVALUATION
7
III
METHODOLOGY
8
1
1. Sample selection
2. Source of data
3. Instruments of data collection
4. Data collection
8
11
11
12
OBSERVATIONS
18
1. National profile of leprosy
2. Case detection and treatment
3. Regularity of treatment
4. The MDT programme
5. Modified MDT programme
6. Manpower performance
7. Laboratory services
8. Training
9. Health education
10. Monitoring and reporting
11. Programme management
12. Expenditure
13. Voluntary organization
18
18
22
23
30
31
38
39
40
45
46
54
54
CONCLUSIONS AND RECOMMENDATIONS
56
IV
V
Abbreviations
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12 .
13 .
14 .
15.
16.
17 .
18 .
19 .
20.
21.
22 .
23 .
24 .
25.
26 .
DGHS
DLO
HE
LCU
LRPU
LT
LTC
MB
MDT
MMDT
MO
MPW
NLEP
NMA
PB
PHC
PMW
SLO
SET
SSAU
THW
ULC
UT
VO
WHO
ZLO
Director general of health services
District leprosy officer
Health educator
Leprosy control unit
Leprosy rehabilitation promotion unit
Laboratory technician
Leprosy training centre
Multi-bacillary
Multi-drug therapy
Modified multi-drug therapy
Medical officer
Multi purpose worker
National leprosy eradication programme
Non-medical supervisor
Pauci-bacillary
Primary health centre
Para medical worker
State leprosy officer
Survey, education and treatment centre
Sample survey cum assessment unit
Temporary hospitalization ward
Urban leprosy centre
Union territory
Voluntary organizations
World health organization
Zonal leprosy officer
I
INTRODUCTION
1.
The National Leprosy Eradication Programme
The leprosy control programme in India had been in
operation since 1955, but only since 1980 did it receive a
high priority. It was redesignated as National Leprosy
Eradication Programme in 1983 aimed at arresting the disease
in all the known cases of leprosy by the turn of the century.
It was a 100% centrally sponsored programme
since 1969,
providing for total expenditure on its account to be borne by
the Government of India.
(a)
Magnitude
India ranked foremost among the countries saddled with
leprosy sufferers, sharing nearly one fourth of the global
leprosy load in estimated cases and over 70% of the
registered cases (1991). There occurred a steady increase in
the number of cases through successive decades starting with
1.5 million in 1941 and reaching 4.0 million estimated cases
in 1981.
The main factors to account for this progressive
rise were
a rapid increase in population, better case
detection activities and greater community
awareness
leading to voluntary reporting.
About 15% of the patients were children.
The
proportion of multi bacillary cases ranged from 10 - 21% in
different regions and the deformity rate was approximately
20%.
The prevalence exceeded 5 per thousand in 201 out of
465 districts in the country.
Nearly 450 million people
lived in these 201 districts.
The magnitude of the problem,
as such, is vast.
(b)
Distribution
The distribution of the disease was uneven,
although it was present throughout the country. The inter
state variation in the prevalence rates and the percentages
of population at risk were quite substantial. The areas of
high orevalence were found mainly in the south - eastern and
central regions of the country, comprising the states of
Tamil Nadu, Andhra Pradesh, Orissa, Bihar, Madhya Pradesh,
Uttar Pradesh, Maharashtra and West Bengal. These states
amongst themselves accounted for 90% of the registered case
load in the country.
(c)
Strategies
In the main, the strategy was based
controlling the disease through reduction in the quantum
infection in the population through continuous treatment
break the transmission of infection. The main component
the strategy were :
1
on
of
to
of
— early detection and regular treatment .of patients;
- providing multidrug therapy (MDT)
*
to all the
patients on domicilliary basis;
- education of the patients, their families and the
community members in general on leprosy and its
curability; and social and economic rehabilitation of
the patients.
Towards achieving
the infective population, the
were developed.
(i)
a total coverage
of
all
following operational
plans
MDT under vertical set-up
Over the years, a separate cadre of health workers
were trained to provide anti - leprosy services. In 1983, MDT
was started in 2 districts following the completion of the
preparatory phase comprising :
- completion of infrastructure in the districts;
- adequate training of staff in MDT operations;
- rapid survey to enumerate undetected cases; and
screening of all the recorded cases and
preparation of individual case records.
The MDT was gradually extended by 1991 to 135
districts where the disease prevalence was 5 or more per 1000
population. Presently, these districts were at various stages
of MDT implementation and provided MDT coverage to 75 percent
of all the recorded cases, numbering 1.5 to 1.6 million
leprosy sufferers.
(ii)
Modified MDT set-up
Besides 135 of the 201 endemic districts where MDT
operated, there still remained 66 districts where leprosy
services were being provided by the existing health services
personnel. These districts did not posses the infrastructure
necessary for establishing vertical MDT set-up. At the same
time it was essential to extend the benefit of multidrug
treatment to nearly 0.6 to 0.7 million patients in these
districts, without further delay, if the objective of leprosy
eradication by the turn of the century was to be achieved.
Therefore, control approach of modified multidrug therapy
(MMDT) was developed(1).
* Rifampicin, Clofazimine and Dapsone
(1) National Leprosy Eradication Programme in India Guidelines
for modified MDT scheme in selected districts. Directorate
General of Health Services, Ministry of Health & Family
Welfare, New Delhi, 1991.
2
The modified MDT approach differed from the
vertical programme essentially in the following respects :
— the district leprosy unit functioned under the overall
charge of the district medical officer;
- the leprosy services were delivered through the
primary health care staff supplemented by leprosy
workers to the extent available in the district;
- the medical officer of the PHC was to be the over all
incharge of MDT operations in the area,
- the treatment points were to coincide with the PHC,
the subsidiary health centre, the community health
centre, the dispensaries and hospitals; and
-cash assistance was envisaged to leprosy patients for
collecting drugs from the treatment points with further
cash incentive to those completing treatment.
It was realized that this approach would not only
extend the overall cover of MDT benefit, but would also gear
the primary health care services towards providing intensive
leprosy care; thus promoting the integration of the two in
the long run.
(d)
Infra-structure
Over the years, a vast infra-structure came up
under the NLEP. The magnitude of the case load and the high
endemicity dictated the deployment of specially trained
vertical staff for rendering leprosy services.
In the rural areas, the leprosy, services were
provided by the leprosy control unit (LCD) while in the urban
areas these were carried out by the urban leprosy centre
(ULC). Yet another centre called the survey education and
treatment (SET) centre was attached to a primary health
Centre (PHC) or a hospital existing in the low endemic areas.
One LCD existed for every 4.5 lakh population , one ULC for
every 50,000 and one SET centre for 25,000 population. A LCU
was manned by four non-medical supervisor (NMS) and 20 para
medical workers. The technical staff of an ULC comprised a
para medical worker (PMW)/non medical supervisor (NMS).
responsible to a medical officer (MO) of a dispensary or a
hospital. The SET centre was served by a PMW under the
guidance of a medical officer.
Separate training centres answered the need for
trained manpower. In addition to organizing courses for
training of medical officers,
PMWs,
NMSs,
laboratory
technicians and physiotherapists,
these centres also
conducted task oriented courses to fulfill special, programme
needs, such as training of manpower for MDT and MMDT.
3
Temporary hospitalization wards (THWS), were
established to provide specialised services in leprosy.
The
THWs were supplemented by a limited number of reconstructive
surgery units.
A district or zonal leprosy officer (DLO/ZLO) with
a team of supporting staff functioned at the district level.
The programme was executed through a
central programme
officer of the rank of a Deputy Director General. He was
responsible for planning, programming, organization and
implementation of the eradication programme, in keeping with
the policy decisions of the National Leprosy Eradication
Commission and under the direction of the National Leprosy
Control Board.
The existing infrastructure is shown in table 1.
TABLE 1
Infrastructure under NLEP - 1991
Facilities
Number
Leprosy Control Units/Modified Leprosy
Control Units
Urban Leprosy Centres
Survey, Education & Treatment Centre
Temporary Hospitalization Wards
Reconstructive Surgery Units
District Leprosy Units
Leprosy Training Centres
Sample Survey cum Assessment Units
758
902
6,099
291
75
277
49
41
(e. )
Services
Important services provided for containment of
infection in the community are briefly described below:
(i)
Case detection
Early finding of new cases was the most important
of NLEP activities. It promoted better results of treatment,
prevention of deformities and an early cure. The several
means employed for detection included population survey by
physical examination in schools, industrial populations,
contact examination and examination of slum populations in
urban areas. Voluntary reporting was encouraged through
health education campaigns. Total population surveys were
organized in the villages.
(ii)
before
Laboratory services
As a pre-requisite for disease
starting treatment, bacteriological
4
classification
examination of
skin smears was carried out. Bacteriologic surveillance also
formed an essential part of disease follow-up. Additional
laboratory facilities were available for the examination of
urine, blood for hemoglobin and sputum for acid fast bacilli.
i (iii) Treatment delivery
(a)
Delivery point
Treatment was given at the out-door clinics held
at fixed road side points for every 5-10 villages every week.
' This was affected by a team of a medical officer and a nonj medical supervisor going in pre-determined circuits so that
' no, patients
traveled more than IKm to collect his dose.
Clinics were also held in dermatology or medical out patients
departments in general hospitals and health centres.
(b)
Case taking
As the new patients came for advice, a 'Case Card'
was prepared for each, in which the clinical findings and the
bacteriological status of the disease was entered. The
personal data on name, age, sex and village identification
was also noted.
(c)
Drug regimen
Guidelines for multi .drug treatment were supplied
to every paramedical worker and NMS. It described in detail
the drug schedules for different age groups in multibacillary
and paucibacillary types' of disease, recognition of toxic
reaction, monitoring of drug intake and surveillance
throughout the period of treatment (2) .
(f)
Health education
As far as possible, the .patients were treated in
their existing social setting. They were taught the care of
the eyes, hands and feet to prevent deformities. Potentional
patient trainees were identified for vocational and economic
rehabilitation. An important component of health education
was to increase awareness of leprosy, encourage self
reporting, stress the need for continuous treatment and
promote social acceptance of the programme.
2.
Leprosy, National leprosy Eradication Programme in
India, Guidelines for multidrug treatment in endemic
districts. Directorate General of health services,
Ministry of Health &.Family Welfare New Delhi; 1989.
5
(g)
Monitoring & maintainance of records
The data generated in the field at the LCU,ULC and
SET Centres was reported through the district to the state
head quarters for transmission to the Programme Officer in
the DGHS. The progress of the activities was reported in the
form of monthly, quarterly and annual reports. The format for
the various cards and the registers required to be maintained
in an MDT district was prescribed. Officers at different
levels were
made responsible for the submission of reports
in time, their analyses and initiating the required follow up
actions.
6
OBJECTIVES OF EVALUATION
It was recognized that the primary objective of
the evaluation was to determine how well the eradication
programme functioned operationally as also to derive the
trends of epidemiological estimates. There were three
evaluations preceding the present one, being performed in
1986, 1987 and 1989. During these years the spread of the MDT
9reatly increased, covering 135 districts. A variant in the
form of modified MDT programme was introduced in 1990 which
was not still fully operational. It covered sixty six
districts. It was necessary to know how well were these
districts prepared to embark on MMDT activities.
The terms of reference for the Evaluation Teams
/a were:
1.
To assess the effectiveness of
the
various
operational activities relating to the programme at the
unit, district and state levels, including :
(a)
(b)
(c)
(d)
detection
of
new
cases
and
discharge
of
inactive patients,
reliability
of
diagnosis
and
disease
classification ,
regularity of drug intake and reasons for
default ,
dependability of laboratory services;
2. to assess the utilization of infrastructural facilities
including the training centres and sample survey cum
assessment units as well as the effectiveness of the manpower
deployed;
3.
to validate
the
reported
data
through
personal
observations in the field and examination of records;
to assess the impact of health education in the community
providing knowledge about leprosy, including prevention of
deformities, dispelling prejudice against the disease and
promoting social acceptance of leprosy sufferers;
4.
•4 in
5.
to assess the adequacy of information reporting system ;
6.
to ascertain the preparedness of modified MDT districts
for initiating programme activities ;
7.
to examine the provision/creation of infrastructural
facilities and ascertain the reasons for shortfall, if any ;
and
8.
to submit a report with collected data and make suitable
recommendations on its basis.
7
Ill
METHODOLOGY
The Evaluation teams visited 24 of the states/UTs
in the country from December 10 to 19,1991. An unbiased
selection of certain districts in each state was made without
prior knowledge of the performance rating of the districts.
Since the sample selection was based on statistical
principles, it can be expected that conclusions made on the
basis of data collected from these areas reflected the
national profile.
1.
Sample Selection
The programme objectives and logistic reasons
imposed certain restrictions in the selection of the samples. ,1
It was planned to have fifteen teams during the evaluation
and the time period allowed was a maximum of ten days for
visits, discussions and field investigations.
It was
considered that each team could not evaluate more than 5 to 7
districts within the time allotted , depending upon the
logistics of travel.
The following considerations were important in
affecting selection :
(a)
Taking
into
account
the
epidemiological
characteristics and logistic features, the states of india
were combined in such a way that they formed fifteen groups,
so that each team could be assigned to one group.
(b)
It was desired that there should also be a
representation of districts where the leprosy programme was
funded by external agencies.
(c)
The sample should include districts where MDT was
introduced at different periods of time. For this purpose the
following classification was made:
z
(i)
Districts where MDT was introduced before 1987
(ii)
Districts where
1987 and 1990
(iii)
Districts where MDT
1990
(iv)
Districts where modified MDT operated
(v)
Districts still on Dapsone monotherapy.
It
was
also
8
MDT
was
important
was
introduced
between
introduced
that
the
after
adequate
representation be made of districts with different levels of
disease endemicity. For this purpose the districts were
grouped as below :
(i)
estimated prevalence
per 1000 population
rate
of
10
and
above
(ii) estimated prevalence rate between 5tol0
(iii)
estimated prevalence rate between 2 to 5
(iv)
estimated prevalence rate less then 2
There were 45 districts funded by the overseas
agencies like, UNICEF, NORAD, SIDA, LEPRA, Italian Leprosy
Mission, US Leprosy Mission and the Damien Foundation. Out of
these, eleven were chosen at random. Thus there remained only
sixtysix districts that could be selected with due regard to
their level of endemicity.
Two districts were initially selected at random from
each of the 15 groups of States. Some of these random cnoices
coincided with the selection made on the basis of funding
agencies. A list of districts within reasonable traveling
distance from the districts selected was drawn up and three
more were selected, the selected districts are shown in Table
2 .
TABLE 2
States, Union Territories and districts selected for evaluation
State/UT
District
Endemicity
Andhra Pradesh
Prakasam
Nalgonda
West Godawari
Cuddaooah
Vishakhapatnam
5.4
15.3
9.3
18.5
6.4
Assam
Kamrup
Nagaun
1.3
1.05
Bihar
Siwan
Patna
Ranchi
Singhbhum
Rohtas
Deogarh
13.5
19 : 9
3.1
15.4
18.2
10.8
Chandigarh
Chandigarh
1.3
D.« N.Haveli
Nagar Haveli
1.1
MDT/MMDT
Non MD'
MDT
MDT
MDT
MDT
MDT
MMDT
MMDT
MDT
MDT
MDT
Ahendabad
Surat
Junagarh
Kheda
0.4
5.6
1.1
0.9
Haravana
Ambala
Sonipat
0.05
0.2
H. P.
Sirraor
Solan
2.6
0.4
J & K.
Udhanour
Kathua
1.07
1.03
Karnataka
Bangalore
Chitradurga
Bijanur
Tumkur
Dharwad
Bidar
3.0
1.5
5.9
1.9
3.5
8.0
Trivandrum
Quillon
Pathananthitta
PaIgnat
Iddukki
6.0
7.2
3.3
10.0
3.1
Madhya Pradesh
Bilastur
Bastar
Jabaltur
Durg
13.5
5.2
6.9
11.6
Maharashtra
Ahmad Nagar
Anravati
Aurangabad
Jalgaon
Sholapur
2.7
6.9
2.3
4.1
8.5
Manipur
Bishanour
Tatienlong
8.4
7.0
Meghlaya
East Khasi Hills
Jaintia Hills
0.6
0.4
Mizoram
Aizwal
0.7
Nagaland
Kohiza
1.6
Orissa
Balasore
Keonjzar
Dhar.kanal
Mayurrhanj
Puri
8.6
4.3
11.3
12.3
10.5
Punjab
Roper
0.17
Gujrat
Kerala
10
MDT
MMDT
MDT
MDT
MDT
MDT
MDT
MDT
MDT
MMDT
MDT
MDT
MDT
MDT
MMDT
MDT
MMDT
MDT
MDT
MDT
Rajasthan
"
Alwar
Bharatpur
Jaipur.
2.7
2.6
2.0
Tamil Nadu
Chingleput
Kamarajar
Madras
South Arcot
Anna-Dindigul
Madurai
16.4
12.8
14.3
16.9
8.5
14.3
MDT
MDT
MDT
MDT
MDT
MDT
Uttar-Pradesh
Azamgarh
Fatehpur
Gonda
Shahjahanpur
Kanpur-Rural
7.0
9.6
5.9
7.9
10.7
MDT
MMDT
MMDT
MMDT
MDT
West Bengal
Burdhwan
Jalpaiguri
Maida
Murshidabad
Purulia
10.0
7.0
6.0
6.0
7.9
MDT
MMDT
MMDT
MMDT
MDT
Tripura
West Tripura
3.1
2. Source Of Data
The data sources comprised the records and
registers maintained at different levels of NLEP functioning.
In addition, documents were made available by the state
Director Generals Of Health services. Discussions were held
at the state and district head quarters with officers
incharge of NLEP to assess the adequacy of supervision,
staffing and availability of drugs. It was possible to probe
the perception of state and district officers on the
strengths and weaknesses of the NLEP management. The unit
level constituted the interface between the programme and the
people. Therefore records maintained at the LCDs, ULCs,SET
centres and the PHCs formed the key sources for the
assessment of new case detection, disease profile, patient
discharge and surveillance.
Much of the information, however, came from
interviews with NMSs, PMWs, patients and the members of the
community in the villages. This afforded opportunities to
judge the progress of programme activities, technical
competence and devotion of the staff, the role of health
education in influencing social perception of the disease and
acceptance of the programme in general.
3.
Instruments Of Data Collection
Compared to earlier evaluations, the data base was
considerably enlarged, not only in numbers but also to
11
include newer categories consequent upon introduction of the
modified MDT scheme. As such 21 different proformae were
developed for interviewing respondents operating at the
state, district and unit (LCU/ULC/SET/PHC) levels. Separate
questionnaires were constructed to elicit information from
the patients and members of the community. The epidemiologic
information on the MDT and MMDT districts was elicited on
proformae specifically constructed for the purpose. The
questionnaires had been extensively pre-tested before and may
be seen at Appendices IELP - 1 to IELP - 21
4.
Data Collection
Data from the field was collected by teams of
investigators, each comprising an international specialist,
an epidemiologist and a leprologists, besides a health
administrator. The team composition is presented in Table 3.
TABLE
3
Coordinators
Government of India
Dr.B.N.Mittal
Directorate General of
Health Services,
Nirman Bhawan,
New Delhi
WHO
Dr.S.K.Noordeen
WHO, Geneva
Dr. Sharad Kumar
Temporary Advisor
WHO, New Delhi
Mr. T.Sundaresan
Former Statistician
WHO, Geneva
Team Composition
Team No. Govt, of India
1. Dr. A.K.Chakrobarty
Prof. Epidemiology
A.I.I.H & P.H.
Calcutta.
Dr. A.Dutta
Director,
CLTRI, Chengalpattu
Dr P.S. Rao
Dy. Director,
CLTRI, Chengalpattu
2. Dr.S.D.Chaudhary
Prof. & Head of
Deptt. of Dermatology
Rohtak Medical College
Rohtak, Haryana
12
WHO
Dr.(Mrs) K.Norlin
D/o Inf. Dis.
University Hospital
S-22185 Lund
Dr. Gerson 0.Penna
National Programme
Manager,
Ministerio Da Saude
Fundacao Nacional Da
Saude,Demmatologia
Sanitaria, Block 'G'
Anexo Ala 'A'20 Andar
Salas 219/221 CEP 70058
Brasilia - DF Brazil
State(s)
A.P.
Bihar
Dr. C.R.Revankar
Dy. Director
Bombay Leprosy Project
11, V.N. Purav Marg,
Sion Chunabhatti
Bombay - 400022
3 • Dr. H. Srinavasan
Hon. Editor
Indian Journal of
Leprosy ,
245 TTK Road, Madras
Dr. M.D.Gupte
271 Nehru Bazar,Avadi
Madras - 600054
Dr. D. Porichha
Dy. Director,
RLTRI, Raipur
4• Dr. D. Lobo
Medical Advisor
4, Gajapati Street
Shenoynagar, Madras
Dr. D.A.W.Nugent
Craigieever
27 Golf Side
Cheam SMZ 7 HA
Surrey, Engaland
Dr. P.Vijaykumaran
Sr. Medical Officer
SLRI & TC Karigiri
North Arcot, T.Nadu
5. Dr. B.N.Mishra
Director of Health
Services,
Bhubaneshwar, Orissa
Dr. J.P. Mulliyal
Asstt. Profesor
CMC Vellore,
North Arcot,T.Nadu
Dr. N.S.Dharmshaktu
ADG(Lep)Dte.G.H.S.
New Delhi.
6
Dr. J.Ponniah
Director, SLRI & TC
Karigiri, North Arcot
Tamil Nadu.
Dr. A.Thomas
Medical Supdt.
TLM Hospital
Vadathra Salur
Thiyagadrug - 606206
Dr. K.V.Krishnamurthy
Director,
RLTRI, Aska, Ganjam
Orissa.
13
Gujarat
Kerala
Dr. R. soldenhoff
Netherlands Leprosy
Relief Association
For the Leprosy
Control Project in
Eastern Nepal (ELCP)
PO Box 134 Birarnagar
Nepal.
Maharashtra
7 ■ Dr, C.S. Walter
Director,
The Leprosy Mission
16 Pandit Pant Marg,
New Delhi.
8.
Dr. M. Mathews
Vijay Apartments
1st Floor 'C 47
First Main Road,
West Shenoy Nagar,
Madras - 600030.
Dr. V.P.Bhardwaj
Director,
Jalma Instt.for
Leprosy, Agra,L'P.
Dr. P.D.Samson
Medical Supdt.
Richardson Leprosy
Hospital, Mi raj Sar.gli,
Maharashtra
Dr. P.
.rti.v
;’h. S.P.Tare,
Director,
Gandhi Memorial
Leprosy Foundation
Warcha, Maharashtra
□r. Niran Katoch
Jalma Agra
Dr. 3. M. .Reddy,
Director,RLTRI, Lalpur,
P.aipur, Madhya Pradesh
10. Dr.V.Ekambaram
23,V P Colony,
Madras - 23
Dr.Haidar Abu Hamed
Department of
Community Medicine,
University of
Khartoum, ■ Khartoum,
Sudan.
Madhya
Pradesh
Dr. Cesar Viardo
Chief of Hospital
III, Regional Health
Office No.4, Dr.Jose
N Rodriguez Memorial
Hospital, Tala,
Caloocan City,
Philippines
Orissa
.
Dr.Anand Raj
1-8-702/32
Nallakunt,
Hyderabad-500044
Dr.R.S.Mishra,
Head of Department
of Skin & VD
Safdarjang Hospital,
New Delhi.
H. Dr.R.Ganapati
Director,
Bombay Leprosy Project
11 V N Purav Marg,
Sion Chunabhatti,
Bombay.
14
Dr.C.McDougall
87 Lower Radley,
Near Abingdon,
Oxfordshire
Rajasthan
J & K
Assam
Meghalaya
& Tripura
Dr. Atul Shah
Project Director,
CLC Project
C/o Plastic Surgery Deptt.
JJ Hospital, Bombay-400008.
Dr.T.Abrahim
16 Railway Colony
4th Street, Aminji Karai
Madras-600 029
12 • Dr.G.Raman
Srepura-228 KRS Road
Metagalli Extension
Mysore - 570016
Dr.. K. Koticha
Superintendent,
Acworth Leprosy Hospital
Wadela, Bombay.
Dr.B.N.Barkakaty
Addl. DDG (RHS)
Dte.G.H.S.New Delhi
13- Prof.L.M.Nath
Dr.Kyaw Lwin
Head of Deptt. of
Burma
Medicine of Community,
AIIMS, New Delhi
Dr.Tadele Tedala
Dr. T. Prabhakar Rao
Epidemiology Deptt.
Addl. Director
Ministry of Health
I/c (Leprosy)
P.O. Box.1038
Directorate of Health,
Addis Ababa,
Hyderabad,
Ethiopia
Andhra pradesh
Dr.Le Khin Due
National Institute
of Dermatology &
Venerealogy,
Hospital Batch Mai
Hanoi, Viet Nam
Dr. N. Chitimba
14. Dr. VP Macaden
Swiss Emuss Leprosy
Medical Officer
WHO Sub - Regional
Hospital & Training
Centre, Hubli, Dharwad, Office III,
PO.Box 5160, Harare,
Karnataka
Zimbabwe
Prof. A.R.K.Pillai
President,
Indian Leprosy Foundation
Field Office L - 10/3&4
Jal Rattan Deep,
Bangur Nagar, Bombay - 90
Dr. B.T.Uke,
ADG(TB)
Dte.G.H.S.New Delhi
15
Nagaland,
Manipur &
Mizoram
Tamil Nadu
Kerala
Uttar
Pradesh
15
Dr.Andy Louhenapessy
west Bengal
Dr.V.Kandaswamy
Indonesia
AL-189,lst Street
12th Main Road
Anna Nagar(West)
Madras — 600040.
Dr.Sorenson
DANIDA, 7, Golf Link Area
New Delhi.
Dr.S.S.Naik,
RRE Society,
Acworth Leprosy Hospital,
Wadala, Bombay - 400 031
These teams collected data in the field from Dec.
10th to 19th, 1991. At the district headquarter, each team
randomly selected for their visit 2 LCU/Modified LCD or PHCs,
if the district was under primary health care centre. Besides
the ULCs, at least one third of the existing number of SET
centres other than those attached to the LCDs, the training
centres, voluntary organisations providing leprosy services,
temporary hospitalization units and SSAUs falling within the
geographic area of the district were also visited. In
addition, 4 villages per LCU/PHC were randomly visited by the
teams.
The respondents interviewed at the district head quarter
included besides the DLO, at least one NMS, a health
educator, a physio-therapist and a laboratory technician. Two
PMWs, One NMS and one laboratory technician were selected for
interview together with the medical officer at each LCD or
PHC,if the district was under MMDT or was looked after by the
primary health centre . In every village 15 leprosy patients
and an equal number of community members were interviewed.
The organizations and the respondents forming the data base
may be seen in Table 4 and Table 5.
TABLE
4
Fourth independent evaluation of NLEP
data base
Number
States/UTs
Districts
Urban Leprosy Centres
Leprosy Control Units
Modified Leprosy Control Units
Survey, Education & Treatment Centres
Primary Health Centres
Sample Survey & Assessment Units
Leprosy Training Centres
Villages
Voluntary Organisations
16
24
77
16
83
4
3
19
10
11
88
29
The data gathered in the field was summarized and a
report presented at a plennary session, during which the
members also highlighted their unrecorded observations before
the Union Health Secretary and other officials of the
Government of India and WHO, SEARO, New Delhi.
TABLE 5
Fourth independent evaluation of NLEP
respondents interviewed
Categories
*
■'
Number
State Leprosy Officers
DLOs/MOs
Non Medical Supervisors
Laboratory Technicians
Para Medical Workers
Multipurpose Workers
Physio-therapist/Physio-technicians
Health Educators
Community members
Patients
:
:
:
:
:
:
:
:
:
:
24
198
174
98
167
15
34
41
424
466
Not all the questionnaires were properly filled. Data
from completely filled proformae was fed for analysis into a
computer. Conclusions were drawn from the entire consolidated
data as also separately from data collected from the MDT and
MMDT districts. Observations embodied in this report are
based on these analyses.
17
IV
OBSERVATIONS
1.
National Profile Of Leprosy
The total number of leprosy cases in the 77 districts
spread over 24 states or Union Territories stood at 4,61,937
on April 1, 1991.
One fourth of them were multibacillary.
Disabled patients averaged 13% and in another 13% the disease
was seen in children below 14 years.
Likewise, in 1,14033
new cases registered in the current year (April 1990 to March
1991), the childhood leprosy occurred in 20.3% while those
disabled constituted 17.3% of the MB and 8.4% of the PB
forms.
In the voluntary sector, among the 10,490 patients
currently registered by 29 organisations, the MB and
disability rates were 29.0% and 7.8%. At the village level
28% of the 8158 recorded cases were multibacillary and 2720
(33%) seen in the children.
These figures are in close
approximation and reveal an increase in the proportion of MB
cases and those in children compared to the recorded national
of average of 20% multibacillary cases and a child rate of
15% at the national level.
A rise in the proportion of multibacillary patients
and an increase in the child rate could both be related to
the extended coverage of multi-durg therapy brought about in
the past few years.
It is well recognized that the early
phase of MDT was characterized by an increase in the
proportion of MB cases consequent upon a relatively rapid
elimination of the paucibacillary form of disease.
Likewise,
as the older cases yielded to MDT, the proportion of disease
in the children appeared more. The
significance of these
epidemiological parameters would become clearer in the
analysis of data from the districts that completed the
intensive phase of MDT.
2.
Case Detection And Treatment
The twin activities of prompt detection of new cases
and their expeditious treatment constituted the hub of the
leprosy control program.
No less important was case holding.
Leprosy Control Units were established on these principles.
case finding was a continuous on going activity, affected
through mass and school surveys as well as house to house
searches by the front-line leprosy workers.
case dptpr^ survey formed the single most effective mode of
50 si^ t °n Jln the Indian Programme.
in a population of
o?' the oaHpnid
th<2 ™SS in the Past ^ree months, 56.1
throuah 4hnniS WSre detGcted through mass survey, 39.4%
r •v
?
school survey and only 4 5% throuah contactthleWpMWS amtheSt the 1,320 lePr°sy patients identified W
responsible for
Sch°o1 and contact surveys were
responsible for detection of 69.3, 20.5 and 10,2 per cent of
18
the cases. Greater emphasis on school survey was a
commendable feature of case detection in recent years. That
may also be the reason to account for an increase in the
childhood leprosy among new patients. It not only led to the
recognition of leprosy in the most vulnerable section of the
population but also in an earlier phase of its development.
Another encouraging observation was voluntary reporting of
patients to the extent of 35.0% in the 2,41462 cases brought
under MDT in the 35 districts.
In order to intensify the crucial activities of case
detection and treatment, it had been the practice in the NLEP
to allocate annual targets to the individual states for these
activities. The performance of the program in this regard was
measured on the basis of these two indices, namely,
a
percent of the allotted cases detected during
1990-91,and
b
percent of the detected cases treated in the same
period.
The data on case detection, treatment and release of
patients
during 1990-91 is presented in the table 6.
It
showed that with the exception of the states of Himachal
Pradesh, Madhya Pradesh, the eastern states of Meghalaya,
Mizoram and Nagaland as well as West Bengal, the achievement
in all other states exceeded the case detection target by 104
to 280%.
Even in these states, except for the eastern
region, the case detection was at least 80.0%. Since nearly
all the detected cases were brought under treatment, the
number of treated cases also exceeded the allotted target by
101 to 233%.
The states that failed to bring under the
treatment all the detected cases were Himachal Pradesh,
Meghalaya, Mizoram, Nagaland and West Bengal.
In Nagaland
only 30% of the detected cases were treated followed by 60%
in Meghalaya, 68% in West Bengal and 80% in the states of
Himachal Pradesh and Mizoram. On an average 98.4% of all the
detected cases were put on treatment in 24 states /UTs. This
was a remarkable performance.
If treatment of all the cases was inescapable
in the interest of program efficiency, it was even
more
important that they completed treatment. The patients listed
as discharged in the table included not only those who
completed treatment but also others who died or migrated from
the( area.
Against 877.5 thousand cases targeted to be
discharged at the aggregate level, those actually discharged
numbered 981.7 thousand.
Obviously, the latter included
cases in the backlog besides others who migrated.
19
TABLE 6
Detection, treicaenl and discharee of cases(xlOOO)
STATE/UTs
o
;
UPTO 1.4.91
! CASES ON
CASES UIIOEE
B3COBD
TBEATHEHT
FROM 1.4.90 TO 31.3.91
CASES
!
CASES DETECTED
DISCHAEGEO 1 TAEGET
CASES DISCHAEGEO
CASES UIIOEE TBEATHEHT
ACHIEVEMENT
iage
TARGET
ACHIEVEHEKT
lags
TAEGET
ACHIEVEMENT
Xage
ANDHEA PEADESH
I
214.23
214.23
1190.03 ;
50.00
85.19
111.58
50.00
85.19
111.58
200.00
141.35
10.68
ASSAM
I
18.76
18.44
13.11 :
1.50
1.64
109.33
1.50
1.64
109.33
1.50
1.81
18.61
BIHAB
I
<62.11
418.68
264.06 1
25.00
26.10
104.40
25.00
25.40
101.60
30.00
29.95
99.83
CHANDIGARH
:
.93
.81
■oi
:
.05
.14
280.00
.05
.11
220.00
.05
.01
14.00
D A N HAVELI
!
.38
.36
.06 ;
.05
.10
200.00
.05
.10
200.00
.05
.06
120.00
GUJ8AT
;
24.90
24.86
128.23 1
6.00
9.12
121.50
8.00
9.10
121.25
25.00
13.39
53.56
HABTAHA
:
1.28
1.28
.92 1
.10
.26
260.00
.10
.26
260.00
.10
.32
320.00
HIMACHAL PEADESH
1
3.95
3.95
3.29 ;
.20
.16
80.00
.20
.16
80.00
.20
.53
265.00
JAMMU I KASHMIR
1
5.35
5.45
i.8i :
.20
.26
130.00
.20
.26
130.00
.20
.25
125.00
EAENATAEA
1
39.41
39.41
263.85 1
18.00
19.18
109.89
18.00
19.18
109.89
60.00
16.19
126.98
EBBALA
I
65.81
53.54
79.20 ;
6.00
1.31
121.83
6.00
6.11
102.83
9.00
10.06
111.18
MADHYA PEADESH
1
159.85
124.59
188.86 ;
21.00
26.52
98.22
21.00
26.52
98.22
30.00
35.49
118.30
KAHABASHTBA
f
166.61
166.61
839.56 I
55.00
89.69
163.01
55.00
89.69
163.01
190.00
118.32
62.21
HANI PUB
;
1.36
1.36
4.66 I
.08
.12
150.00
.08
.12
150.00
.10
.13
130.00
MEGHALAYA
:
i.39
1.39
i.i9 :
.05
.03
60.00
.05
.03
60.00
.05
.04
80.00
KIZOBAH
;
.20
.19
.68 :
.05
.04
80.00
.05
.04
80.00
.05
.22
440.00
NAGALAND
:
2.03
2.03
.58:
.10
.03
30.00
.10
.03
30.00
.10
.01
10.00
OEISSA
;
151.62
156.96
330.10 ;
30.00
41.32
157.73
30.00
41.32
151.13
50.00
68.20
136.40
PUNJAB
:
3.29
2.99
4.65 1
.20
.55
215.00
.20
.55
215.00
.20
.13
365.00
BAJASTHAN
1
15.54
13.96
8.02 ;
.80
1.01
126.25
.80
1.01
126.25
.80
2.64
330.00
TAMIL NADU
1
201.11
202.89
:
15.00
94.79
126.39
15.00
90.51
120.16
200.00
2(9.33
124.61
TEIPUBA
:
2.70
2.10
2.44 ]
.15
.35
233.33
.15
.35
233.33
.10
.59
590.00
1171.89
UTTAB PEADESH
:
361.56
316.93
368.11
:
15.00
50.96
113.24
<5.00
<9.56
110.13
50.00
42.03
84.06
VEST BENGAL
1
114.34
92.91
529.56 I
25.00
11.13
68.52
25.00
11.13
68.52
30.00
190.68
635.60
TOTALS
1
2032.32
1866.16
1 361.53
4 79 80
130.55
361.53
<12.29
128.50
811.50
981.10
111.81
5395.61
.
.
Perforn>ance in respect of release of cases by
individual
states was not quite as striking as that
for
detection
and treatment. As many as 8 of the states/UTs
tO k®ep up
to the target, with Nagaland and
Chandigarh being on one end of the
spectrum
discharging
only 10 and 14 percent of the cases respectively,
and Gujrat
(53.5%) Maharashtra (62.2%), Andhra Pradesh (70.6%), Assam
(78.6%) and Uttar Pradesh (84.0%) on the
other end. Judged
on the scale of achievement of targets , most of states were
performing
more
than satisfactorily in respect of
detection, treatment
and discharge of cases . It was,
however doubtful ,. if target achievement served as a true
index for performance . Gross overshooting of target raised
the doubt that the allotment of targets had been unrealistic.
It was observed that with the introduction of MDT in
the control programme, exceeding of targets showed an
increasing trend over the years. Table 7 compares the percent
achievement of targets for detection, treatment and discharge
TABLE 7
Percent achievement of targets for case detection,treatment
Coverage and discharge in selected states in 1986, 1987, 1989 and 1991
State
Case detection
1986 1987 1989 1991
154 . 9 86.7 138 171.5
A.P.
88
10f
146 104.4
Bihar
Gujrat
118 121.5
81. 1 95
158 109.9
Ka'taka 132
142
110 121.8
67
94
Kerala
93
89
111 98.2
M.P.
186 163.0
172 191
M.P.
98
140 157.7
92
Orissa
97
149 126.3
96
Tz nadu
156 113.2
123
130
U. P.
89 68.5
75
W.Bengal 60
Treatment coverage
Treatment completed
1986 1987 1989 1991 1986 1987 1989 1991
—
107 70.6
171.5 153
100 86.4 164
—
43 99.8
134 95.5 165 101.6 202
—
217 53.5
86
101 101 122 121.5
82 126.9
100 142 142 109.9 162
—
96 111.7
80
80
91 102.8
84
—
120 118.3
98.2
113
100
89 111
—
112 62.2
100 191 186 163.0 183
—
146 136.4
155
99
67 140 157.7
—
92 124.6
145
120.7
83
88 142
—
67
125 84.0
88 117 151 110.1
122 635.6
68.5
33
89
75
89
-
of patients over the years in certain selected states to
elucidate the point.
Some of the reasons why achievement exceeded the
targets may be found in a massive increase in NLEP
infrastructure
simultaneous with the extension of MDT
and
adoption of rapid methods of screening leading to an
increase in case detection. It is, however, for consideration
whether target allocation
should be continued save for
exerting pressure on the states . One of its possible outcome
could be
an over diagnosis
of disease under target
pressure.
The credibility of the entire NLEP rested on the
reliability of the figures maintained at the national level.
The
information collected at the state headquarters
represented in an aggregate form the data generated at the
level of LCU, ULC and SET centres and transmitted through the
districts. To validate the authenticity of the achievement on
detection , treatment
and release of patients , the data
21
obtained at the state , district and unit levels were
compared in table 8. It would be seen that the data in
possession of the district and state headquarters faithfully
reflected the field conditions.
3.
Regularity Of Treatment
Drug defaulting was the bane of many a leprosy control
programmes. It called for particular qualities of tact and
patience in those responsible for ensuring that the treatment
was carried out . The risks involved were far too serious to
spare any effort in seeking out the defaulter to prevent
interruption in treatment. With the incorporation of
multidrug regimen in the NLEP, the continuity , regularity
and completion of treatment became of paramount importance
for the success of the programme. If the MDT ever failed to
make its impact, it would not be so for want of technical
reasons as for operational factors.
TABLE
8
Case detection, treatment coverage and completion
at the unit, district and state levels
(1.4.90 to 31.3.91)
Level
/ detected
Target Actual
I
/ under treatment
/ discharge
Target Actual % Target Actual *
LCU/ULC/SET 475481 46594 97 74075 72802 98
(121)
Distr ict
103084 114033 110 78075 183579 235
(55)
State
367530 479800 130 367530 472290 128
(406563)
58743
56507
96
110618 167916 151
877500 981700 111
In the 77 districts , there were a total of
4,61,937 patients of both MB and PB types of leprosy
as on
31.3.1991. They represented patients
on the register since
the inception of the programme. Of these, 402347 (87.0%) were
under treatment . The proportion of MB patients taking
regular treatment was 88.6% while 73% of the paucibacillary
were regularly taking drugs. To maintain an overall treatment
compliance of over 75.0% in all the patients, which included
many enrolled decades ago spoke of the commendable effort.
Default rate of less than 15% in MB cases in aprogramme of
this magnitude could not be viewed with alarm.
Td access the regularity of treatment ,
the records
maintained by 167 paramedical workers were analyzed . Amongst
8,158 patients looked after by the PMWs 1305 (16.0%)
defaulted in collecting drugs in the past 3 months. Of these,
1017 (78%) were personally contacted by the PMWs and 440
motivated to start regular treatment. It was unfortunate that
577 patients were left out from personal contact otherwise,
the default retrieval was. quite satisfactory. At the village
22
level, likewise , 398 (96,1%) of the 414 patients were taking
drugs regularly. The majority of the defaulters failed to
assign any reason for not collecting the drugs. It certainly
was not their lack of faith in the treatment, since 84.2% of
the 414 patients interviewed in the villages admitted of
benefit on the treatment given. In the absence of any
response, the reasons for defaulting treatment could only be
a
matter of conjecture. The visiting
teams
ascribed
absenteeism to an unwillingness on the part of the patients
to accept the diagnosis, particularly in the absence of
deformity or any other alarming symptom.
4.
The MDT Program
Presently,
there were 135 districts under the
combined drug treatment covering nearly 28.5 crore of the
population and accounting for 65.0 to 68.0% percent of the
recorded disease load. Thirty four of these districts with a
population of 673.5 lacks were included
for
assessment.
These districts were at various stages of MDT implementation.
Ten of the districts had compelled the intensive phase while
in 6 others the programme began only in 1990.
(a)
Infrastructure
Extension of combined drug therapy to a district
entailed the establishment of additional infrastructure,
ensuring the continued availability of trained personnel of
every category at each level of operation.
The existing
manpower
in
these
districts was
examined
for
its
availability and the training status. The observations are
summarized in table 9.
TABLE 9
The availability- of trained manpower in the MDT districts
Post
Number
Sanctioned
In
Position
Number %
Number
%
Vacant Vacant Trained Trained
M.O.
N.M.S
Lab.Tec.
P.M.W.
180
577
237
2714
151
508
192
2297
29
69
45
417
16.11
11.96
18.99
15.36
109
387
159
2229
72.19
76.18
82.81
97.04
3708
3148
560
15.1
2884
91.6
The overall position of staff was satisfactory with
only 15% of all posts remaining unfilled and over 90% of the
staff being trained. However, one fourth of the doctors and
the nonmedical supervisors were without training. This was an
avoidable level of technical weakness in the MDT program.
Very few posts of physiotherapists and health educators
existed.
Deformity prevention being an integral part of
combined
therapy
program,
the
non-availability
of
physiotherapists was a serious lacunae.
23
(b)
Case detection and treatment
The total number of cases in these districts at the
commencement of MDT numbered 5,35,287. Out of these, 2,91566
had been released leaving a balance of 2,43,721. Of these,
2,13,060 patients
(87.4%) were put under treatment. One
fifth of all cases were multibacillary. Cases with disability
averaged 13% and 18% were children below 14 years.
At the commencement of MDT, 77.5% of the cases were
under regular treatment; their number increased to 84.4% by
March 1990 while during the present year 85.5% of all cases
were under regular treatment. Thus, not only was the number
of patients brought under treatment satisfactory but also a
high proportion of them continued with the
prescribed
regimen of the combined drug treatment. A discharge rate of
79.9% (88,452 out of 110658) implied that the programme
functioned at a high level of efficiency.
There were 6,47,244 cases in total on combined drug
therapy in all the districts of the 24 states/UTS as recorded
at the state headquarters. Of these, 11757 were present in
districts outside the MDT program. Whereas over 80% patients
in the former group continued with regular treatment, only
63% in the latter received uninterrupted therapy. It was
obvious that MDT delivery in the districts under vertical
coverage was far superior to that provided through the
primary health care services. The availability of trained
manpower in the former made all the difference.
(c)
Surveillance
In the combined drug therapy programme, clinical and
bacteriological examinations were essential before the start
of the treatment. Periodic examinations were also required
during the subsequent period.
(i)
Bacteriological surveillance
Skin smears were examined only in 46% of the
6,47,244 patients registered with all the states. In 24% of
them the smears were positive. On the other hand, amongst
2,43721 cases currently on combined therapy in the 35 MDT
districts, bacteriological coverage
was available to 72.5%
of the MB and 57% of the PB patients with an overall
surveillance of 60.1%.
The positivity rate varied from 0.77%
in the PB to 47.6% in the MB types. The observations are
summarized in table 10.
24
TABLE
10
Bacteriological coverage in the MDT districts
Disease
found
type
Multibacillary
(47.6%)
Paucibacillary
(0.77%)
Total
(12.1%)
#
of cases
Detected
t
of case
Examined
Cases
Bacteriol ogically
Positive
48,745
35,342
(72.5%)
16,367
1,94,976
1,11,136
(57.0%)
864
2,43,721
1,46,478
(60.1%)
17,731
It will be seen that nearly one-fourth of the
MB and 43% of the PB patients were left without pre-treatment
bacteriologic cover.
At the aggregate level 40.0% of the
cases remained unexamined. Bateriologic examination was an
important adjunct for classification of the disease,
and a
deficiency in this vital activity should be cause for serious
concern to the program managers. There is no doubt,
that
there existed an inadequate infrastructure of
laboratory
services,
characterized by lack of manpower,
equipment and
space in the face of mounting work.
In August 1985, a system of cross check of skin
smears by selected institutions was introduced to ensure the
quality of bacteriologic services. To determine the accuracy
of skin smear reporting, the performance of 98
laboratory
technicians was analyzed.
The results are shown in table 11.
There were 8114 referred for cross check of which ultimately
2200 turned out to be positive.
However, only 1760 of them
were found positive by the technicians.
This would imply that 20.0% of the positive smears
were missed and reported as negative.
It was,
however,
gratifying that only 1.9% of the negative smears were, read as
positive. Thus, the quality of bacteriologic surveillance was
sub-standard.
The reasons for the deficiency of
laboratory
services are discussed under manpower performance.
TABLE 11
Observations on bacteriological cross check
Number
Number
Number
Number
(ii)
of
of
of
of
slides sent for cross check
positive verified as. positive
negative verified as positive
positive verified as negatives
8114
1760
112 ( 1.9%)
440 (20.0%)
Clinical surveillance
The
performance of clinical surveillance
25
in
the
programme was relatively better. In the states(24) a total of
11,57,102 inactive patients were targeted for surveillance.
Of these, 67% were actually accessed. Similarly, amongst
70,602 inactive cases allotted to 121 LCU/ULC/PHC, those
assessed numbered 56,664(80%). The 174 NMS interviewed who
were required to complete surveillance of 56,912 inactive
patients in the preceding 3 months, achieved nearly 75% of
their target.
Surveillance was very weak in Madhya Pradesh. Large
number of patients who completed the prescribed surveillance
period were still awaiting their release from control .
Similarly, the otherwise commendable performance in Tamilnadu
suffered because of weak surveillance.
(d)
Program performance
Program performance in the 33 MDT districts in
respect of certain selected activates as summarized in table
12 indicated a distinctly satisfactory level of efficiency.
TABLE 12
Programme performance in the MDT districts
Value
Indicator
Average Population examined per PMW
in the last 3 months
Average population examined by PMW/day
Proportion of registered MB cases on MDT
MB cases on regular treatment
PB cases on regular treatment
Clinical surveillance rate
(e)
3280
76.18
83.92
81.66
76.22
Impact of MDT
The MDT Programme in the 34 selected districts had
been in different stages of operation.
While 10 of the
districts had completed the intensive phase, in 7 of them it
had been in operation only from 1-2 years.
It would,
therefore, not be justifiable to assess the impact of
combined therapy on the overall status of the disease. Even
so, in 20 of the districts the disease load significantly
decreased as indicated by a decline in its prevalence rate.
It was, however, realized that application of
certain selected epidemiologic indices to districts where
combined therapy had operated for 5 or more years may
indicate the trend in disease epidemiology.
The parameters
selected were:
- prevalence rate per 1000
- annual case detection rate per 1000
- proportion of MB cases among the new cases
- childhood leprosy rate among new cases%
26
-
deformity rate %
relapse rate per 1000 cases
voluntary reporting%
per cent of villages without active leprosy cases
Observations in respect of these parameters in 10 of
the districts completing the intensive phase of operation are
summarized in table 13.
Prevalence rate
A dramatic decline occurred in the prevalence rate in
all the districts, the average fall being 71.6% from its preMDT value.
The maximum decrease of 89.2% was witnessed in
Vishakhapattanum while the least that occurred was 13.5% in
Balasore. Since the detection of new cases in the districts
had been thorough, the prevalence rate denoted the actual
number of cases.
There is no doubt that the case load in
these districts declined simultaneously.
Annual case detection rate
Like the prevalence rate, the annual case detection
also decreased uniformly in all the districts.
The average
decline was 44.5%.
It was only in 3 districts that annual
case detection decreased by more than 50%, in the remaining
7, the reduction averaged 4 0%. The true reflection of the
disease in an area was its incidence.
However, the measure
of incidence of leprosy was particularly difficult to obtain.
Instead most control programmes employed case detection
rates.
MB Ratio in new cases
The proportion of multibacillary cases increased in 7
of the 10 districts, while in the remaining 3, it witnessed
an average decrease of 11.0%.
It was logical to expect an
increase in the MB cases during the early stages of combined
therapy.
Some of the paucibacillary
cases resolved on
their own so that the duration of the disease, on an average,
was shorter in PB compared to MB patients.
The backlog of
cases prevalent during the early stages of MDT would also
disproportionately increase the multibacillary cases.
Childhood leprosy rate
An increase in the proportion of children among the
new cases characterized all the districts compared to what it
was
at the commencement of combined therapy.
The increase
varied from 20.6% in Durg to 84.3% in Puri.
The above age
distribution may be related, to an extent, to the increasing
its near absence earlier.
As stated earlier, one fifth of
the new cases were detected through school surveys.
27
TABLE 13
Selected eoideaiolojical indices in districts coapletiot intensive HOT Phase
3
3
I Annual Case
Prev. rate 1
District
4
J
*
[
HB ratio in
1
new cases
IVar i.l Detection rate 1 Vari.
Current 1
IPrev.
IPrev. Current.!
6
5
1
Prev.
Current
X
Vari.
8.1
7.0
1-13 51 0.8
0.6
1 -25.0 1
35
-33.0
-7.1
CBENGAI KC2
112.8
3.3
1-71 21 2.4
1.6
1 -33.3 1
32.8
-27.6
-15.8
DEOGAEStDUKKA
110.8
1.9
1-82 <1 2.3
1.7
1 -26.0 1
31.0
(15.0
-
6.2
1.0
1-83 81 2.1
1.2
1 -50.0 1
27.8
-25.6
-10
BALASO2E
DBABVAD
9.0
2.7
1-70 01 2.8
2.0
1 -28.5 1
29.0
(38
HAYU2BHAMJ
111.4
<■5
1-60 5] 5.7
2.0
1 -64.9 1
32
(50
PU2I
110.5
2.0
1-80 91 1.9
1
1 -47.3 1
19.0
(23.0
PU2ULIA
133.7
4.4
1-85 91 2.6
1.7
1 -34.6 1
29
(31
VISBAIHAPATHAK
9.3
1.0
1-89 21 1.9
1.0
1 -79.5 1
33.0
(35.8
VEST G0DAVA2I
6.6
1.7
1-71 21 2.7
1.2
1 -55.5 1
12
(14
DURG
7
Childhood
1
A
1 Vari.
5
IO
7
8
1 Disabilitj rate!
I in new cases
Current
12.7
<9.0
! (285 1
12.2
HA
1
H.5
19.2
*32.4
1
1
6.8
16.0
12.0
1-25
1
15.1
13.0
20
1(53.8 1
18.6
21
1(12.9 1
15.0
19
1(26.6 1
18.0
23.0
1(39.0
16.0
17.5
1 (9.3 ;
14.2
31.0
1(118. 31
15.6
38
1(146. 11
Prey. - Before KOT
1 Belapee rate
! Vari. 1 in ne
Prev.
•
I
«
Current!
/L
/3
X
1 Voluntary
1 x
IReporting rate
1 Vari.;
1
1 Vari
cases
/❖
1
5 Prev.
Current!
0
0
1
2.4
1 -64.71 0.8
10.1
; -34.4,' 0.3
2.0
i.i
: -30.0]
.02
.01
1-50
1 <6
52
1
(8
1
11.6
5
: -20.51 0.5
0.2
1-60
1 22
30
1
(8
1
HA
SA
1 SA - 1
0
1
-
1 15
25
1 (13
1
: s.<
1.0
1 -84.31 0.2
0.18 1-50
1 21
34
9.6
5.8
1 -29.11 1.6
1.4 1-12.5
19
27
1 (8 1
1 (7 1
3.1
2.0
1 -<1.11
0
0
1
-
1 33
27
1
(8
1
5.4
1
1 -81.<1
0
0
1
■
1 36
51
1 *15
1
1 Prev.
HA
1
0
Vari. : Variation
28
1 Prev
Current
1 20
60
1
(40
1
0.7
1-12.5 1 23
360
1 (13
1
0.3
1
35
; (9 1
HA
-
1 26
•
1
Disability rate
The disability rate also showed a fall in each of the
ten districts.
It was dramatic in the districts of Puri and
West Godawari, where the proportion of deformity came down by
over 80%, followed by 64.7% in Chengi Anna.
In the remaining
6 it varied from 20-4%.
No information was available for the
districts of Balasore and Mayurbhanj.
It was not easy to
comment on the decrease in the disability rate.
There was no
doubt that, in part, it was due to the effect of MDT.
In
several of these districts, the MDT had operated for more
than 5 years.
On the other hand, the point cannot be lost
sight of that there was a large scale elimination of disabled
patients during initial screening at the commencement of MDT.
Relapse rate
The relapse rate remained unaffected in 5 of the 10
districts. In the other five,it declined by an average of 37%
Voluntary reporting rate
An increase in self reporting varying from 8 to 40%
in different districts was in fact a measure of the
effectiveness of MDT and of an increasing awareness by the
people of the availability of cure for leprosy.
Count down of villages with active leprosy cases was
included as an additional
indicator.
The available
information is tabulated in table 14. However, in the absence
of information on number of villages without active leprosy
patients prior to MDT,the indicator lost much of its meaning.
TABLE 14
Villages rendered leprosy-free since MDT commencement
in districts completing intensive Phase
I Total No.
No. of Villages
| of Villages without active
cases
Districts
BALASORE
- CHENGAI MGR
DEOGARH+DUMKA
DHARWAD
DURG
MAYURBHANJ
PURI
PURULIA
VISHAKHAPATNAM
WEST GODAVARI
1971
2324
3338
1322
1869
3914
4802
NA
4293
839
182
448
1212
570
499
825
1322
NA
3272
135
Totals
46255
14966
NA = Not available
29
% of villages
without active
cases
9.23
19.28
36.31
43.12
26.70
21.08
27.53
*★★X★
76.22
16.09
Even as the effect of MDT on the disease epidemilogy in
the above districts was positive, it would be facile to
explain away an increase in childhood leprosy among the new
cases and a dramatic decline in the disability rate in some
of the districts. In fact, it would be opportune now to
initiate
detailed
epidemilogic
studies
in
districts
completing the intensive phase of MDT to get at the root
cause of the changes.
5.
The Modified MDT Programme
In 1990, the scheme of modified multi-drug therapy
was introduced which entailed the fulfilment of certain
administrative prerequisites before the treatment commenced.
The assessment,
as such,
pertained primarily to the
establishment of the required administrative structures.
In all 12 districts were visited. Save for the
registration of the
District
Leprosy
Society,
other
administrative steps were completed in only 3 of the 12
districts.. The registration was done, perhaps, because,
through it was to flow the financial assistance. Village-wise
list of leprosy patients was ready in half of the districts.
Reorganization of the units, redistribution of PMWs and to
make the NMS headquarter co-terminus with the PHC/CHC largely
remained undone.
Of the 12 DLOs interviewed,
9
had earlier
experience of work in the field of leprosy but none of them
was trained. Likewise, only 68 of the 250 medical officers at
the primary health centres had received any training in
leprosy. One fifth of the sanctioned posts of para-medical
workers of all categories were unfilled. However, 98% of the
multi-purpose workers were in position.
New cases detected during the present year
numbered 9356. However, twice as many were on treatment.
Eighteen percent of the new cases were multibacillary. No
information was available on the child rate, the disability
rate and the relapse rate.
Not much field activity was in evidence in the 11
PHCs visited. That was understandable since the scheme was
yet to take off the ground. It was barely an year that the
concept of MDT was formulated and orders issued for its
introduction in some of the districts. Amongst the 1937 cases
available for screening, 1620 were examined and 563 cases
were found to be suffering from leprosy. Eighty percent of
the 1107 cases registered at the PHC were on treatment.
Given the fact that in many of the districts in
the country, integration of health services was presently
being affected through the primary health care approach, it
was important to consider the interrelationship between MDT
implementation
and
the
process
of
health
services
30
integration. Changeover to an integrated approach was bound
to lead to certain administrative difficulties in the
gestation period.
The state of Maharashtra initiated an integrated
programme in certain districts where the prevalence rate
declined substantially, such as Amravati. Even as the medical
officer and the staff of PHC shared the responsibility for
leprosy control, areas such as case finding, documentation
and management of complications werg yet to pick up. Perhaps,
these would be off-set following proper training of the
officers.
In Himachal pradesh, the primary health care staff
refused to undertake leprosy work unless incentives were
paid. By and large the quality of services under the
integrated system was yet to pick up.
6.
Manpower Performance
The greatest handicap of the NLEP was the non
availability
of
motivated
medical
and
para-medical
functionaries in the required numbers. No matter how sound
the strategy, eventually the success of disease control
depended on the quality of men operating the programme. The
manpower included besides the doctors, non-medical technical
personnel like supervisors, laboratory technicians, physio
technicians and para-medical workers. The work at every level
demanded not only considerable knowledge and experience, but
also a highly motivated and sympathetic approach.
(a)
Medical officers
Three levels of medical officers were engaged in
the programme. They were the state leprosy officers (SLO),
the zonal/district leprosy officers (ZLO/DLO)
and medical
officers (MO) in charge of units. These officers were the
crucial functionaries in the NLEP, providing administrative
and technical supervision and support to levels below them.
They
were
responsible
for
programme
planning
and
implementation. Correct perception of the programme and
understanding of the underlying
strategy of leprosy control
on their part were necessary for ensuring optimal utilization
of existing services and material resources.
Twenty four state level officers, 77 DLOs and 121
officers looking after units were interviewed. They were
assessed in respect of their training status, technical
soundness, supervisory and managerial functions as well as
initiative in pushing the programme. The training status is
summarised in table 15.
31
TABLE 15
Training status of medical officers at different levels
of NLEP operation
Level
Number of respondents
Total
Trained
% Untrained
State
District
ULC
LCD
SET centre
PHC
24
77
16
83
3
19
10
51
9
54
1
8
58.3
66.2
43.7
65.0
33.0
42.1
It was found that about 40% of the entire medical
manpower was untrained. More than one-third of the districts,
LCUs and ULCs were manned by untrained doctors while at the
state level only 42% had had training in leprosy.
An immediate outcome of lack of training was that
it affected the technical soundness. As shown in table 16,
only 48% of the doctors were adept and familiar with leprosy
classification and recommended treatment schedules and the
regimen of the therapy. These officers were supervising the
adequacy of treatment by the staff under them. Such ignorance
could contribute to an all round incompetence. It was further
observed that the technical quality of the medical men
suffered progressively over the years. Perhaps, a rapid
expansion of the programme under the pressure of MDT
compromised with the quality.
TABLE 16
Selected indicators of performance of medical officers
Parameter
Number of
# Performing
Respondents Adequately
Technical knowledge
Regular assessment of junior staff
Regular submission of reports
X-notification of migrated cases
Received feedback on reports sent
Provided field support
Initiative for programme promotion
Providing home service
172
220
95
125
125
149
95
125
83
168
65
48
62
112
60
74
%
48.2
76.3
68.4
38.4
49.6
75..1
63.1
59.2
Assessment of the managerial and supervisory
functions of medical officers as given in table 17 showed
that nearly three-fourths of the medical officers regularly
reviewed the work of staff under them. A high proportion of
them (90.2%) could recollect the name of the best worker
under them as also those who needed improvement. However,
their own submission of reports was not so good. Sixty eight
percent submitted their reports regularly. Report writing was
32
undertaken more as a routine procedure than a means of
programme promotion. Only half of the junior officers
admitted of having received any feedback on the reports
submitted by them. It was, however, encouraging that 75% of
the doctors regularly visited their staff in the field for on
the job support which contributed to the technical excellence
of these workers. Such support was essential for solving the
practical problems. While most of the unit officers provided
adequate supervision to the supervisors and para-medical
workers, only 15 of the 24 SLOs made field visits. They spent
on an average 10 days in the field in the past 3 months. Not
many officers (60%) displayed the quality to push the
programme on their own, such as visiting other organizations
engaged in leprosy control or visiting and attending meetings
of other district officers to elicit their support for
programme promotion. Only 35% of the officers took the
trouble of cross notification of the migrated cases.
TABLE 17
Comparison of the technical soundness of medical officer
through successive evaluations.
#
resp.
155
1986
1989
1991
# performing #
# performing #
# performing
adequately resp. adequately resp.
adequately
85 (74%)
174
87 (50%)
172
83
(48.2%)
resp. = Respondents
Utilization
of
existing
facilities
was
unsatisfactory. Repair of unserviceable vehicles was tardy
and the temporary hospitalization wards meant for providing
specialised leprosy services remained under utilised. The
average patient load per month in the 25 specialised care
units was a meager 27% and the average bed occupancy rate was
37% (see the programme management)
On the whole, while the technical supervision was
excellent, the overall performance of medical officers in
other areas turned out to be below par.
(b)
Non-medical supervisors
Non-medical supervisor was a functionary placed
mid way between the medical officer and the front-line
workers in the field. He was primarily responsible for
providing technical guidance to the para-medical workers
besides supervision in the field. Organising field surveys,
checking treatment compliance, referral of patients to
medical officers where required and arranging discharge of
cured patients were some of the other duties assigned to
NMSs.
respondents
The assessment of NMS was based on questioning 174
posted at the district head-quarters, LCU, ULC
and the PHC. Their placement and
summarized in table 18.
TABLE 18
training
status
are
Training status of Non Medical Supervisors
Level of posting
Number of
Respondents
District
ULC
LCD
SET centre
Number
Trained
12
19
80
5
14
23
92
5
Percent
Trained
85.7
82.6
86.9
100
In contrast to the medical officers, the great
majority of NMSs at each level had received formal training
and this was adequately reflected in their performance.
Seventy five percent of them were found sound in their
technical knowledge. The parameters against which the non
medical supervisor's performance was measured may be seen in
table 19 1
TABLE 19
Performance assessment of non medical supervisors
Number of
Respondents
Functional parameter
Provided supervision and
technical support to PMW
Carried out survey ini last 3 months
Possessed adequate technical
knowledge
Interacted with the community
Performing
Adequately
%
174
174
149
109
85.6
62.6
174
174
130
138
74.7
79.3
In the last 3 months 109 of the 174 NMSs had
participated in surveys for case detection in their allotted
area. Total population surveyed amounted to 506190, averaging
1547 persons per NMS per month. This was a great achievement.
However, the fulfillment of target for surveillance of
inactive cases was disappointing. Only 55% of the 56912
allotted patients were assessed. Most of the NMSs (85.6%)
regularly guided the PMWs in the field and offered them
technical support at least once a month.
In the preceding 3 months, 4,387 patients were
referred by the PMWs for the opinion of the NMSs. By
themselves, more than half of the NMS sought opinion on the
patients from the medical officers. These referrals were made
to clarify disease classification or confirmation of reaction
due to disease. Most of the NMS maintained rapport with the
community leaders and sought their assistance for programme
promoting activities such as health education and motivating
drug defaulters.
34
Monitoring
of
treatment
and
finding
drug
defaulters were among the more important activities of the
NMS. These activities were therefore, probed in some detail.
The observations are presented in table 20.
TABLE 20
Assessment of treatment monitoring by
non medical supervisors by patient coverage
Functional parameter
Number
Number of patients on treatment in
the alloted area of NMS
Number of defaulters contacted
Number of defaulters
Number of patients monitored by tablet
count in last 2 months
72878
12278
16904
11139
There were 72,878 patients on treatment under the
charge of the NMSs. The number of drug defaulters among these
was found to be 10,904 (15.0%). The number of patients
contacted for tablet counting by NMS in the preceding 8 weeks
was 11,139. Nearly 73% of the defaulters were personally
contacted. As many as 120 of the 174 NMS were regularly
meeting the
patients under them
for
assessing
drug
compliance. Except for case detection through surveys, the
performance of NMS was eminently satisfactory on all other
counts.
(c)
Paramedical workers
The position of paramedical workers was pivotal in
the NLEP, among all the peripheral functionaries. Not a task
was left out to which he did not contribute. Starting from
detection of cases through house to house searches and
contact, school and mass surveys, the PMW provided treatment
and advised patients on physio-therapy as well as prevention
of deformities. He assisted the NMS in drug delivery and
treatment compliance and also the laboratory technician in
preparing skin smears. He was the first line contact between
the programme and the people. As such the performance of the
PMW was crucial to the programme.
One hundred sixty seven PMWs were interviewed.
They were assessed on certain selected parameters derived
from their job requirements. The findings are given in table
21.
35
TABLE 21
Performance assessment of paramedical workers
(N = 167)
Function Assessed
Outcome
Case detection 1990-91 (% of targtted)
94.6
Case discharge 1990-91 (% of allotted)
130.4
Number of PMWs doing survey in last 3 months
140 (87.5%)
Avg. number of days spent for field survey
in last 3 months
28 days
Cases assessed (% of due for assessment)
60.8
Avg. number of skin smears for PMW per month
108
Number of PMWs advising physiotherapy
147 (80.0%)
Number of PMWs receiving guidance on physiotherapy 62
Most of the PMWs were trained (96.0%) , their
training being the highest amongst all categories of NLEP
personnel. The performance of the PMWs on most of the scores
was found to be very good.
Over eighty seven percent of PMWs regularly
participated in surveys for detection of new cases. This was
in encouraging contrast to nearly 25% of them observed to
avoid field survey in the last evaluation (1989). Nearly onethird of the working time was spent in the field. More than
100 skin smears were prepared by a PMW in a month and over
30% of them were conscious of their duty to advise patient on
the prevention of deformities.
The case detection was absolutely satisfactory. Of
the 5105 cases allotted in the current year, 4834 (94.7%)
were detected. The target for discharging patients exceeded
by 130%. However, the surveillance of inactive cases, in
contrast, appeared below par, the assessed cases being only
61% of the targeted number.
In order to authenticate the technical competence
of the PMWs, the team members were asked to verify the
diagnosis and disease classification made by them through
personal observations in the field. Of the 414 patients
contacted the disease had been correctly classified in 398
(96.1%) . Likewise, among the 88 patients registered as
multibacillary the disease classification was doubtful only
in 15% of them. There was no doubt that these workers
possessed the required technical competence. An assessment ny
NMS of PMWs working under them revealed that in 83.0% of the
patients the disease was correctly diagnosed.
monitoring
Like for the NMS, the activity of treatment
by the PMW was examined in some detail. The
36
are recorded in table 22.
observations
TABLE 22
Treatment monitoring by PMW
Function
Number
Number
Number
Number
of
of
of
of
Number
patients under treatment
drug defaulters
defaulters contacted personally
drug defaulters motivated to resume
8158
1305
1017
440
In a group of 8158 patients receiving treatment
under the charge of the PMWs,
16% were irregular in
collecting the drugs. Of these, 78% were personally visited
to convince them for regularity in drug intake and 440 were
motivated.
Realizing how difficult it was to change
attitudes, the failure to motivate the remaining 577 drug
defaulters was understandable.
(d)
Physiotherapist
For some unknown reason disability care and
physical rehabilitation of the handicapped patient remained
confined to the voluntary sector for a long time. Belated
recognition of the importance of physiotherapy that it
deserved was accepted under the NLEP only during the past one
decade. It was therefore, not surprising, that physiotherapy
remained the weakest link in the program even today.
There existed a total of 25385 posts of non
medical technical personnel in the NLEP; only 641 (2.5%) were
meant for physio-technicians. Even "among them more than onethird (35.5%) remained unfilled. Certain states, however,
paid due attention to physiotherapy. In Assam, Tamilnadu and
Uttar pradesh, all the posts were filled, while in Bihar only
5-6% were vacant. The West Bengal government did not create
the post of physio-therapist.
Thirty
four
of
the
physio-therapists
were
interviewed and encouragingly all of them were trained.
Fourteen had received retraining. In addition to patient
care, the physiotherapist were required to educate, guide and
supervise the PMWs who supplemented them in the task of
physical rehabilitation.
On an average, 116 patients were attended to in
the last 3 months,
which would amount to providing
physiotherapy to less than 2 patients in a day. This
performance could not be justified on any account. It was not
because facilities for physical treatment were deficient.
37
When questioned, 64% of the physiotherapists admitted that
the facilities were adequate. In 4057 patients who required
physical treatment, it was given to only 48.6%. Nearly half
the patients were referred (46%) while the remaining came on
their own.
An analysis of the work-time showed that on an
average, one third of the physiotherapist's time was spent in
the guidance and supervision of PMWs- and one-fifth in
advising patients on the prevention of deformities. The
remaining time was devoted to patient care. Thirty seven
percent of the 167 PMWs confirmed receiving guidance from the
physiotherapist.
The
performance
assessment
of
physiotherapist may be seen in table 23.
TABLE
23
Assessment of the performance of physiotherapists
N = 34
Parameter
Observation
Average time spent in the past 3 months on
Education, guidance & supervision of PMWs
Care of ulcer patients
Care of other deformities
Education & guidance of patients
Number who found facilities to be adequate
Average no. of patients seen in the past 3 month
Patients reporting voluntarily
Patients referred
Patients in need of physiotherapy in the current
year
Patients who received therapy
17.7%
26.7%
25.0%
22.0%
22
116
63
53
4057
1972
Physical rehabilitation in general was not the
strongest activity of the NLEP. Deformity care was yet to
start in Bihar even by the voluntary organizations. In the
governmental sector, it was confined only to advising on the
care of anaesthetic hands and feet. In Andhra pradesh, NORAD jconducted a physical care programme for the deformed that
appeared promising. Tamilnadu was supplying micro-cellular
footwear to the handicapped but only to a limited- extent. The
CLC project run by the state government in Gujrat with the
aid
from CIBA-GEIGY,
at Borsad
(Kheda)
particularly
emphasised deformity care, use of modulan grip aids and
corrective surgery.In most other states, the programme for
the care of the deformed needed considerable strengthening.
7.
Laboratory Services
The importance of a reliable laboratory backup in
furthering the effective operation of MDT programme cannot be
over-emphasised. Despite this, the general standard of
laboratory services under the NLEP was particularly poor. The
results were unreliable, the manpower not available and if
38
available not trained. Many of the trained technicians did
not have any exposure in the preparation and reading of skin
smears. There was hardly a state that could take credit in
maintaining good laboratory services.
The laboratory services were strengthened in the
later part of the intensive phase in all the MDT districts.
Even so, the laboratory technician's post constituted only
5.4% of the sanctioned posts of all the non-medical technical
personnel. One third of the sanctioned posts of laboratory
technicians were lying vacant. The states of Bihar and Madhya
pradesh were most affected where only 12% to 18% of the
technicians were in position. Andhra pradesh and Tamilnadu
were in no happier situation. (See table 28A)
The assessment of laboratory technicians was based
on interviewing 98 respondents. Only 60 of them were trained
in reading skin smears. The average number of slides examined
by a technician in one month came to only 11 and the average
reporting time after receiving the smears was 11 days. This
amounted to negligence of work. The number of fields examined
before labelling the slide negative averaged 7. Forty three
percent of the technicians did not care to send the slides
for cross checking. The quality of bacteriologic services is
discussed under Bacteriological surveillance.
Most members of the visiting teams found that the
microscopes were in bad state of maintenance. The laboratory
facilities were absent in several places in Karnataka and
Bihar, while in Kerala the space alloted for laboratory was
meagre.
8.
Training
The switch over from dapsone monotherapy to
combined drug treatment in the programme imposed its own
requirements for the rapid training of additional manpower
and orientation of the existing personnel.
In 1986-87, a WHO consultant visited 30
of the
then 45 existing training centres and concluded that while
the recruitment and training of PMWs was on the whole
satisfactory, the same could not be said of medical officers,
non-medical
supervisors,
laboratory
technicians,
physiotherapists and health educators. In fact, he warned
that the situation had taken a critical turn and demanded
action at the concerned levels. It was not known, if any
changes were made since then.
Eleven of the existing 49 training centres were
visited spread over 8 of the states. The assessment of these
training centres was not done in any detail. No efforts were
made to go into the educational content of the courses or the
training technology for want of time. Further, no information
was available from two of the centres in Boko in Assam and
39
Jalgaon in Maharashtra, while in another 3 the available
information was sketchy. The observations regarding the
remaining six centres is summarized in table 24.
TABLE 24
Utilization of training capacity of training centres
Category
Medical officer
NMS
PMW
Annual training
Capacity
75
90
1025
No.
of
Courses run
13
13
10
Average
Duration
Number
Trained
5
5
34
265
78
356
Even as the number of centres examined was small,
it clearly showed that the capacity utilization was extremely
poor, the highest being 49.2% for the PMWs, followed by 31.6%
for the NMS and 16.7% for the medical officers. In the face
of substantial number of workers observed untrained in each
category, idling of the training capacity of the training
centres remained inexplicable. Almost identical observations
were made during previous evaluations as well but the
situation still remained unchanged.
It was observed that the training centre at Brombe
(Ranchi) possessed a good library, classrooms, laboratory,
operation theatre and even a hostel for 50 trainees, yet no
trainees were sent to the centre from the state, even as the
number of untrained staff in the state was the highest.
Likewise, in Hyderabad and Madras, the utilization of
training
centres
was
sub-optimal
despite
very
good
infrastructural facilities.
There were 147 sanctioned posts of teachers in
these institutions, of which 136 (92.5%) were filled.
However, only 6.0% of the- teachers had received any training
themselves. This was a bad situation where new recruits to
the NLEP were entrusted to teachers who themselves had not
been exposed to any training in leprosy. No further reasons
need be found to explain poor technical competence of some of
the staff encountered during the evaluation.
9.
Health Education
Recognition of the fact that health education
formed an effective means of promoting leprosy control
programmes was relatively recent. Age-long prejudice and
ignorance on the part of the community regarding the nature
of the disease and the possibility of arresting and curing it
came in the way of leprosy control. A change in the general
prevailing attitude would immediately sharpen the cutting
edge of our available weapons against leprosy.
With the acceptance of MDT as the sheet anchor for
arresting the disease, it became all the more important to
prepare the community on the curative role of these drugs,
40
the need for continued treatment for prolonged periods,
assistance in default retrieval and social integration of the
general patients.
Health education in the programme aimed at :
creating awareness on the availability of free treatment;
developing knowledge on the nature of leprosy, its
amenability to cure, recognition of early signs of the
disease and prevention of deformities;
c. promoting social integration of leprosy patients; and
d. promoting community's committment to the programme.
a.
b.
The success of health education depended not only
on the educational content but also on the availability of
skilled communicators.
In examining health education,
therefore, both were assessed.
(a)
Infrastructure
Forty one of the health educators were contacted.
More than three-fourths of them had received training in
health education. All of them possessed adequate amount of
health education material by way of pamphlets, picture
posters, flip charts and booklets. All but 4 of them had
access to audio-visual facilities. In Tamilnadu,
the SLO
displayed initiative in innovating a light weight kit and an
audio pack to be carried by all the health educators.
The health educators were questioned on their main
target groups and on the effectiveness of the various methods
of communication employed by them. The observations presented
in table 25 revealed that all of them were primarily engaged
in the education of the community members. Patients of
leprosy were approached by 73% while the NLEP staff received
the least attention (24.3%).
TABLE 25
Performance profile of health educators
Number
Parameter
Number of respondents
41
Number involved in the education of
41 (100.0%)
- Community members
30 ( 73.1%)
- Patients
10 ( 24.3%)
- Paramedical workers
Number of patients advised on prevention
of deformities in past 3 months
2486
Number of drug defaulters contacted
in the past 3 months
1222
The most effective method of communication reported
- Word of month
13
- Audio-visual
20
- Graphic aids
8
41
In the preceding three months, an average of 2486
patients were covered. This number was inadequate and more
patients could have been contacted. Over 1200 drug defaulters
were visited in their hones and of these 663 were motivated
towards taking regular treatment.
Methods
of
communication
employed
included
lectures and small group discussions with the help of
educational aids. The connon graphic aids employed were in
the form of maps, charts, flip charts, flat pictures and
flash cards, while the audio-visual aids comprised film
strips, slides and over-head projectors. In Dhenkanal, the
educational effort was strengthened through simulations with
members of the community participating in the educational
campaign through street plays.
In the experience of the majority of health
educators (20), audio-visual communication was the most
effective method of putting the message across while 13 found
inter-personal communication to
be
superior.
Only
8
respondents relied on graphic aids.
Lack of transport was the main impediment faced by
many a health educator to extend their coverage.
(b)
Educational content
For evaluating the educational content, questions
were developed for the patients and members of the public to
elicit information specific to the areas of programme
awareness, knowledge regarding leprosy and their own role
perception. The respondents included 424 members from the
community and 466 patients drawn from 88 villages. The
observations are tabulated in tables 26 and table 27.
(i)
Awareness
A high degree of programme awareness prevailed in
the community. A great majority of the villagers (71.2%) were
aware of the leprosy workers visiting the villages. Nearly
half of them knew the workers by name. As many as 65% were
familiar with the work the PMW was performing in the
villages. Many of them had been contacted by the workers for
one reason or the other. When asked to narrate, the typical
42
TABLE
26
Community awreness and knowledge of leprosy
No.
No.
No.
No.
No.
No.
of Community members interviewed
who have seen leprosy worker visiting
who can recollect the name of the worker
with leprosy case in the family
who were familiar with the work of leprosy workers
contacted by the leprosy workers
Agree
Disagree
If a person once gets leprosy,
he gets it forever
61
305 (71.9%)
Leprosy patient should not be
kept in the family
103
284 (67.0%)
Leprosy spreads easily from
one to another
113
250 (59.0%)
Deformities in leprosy can
be prevented *
317
33
If a woman has leprosy, her
child will be born with it
86
241 (56.8%)
No. who feel treatment is most effective - allopathic
- homeopathic
- ayurvedic
No. willing to support NLEP
424
302 (71.2%)
206 (48.5%)
53
I 278 (65.5%)
| 214
Uncertain
58
3*7
61
74
97
338
12
14
339
No. = Number
responses were: 'he came to find out about leprosy patients'
or that 'he distributed pills'. Undoubtedly, the programme
had percolated to the people. Community awareness, however,
was not so good in West Bengal, perhaps because the state
does not have any post of health educator.
TABLE 27
Socio-economic profile of patients
No. of patients interviewed
No. of these living with families
Any other family member having leprosy
No', of patients employed
Of these patients
In service
Self employed
Daily wages
Any other
No. reporting to doctor themselves
No. who felt improvment on treatment
No collecting drugs regularly
Who drew first attention to your illness
Family
Self
NLEP
Community member
No. = Number
43
446
439
99
242
23
116
98
5
225
395
424
20%
20%
45%
15%
(94.2%)
(ii)
Knowledge about leprosy
Nearly 60% of the respondents believed that
leprosy did not spread easily. More than 70% knew that the
disease was curable while three fourths of them were aware
that deformities in leprosy were not inevitable. A high
proportion of the villagers (67%) knew that a leprosy patient
could be safely kept in the family. A’ majority (57%) was
knowledgeable about the non-hereditary nature of leprosy.
While patients in several districts of Uttar Pradesh, such as
Gonda, Shahjahanpur and Fatehpur did not know the cause for
the disease nor what exactly would follow if they did not
take
treatment
regularly,
yet
in
general,
people's
knowledgability on leprosy was satisfactory.
(iii)
Social perception
The general belief that the leprosy patients were
shunned by one and all was not borne out by this assessment
(table 27). More than 90% of the 466 patients lived with
their families. Half of the respondents were occupied in one
vocation or the other. The largest number of them (48%) were
self-employed while 98 out of 242 patients worked on ad-hoc
basis. However a very small proportion of them (9.5%) were in
service. It is true, that to expect that prejudice against
leprosy had completely disappeared was a far cry.
The general attitude towards the disease was
positive. The proportion of self-reporting patients steadily
went up over the years. In the 10 MDT districts studied in
detail,
self reporting accounted for 7 to 40% of the
patients. Among the 466 patients interviewed in the 255
villages 48.2% came to the doctor themselves. While in the
majority of the cases, the disease was first recognized by
the NLEp staff, in one third of them, it was patients
themselves who first became aware of their disease. In an
equal proportion attention to the disease was drawn by a
family member. In most of the instances (76%) the first sign
of the disease noticed was the appearance of a patch. The
belief of the vast majority lay in the efficacy of trie
allopathic form of treatment (table 27) .
In the 24 states/union territories, the health
education component of the programme needed strengthening in
most. In Andhra pradesh, no specific plan existed for health
education in many of the districts. The services of health
educators were being utilized for some other work. Most units
in Bihar were devoid of the services of a health educator. In
Karnataka, both the coverage and quality of health education
needed considerable improvement; while in Jammu & Kashmir,
Assam. Madhya pradesh, Uttar pradesh and West Bengal, health
education activities were patchy and inadequate. It was only
in the states of Gujrat, Orissa and Maharashtra that health
education seemed to have made- some Impact. In Jammu b
Kashmir, unlike most other states, widespread prejudice
existed against patients with stigma of the disease.
10.
Monitoring and Reporting
The NLEP maintained a well developed system of
programme monitoring and reporting. It operated at all levels
of administrative hierarchy. The data originated at the
peripheral level of the units and was reported to the
district headquarters which, in turn, forwarded it for
aggregation to the state. An efficient management of the
programme depended on continuous monitoring and initiating
remedial measures in time. For this reason, an elaborate
system of data collection, recording and reporting was
prescribed in the programme. Monthly, quarterly and yearly
reports were envisaged. Certain MDT districts were required
to send special reports.
Even the highest level
of
administrative control in the Government of India set a great
store
by
regular
programme
monitoring.
The
Leprosy
Commission, under the chairmanship of the Health Minister met
at least once a year to lay down plan and policies for
leprosy eradication which were implemented by the Leprosy
Eradication Board. The latter held six-monthly meetings.
The system was- assessed with regard to :
(a) Authenticity of data originating in the field;
(b) Timely reporting of information from the units, district
and state head-quarters to the respective higher echelons;
and
(c) Analysis and review of reports and the follow up action
taken.
The field staff often operated under difficult
conditions, and if this staff were to be motivated to collect
data completely and accurately, they must understand its
purpose and be able to make use of the data themselves. This
was not so. In Madhya pradesh, many health workers did not
have any understanding of why the reports were required. They
did not receive any training in filling up the forms. Skills
in interpreting data and using the information for programme
management was inadequate even at certain supervisory levels
in Kerala. In the district of Puri in Orissa, the case cards
used were other than those prescribed by the NLEP, defeating
the purpose of maintaining uniform reporting. Disability
charting and recording of nerve involvement, reactions and
side effects of drugs were observed to be perfunctory in the
districts of West Godavary, Jaintia Hills and Puri.
45
A monitoring system can be only as good as the
data upon which it was based. In this context a high degree
of reliability existed in the reported information from the
units with regard to case detection, disease classification
and treatment coverage. The data on the parameters verified
in the field through personal observations was found to
faithfully reflect the documented information in the state.
The
discrepancy
between
the
disease
diagnosis
and
classification made in the field with that observed by the
members of the evaluation teams was of the order of 4% and
15% respectively.
As the reliability of field data was a matter of
satisfaction, so was its timely reporting. In a total of 323
districts of the 24 states/UTs, those regularly sending
information to the state head-quarters were 259 (80.1%); only
4.6% did not send any report at all. Reports from over 90% of
the LCus, ULCs and PHCs were received in the district on
time. From the state headquarters, it was from Kerala and
West Bengal that the reports often reached DGHS late.
Otherwise, the reporting was regular and timely.
If submission of the reports was up to the mark,
their review and follow up were not. Even though the reports
were routinely reviewed in all the states and districts,
their analysis was perfunctory. The collection of data was
often used to initiate disciplinary action rather than to
make better decisions for day-to-day programme management.
Very few officers received any feed back from above. In
Chandigarh, there was extensive documentation of data but its
quantification was defective.
11.
Programme Management
NLEP had considerable inputs that were vital to
its functioning. A vast network existed under it. The
programme maintained its own exclusive cadre of medical
officers, non-medical supervisors, paramedical workers,
laboratory
technicians,
physiotherapists ' and
health
educators, numbering 26,788 persons in all. Centres were
maintained to train manpower and facilities were created in
the
form
of
temporary
hospitalization
units
and
reconstructive surgical units to provide specialised care.
These called for considerable managerial skill for their
optimal utilization. In addition, it was essential to ensure
a continuous supply of adequate anti-leprosy drugs, equipment
and transport at all levels. If leprosy control was ever to
flounder, it would not be for unsound technical strategy as
for want of an efficient managerial system. For these
reasons, an attempt was made to examine some of these aspects
of the programme. While the technical component of the
programme was quite satisfactory, the same cannot be said of
its management.
46
(a)
Cadre management
Cadre management presented many a lacunae in
several states. The Swaminathan Commission recommended that
the SLO being the chief co-ordinator and technical advisor to
the state government on NLEP, his post should be held by a
senior officer with adequate administrative experience,
holding at least the rank of a Deputy Director of Health
Services. He should remain in position for a minimum period
of 10 years to enable him to take a long view of the problem.
However, only 13 of the 24 SLOs possessed earlier experience
of work in leprosy. The average stay of the SLO at his post
was found to be only 1 year and 8 months. It was observed
that the Joint Director of Health Services holding this
position in Orissa was transferred 8 times in 3 years.
Likewise, frequent transfers of MOs were affected in many of
the states like Bihar, Karnataka, Orissa etc. In Kerala, the
SLO was of the rank of an Assistant Director, while in Bihar
he functioned under the Deputy Director of communicable
diseases programme. In Rajasthan, the SLO was denied adequate
administrative authority to monitor the programme. At the
district level, the DLO and the leprosy workers were
administratively under the control of the civil surgeon. Such
administrative impediments came in the way of. effective
planning and efficient discharge of the duties of the
concerned officer.
NLEP called for special committment on the part of
its staff; but these trivial administrative setbacks could be
the source of demotivation of the workers and generating an
avoidable feeling of frustration.
(b)
Vacant posts and untrained personnel
The overall vacancy position and the training
status of the staff state-wise is shown in table 28, while
the same by category of staff may be seen in table 29.
TABLE 29
Vacancy and training status by catgepry of staff
Post
Number
Number
% Number
%
Saiictioned Vacant Vacant Trained Trained
271
Zonal/DLO
1132
Medical Officer
Non Med. Supervisors 4034
19327
Para Med. Workers
1383
Lab. Technicians
Physiotherapist
641
409
Health Educator
75
320
717
4249
426
228
95
27.6
28.2
17.7
21.9
30.8
35.5
23.2
148
516
2137
14200
875
360
163
75.5
63.5
64.4
94.1
91.4
87.1
51.9
Nearly 23% of all posts lay vacant. The worst
affected states were Bihar, Karnataka, West Bengal, UP,
47
TABLB
28
Vacancy aod training status of stiff bj category and state
II Zonal/District Leprosy Officers
STATE/UT
CO
|
1 Medical Officers
1 Nor-Medical Supervisors
1
ISanct. Pos.
Vac. XVac Tran . XT ran.!Sanct.
Pos.
Vac. XVac Tran. STrat.l Sanct. Pos. Vac. XVac Tran. XT ran. 1
ANDHRA PRADESH
!
21
20
4
16.6
20
100.0
:
in
161
6
3.4
123
73.£ :
<83
411
10
2.0
(73 ioo.o :
ASSAM
!
5
3
3
50.0
0
0.0
:
23
23
0
0.0
0
o.o;
51
39
12
23.5
39 ioo.o :
BIHAR
I
22
21
1
(.5
5
23.8
1
115
102
11
11.3
9
8.e :
(70
2(6
224
<7.6
12
CHANDIGARH
:
o
0
0
mi
0
Itlll
1
0
0
0
nit
0 nm ;
0
0
0
nm
0 nm ;
D I N RAVELI
:
o
0
0
mi
0
mu
1
o
0
0
Htl
0 inn ;
0
0
0
inn
GUJRAT
;
i
1
0
0.0
7
100.0
:
21
21
1
11.1
18
75.0 1
152
126
26
11.1
BARIANA
;
o
0
0
llll
0
nm
1
o
0
0
ini
0 inn ;
0
0
0
nm
0 nm ;
HIKACHAL PRADESH
1
2
2
0
0.0
2
100.0
:
12
12
0
0.0
6
IS
14
1
6.6
l( ioo.o :
50.6 :
■
4.8 1
0 nm ;
126 ioo.o :
JAMMU A KASHMIR
;
i
1
0
0.0
1
100.0
:
i
2
2
50.0
0
o.c;
9
9
, 0
0.0
KARNATAKA
:
20
16
1
20.0
8
50.0
1
61
51
7 ,10.9
20
35.0 ;
268
115
93
31.7
IBRALA
;
s
1
1
12.5
6
85.1
I
28
22
6
21.4
8
36.3 :
131
111
0
0.0
6
(.5 1
MADHTA PRADESH
;
2j
1
22
95.6
1
100.0
I
85
32
53
62.3
19
59.3 i
392
389
3
0.7
10
i7.9:
5
55.5 :
115 ioo.o :
MAHARASHTRA
:
2<
21
0
0.0
21
81.5
:
65
65
0
0.0
65
ioo.o :
375
3(7
28
1.4
3(1 100.0 :
NANIPUI
;
3
2
1
33.3
2
100.0
:
s
5
0
0.0
5 100.0 1
22
21
1
4.5
U 100.0 I
HBGHALAT
'!
1
1
0
0.0
1
100.0
;
2
2
0
0.0
2 ioo.o :
•9
9
0
0.0
2
MIZORAM
:
i
1
0
0.0
1
100.0
;
2
2
0
0.0
2 ioo.o :
8
5
3
31.5
5 ioo.o :
22.2 ;
NAGALAND
:
3
3
0
0.0
2
66.6
;
2
0
2 100.0
0 inn ;
22
22
0
0.0
13
ORISSA
i
n
11
0
0.0
3
21.2
:
83
15
8
56
236
HI
92
38.9
144 100.0 :
PUNJAB
i
i
1
0
0.0
1
100.0
;
5
5
0
0.0
RAJASTHAN
;
<
2
2
50.0
2
100.0
;
5
4
1
20.0
TAMIL NADU
1
21
20
3
13.0
20
100.0
1
151
145
9
5.8
TRIPURA
;
i
1
0
0.0
1
100.0
1
3
3
0
0.0
UTTAR PRADESH
:
12
39
33
15.8
33
81.6
1
135
65
70
51.8
41
VEST BENGAL
!
14
13
1
1.1
11
84.6
:
no
0
HO 100.0
TOTALS :
211
198
15
27.6
1(8
15.5
1 1132
812
Sauct. : Sanctioned,
Pos. : Position,,
Vac. : Vacancy,
320
Trao. : Trained
9.6
28.2
.
74.6 ;
59.0 ;
5 ioo.o :
5
0
5
100.0
0 nm ;
4 ioo.o i
50
(9
1
2.0
49 ioo.o :
89.6 :
(23
(10
13
3.0
410 ioo.o ;
3 ioo.o ;
10
7
3
30.0
7 ioo.o ;
63.0 |
5(1
(59
72
13.3
89
18.9:
0 nm ;
362
232
130
35.9
130
56.0 ;
63.5 ; 4034 3311
717
11.7 2131
64.4 1
130
516
A
TABLE 28-A
-
Vacancy and tnicic. sticks c( stiff bj c Sier ry me sine
!
ST1TE/UT
£
1 Para-Medical Worker!
iSanct. Pos.
Vac. XVac
8(11521 PRADESH
: 2H5
1915
110
ISSUI
:
Asr
<01
61 .11.2
BIE12
: 2182
C81I0ICAEH
:
o
0
0
0 1 I HAVEL!
:
i
8
cweii
;
65i
532
B1ETAHA
:
o
HIKACHAL PEADESB
:
85
J1HH 1 EASHKIB
:
n
68
iarkataia
! 1239
iEEAU
:
65<
KXD’IA PRADESH
1 Liooratorj
;
Te miciaas
!
1 Fbysiotberapm/Fhysioiecb
Tran STratJSanct. res. . Vac. 'Vac liar. ITniiSanct. Pos.
:
i
Educators
HeaJth
Vac. I'.ic
Tran
STrm. ISanct. Pos.
Vac. IVac Tran
JTtic."
100.0 :
221
163
58
26.2
163 100.0 :
109
16
33
35.2
16
100.0 :
53
S3
0
0
0
o
100.0 :
18
18
0
6.0
18 100.0 1
l(
U
0
5.0
!<
100-0 :
ii
5
6
58.5
5
ioo.o
<5.2 101!
91.2 1
101
1!
88
82.2
5
26.3 !
55
56
5
9.0
3
6.0 :
si
11
26
10.2
0
o
::
nn
o
mn ;
0
0
0
nit
0 tint ;
o
0
0
:::::
0
mn 1
0
0
0
mt
b
inn
;;
-1 -13.1
2
50.0 1
0
0
0
tin
0 mn ;
o
6
0
:::::
0
rm:
:
e
0
0
mt
0
nn:
;•
531
99.8 1
(5
<0
5
11.1
2!
60.0 :
18
1
11
:!.l
1
100.0 :
it
13
1
18.1
13
ioo.o
1182 1000
1.9 1916
(01
::
125
19.0
0
0
nit
o
tint ;
0
0
0
mt
0 tttii ;
o
0
0
:::n
0
mn :
o
0
0
nn
0
inn
;;
61
21
2(.1
61
95.1-1
6
5
0
0.0
1
U.6 ;
i
0
1
ic:.o
0
mn :
o
0
0
tin
0
nn:
;;
8
5.5
50
13.5 1
6
3
3
50.0
1
nJ :
<
2
55.0
I
50.0 :
i
0
1
ioo.o
(It
38.5
16!
100.c ;
18
(1
31
(1.8
13 100.0 ;
52
2(
i-.i
28
100.0 :
so
1
22
0
161
I
It
8
26. .
0
o
::
2B0
311
51.1
280
100.0 ;
36
25
11
30.5
25
ioo.o ;
io
10
0
6.0
10
100.0 :
5
5
0
0
•
ioo.t
;;
: i2<8
980
268
21.1
980
100.0 ;
98
16
82
81.6
8
50.0 ;
18
10
28
::.6
9
90.0 1
38
12
6
15.1
2(
i5.o
rjRARASRTRA
; 1920
1920
0
0.0 1920
100.0 ;
It
18
0
0.0
18 100.0 1
IU6IPUE
: ioo
95
5
5.0
81
85.2 1
8
3
5
62.5
naan
1
2!
25
0
;.o
29
100.0 :
o
0
0
nn
0
nm
ioo.o ;
6
Z
8
55.6
2
100.0 ;
100.0 1
6
*
5
1
16.6
2
(o.o
2
0
0
1
so.o
;;
1
100.0
;
i
0
2
100.0
0
mn
••
:
<3
(3
0
0.0
11
19.5 1
2
1
1
50.0
I ioo.o ;
2
2
0
0.0
MUOBAK
1
10
6
8
(0.0
6
100.0 I
(
2
2
50.0
2 ioo.o ;
i
1
0
0.0
;;
maun
:
is
13
5
i.<
56
16.1 1
(
(
0
0.0
8 ioo.o ;
(
0
(
1C. 0
0
mn ;
(
8
0
0
1
25.0
1!
ORISSA
1 1252
988
261
21.0
988
100.0 ;
135
119
16
11.8
H9 ioo.o ;
it
12
32
".1
12
16
61.5
10
ioo.o
;;
:
io
5
8
61.5
5
100.0 1
5
1
1
20.0
I ioo.o ;
o
0
0
mn
0
26
J
10
PKJIB
100.0 :
nm •
5
0
0
5
ioo.o
::
RAJASTHAN
:
ii<
119
<5
21.8
<1
39.5 1 . 11
1
(
36.3
3
(2.8 ;
0
0
0
mn
0
mn
;
<
<
0
0
2
so.o
T1EIL MADU
1 2331
2’59
15
3.2 2259
100.0 ;
2’8
115
53
23.2
IIS 100.0 :
8
(.1
93
ioo.o
T£I?UEA
:
so
18
6
1.5
6<
86.< 1
5
3
2
(0.0
0
0
c::ae PEADESH
; 2590 -3 783
801
31.1 1183
100.c ;
191
i:(
33
VEST BENGAL
1 1995
530
26.5
853
58.2 1
95
t(
31
1(65
TOTALS 119327 15018 8249
5::ct. : Sanctioned,
Pot: : Position,
22.0 1(200
98.1 1 1383
Vic. : Vacancy,
9'1'
(26
Irin. : Trained
125
119
6
(.8
119
100.0. :
9i
93
o.o;
i
0
106.0
I
nm :
i
1
::
!S( ioo.o ;
((
0
5.0
(8
100.0 :
68
(5
zS
o
16.1
«
2
33.8
0
o
::
38.6
38
51.1 •
ii.
1
10
96.9
4>
22.5 •
1
1
0
0
1
•■ii.:
;;
111
95
23.2
161
si.!
::
10.8
0
815
63.’’ 1
6(1
111
228
35.5
360
11.1 :
(os
Madhya pradesh and Kerala in this order, where 45% to 24% of
the posts remained unfilled. The most affected category was
that of the physiotherapist (35.5%) followed by those of
laboratory technicians (30.8%) and medical officers (28.2%).
A well thought out staffing pattern had evolved in the
programme in keeping with the job requirements at various
levels. It was a traversity of manpower management that
deficiencies to the extent of 60% to 80% affected certain
categories of posts in several of the states.
While the overall vacancy position was bad, the
training status was no better. Half of the health educators
had not received any training while more than one-third of
the medical officers and non-medical supervisors remained
untrained. In the face of unutilized training capacity
observed in many of the training centres, presence of
untrained workers within the programme was not good
management.
None of the medical officers was trained in Assam,
Bihar and West Bengal. Likewise, the states of Bihar,
Himachal pradesh, Jammu & Kashmir, Madhya pradesh and West
Bengal
were
content
to
employ
untrained
laboratory
technicians. It was distressing to observe that in some
states such as Andhra pradesh, Bihar, Karnataka, Tripura and
Uttar pradesh, health education was imparted by educators who
did not themselves had exposure to leprosy programme.
In the training centre at Boko in Naugaon
district, the head of the centre as well as other trainers
were -untrained. They followed the Dharmendra scale of
bacteriological index. The lack of training of staff was
encountered as a major problem for the state of Meghalaya for
committment to leprosy work.
It hardly needed emphasis that this specialised
facility was being maintained at considerable cost to the ex
chequer. Its non-utilization amounted to waste of scarce
resources.
(c)
Supervision
The need of active and close supervision of NLEP
related activities was, in general,
recognized. While
supervision at all levels was important, greater emphasis
need be put on the technical supervision and support of
peripheral non-medical technical personnel.
A general laxity of supervisory functions existed
at several levels. As already brought out, a large number of
posts were not filled; when they were filled the incumbents
were untrained. Follow up action on the monthly, quarterly
and annual reports was tardy. Six of the DLOs did not assess
their staff. Bacteriological surveillance was a neglected
field as the laboratory technicians did not get proper
50
guidance. The microscopes were ill-maintained and the quality
of available stain poor. The task of case detection,
confirmation of diagnosis, treatment and follow up of
patients in Alwar, were left entirely to the para-medical
workers without any supervision from the medical officers.
One control unit looked after a population of 17 lakhs in
this district and that too with only 17 PMWs.
A heartening feature, however, was the emphasis
accorded by the MOs to the quality of performance by workers
looking after the units. These officers, not only assisted
the peripheral workers in their job on the spot but also
developed a system of grading their staff. On the basis of
review of 1022 workers in the field during the preceding one
month, the MOs suggested the following actions for improving
the quality of their work:
Re-training
Transfer
Punishment
Encouragement
638
28
338
18
Likewise, on the basis of field supervision, the
NMSs recommended that 286 of the 1143 PMWs working under them
required retraining.
Temporary hospitalization ward was the most mis
managed facility. With three-fourths of the physio-therapist
without any' work experience (73.3%) half of the medical
officers (42.4%) untrained and one-fourth of the laboratory
technicians (26.6%) without the requisite skill, the wards
showed an average bed occupancy rate of only 37%. In Bihar,
the THWs had been converted into office space. While in
karnataka several of them did not function at all, the THWs
were under dual administrative control of the Joint Director
(Medical) and the DLO in Tamilnadu, with the result that at
Cuddalore, the utilization of the ward was less than 40%.
Temporary hospitalization wards for inpatient services were
non-existent in West Bengal, with the result that ulcer and
deformity prevention services were much neglected. None of
the 14 THWs in Madhya pradesh had a full time medical
officer. The THW earlier maintained by the Damien Foundation
at Deeg in Bharatpur district, now handed over to the state
government was languishing for want of funds. The THWs in
West Godavary district were afflicted with inadequate budget.
In Bihar, a total of 805 THW beds were available. These were
however, not under use and many of the THWs had been
converted into offices.
(d)
Logistics of supplies
For implementing MDT, it was imperative to ensure
a continuous supply of anti-leprosy drugs for at least 5
years. National logistics must ensure proper accounting of
drugs and timely transfer of sufficient stocks to the
51
peripheral worker. Progranne manager should spare no effort
to make regular stock checks and take timely initiative to
avoid programme interruption.
There was, however, shortage of drugs affecting
the units, the districts as well as the state headquarter.
Both rifampicin and clofazimin ran into short supply,
particularly the latter. The shortage lasted for periods
varying from a week to more than 3 months in one instance. It
was observed that clofazimin was out of stock in Manipur,
Rajasthan and Gujrat at the state head-quarter for 7,10 and
15 days respectively. Likewise, the 9 districts of Balasore,
Mayurbhanj, Bilaspur, Prakasham, Vishakhapatnam, Singhbhum,
Puri and Purnea reported non-availability of both rifampicin
and clofazimin during 1989-90 and 1990-91. What was really
disturbing was the interruption of therapy because of drug
shortage in the LCus and ULCs . As many as 13 units
experienced the break in receipt of drugs one time or another
during the current year. These units were located in the
districts of Balasore, Dhenkanal, Mayurbhnaj and Puri in
Orissa; Amravati and Jalgaon in Maharashtra; Bilaspur and
Bastar in Madhya pradesh; Surat in Gujrat; Purulia in West
Bengal and Kanpur Dehat in Uttar pradesh. The break lasted
for 1 to 5 days and the shortage was made good by diverting
supplies from nearby areas where the drugs were available.
The Dte General of Health Services made emergency procurement
through the assistance of WHO and other international
agencies.
Examination of stocks for dapsone, clofazimin and
rifampicin at the state head-quarters revealed that while
dapsone was grossly over-stocked by almost all states,
clofazimin and rifampicin were hardly adequate to last for 45
days as calculated on the basis of annual requirements.
Maharashtra had 375.6 lakh tablets of dapsone in stock
against the annual requirement of 14.2 lakh tablets. No
information on drug stocks was available in 4 of the 24
states/UTs. Likewise, among the 71 districts, there was no
stock of rifampicin and clofazimin in 12 while in the
remaining the drugs were grossly under stocked except in 10
of the districts.
(e)
Transport
The NLEP envisaged a vehicle exclusively for the
programme use at the leprosy control units. The most
important vehicle dependant activity at this level was drug
delivery to the patients at fixed points in a pre-determined
circuit. An inefficient transport system prevailed in nearly
all the states including Assam, Bihar, Gujrat, Himachal
pradesh, Jammu & Kashmir, Karnataka, Manipur, Orissa and
Rajasthan. This was so because of lack of maintenance of
vehicles or replacement of condemned ones. Difficulty in
getting vehicles was experienced in several districts in
Karnataka. In Dhenkanal and Mayurbhnaj districts 4 of the
52
vehicles had been off the road for long time and so also in
Manipur, where only 4 of the 9 sanctioned vehicles were road
worthy. Rajasthan had not only given a single vehicle to be
shared amongst the SIX), DLO and the medical officer, but also
restricted touring to certain days of the week. The civil
surgeon of Rohtas district took the transport with him on
transfer. Thus, lack of mobility of concerned officers
affected programme monitoring, supervision and sometimes even
drug distribution.
(f)
Sample survey and assessment units (SSAUs)
The SSAUs were formed mainly to assess the quality
of data generated by the district leprosy services by
validating the data arrived at by the NLEP staff. These units
also laid down base-line epidemiological indicators after
conducting sample surveys. They assisted in evaluating the
effectiveness of treatment including MDT at periodic
intervals by recomputing the various operational and
epidemiological indicators. In those areas where the NLEP set
up was not geared for estimating the magnitude of leprosy in
terms of its prevalence, the SSAUs provided such information.
There were 41 SSAUs in the country of which 10
were included in evaluation. They possessed only 72% of the
sanctioned staff of which only 65% had undergone orientation
training. Only 1 out of the 5 SSAUs sanctioned- for Madhya
pradesh was functioning while the unit stationed in Punjab
functioned beyond the given guidelines. It was engaged in
survey on a selective basis. There were 3 SSAUs in the state
of Gujrat of which only 1 was functional. All the units were
understaffed particularly with regard to PMWs. Three SSAUs
were visited in Bihar, only 1 had adequate staff strength.
The performance of the SSAUs with regard to the
population surveyed showed'that 92 districts with the total
population of 684.6 lakhs were under their jurisdiction.
Twenty five of the districts were covered in the current
year. The population to be enumerated was 4,06,715; of which
80% was actually assessed. In a sample population, the NLEP
staff identified 310 leprosy patients while.SSAU discovered
more than 4 times as many, numbering 1257 cases. It is highly
unlikely that the programme workers missed such a large
number of cases. Obviously, the SSAU grossly over-diagnosed.
Several observers were struck by the fact that disease
diagnosis made by the SSAU staff in general was on the higher
side.
In the current year, of the 475 patients for
surveillance by the SSAUs, only 232 were examined. Cases
detected as relapsed numbered only 20 in a year. Such inept
performance may be due to the fact that many of SSAUs were
unclear about their role in the NLEP. Large areas in the
country awaited attention of the assessment units for survey
and confirming the changing epidemiological indices observed
53
in several districts under the impact of MDT. No information
was available on true disease prevalence in Kerala as the
state did not have a SSAU. Survey for leprosy was carried out
in J&K a long time ago in 1965 by Dharmendra. Since then,
there was no information on disease prevalence in that state.
No survey had been carried out in Chandigarh and several
districts of Assam. Now that plans are afoot to extend MDT
coverage to the entire country, it became necessary to
organize surveys to bring out true picture of leprosy in
hitherto uncovered areas.
12.
Expenditure
Utilization of development budget formed an
important indicator of any programme efficiency. While the
utilization of total budget provision was more than 90% in as
many as 14 states, it was not so in the case of another 5. No
information was available in respect of 6 states. What was
really disconcerting was the non-utilization of plan
provision. Bihar surrendered the entire amount of Rs. 107
lakhs provided in the year under evaluation. Likewise, the
utilization of plan provision was about 50% only of the
outlay in the states of Andhra pradesh, Kerala, Maharashtra,
Rajasthan and Tripura. Appraisal of the state expenditure for
the current financial year revealed that several of the
states incurred expenditure in excess of plan provision for
development; the excess contribution of state varying from
8.0% in Madhya pradesh to 15.0% in Karnataka, 45% in
Tamilnadu and 195% in Assam. The fact indicated a great
committment on the part of the state governments to give a
fillip to leprosy eradication.
12.
Voluntary Organisations
Administratively, the voluntary organizations were
not a part of NLEP. However, ever since the meeting to co
ordinate the activities of these organizations by the
Government of India n 1986,. efforts were made to draw the
mass base of voluntary committment to leprosy into the
technical ambit of the NLEP; by concentrating on mutually
agreed activities for leprosy control.
Twenty nine voluntary organizations were seen. By
and large, their activities converged on NLEP goals. They
maintained 1,333 beds amongst them. All but one concentrated
on case detection and treatment activities. The remaining one
had rehabilitation work as its main focus.
They were staffed by trained personnel. In the
total staff strength of 683' posts, only 4 were vacant.
Likewise, 85% of them had received training.
As on 1.4.91, 55,331 patients of leprosy were
registered under them, of which 29% were multibacillary and
8% had deformities. However, during the current year 10,490
54
new cases were detected and 94% of them were put under
treatment. The treatment regimen followed by them for dapsone
monotherapy as well as for MDT were those recommended by
NLEP.
In the 2200 multibacillary patients identified in
the current year, 80% showed smear positivity.
Twenty of the organizations undertook health
education activities with members of the community being the
main target groups. None of them was engaged in the training
of leprosy personnel. The purpose of the visit was not so
much to assess the activities of these organizations as to
determine the participative nature of their functions in
promoting NLEP activities. All save 4 of the VOs, shared
their experience and information with the district health
authorities in the form of regular reporting to the district
health authorities.
The total amount of money spent by these
during 1990-91 was of the order of Rupees 5.0 crores.
bodies
The quality of service rendered by these bodies
varied from state to state. In general, they rendered
commendable service to the society. Some of them were
however, beset with administrative problems. The Gandhi Kusht
Nivaran Sevashram in Siwan did not receive the grants and the
workers were on strike posing a threat to MDT programme in
these districts.
Mother Teresa Leprosy Charity Home in Khasi Hills
rendered valuable services to the neighboring states. It
maintained a 95 bed leprosy ward besides providing out-door
services.
V
CONCLUSIONS AND RECOMMENDATIONS
1.
2.
Commendable as the new case detection, MDT coverage and
release of treated cases were, these activities
needed to be
strengthened in general and
particularly, in states whose
performance was
not
so
good
in
this
regard.
Case
detection
should be activated through mass surveys, school surveys
and
house to house searches. Frontline workers
should be
encouraged to make greater efforts for
retrieval of drug defaulters.
Detailed epidemiologic studies should be initiated in
districts completing 5 years of MDT implementation,
where the
prevalence rate markedly declined and yet
the proportion of
child cases among the new cases
showed an increase and there
was no appreciable
decline in the new case detection rates.
3.
Monitoring of multi-drug therapy be augmented to detect
drug
resistance
and
post
RFT
surveillance
strengthened.
4.
Untrained staff in sufficient numbers existed within the
programme at all levels. Tine bound, phased leprosy
training
should be arranged for all categories of
untrained staff.
DLOs -'and MOs must be trained both
in the management of the programme and the clinical
aspects of leprosy to improve guidance and supervision
of the field workers.
5.
The training centers were grossly under utilized. The
training capacity should be fully consumed and extended
to look after the needs of neighboring states without
such centers.
6.
An extensive data was collected through the net-work of
information reporting system. Not much use was made of
it for improving the programme performance. Basic
workshops for all health workers in data collection ,
compilation , analysis and usage should be organized to
remove this weakness. The supervisory and paramedical
staff be given orientation training in programme
awareness creation amongst the public.
7.
The programme suffered from significant number of
vacancies at each level. These should be filled at the
earliest possible. Particular attention need be paid to
the posts of physiotherapist, laboratory technicians and
health educators. States like West Bengal may be
requested to create the posts of health educators and
physiotherapists that were almost non-existent.
56
8.
Bacteriological surveillance continued to be a weak link
in the programme. The laboratory services must be
improved by :
(a) immediately filling up the existing vacancies;
(b)
expeditious training of the untrained laboratory
technicians by organizing crash courses in skin
smear preparation and reading;
(c)
provision of good workable microscopes; and
(d) creation of new posts of smear technicians in
keeping with the work load.
It is for consideration if the work load of
existing laboratory technicians be reduced by limiting
the skin smear examination only to the multibacillary
cases.
9.
Regular and adequate supply of anti-leprosy drugs is a
pre-requisite for implementation of MDT. Drug shortage,
particularly of clofazimine and rifampicin, affected
several of the districts and units. Buffer stocks of
these drugs at the state headquarters to last at least
for 3 months should be ensured. Drug requirements at all
state and lower levels should be preplanned and
periodically reviewed.
10.
The state leprosy officers should be at least of the
rank of a state joint director, must to exposed to
leprosy work, and must exercise administrative and
financial- independence. Frequent transfers of the state
leprosy officer, the district leprosy officer and
medical officers should be avoided, particularly of
those who were trained and possessed experience in
leprosy.
11.
The replacement of condemned vehicles should be an
automatic and expeditious process. Mobility of all the
staff should be assured by providing vehicles and
adequate
funds
for
POL.
Imposing
governmental
restriction on touring adversely affected supervision.
States doing so, may be requested to waive such
restrictions.
12.
Working of temporary hospitalization units must be
radically activated. Their possession of full complement
of trained staff must be assured to promote disability
prevention by bringing them under the administrative
control of the SLO/DLO, as also their utilization for
the purpose these were created for.
13.
The SSAUs should be looked into both in respect to their
staffing and workload. With rapidly advancing MDT
coverage in the country, true disease prevalence should
be worked out for states that were attended to decades
ago. So called low endemic areas should be focused on in
a phased manner.
57
14.
Under the impact of MDT as a dramatic decline occurred
in case load, continued emphasis to the endemic
districts left the non-endemic ones in relative neglect.
Extension of MDT to these areas should be expeditiously
considered.
15.
Integration of leprosy services with primary health care
presented certain difficulties as seen in Rajasthan and
Himachal Pradesh, while the extension of modified multi
drug treatment scheme was beset with other local
problems. These should be carefully considered before
pushing forward these schemes.
16.
Growing awareness of the programme in the community and
the sharp rise in the rate of voluntary reporting were
encouraging. Efforts at health education, however,
should be further augmented particularly, with greater
emphasis on imparting knowledge of leprosy to the
people.
58
National Health Programme Series 6
NATIONAL
LEPROSY
ERADICATION
PROGRAMME
ewieeei ot ufe®
era®
NATIONAL INSTITUTE OF HEALTH AND FAMILY WELFARE
NEW MEHRAULI ROAD, MUNIRKA.NEW DELHI-110 ©S7
NATIONAL HEALTH PROGRAMMES SERIES
This series of publications is intended to promote the continuing
education, dissemination of information as well as the study of
health problems and major diseases in India for those who have
concern for the health and well-being of the people. It is also
intended to foster the development of an efficient system of health
care service delivery in the country on the basis of such up-dated
publications on the national programmes for the prevention and
control of health problems. In this task, the practitioners and
trainers/teachers of health systems, as also the policy-makers and
those affected by their policy, must be brought together. The
publications, issued in this series, will strive to bring them together
in thought, so that they might work together in action.
NATIONAL HEALTH PROGRAMME SERIES 6
NATIONAL LEPROSY
ERADICATION PROGRAMME
C.K. Rao
Former Deputy Director General of Health Services
(Leprosy)
Directorate General of Health Services
Nlrman Bhavan, New Delhi
NATIONAL INSTITUTE OF HEALTH AND FAMILY WELFARE
NEW MEHRAULI ROAD, MUNIRKA,NEW DELHI-110 037
Series Editors
J.P. Gupta
S. Bhatnagar
© 1988, by the NIHFW, New Delhi
The views expressed in this publication are those of
author and do not necessarily represent the decisions of
the stated policy of the National Institute of Health and
Family Welfare, New Delhi.
Printed and Published by the Department of Publications, National Institute of Health and
Family Welfare, New Mehrauli Road. Munirka, New Delhi-110 067.
April 1989/2000
CONTENTS
Introduction
9
Case l.oad and Its Distribution
9
Inter-State Variations
11
Epidemiology
11-
Classification
13
Evolution of the Programme
14
Objectives
14
Strategy
15
Findings of Independent Evaluation
26
Constraints
27
Research Findings
28
Future Prospects
28
Summary
28
Appendix
33
Statements
34
FOREWORD
One of the cardinal factors for achieving Health for All by 2000 A.D. is the ability
of the individual and the organisation to recognise and respond to changes in
advancing technology for health maintenance and promotion, new pattern of
disease, disability, etc. new social policies, expectations and programmes for
better health services. Towards this end, the education of the people
concerning prevailing health problems and methods of preventing and
controlling them is the first requisite of Primary Health Care. This is more so in
the case of public welfare personnel and professionals through whom the
knowledge and skills should percolate to the grassroot level.
In adhering to the above perspective, the National Institute of Health and
Family Welfare conducts nearly fifty training courses/workshops annually
towards requirements of a system of continuing education for health
administrators of States and Districts, teachers of medical college, and also
the members of Indian Administrative Service. However, the problem of
updating the knowledge and skills of these personnel, already on the job, still
remains. It has proved arduous to have them re-trained at institutions. The
snail-like pace of implementation reflects in many instances the fact that this is
an area where most professionals feel unprepared. It is, therefore, essential to
initiate a programme to get relevant information out to individual participant. As
such, the development of self-learning resource materials to keep abreast of
scientific advances in research as well as in programme strategies is an
enviable task which the NIHFW has undertaken with large-scale efforts.
These resource material present an assiduous expatiation of various
National Health Programmes and Schemes currently in operation in the health
services system. Each of these expatiates the genesis, strategy, current
status, and the outcome of the evaluation of individual programme. Thus, the
primary aim of thisSer/'es would be to share and utilise the available resources
to update the knowledge and skills of programme personnel at their own place.
I fervently hope that this publication will provide orientation on the use of
such self-learning materials to learners/participants. I also wish to asseverate
that these resource materials will be updated periodically and as such, I am
sure, they should be a valuable aid in overcoming the lag.
Much of the positive value in this Series originated with one or another of
our associates, sincerely thank these Programme Officers who had so kindly
undertaken the onerous task of compilation and completion of these
documents.
New Delhi
December, 1988
J.P. Gupta
Director
INTRODUCTION
Much has been said and written about leprosy. However, many
misconceptions and superstitions still prevail and shroud the disease in
mystery. Leprosy is still commonly considered in certain parts of the country to
be a curse of God or due to the visitation of an evil spirit. Social ostracism has
been the most prevalent abuse of the affected.
The disease has been known for many centuries and reference to it is
found in ancient Hindu scriptures. Until a few decades ago, the disease was
one of neglect; the Effected were interned in leprosariums mainly managed by
charitable trusts and voluntary organisations. With the establishment of the
Indian Council of the British Empire Leprosy Relief Association in 1925
(renamed as Hind Kusht Nivaran Sangh in 1947), the foundations were laid for
the beginning of organised leprosy work in India. A Committee appointed by
the Government of India in 1941 reviewed the extent of the leprosy problem in
the country and made specific recommendations for anti-leprosy work. This
was followed by another Expert Committee in 1954 that gave rise to concrete
plans for the control of leprosy in India, including legislation.
The middle of the present century witnessed certain breakthroughs in the
knowledge regarding causation, spread and treatment of leprosy. Organised
efforts, supported by the national government, were launched in India to cure
the affected, to contain further spread of the disease and impart education to
the people about it. The present paper traces the development of anti-leprosy
work in India leading to the National Leprosy Eradication Programme (NLEP)
announced in 1983, including its achievements upto December, 1987, the
imbalances of such efforts, the barriers in their promotion and the measures
that may be integrated into future plans to achieve the goal of eradication of
leprosy in the country by the year 2000 A.D.
CASE LOAD AND ITS DISTRIBUTION
World Scene
About 70 countries are reported to be endemic for leprosy with an estimated
11 million cases in the world. In the African region of WHO, 45 countries are
endemic with a registered case load of 1.5 million. The problem has yet to be
delimited to get accurate estimates in most countries of Africa. The Western
Pacific region has about 2 million cases with China, Vietnam, the Philippines,
Korea contributing about one-fourth of the cases. Of the countries in South
and Central America, the largest number of cases appear to occur in
Argentina, Brazil, Colombia, Mexico and Paraguay. The prevalence rates are
lower than in endemic countries in Asia. In the South East Asia region, Burma
has an estimated 7 lakh cases, Indonesia 2.5 lakhs, Bangladesh 1.5 lakhs,
Thailand 1.4 lakhs, Nepal 1 lakh as against 40 lakh cases in India. Thus, one
out of every third leprosy case in the world is in India.
9
Of the 11 million leprosy cases in the world as estimated by the WHO,
about 5 million were registered in 1986-87; 3.8 million of them were from the
South Asia region and 3.3 million were contributed by India alone. The African
region has about 6 lakh cases, the American region 3.3 lakhs and the Western
Pacific region 2.4 million registered cases.
About 1.3 million leprosy cases were under MDT at the end of 1987 in the
world and about 1.1 cnillion of them were in India.
Problem in India
A leprosy survey was included for the first time in India as a part of British
Imperial Census in the year 1871-72. Later, its extent was reviewed in the
country by the British Leprosy Commission in 1890-91. The prevalence rate of
leprosy in India during the period prior to 1950 was essentially obtained as part
of decennial population censuses. According to the census in 1931, there
were about 160 thousand cases giving a prevalence rate of 0.5 per 1000
population. This would, however, be an under-statement becuase of several
reasons, namely:
i. it included the cases with advanced forms of the disease only;
ii.
all cases had not been reported because of the social stigma attached to
the disease;
iii.
many cases (early and with minor symptoms) were not recognised;
iv.
errors in coverage of population.
Similar estimates available based on successive censuses may be seen
in Table 1.
TABLE 1
PREVALENCE OF LEPROSY IN INDIA
Year
Population
(million)
1871
1881
1891
1901
1911
1921
1931
1951
1961
1971
1981
198.291
216.679
274.334
294.361
315.156
318.942
324.753
360.958
439.118
547.958
685.185
10
Estimated No. of Prevalence rate (per
1000 population)
leprosy patients
(.000)
108.81
128.09
126.24
97.36
109.09
102.51
159.80
1,374.01
2,561.60
3,200.90
3.919.337
0.55
0.59
0.46
0.33
0.35
0.32
0.49
3.81
5.83
5.84
5.72
Present estimates indicate that 20 to 25 per cent of all cases occur in
children; nearly one-fourth are infectious and 15 to 20 per cent suffer from
disabilities.
INTER-STATE VARIATIONS
While the disease existed all over the country, the inter-State variations in the
prevalence rates and the percentage of population at risk were quite
substantial.
The disease is widespread throughout the country. The current Statewise
leprosy profile in the country is given in Table 2.
The subsequent reviews showed a slightly different pattern of endemicity.
According to the 1987 review, there were States/UTs namely Pondicherry,
Lakshadweep and Tamil Nadu with a registered prevalence of above 10 per
1000 population as against 5 in this category in 1981. The prevalence rates
were between 5 and 10 in Andhra Pradesh, Bihar, Maharashtra, Orissa and
West Bengal.
According to current estimates, about 430 million people were estimated
to be at risk due to leprosy in areas with a prevalence rate of 5 and
above/1000. The population at risk is uneven from State to State and even
within the States.
Data collected from the States/Union Territories on the leprosy
prevalence rates in each of the districts based on the latest information 1987
show that 196 districts out of 435 have a prevalence rate of 5 and above per
1000 population. This status was 201 against 412 districts in 1985.
EPIDEMIOLOGY
Leprosy occurs in all ages but new case occurrence is very low in infants and
the very old. Prevalence of the disease is higher among adults than among
children.
The disease affects both sexes with a preponderance in males.
Incomplete detection of cases in females does not explain the difference.
The occurrence of high prevalence with a low proportion of lepromatous
cases in some countries while in some others, low prevalence with a high
proportion of lepromatous cases, suggests the influence of host factors.
Leprosy occurs more frequently in some families. Exposure to infection
plays a more important role than hereditary predisposition.
The roles of climate, overcrowding in the house, nutrition, socio
economic status, literacy, etc. in the causation of disease have not been
clearly established although the prevalence rates are high among groups with
poor nutrition, overcrowding and low income.
11
TABLE 2
STATE-WISE LEPROSY PROFILE AND THE PROGRESS OF NLEP IN INDIA
DECEMBER. 1987
s.
Name of Stale
No.
1.
2.
3.
4.
5
6.
7.
8.
9
10.
11.
12.
13.
14
15.
16
17.
18.
19.
20.
21.
22.
23.
24
25.
26.
27.
28
29
30.
31.
Andhra Pradesh
Arunachal Pradesh
Assam
Bihar
Goa
Gujarat
Haryana
Himachal Pradesh
J & K
Karnataka
Kerala
Madhya Pradesh
Maharashtra
Manipur
Meghalaya
Mizoram
Nagaland
Orissa
Punjab
Rajasthan
Sikkim
Tamil Nadu
Tripura
Uttar Pradesh
West Bengal
Andaman & Nicobar
Chandigarh
D&N Haveli
Delhi
Lakshadweep
Pondicherry
Popu
lation
1981 in
lakhs
Esti
mated
prev
Rate
Regd.
Prev
prev.
535.5
6.3
199.0
699.0
10.9
341 0
129.2
42 8
27 0
371.4
254.5
521 8
6278
142
13.4
4.9
7.8
263 7
167.9
342.0
3.2
484.1
205
1108.6
545 8
1.9
45
1 0
62.2
0.4
6.0
11.8
36
1 5
5.4
5.0
2.9
0.08
1.6
2.2
6.0
5.8
2.3
6.2
4.5
4.6
1.0
3.9
121
01
1.6
7.8
12 9
4.9
3.7
6.9
4.9
NA
1.0
0.4
25.0
15.0
8.6
2.3
0.9
6.2
1.9
1.9
0.1
1.1
1.2
39
3.0
39
5.5
38
1.2
1.3
2.3
7.9
0.2
0.5
1.1
11.3
27
43
5.2
4.9
1.3
1.1
1.6
10 1
11.7
6818 3
5.7
4.9
Distts. under MDT
No. 3l Distts. with PR
41
3
12
12
6
9
4
1-5
5 + Total
1
6
13
15
3
2
22
4
1
16
1
1
3
23
10
17
31
3
19
12
12
14
20
14
45
30
8
5
3
7
13
12
27
4
20
3
56
17
2
1
1
1
1
4
159
96
435
3
2
4
6
5
10
4
23
11
5
2
1
2
12
8
19
5
80
3
21
2
1
1
1
1
5
6
10
22
19
3
1
13
4
20
0
30
15
1
No. Popula
tion
Cases
251.54
358897
10
Nil
1
10 80
15760
32703
206
NA
2
1
2
9
47.47
13.41
3.03
59.25
1895
30 57
132 44
31184
10042
20727
171178
1
1
3
3.40
0 79
101 79
246
1700
149677
1
1771
6357
10
1
3
2
235.13
9 76
64 46
44.13
404109
NA
48766
88793
-
-
1
040
404
53 1045.03
1340749
3
1
1
Cases
on record
Cases
under
treatment
Cases
disch
arged
Cases
under
MDT
461598
1466
17577
435337
2082
71201
1086
4751
5412
144718
76041
203496
342572
5402
1573
631
1767
208229
3183
15648
338
545129
5617
479452
284766
940
595
114
9936
404
7008
424159
1466
17577
395610
2082
68216
1086
4751
5412
116349
67338
199478
324028
3350
1573
631
1767
202901
3124
14140
338
451613
5617
443527
110321
940
595
99
8752
404
5350
723172
687
8545
168960
3090
54887
212
1878
1919
61302
49948
76838
322074
2408
1043
232
550
138284
2458
3679
98
653970
2617
206121
74255
1066
24
NA
NA
169
4306
78998
75
3861
12977
1639
22106
206
NA
Nil
23601
4055
4746
38482
153
Nil
246
143
60585
361
6357
237
58384
3338069
2882594
2582252
392537
32092
33100
86
555
Nil
8752
404
336
The portal of entry of the bacilli is through the respiratory route and the
skin. Similarly, the bacilli are discharged from the patient's nose, throat and
skin.
The incubation period generally ranges between 3 and 5 years although it
has been reported rarely as short as a few weeks/months or as long as 25
years.
Twenty to 25 per cent of the cases in the country are multi-bacillary (MB)
and the rest are paucibacillary (PB). The risk of infection among family
contacts of a MB case is eight times more than those with no leprosy case in
their family and two times more than those with a PB case in their family.
CLASSIFICATION
The classification of leprosy followed under the NLEP with equivalents of
different classifications is as follows:
Other Classification
Current Classification
Multi-bacillary
Paucibacillary
1.
International
(Madrid 1955)
i. Lepromatous
ii. Borderline
iii. Smear positive
indeterminate,
tuberculoid and
Borderline
tuberculoid
i. Tuberculoid
ii. Indeterminate
2.
Ridley and Jopling
i. BB
ii. BL
iii. LL
i. I
ii. TT
iii. BT
3.
Indian
i. L
ii. N L
i.T
ii. MA
iii. P under N
iv. Early indeterminate
under N L
4.
Indian Association
of Leprologists
(1981 Census)
i. Lepromatous
ii. Borderline
Lepromatous
i. Indeterminate
ii. Tuberculoid
iii. Pure Neuritic
iv. Borderline
Tuberculoid
13
EVOLUTION OF THE PROGRAMME
Leprosy Control Before 1955
Prior to the launching of the National Leprosy Control Programme in 1955,
though anti-leprosy activities were available in the country, they were primarily
concerned with the treatment of patients, and were organised by charitable
missions and non-governmental agencies.
The physical facilities available were far from satisfactory. There were
152 institutions with in-patient facility for admitting and treating leprosy
patients with a total bed strength of 19,600.
The inter-State distribution of beds was substantially uneven, the largest
number being provided by the then Madras State (1:1261), followed by
Manipur (1:3656) and Himachal Pradesh (1:4675). When contrasted with the
estimated number of cases, the picture was really dismal in most States, with
Uttar Pfadesh being at the bottom, with 1 bed for 40,435 estimated cases.
In addition to 152 institutions with provision for in-patient care, there were
1,203 clinics in the country, providing out-patient services for leprosy patients.
It was estimated that, on an average, there was one clinic per 300 thousand
population, which again varied greatly from State to State. 1 ms, however, was
quite understandable since most of anti-leprosy activities were being
undertaken by several independent agencies such as voluntary organisations,
religious institutions and charitable trusts without any plan and coordination to
provide services on a rational basis. Lack of any organised efforts triggered off
the governmental action to control the disease through the establishment of
the National Leprosy Control Programme in 1955, based on the
recommendations of an Expert Committee.
Current Status of National Leprosy Eradication Programme
The NLCP was launched in 1955, the last year of the First Five Year Plan, with
the main objective of controlling leprosy through domiciliary sulphone
treatment. It stared as a Centrally Aided Scheme with its focus on rural areas
of high and moderate endemicity. In the low endemic States, the expectation
was to provide the leprosy services through the existing infrastructural
facilities meant for general health services. The scheme was converted into a
Centrally Sponsored Programme in 1969-70 to give impetus to control work.
OBJECTIVES
The programme did not have a clearly defined policy or operational objectives
for nearly two decades. The Plan documents (1951,1956,1961 and 1969-74)
only stated the problem and described the inputs that would be made available
to strengthen the programme. In other words, the programme has all along
been input-oriented and not performance-oriented. This was necessitated
because of several factors:
14
i.
lack of primary prevention (vaccine) and non-culturability of leprosy
bacilli;
ii.
non-availability of potent drugs for quick and complete care;
iii.
isolation of 100 per cent cases was not feasible as benefits were not
commensurate with the costs involved;
iv.
the population was not fully co-operative due to the social-stigma
attached to the disease; and
v.
legislation on leprosy with its negative and un-scientific approach.
It was only from 1976 that the programme was made performanceoriented. Each of the States was given certain targets by the Government of
India in respect of (i) new cases to be detected and brought under treatment;
and (ii) number of patients to be discharged as disease-arrested or cured
during each year. The targets, however, were based on certain assumptions
(Appendix I).
STRATEGY
The strategy of the programme was to control the disease through reduction in
the quantum of infection in the population, reduction of infective sources and
breaking the chain of disease transmission. Four basic activities were
envisaged, namely:
i. survey and case detection;
ii
registration of cases for treatment;
iii. provision of continuous treatment with sulphones to all cases, as close to
their homes as possible; and
iv. education of the patients, their families, and the community about leprosy.
The NLCP was launched in the rural areas since 80 per cent of the
population lived in the villages and a large percentage of cases was expected
there. It was further considered that leprosy being a disease of rural incidence
and urban prevalence, control in rural areas would automatically reduce the
migration of cases. However, several indigenous foci have been observed in
urban areas. Hence, during the Fifth Five Year Plan, it was extended to urban
areas as well. It was stipulated that by detecting all cases and bringing at least
90 per cent of them under continuous treatment with sulphones, it would be
possible to bring down the load of infection by about 80 per cent, thereby
making the disease control effective.
While there has been a substantial expansion of the control activities and
good results have been obtained in selected centres, the impact of the
programme on the country as a whole has not been as expected. As
mentioned earlier, large variations still exist in the prevalence of the disease,
15
not only from State to State but also from district to district in the same State.
For example, in Tamil Nadu, the range of variation is from 5.0 to 28.7 per 1000,
and in West Bengal from 4.0 to 25.0 per 1000. This unevenness called for an
effective strategy for disease control in high endemicity districts on a priority
basis.
Recently, with the discovery of a number of highly effective bactericidal
drugs and better understanding of the disease, a radical change in the
approach became necessary. Substantial reduction in the disease within a
specified period of time appeared possible. In the meantime, there also
developed in the country a new political will for controlling leprosy.
The late Prime Minister of India, Smt. Indira Gandhi, in her address to the
World Health Assembly in May, 1981, made an appeal to all the developed
countries, to help in leprosy eradication. While addressing a joint meeting of
the Cabinet Committee on Science and Technology and Science Advisory
Committee to the Cabinet in May, 1981, she again asked the Indian scientists
to develop a leprosy eradication strategy. In pursuance of this determination,
the Ministry of Health and Family Welfare constituted a Working Group to
devise a new strategy and action plan for the control and ultimate eradication
of leprosy. Dr. M.S. Swaminathan, the then Member, Planning Commission,
was the Chairman and eminent scientists, leprologists and social scientists
were the Members of this Committee.
The recommendations of the 'Group' brought about certain changes in
programme administration and strategy, namely:
- the NLCP was changed into a time-bound eradication programme (NLEP)
with the specific goal of arrest of disease activity in all leprosy cases by the
turn of the century;
- the existing single drug therapy by sulphone was supplemented by one or
more bactericidal drugs for treatment of the disease in the form of a
campaign with a view to achieve its effective control;
- efforts were to be made to obtain self-sufficiency in the requirement of anti
leprosy drugs;
- measures were initiated to attract and retain medical officers in leprosy
control services;
- the activities of voluntary organisations in leprosy control are recognised
. and supported;
- the Lepers Act 1898 has been repealed;
- mass education campaign has been intensified;
- community based rehabilitation of disabled leprosy patients is planned to be
given priority;
16
- screening of pre-school children and youth is emphasised for detection of
early leprosy;
- the National Leprosy Eradication Commission under the chairmanship of
the Union Minister of Health and Family Welfare for programme policy
guidance, and the National Leprosy Eradication Board under the
chairmanship of the Union Health Secretary for monitoring the activities of
the programme have been constituted and are in operation.
Organisational Structure
A five-tier organisational structure was created over the years as part of the
NLCP/NLEP. The present basic elements of the structure are given in an
organisational chart (Fig. 1).
The National Leprosy Eradication Commission (NLEC) functions as the
policy making body for the guidance and surveillance of the programme. It is
the responsibility of the National Leprosy Eradication Board (NLEB) to
implement the plan and policies as laid down by the NLEC. An officer of the
rank of Deputy Director General of Health Services is the Director of the
programme and is basically responsible for planning, programming,
organisation and implementation as per the policy decision of the NLEC and
under the direction of the NLEB. The Programme Director is assisted by the
technical officers of the rank of ADG and DADGs in planning, guiding and
monitoring the programme and by the Central Leprosy Teaching and
Research Institute, Chengalpattu, and three Regional Leprosy Training and
Research Institutes at Aska (Orissa), Raipur (M.P.), and Gouripur (West
Bengal), for assisting in manpower development and operational research.
The Additional/Joint Deputy Director of Health Services at the State level
is the State Leprosy Officer. He performs the same functions at the State level
as the DDG (Leprosy) does at the Centre.
For many years under the NLCP, the District Medical Officer of Health was
looking after the work of leprosy in his district, in addition to his numerous other
duties. During the Fifth Five Year Plan, however, Leprosy Officers were made
available at the district/zonal levels also, at the rate of one per district where
leprosy was highly endemic and one per two or three districts where it was of
moderate endemicity. With the NLEP coming into being, one DLO was planned
to be provided for every district where the prevalence rate was 5 per 1000.
Two types of units were in operation at the periphery. One Leprosy Control
Unit serves 4 to 5 lakhs population. The staffing pattern of the LCU is:
Medical Officer -1, NMAs - 4, Para-Medical Workers - 20, in addition to
other ancillary staff.
Survey, Education and Training (SET) Centres were established and each
SET Centre serves a population of about 25,000. A para-medical worker
17
FIG. 1: ORGANISATIONAL CHART OF NLEP
oo
Central & Regional Leprosy
Training and Research
Institute
Voluntary Organisations
National Leprosy Eradication Gommission
+
I
National Leprosy Eradication Board
Leprosy Division, Dte. General of Health Services, Ministry of
Health and Family Welfare
Directorates of Health Services of States/UTs
Leprosy Training Centres
Reconstructive Surgery Units
i
Leprosy Bureaux in States/UTs
♦
District/Zonal Leprosy Office
Leprosy Control Unit
(450 thousand population)
Medical Officer -1
Non-medical
supervisors - 4
Para-medical workers - 20
Lab. technicians -1
Health educator &
other staff -1
Survey Education &
Treatment Centre
(20-25 thousand
population)
Para-medical worker -1
Urban Leprosy Centre
(50000 population)
Temporary Hospitalisation
Ward (20 beds)
Non-medical
supervisor -1
Medical Officer -1
Nursing and other staff
(PMW) or a non-medical assistant (NMA) is given for each SET Centre and is
attached to a PHC located in the area.
The programme was extended to urban areas during the Fifth Five Year
Plan period. Urban Leprosy Centres (ULCs) were created at the rate of one per
50,000 to 70,000 population. Each ULC was manned by an NMA who functions
under the supervision and guidance of a medical officer in-charge of the
dispensary/hospital to which the ULC was attached.
In addition, facilities for hospitalisation of those needing special care were
planned. Hospitals with facilities for reconstructive or corrective surgery were
developed.
In order to facilitate understanding of the programme, its components,
activities and responsibilities equally well by all concerned and to ensure that
the peripheral workers perform their jobs in a uniform and comprehensive
manner, several Operational Guides were developed during the 1980s and
disseminated.
Infrastructure
After its introduction in 1955, as the NLCP progressed, a number of
infrastructural facilities were developed during the successive Five Year
Plans. The physical infrastructure in operation under the programme at the
end of 1987 includes 601 Leprosy Control Units, 919 Urban Leprosy Centres,
6239 SET Centres, 215 district leprosy office units, 294 temporary
hospitalisation wards. 45 leprosy training centres and 22 sample-survey-cumassessment units. The organisational chart of the NLEP is given in Fig. 1
referred to earlier.
The salient features of the infrastructure development are summarised
below:
- Creation of LCU started in the very first year of the programme.
- Establishment of SET Centres commenced during the Second Plan.
-
Other facilities, especially urban leprosy centres
hospitalisation wards, started during Fifth Plan period.
and temporary
- During the Sixth Plan period, with the change in strategy and provision of
additional funds, the achievement of the targets has increased
- Inclusion of MDT in the programme called for an augmentation in the infra
structural facilities to be provided in a phased manner. It is envisaged that by
the end of 1995 in all the 196 districts with a prevalence rate of over 5 per
1000, these facilities will be established.
It can be said that the programme acquired a major thrust with all-round
development of infrastructural facilities to meet the varying needs of patients
19
during the Fifth Plan period and further significant impetus during 1980-88
following the introduction of MDT as a programme component.
Population Coverage
The total population covered upto 1966 was 54,724 million constituting 14.7
per cent of the endemic population of the country. About 16.3 per cent of
additional population was covered during the Fourth Five Year Plan and
another 35.99 per cent was provided for during 1974-77. The total population
covered upto the end of 1985 was 439 million and 470 million by the end of
1987.
The State-wise estimated population, leprosy cases, leprosy prevalence
rates, cases on record, cases under treatment and cases discharged as cured
upto December, 1987 are given in Table 2. Year-wise detection, treatment and
discharge of Iqprosy cases between 1980 and 1985 under the NLEF
*
1 are given
below in Table 3.
TABLE 3
NO. OF CASES DETECTED, TREATED AND DISCHARGED IN 1980-1988
(CASES IN LAKHS)
1980-81
1981-82
1982-83
1983-84
1984-85
1985-86
1986-87
1987-88
No. cases
detected
No. treated
No. discharged
3.01
3.68
5.13
4.82
4.06
4.08
5.07
4.49
2.90
3.47
4.86
4.56
4.34
4.60
4.90
4.33
1.81
2.59
2.69
2.69
2.18
4.45
5.07
5.03
A total 2.9 million cases have been discharged due to cure of the disease
from the inception of the programme till the end of March, 1988.
Multi-drug Therapy (MDT)
Because of the problem of drug-resistance of bacilli towards Dapsone, the
WHO Study Group on Chemotherapy of Leprosy in 1981 recommended the
use of combined chemotherapeutic regimens based on sound microbiological
principles for the treatment of all multi-bacillary and pauci-bacillary patients.
The Working Committee report of 1982 mentioned earlier had emphasised the
introduction of multi-drug treatment of leprosy cases in the country in a phased
manner as one of the important strategies of the eradication programme.
20
Following a policy decision by the Government of India, a programme ot
combined therapeutic regimen (MDT) was launched in 1982 to replace
Dapsone monotherapy for leprosy control. MDT was introduced in 15 endemic
districts with the financial assistance of the Swedish International
Development Agency through WHO in 12 districts and through UNICEF in 3
districts, between 1982 and 1985. Subsequently, 58 endemic districts were
brought under MDT. Thus, 73 out of 196 endemic districts with over 50 per cent
of the case load in the contry had been brought under MDT coverage by
March, 1988.
Intensive 14 daily doses, and subsequently, monthly doses are given
under the direct supervision of the Medical Officer. Cases detected on any day
of intensive treatment are given supervised doses only for the remaining days
of the 14-day course followed by monthly supervised and daily unsupervised
treatment for a minimum of 24 months or till smear negativity, whichever is
later. MB cases detected after administration of 14 intensive daily doses
receive only monthly supervised and daily'unsupervised doses for at least 24
months or till smear negativity.
The multi-drug treatment (MDT) regimen followed under the programme
is as follows:
MULTI-BACILLARY (MB) CASES
Intensive
for 14 days
Continuation
phase for a
minimum of
2 years
Rifampicin
Clofazimine
Dapsone
Rifampicin
600 mg daily
100 mg daily
100 mg daily
600 mg once a
month
Supervised
Supervised
Supervised
Supervised
Clofazimine
300 mg once a
month
50 mg daily
Superised
100 mg daily
Unsupervised
Dapsone
Unsupervised
PAUCI-BACILLARY (PB) CASES
Continuation
phase for a
minimum of
6 months
Rifampicin
600 mg once a
month
Supervised
Dapsone
100 mg daily
Unsupervised
MDT was found to be safe and acceptable to the patients, and effective. In
21
the five endemic districts under MDT, the prevalence rate decreased by over
85 per cent after 5 years and there is a decline in the new case detection rates
after 4 years of MDT. The deformity rates in new cases also greatly declined
after 3 years of MDT. The relapse rate was low at 0.9 per 1000 MDT cases (1.2
for MB and 0.8 for PB cases).
MDT was also introduced in 5 low endemic districts (prevalence rate 5 per
1000) involving the general health care staff on an experimental basis during
1986-87. In these districts, the patients collect their drugs at the nearest
primary health centre from the Medical Officer. Based on the experience
gained, MDT will be extended to all the other low endemic districts in a phased
manner.
In every district under Dapsone monotherapy, patients who have not
improved clinically and/or bacteriologically after 5 years of Dapsone
treatment are identified as Dapsone refractory cases and are put under MDT
with the help of available staff. This step is expected to arrest the disease
activity in these problem cases and prevent the spread of resistant bacilli.
Rehabilitation
Rehabilitation of leprosy patients is the joint responsibility of the Ministry of
Health and Family Welfare and the Social Welfare Ministry. It includes
physical, vocational and social rehabilitation. The physical rehabilitation rests
heavily on medical personnel and involves the following activities: care of
ulcers, correction of deformities, physiotherapy, proper health education, etc.
Physiotherapy is useful for functional restoration. Under the NLEP, there are 13
Leprosy Rehabilitation and Promotion Units, 75 Reconstructive Surgery Units,
and 294 Temporary Hospitalisation Wards to promote rehabilitation of
deformed patients. The voluntary organisations are mainly providing the
rehabilitation services in the country.
Health Education
The problem of leprosy is a complex one and has serious social overtones A
change about the image of leprosy in the minds of the people is as important as
the treatment of diseased persons. For this, the active participation of the
society and the patients is important. The people have to be educated about
scientific facts of the causation and complete curability of leprosy and the
prevalent prejudices and misconceptions have to be dispelled. Every worker
under the NLEP is expected to be a health educator. However, inspite of the
educational component incorporated in the methodology of leprosy control
since the inception of the NLCP, the necessary messages have not reached
the people to the desired extent. The financial outlays have been substantially
enhanced under the NLEP towards health education from 1984-85 onwards.
Some voluntary organisations have been playing an important role in the
dissemination of correct knowledge on the disease. The Gandhi Memorial
22
Leprosy Foundation, Wardha, has recently developed a master plan for mass
awareness, health education and community participation by constituting a
Task Force and the Health Education Plan. The Hind Kusht Nivaran Sangh
continues to develop health education material for the use of medical and
para-medical personnel and also the community, and to disseminate
knowledge about leprosy.
Voluntary and International Agencies
A large number of organisations have been involved in various activities
pertaining to the control of leprosy in India. While some of them are engaged in
training, education and research, others are engaged, in addition, in case
detection, treatment, rehabilitation and control work. A large number are
voluntary, while some are governmental organisations and some others are
international agencies.
Voluntary Organisations (VOs)
These organisations had been playing a pioneering role in anti-leprosy work in
India. The first known leper asylum was established in Calcutta edirly in the
19th century followed by another in Varanasi.
Mission to Lepers, (now known as the Leprosy Mission) started in 1875, at
Chamba (Punjab), has been by far, the biggest single agency, undertaking
leprosy work. To evolve a mechanism for coordinating the activities of the
voluntary bodies engaged in leprosy control activities among themselves and
with the NLEP, annual meetings with representatives of voluntary
organisations are organised by the Ministry of Health and Family Welfare,
Government of India. Their number was about 150 in the country. Some of the
prominent voluntary organisations in the field are:
- Hind Kusht Nivaran Sangh, New Delhi
- Gandhi Memorial Leprosy Foundation, Wardha
- Bharat Sevashram Sangh, Jamshedpur, Bihar
- Kashi Kusht Seva Sangh, Varanasi, U.P.
- Tapovan, Amravati, Maharashtra
- Hindu Mission, Madras, Tamil Nadu
International voluntary organisations are the pioneers in leprosy control
work in India. They continue to play a major role in NLEP activities. The
Leprosy Mission, German Leprosy Relief Association, Emmaus Swiss,
Damien Foundation and Italian Leprosy Association are some organisations
which have extensive field centres and are involved in different aspects of
control/training/service of leprosy patients.
The contribution of voluntary organisations with regard to SET activities,
23
provision of hospital beds, vocational or medical rehabilitation, etc., as
provided by 106 of them in 1987, is summarised as under:
About 6.0 crore population is covered under SET activities, about 8.0 lakh
cases have been detected and about 6.5 lakhs are reported to be under
treatment. About 3.0 lakh cases have been discharged, 16000 hospital beds
are available for leprosy patients with 115 VOs. About 20,000 patients are
undergoing vocational rehabilitation. A total 2941 medical and 8900 para
medical staff have been trained in leprosy control activities by 13 leprosy
training centres of voluntary organisations. The annual budget of the voluntary
organisations during 1987 was around Rs.32 crores. The Government of India
provides grants to voluntary organisations involved in survey, education and
treatment activities to partially meetthe costs. Currently, about Rs.75 lakhs are
given to eligible voluntary organisations.
Voluntary organisations are also running a number'of leprosy homes,
hospitals and vocational training institutes for rehabilitation of leprosy patients.
Voluntary institutes are also playing a major role in vocational and social
rehabilitation of deformed leprosy patients. Anandvan of Warora, running
under the dynamic leadership of Baba Amte and Tapovan at Amravati in
Maharashtra, established by the late Dr. S.G. Patwardhan, are shining
examples of such rehabilitation centres. Considering that the majority of
disabled leprosy patients are in rural areas, high investment-oriented
rehabilitation centres like Anandvan, Tapovan, etc. may not be able to meet
the demands. It is propsoed to encourage community based rehabilitation to
help these rural disabled patients for restoration of lost functions and to impart
appropriate skills based on the preference of individuals and feasibility, to
make them physically and economically self-reliant.
International and Bilateral Agencies
Several international agencies such as WHO, UNDP, World Bank, SIDA,
DANIDA, UNICEF, etc., are assisting the country in leprosy control. The most
signficant role has been played by the World Health Organisation in evolving a
global programme for leprosy control and providing technical guidance in
formulating newer strategies from time to time.
WHO's special Programme for Research and Training in Tropical
Disease covers leprosy and focusses on certain significant areas of research,
which include:
1.
development of better diagnostic tests;
2.
determination of the prevalence of resistance to Dapsone;
3.
development of improved methods of treatment including MDT; and
4.
development of new drugs.
The Damion Foundation and Italian Leprosy Association have been
24
supplying the anti-leprosy drugs required under the programme. As mentioned
earlier, SIDA is providing financial assistance for introduction of MDT in 18
endemic districts and UNICEF/Leprosy Mission in 3 districts.
Training of Personnel
Forty-five leprosy training centres were established during the successive
Five Year Plans. Thirty-eight of them are located in the seven major States,
namely, Andhra Pradesh (7), Bihar (3). Karnataka (4), Maharashtra (8), Tamil
Nadu (8), Uttar Pradesh (4) and West Bengal (4). Institutional data available on
the number of personnel of different categories trained and their annual
training capacity will provide some insight into the performance of these
institutions.
There are, at present, about 19,000 para-medical staff (PMW) in position,
of whom about 5000 are untrained. Taking into account the vacancies arising
due to manpower addition and transfers, it is estimated that, on an average,
1700 new and/or untrained workers would require to be trailed annually in the
coming years. The existing training capacity is adequate to fulfil this task. Over
20,000 para-medicals and 5,000 medical officers have been trained so far.
It is estimated that at any point of time, 1,500 doctors would be working full
time on leprosy. Taking into account transfer of doctors from leprosy service,
and their addition, about 250 doctors would require to be trained annually, and
facilities for the same are available.
Involvement of the Primary Health Care (PHC) System
The NLEP continues to be a vertical programme in all 196 endemic districts.
However, after 8-9 years of MDT, when the prevalence rates come down in
these districts to less than 1 per 1000 population, the primary health care staff
would take over the responsibilities of the NLEP with the help of a small number
of leprosy staff. Steps have also been initiated to actively involve the PHC staff
in low endemic districts (prevalence rate 5 per 1000) for improving the quality
of NLEP activities in these districts.
Expenditure
At what cost were the foregoing infrastructural facilities for providing leprosy
services established? The question, though apparently simple, is difficult to
answer. Analysis of available data may throw some light on this question.
The NLEP had been a Centrally Aided Programme upto 1968-69 when it
was developed, managed and financed by State Governments with
assistance from the Government of India. However, during the Fourth Plan
period commencing from 1969-70, the programme was fully supported by the
Government of India as a Centrally Sponsored Programme and the total
expenditure on it was to be chargeable to the Government of India but
implemented by State Governments according to the guidelines of the Centre.
25
The year-wise/plan-wise expenditure of the Government of India under the
NLCP/NLEP is as follows:
EXPENDITURE OF NLCP DURING SUCCESSIVE FIVE YEAR PLAN PERIODS
Plan period/years
Expenditure (Rs. in million)
1955-56
3.50
1956-61
52.90
1961-66
42.50
1966-69
6.30
1969-74
28.60
1974-79
202.30
1979-80
23.20
1980-85
412.00
1985-86
139.20
1986-87
153.90
1987-88
185.60
The expenditure on the NLCP suddenly increased during the Fifth Plan
period when a large number of institutions came into being. This constituted
more than 50 per cent of the total estimated expenditure on the NLCP. The
expenditure during the Sixth Plan doubled that of the Fifth Plan, and the
Seventh Plan expenditure will nearly double that of the Sixth Plan.
It may be mentioned that the expenditure currently incurred by the State
Governments will be double of the Government of India's expenditure.
FINDINGS OF INDEPENDENT EVALUATION
The programme has been subjected to annual independent evaluation jointly
by the Government of India and WHO since 1986, the first one in February,
1986, the second in April, 1987. Nine teams were formed with an experienced
public work administrator and an epidemiologist from within the country
representing the Government of India and a leprologist from outside the
country representing WHO as members in each team.
The 1986 evaluation covered 15 States, 18 districts, 29 Leprosy Control
Units/Urban Leprosy Centres, 42 villages and interviewed 72 para-medical
staff, 182 patients and 134 community members. The 1987 evaluation
focussed on in-depth examination of 5 districts which had been under MDT for
26
more than 5 years besides reviewing other components of the NLEP. The
teams visited 15 States, 28 districts, 47 Leprosy Control Units/Urban Leprosy
Centres and 103 villages, and interviewed 30 district leprosy officers, over 125
para-medical staff, 382 patients and 418 community members during the April,
1987 evaluation.
The conclusions and recommendations of the February, 1986, and April,
1987, joint independent evaluations are in Statements I and II respectively.
CONSTRAINTS
The programme has ben examined critically several times since its inception
in 1955 and the limitations have been brought out by the examination reports.
It is a matter of satisfaction that both the Central and State Governments
have been aware of the weaknesses affecting the programmes. A system of
annual independent evaluation and continuous monitoring of the programmes
has been established during the Seventh Plan period. The services of 13 fulltime NLEP consultants with long and rich experience in the management of
health programmes have been made available and eacn was assigned one or
more States depending on the level of endemicity, population and geographic
contiguity. These consultants guide the programme functionaries at State,
district and peripheral levels and validate the reported NLEP data. Higher
priority was given during Seventh Plan period for creation of sample surveycum-assessment units in the States so that the reported data underthe NLEP
is validated independent of the set-up at district and lower levels. The
constraints in the programme are listed below:
1.
lack of motivation of workers and poor enthusiasm by senior Government
officials;
2.
lack of interest and support by medical men for leprosy work;
3.
full complement of staff sanctioned has not been in position;
4 frequent transfers of medical officers and other field staff;
5.
large number of untrained medical officers and para-medicals working for
the programme;
6.
lack of desired emphasis and priority to health education;
7.
lack of rehabilitation facilities for the cured/deformed patients;
8.
inadequate' training in leprosy of undergraduate medical students,
laboratory technicians, NMAs and PMWs;
9.
delays in release of funds due to administrative bottlenecks;
10,
non-utilisation of funds made available to the States;
11.
inadequacy of vehicles and their disrepair and poor maintenance;
27
12.
low priority to leprosy control by some States;
13.
lack of operational research in leprosy to solve problems arising in the
field;
14.
lack of an effective monitoring system at different levels.
RESEARCH FINDINGS
Newer anti-leprosy drugs which are more effective and easy to administer
have been developed/identified recently and field studies to assess their
safety, acceptable dosages and regimens are yet to be initiated in different
endemic areas of the world.
A vaccine against leprosy-one developed by WHO with killed M. leprae
from arnadillos and two indigenously developed vaccines (ICRC bacillus and
M.W) from cultivable mycobaceteria are under different stages of trial. The
relative efficacy of these vaccines will not be available for the next 6 to 7 years
for using them as tools for immunotherapy/immunoprophylaxis against
leprosy under the field programmes.
None of the available diagnostic techniques developed/described could
as yet replace or improve the traditional skin smear examination and the
clinical assessment of patients for diagnosis of leprosy.
The Indian Council of Medical Research is according high priority for
leprosy research.
FUTURE PROSPECTS
The recent years have witnessed an increase in activities on various facets of
the NLEP. For the first time, during the year 1987-88, the number of leprosy
cases cured was higher than those detected and this trend is expected to
increase consistently to achieve the goal set for the programme. The
proposed annua! targets for case detection and cure and the number of cases
at the end of each year upto the year 2000 have been worked out to achieve
the goal of arrest of disease activity in leprosy cases in the country, subject to
the availability of adequate resources to create additional infrastructure and to
extend MDT to all the districts in the country in a phased manner. Improved
tools to prevent and control leprosy, if made available, would hasten the
achievement.
With the early detection of leprosy cases and their complete cure, it is
expected that the deformities will be prevented, thereby, further reducing the
stigma attached to the disease.
SUMMARY
Leprosy is a major health as well as social problem in India. About 4.0 million
leprosy cases are estimated to be present in India, one-fifth of whom are
28
infectious. Twenty to twenty five per cent of the cases in the country are among
children while another 15 to 20 per cent have deformities. Cases have been
reported from all over the country. However, the States of Tamil Nadu, Andhra
Pradesh, Orissa, West Bengal, Nagaland, -Bihar, Karnataka, Maharashtra,
Meghalaya, Manipur, Sikkim, Tripura and the Union Territories of Pondicherry,
■ Lakshadweep, Andaman and Nicobar islands. Goa, Daman and Diu have
prevalence rates of 5 and more per i000 population in order to endemicity with
88 per cent of the cases resident in these States/Union Territories. Of the 435
districts, the prevalence rate exceeds 5 per 1000 population in 196 districts.
The National Leprosy Control Programme was in operation as a vertical
programme since 1955 but it was only after 1982 that it received high priority
from the Government of India. The National Leprosy Control Programme
(NLCP) was redesignated as the National Leprosy Eradication Programme
(NLEP) in 1983 with the goal of arrest of the disease in all known leprosy
patients by the turn of the century. The programme has received 100 per cent
financial support from the Central Government in all States/Union Territories
in the Sixth and Seventh Five Year Plan periods (1980-90). The programme
has been included in the 20-Point Programme of the Government since 1980.
The strategies formulated for achieving the above objectives are:
i.
early detection and regular treatment of cases;
ii. multi-drug treatment (combination of drugs) to all the patients in place of
administration of the single drug Dapsone;
ill. education of patients, their families and the community about leprosy and
its curability;
iv. rehabilitation of cured patients with a view to make them economically
self-reliant and socially acceptable.
By the end of 1987, there were 601 Leprosy Control Units, 919 Urban
Leprosy Centres, 215 District Leprosy Units, 6239 SET Centres, 45
Leprosy Training Centres, 294 Temporary Hospitalisation Wards, etc., and 22
Sample Survey-cum-Assessment Units.
At the end of 1987, 3.30 million leprosy cases were on record and 3.04
million had been brought under treatment; 2.6 million cases had been
discharged as cured/migrated/dead since the inception of the programme.
During 1987-88, the number of cases discharged after cure exceeded the
cases detected for the first time in the history of the NLEP.
In India, voluntary organisations (VOs) have played a pioneering role all
through the history of leprosy control in the country. Since 1951 .there occurred
an extensive expansion in voluntary services for leprosy patients all over the
country. Presently, about 150 VOs are actively engaged in leprosy relief
services and information on their activities is available with the Government
from 106 of them.
29
In recognition of the great potential of voluntary institutions in leprosy
control, the Government of India has evolved a mechanism for annual
meetings with them with a view to establish communication, to exchange
information, to understand the nature of their work and to support and
recognise their contribution.
The voluntary organisations currently contribute to the treatment of onefourth of the leprosy cases on record in the country and the rehabilitation
services to the disabled are provided primarily by the voluntary organisations.
Seventy-five Reconstructive Surgery Units and 13 Leprosy Rehabilitation
and Promotion Units (LRPUs) are functioning under the NLEP to cater to the
medical and vocational needs of disabled patients. The LRPUs aim at
providing vocational rehabilitation besides facilities for surgical correction of
deformed/disabled leprosy patients. The Social Welfare Ministry has plans to
develop a pattern for providing grants-in-aid to voluntary organisations
involved in vocational rehabilitation services.
The Lepers Act, 1898, has been repealed by the Government of India in
respect of Union Territories without legislatures The States of Maharashtra,
Madhya Pradesh, Orissa, Kerala, Tamil Nadu, Tripura, West Bengal,
Arunachal Pradesh, Uttar Pradesh and Mizoram have also repealed the Act.
The Act is not applicable in Sikkim, Goa. Pondicherry and Rajasthan. Other
States are expected to do so shortly.
High priority has been given to health education of patients, their families
and the community since the inception of the prog ramme, in view of the stigma
attached to the disease. However, the inputs have increased substantially in
recent years and all the available media and methods are employed to
disseminate correct messages. Currently, about 95 per cent of the patients
under treatment live with their families. However, treatment regularity among
patients on Dapsone therapy has to be improved further through intensive
education both before and during the treatment phase. The modern media of
communication with the extension of network are to be involved to a greater
extent in bringing about awareness.
Periodic reports received at different echelons are monitored. The reports
have to be regular, timely and comprehensive. Field visits by supervisory staff
are made to validate the accuracy of reported data.
In February, 1986. for the first time, the programme was subjected to an
independent evaluation jointly undertaken by the Government of India ana ine
World Health Organisation. Eighteen districts in 15 States were visited. The
programme activities were considered very satisfactory at aggregate level.
The programme was again evaluated in April, 1987, when 15 States and 28
districts were visited by the teams. The performance has been found to be
highly satisfactory. Some constraints in the implementation of the programme
at the grassroot level were identified and efforts to remvoe these constraints
30
are under way. The indepth evaluation of activities in districts under MDT for
five years validated the reported encouraging results — MDT was found to be
safe, acceptable and effective.
Forty-five Leprosy Training Centres established during successive Five
Year Plan periods are functioning throughout the country to cater to the
manpower development, 14 of these are with voluntary organisations. So far,
over 20,000 para-medicals and over 5,000 medical officers have been trained
During the Sixth Plan period (1980-85), about Rs.40.00 crores were spent
by the Government of India and Rs.75.00 crores have been provided for the
Seventh Plan period (1985-90) for the NLEP. An amount of Rs.13.90 crores
was spent during 1985-86 and Rs.15.28 crores during the year 1986-87.
During 1987-88, the expenditure has been over Rs.18.00 crores. States/Union
Territories spend under non-plan, double this expenditure towards the cost of
infrastructure created during earlier Plan periods. About Rs 75 00 lakhs were
given additionally as grants-in-aid during 1986-87 to VOs involved in SET
activities.
The Government of India has recognised the advantages of Multi-Drug
Treatment (MDT) of leprosy cases over traditional Dapsone mono-therapy.
The regimens recommended by WHO have been adapted to meet the
operational and administrative requirements of the programme.
Before a leprosy endemic district is brought under MDT, it is ensured to
have adequate infrastructure covering the total population, trained personnel,
prior detection of at least 80 per cent of the estimated cases and creation of a
district leprosy society to operate the additional funds provided by the
Government of India to MDT districts. In view of the pre-requisites and the
large quantity of anti-leprosy drugs and funds required for MDT coverage of all
the cases in the country, MDT is introduced in a phased manner. Seventythree leprosy endemic districts are currently under MDT, 1.9 million leprosy
cases are present in these 73 districts.
The benefit of MDT activities is evident in the first 5 districts, namely,
Wardha (Maharashtra), Purulia (West Bengal), Ganjam (Orissa), Srikakulam
and Vizianagaram (Andhra Pradesh), which have completed an intensive
treatment period of five years
The efficacy of treatment regimens was uniformly favourable as
ascertained during the evaluation. Drug side-effects were observed in about
4.0 per cent of MB and in less than 1 0 per cent of PB cases. None of the drug
reactions proved fatal nor did any patient require hospitalisation for more than
one month. In all these 5 districts, there has been a fall in the prevalence rates
by over 80 per cent The deformity rates declined markedly in the new cases
detected in all the 5 districts compared to the earlier years. The annual new
case detection also showed a decline during the 5th year after MDT. The
relapse rate was very low with 0 9 per 1000 cases, 1.2 for MB cases and 0.8 for
PB cases.
31
Plans have been made to achieve the goal of arrest of disease activity in
all leprosy cases in the country by the year 2000 AD by working out annual
targets for case detection, treatment and cure. These plans are operated
subject to the provision of resources.
APPENDIX I
ASSUMPTIONS FOR STATE-WISE TARGETS
The following facts have been kept in mind in fixing the State-wise targets —
1976-77, NLCP.
1. For high endemic States/Union Territories namely, Andhra Pradesh,
Bihar, Maharashtra, Nagaland, Orissa, Tamil Nadu, West Bengal and
Pondicherry, the prevalence rate of leprosy in Leprosy Control Unit area and
SET Centre area is taken, on an average, as 1.5 per cent and 0.7 per cent
respectively. For otherStates/Union Territories, these figures are 1.0 percent
and 0.4 per cent respectively.
2. Targets are based on the
units/centres.
number of sanctioned staff with the
3. It is presumed that a PMW surveys a minimum population of about 5,000 in
a year.
4. For the units/centres established up to the Fourth Plan, calculation has
been made on the fact that about 15 per cent of the estimated number of cases
in their respective areas should additionally be brought under treatment during
1976-77, because, including new cases and the undetected cases, the total
number per year will sometimes exceed 20 per cent of the estimated cases of
an area.
5. For the units/centres established or due to be established during 1976-77,
during the Fifth Plan, calculation has been made on the fact that about 20-30
per cent of the estimated cases in their respective areas should be brought
under treatment during 1976-77.
6. It is assumed that units/centres of 1976-77 will be working for about 3-4
months during the year.
7. About 15 per cent of the total casesthat were brought and remained under
treatment till the end of the previous year i.e. 1975-76, should be made
bacteriologically negative and disease-arrested or cured during 1976-77 by
treatment.
Source
Government ot India, Ministry of Health and Family Planning (Department of
Health) — A communication issued to States vide their T 11023/11 /75-MTP
(C&CD) dated 7.6 1976, under the National Leprosy Control Programme —
Targets for the year 1976-77.
33
STATEMENT I
RECOMMENDATIONS OF INDEPENDENT EVALUATION OF NLEP
FEBRUARY, 1986
1.
Case detection in leprosy should be improved by:
a.
encouraging self-reporting through health education;
b.
strengthening surveys in urban areas;
c.
inclusion of survey as an essential activity in ULCs maintained under
medical colleges; and
d.
adoption of rapid survey method for case detection.
2. While the prevalence rate for leprosy was in consonance with the number
of estimated cases in most of the States, it was underestimated specially in
Madhya Pradesh and Uttar Pradesh. This should be re-assessed.
3. All vacancies at different levels should be filled up expeditiously by trained
personnel. The untrained staff in position at various levels should be quickly
trained without dislocation of work. Only trained PMWs should be appointed
and the practice of their recruitment in anticipation of future training must be
discontinued.
4. The State Leprosy Control Officer should be at least of the status of a Joint
Director, who has experience in leprosy work or of management of other
health programmes with orientation training in leprosy. The District Leprosy
Officer should be provided with sufficient office space and given adequate
financial and administrative powers. His status should be at par with that of
DHO/DMO/CMO.
5. Optimal utilisation of training capacity of the Training Centres requires to
be ensured, the vacant posts of trainers filled and adequate educational
material provided to them. Short-term reorientation courses on specific
operational activities may be developed for para-medical workers.
6. RSUs created under the programme should be reactivated. Training
facilities for specialisation in Reconstructive SOrgery in leprosy should be
augmented and stipends made available for trainees.
7. The disbursement of stipends to trainees should be as prescribed - in full,
regular and timely. The financial allocations made on this account should be
used only for this purpose and be fully utilised.
8
Laboratory services must be strengthened by:
a.
expeditious filling of sanctioned posts of laboratory technicians;
b revising the population and laboratory technician ratio realistically so
34
that there are at least 2 technicians for every 4 to 5 lakhs population;
c. recruiting in the place of laboratory technicians, workers trained as
Smear Technicians having undergone a 3-month training course in
smear examination;
d. provision of good microscopes and standard re-agents; and
e.
introducing quality control through smear cross-check at the referral
laboratories in the region.
9. Since the Modified Control Units are functionally identical with Leprosy
Control Units, the disparity in the staffing pattern of the two should be removed
by providing additional staff to the former.
10. The full utilisation of temporary hospitalisation wards must be ensured by
bringing them under the administrative control of the SLO/DLO, thus
establishing a link between the field and the specialised services.
11. The Urban Leprosy Centres should be fully integrated with the control
programme and placed under the charge of the DLO.
12. The stock inventory of anti-leprosy drugs should be realistic. Requirement
of drugs at the State and lower levels should be pre-planned, periodically
reviewed to avoid shortage as well as ensure timely utilisation, specially of
short shelf-life drugs.
13. Supervision at all levels and particularly in the field, needs strengthening to
ensure regularity of treatment, accuracy of diagnosis and reliability of data.
While timely submission of reports is necessary it is even more important to
review them carefully and provide feedback on them.
14. The number of SSAUs established as independent monitoring structures
in the programme should be increased to provide for wider coverage and
improving validation of data.
15. The discharge of inactive cases needs to be accelerated. The existing
criteria employed for assigning targets for case discharge do not possess
reliable scientific validity. A Committee of experts may be appointed to go into
the whole question of target allocation to States.
16. While the MDT programme has made a satisfactory take off, it must be
ensured that it operates only as a vertical scheme. Only such new districts
should be identified for introducing MDT that totally satisfy the prescribed pre
requisites. Identification of multi-bacillary, Dapsone refractory cases for
providing them with MDT coverage is a timely step in the right direction. This
should be closely monitored until its outcome is assessed.
17. In States like Himachal Pradesh, where the proportion of multi-bacillary
patients is reported to be high, this should also be included, after due
verification, as a criterion besides the prevalence rate for selecting a district for
MDT
35
18. There exists wide awareness in the community regarding leprosy. This
should be fully exploited by strengthening the community's perception of the
disease correctly through dissemination of appropriate messages, provision
of educational material and imaginative use of media.
19. Display of charts, maps, histograms, tables, etc. on leprosy epidemiology
and programme performance should be encouraged at all levels. The
Programme Officer at the Headquarters may issue necessary advice in this
regard.
20. The replacement of condemned vehicles should be an automatic and
expeditious process. Necessary administrative steps be initiated in this
direction.
21. The manual on guidelines for case detection, treatment, follow-up and
reporting is a satisfactory, comprehensive and useful document. Its
dissemination may be carried out widely. The manual may be translated into
regional languages for use by the PMWs.
22. The existing co-ordination between the voluntary organisations and the
programme personnel at various levels is praiseworthy. It may be ensured that
grant-in-aid to these organisations is released timely by the Government of
India.
23. While part-time leprosy specialists may continue to assist in making
reliable diagnosis and classification of leprosy cases, there is need for full-time
consultants, each made responsible for one or more States in respect of
monitoring Dapsone monotherapy as well as MDT.
24. Having acquired experience of an independent evaluation of the
programme and the establishment of baseline data, the NLEP should provide
for this exercise each year.
25. Necessary steps should be initiated to meet the requirements of staff
training, health education and programme monitoring in leprosy low endemic
States.
36
STATEMENT II
CONCLUSIONS AND RECOMMENDATIONS OF INDEPENDENT
EVALUATION OF NLEP - APRIL, 1987
1.
The case detection in leprosy should be further improved by:
a.
greater efforts on the part of supervisory staff at all levels to unearth
missed cases;
b.
strengthening contact and school surveys;
c.
greater emphasis on active case detection in urban areas with support
from the medical profession; and
d.
involvement of NMAs in case detection as in Karnataka State, wherever
possible.
2. While almost all the States over-reached the target of case detection and
treatment, the discharge after treatment called for improvement in some
States. A proportion of cases required to be removed from the records on
account of death, migration or arrest of the disease.
3. The allotment of targets needed to be made more realistic; better and
sensitive indicators of performance should be adopted.
4. Greater attention must be paid to retrieval of treatment defaulters,
specially in areas under Dapsone monotherapy.
5. Data collection and reporting on relapse, reactions and Dapsone
refractory cases was poor and should receive much greater importance.
6. Untrained staff at all levels in sufficient numbers existed within the
programme. They should be expeditiously trained. The availability of trained
manpower for the programme can be augmented by:
a.
improving the existing training capacity utilisation of the training
centres;
b.
developing short-term 'Refresher Training’ both for medical and non
medical workers; and
c.
stopping transfer of trained personnel working under the NLEP at least
for a period of 5 years after they are trained.
7. The available training capacity at the national level for all categories of
personnel and the training requirements in the country should be examined
and mechanism evolved to ensure utilisation of surplus capacity.
8. In view of the workload, a definite staffing pattern existed tor all types of
organisational structures under the NLEP. It was a sad commentry that
37
vacancies in large numbers existed against sanctioned posts for all staff
categories in many of the States. These need to be filled at the earliest.
9. The laboratory services continued to be neglected. In view of the key role
these services played in the success of MDT, it is recommended that:
a. vacancies in lab/smear technicians should be filled up, and the
additional post of laboratory technicians be sanctioned on top priority;
b.
crash training courses for existing untrained technicians should be
organised;
c.
the quality of microscopes and reagents should be standardised;
d.
an extra microscope should be made available to each laboratory to
ensure uninterrupted work in the event of breakdown; and
e.
quality control must be improved through constant cross-checking.
10. To strengthen planning, execution and monitoring of programme activities
in the high endemic States, there is need for creating an additional post of a
Deputy/Asstt. Director to assist the State leprosy office
likewise, the
performance in a district depends on the status and leadership provided by the
district level officer; the status of District Leprosy Officer should conform to
that of a District Health Officer/Chief Medical Officer/District Medical Officer
of Health with commensurate powers.
11. The tendency to compile data only for onward transmission under the
information system needs to be discouraged. Instead.it should be critically
analysed to improve performance. The performance assessment should be
backed up by complete and meaningful feedback. Suitable incentives may be
introduced, as in the State of Maharashtra, for good work.
12. The inadequacy of existing supportive supervision and guidance should
be replaced by effective managerial support to all functional levels.
13. To strengthen rehabilitation of the handicapped, the RSUs should be
made fully operational and supported, where necessary, by the NLEP.
14. In view of the favourable impact discernible in the MDT districts, its
expansion to other areas should be continued after due prior preparation. The
practice of dispensing MDT without prior characterisation of patients, as
observed in some Dapsone monotherapy districts in Karnataka State must be
discontinued.
16. The impact of health education as evinced by greater disease awareness
and increased self-reporting within the community must be further augmented
to cover pockets of urban areas still suffering from prejudice. There should be
greater emphasis on imparting knowledge on leprosy to these people.
38
17. There is need for an independent organisation outside the programme for
continuous monitoring and establishing epidemiological indices. It is
recommended that the existing SSAUs may be increased and new SSAUs
provided where necessary to discharge these functions. Appointment of fulltime NLEP consultants will also fortify this function.
39
NATIONAL INSTITUTE OF HEALTH AND FAMILY WELFARE
(NIHFW) came into existence on 9th March, 1977, after the
Government of India, realising the commonality of objectives of the
two former institutions - National Institute of Health Administration
and Education (NIHAE) and National Institute of Family Planning
(NIFP) - and in pursuance of its policy to integrate health and family
planning services, decided to merge these two institutions into an
Apex Technical Institution.
As sn Apex Technical Institute of its own kind in the country, the
NIHFW has been actively engaged in the promotion of health and
family welfare programmes through education, training, research,
evaluation and advisory-consultancy and other specialised services.
In order to achieve these objectives, the NIHFW, apart from its
regular M.D. Courses in Community Health Administration, also
conducts 30-35 in-service training courses/workshops and seminars
every year, which are attended by a variety of personnel ranging from
high-ranking policy making officials and key trainers to the grassroot
level workers.
Other activities of cardinal importance are research and
evaluation in ths field of health and family welfare. NIHFW conducts
various research and evaluation studies at its own or in collaboration
with other national and international agencies. The results of these
studies are fed to the programme planners, administrators and
managers.
NIHFW also provides advisory and consultancy services to the
Ministry of Health and Family Welfare, to the States, voluntary
organisations and international agencies in matters related to health
and family welfare.
The Institute provides specialised services as a part of Its
education, training and research activities. These include clinical
services, documentation, publication, audio-visual services and data
processing services.
;?v
OSB;
NATIONAL LEPROSY ERADICATION
PROGRAMME
OPERATIONAL GUIDELINES ON CASE
DETECTION, TREATMENT, FOLLOW
UP AND REPORTING FORMS
1992
LEPROSY DIVISION
DIRECTORATE GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH & FAMILY WELFARE
NIRMAN BHAWAN, NEW DELHI-110011
T.K. DAS
Joint Secretary
Government of India
Ministry of Health & F.W.
New Delhi-110011
FOREWORD
Leprosy is one of the oldest disease in the world, probably it is as old
as mankind. There is perhaps no disease which, even today, has more
myths and misconceptions, than leprosy. And it is ignorance and wrong
attitude of people which cause many to shy away from treatment,
bringing themselves even further psychological and physical suffering
instead of consulting doctors early for a cure.
Leprosy continues to be a major public health problem in India.
Leprosy cases are reported from all over the country. However, the
prevalence of the disease is not evenly distributed. It varies from State
to State as also from district to district. National Leprosy Control
Programme has been in operation since 1955. It was redesignated as
National Leprosy Eradication Programme (NLEP) in 1 982-83. Under the
Programme Multi Drug Treatment is extended to all leprosy cases to
ensure their early and complete cure. Broad field of leprosy control
encompasses wide variety of activities such as to develop a suitable and
effective system of NLEP that reach the population, detect cases in early
stages of the disease, ensure regular treatment with MDT and organise
health education and rehabilitation services, etc.
Guidelines on leprosy case detection, treatment, follow up and
reporting were developed in the form of a booklet in 1 987 for doctors,
medical students and leprosy workers. The present edition required
rewriting to the extent of becoming effectively a new publication as a
result of rapid progress in understanding leprosy. In a work like this,
which attempts, in a small encompass, to cover the whole field of
leprosy, it is difficult to maintain appropriate balance and focus. Viewed
in this background, this booklet should prove to be indispensable for
those actively involved in the programme planning and its implementa
tion.
I am sure this book will be of immense help to the leprosy doctors,
workers and other health personnel in the proper management of leprosy
cases. I wish to take this opportunity to congratulate Deputy Director
General, Health Services (Leprosy) and his team fortheir splendid effort
in bringing about his edition.
(T.K.'. DAS)
ABBREVIATION
NLEP
VO
MB
PB
BB
BL
LL
1
TT
BT
Bl
L
N
N?L
T
MA
P
MDT
MT
MIC
MMDT
RFT
RNA
MO
NMS
PMW
Lab.T
DLO
ZLO
SLO
LCU
SET
ULC
UT
M. leprae
National Leprosy Eradication Programme
Voluntary Organisation
Multibacillary
Paucibacillary
Mid Borderline
Borderline Lepromatous
Polar lepromatous
Indeterminate
Polar Tuberculoid
Borderline Tuberculoid
Bacteriological Index
Lepromatous
Non-lepromatous
Borderline
Tuberculoid
Maculo Anaesthetic
Pure Neuritic
Multidrug Therapy
Mono Therapy
Minimum Inhibitory Concentration
Modified Multidrug Therapy
Release From Treatment
Ribonucleic Acid
Medical Officer
Non Medical Supervisor
Para Medical Worker
Laboratory Technician
District Leprosy Officer
Zonal Leprosy Officer
State Leprosy Officer
Leprosy Control Unit
Survey, Education and Treatment Centre
Urban Leprosy Centre
Union Territory
Mycobacterium leprae
CONTENTS
PAGE NO
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
11.1
11.1.1
11.1.2
11.2
11.2.1
11.2.2
11.2.3
12.
13.
14.
15.
16.
16.1
17.
18.
INTRODUCTION ................................................................ 1
NATIONAL LEPROSY ERADICATION
PROGRAMME..................................................................... 1
MULTIDRUG THERAPY .................................................. 1
CASE DETECTION ........................................................... 2
DISEASE CLASSIFICATION........................................... 4
CLINICAL EXAMINATION ............................................... 5
BACTERIOLOGICAL EXAMINATION .......................... 5
OTHER LABORATORY INVESTIGATIONS................ 6
DIFFERENTIAL DIAGNOSIS........................................... 6
DISEASE ACTIVITY STATUS........................................ 7
CHEMOTHERAPY'............................................................ 8
Treatment of Multibacillary Leprosy ...... ........................9
Dapsone Monotherapy.................................................... 10
Multidrug Treatment........................................................ 10
Treatment of Paucibacillary Leprosy............................ 13
Dapsone Monotherapy.................................................... 13
Multidrug Treatment.......................................... ............ 14
Regularity of Treatment ................................................. 15
ASSESSMENT AND SURVEILLANCE....................... 15
CASE HOLDING ............................................................. 16
DEFAULTER (RETRIEVAL ACTION........................... 17
CRITERIA FOR DISCHARGE ..................................... 17
RELAPSE ......................................................................... 18
Precautions of Drug Usage............................................. 18
SIDE-EFFECTS............................................................... 19
REPORTS......................................................................... 20
ANNEXURE I .................................................................. 22
ANNEXURE II.................................................................. 23
"
INTRODUCTION
Leprosy is a chronic graulomatous infection of human beings caused
by Mycobacterium leprae which attacks mostly superficial tissues, espe
cially the skin and the peripheral nerves.
There are 10 million estimated cases of leprosy in the world. India
ranks foremost amongst the countries saddled with this disease sharing
nearly one fourth of the global leprosy load. The disease is present all over
the country but it is not uniformly distributed. Its prevalence varies from
state to state, district to district and within the district itself. The areas of high
prevalence are found mainly in the south-eastern and central parts of the
country, including the states of Tamil Nadu, Andhra Pradesh, Orissa, Bihar,
Madhya Pradesh, Uttar Pradesh, Maharashtra and West Bengal. Between
them, these eight states account for approximately 90% of the registered
case load in the country.
About 15 to 20 percent of the leprosy sufferers are children below 14
years in age and an equal proportion of the patients suffer from deformities.
The magnitude of the problem cannot be defined in terms of numbers alone.
The age old social stigma attached to the disease leads to many a broken
home and economic loss of production in farms, fields and factories.
1.
NATIONAL LEPROSY ERADICATION PROGRAMME
The leprosy control programme has been in operation since 1955 but
it was only in 1980 that the programme was accorded a high priority and
redesignated as National Leprosy Eradication Programme. The approach
to the control of leprosy is based on :
- provision multi-drug therapy to all patients;
- education of the patients, their families and communities about
the disease and its curability; and
- physical social and economic rehabilitation of cured
patients.
There are 455 districts in the country of which in 201, the leprosy
prevalence
rate
exceeds
5
per
thousand
population
(1985). Low endemic areas with prevalence rate below 1 per 1000 popula
tion are located in Haryana, Punjab, J & K, H.P. and Rajasthan.
2.
MULTI-DRUG THERAPY (MDT)
The control strategy was so far based on dapsone monotherapy till
1982. Even as it was widely implemented in the country as a well organized
programme and succeeded in decreasing the disease prevalence in sev
eral of the areas, a parallel decrease in disease incidence was not evident.
Further, the problems of defaulting, drug resistance and bacterial persis
tence associated with dapsone monotherapy brought out its limitations as
3.
1
astrategy for leprosy control. In 1982, the Government of India adopted the
concept of treatment of leprosy cases with a combination of drugs to effec
tively shorten the treatment period and to break the chain of transmission of
infection by regular and adequate treatment of all the cases. The drugs
employed are dapsone, rifampicin and clofazimine. In 1983 MDT was
started in 2 districts.
Under the programme the MDT scheme is being operated in three
forms. In a vertical set up, MDT is provided by a separate, well-trained staff
specifically meant for this purpose. Detailed guidelines for MDT operations
have been provided in a printed form to the 201 districts with leprosy
prevalence rate of 5 and above per 1000 people. MDT through a vertical
set-up is being implemented in 135 districts. In districts with low endemicity,
these services are provided by the existing primary health care staff. The
third variant called the modified MDT scheme (MMDT) operates in the re
maining 66 of the 201 districts with endemicity of 5 per 1000 or more. The
MMDT differs from the regular vertical setup in the following important
respects :
a. The district leprosy unit functions under the overall charge of the
district leprosy officer.
b. Leprosy workers are provided to the district to the extent
available. The MDT services are delivered through the primary
health care set-up.
c. The medical officer of the primary health centre is the over all
incharge of MDT operations.
d. Cash assistance is given to the patients for collecting drugs from
the treatment points, and cash awards are provided to those
completing treatment schedule in time. Cash assistance for
detection/reporting of a new case is also provided.
e. The treatment points coincide with primary health centre, sub
centre, community health centre and hospitals and dispensa
ries.
It is needless to say that the best drug combination will be doomed to
failure unless the regularity of drug intake is maintained and the prescribed
treatment schedule completed.
This manual gives instructions for the efficient and effective perform
ance of principal activities related to the revised strategy. It does not aim at
covering all aspects of the programme but gives practical guidelines for
effective and efficient performance of key activities.
4.
2
CASE DETECTION
The success of the leprosy control programme is dependent upon
early finding and management of cases. Leprosy is a disease with a long
and uncertain incubation period. Very early signs and symptoms of the
disease in many patients are not noticeable by patients nor in any way affect
his life pattern. By the time the patient becomes aware of the manifestations
and presents for advice, there may be a lag period of 2-3 years. Hence,
potentially infectious cases may harbour a high quantum of bacilli in their
body before the clinical disease becomes well evident. Early detection of
disease can be promoted by health education and repeated and continuous
examination of population.
Early detection of all types of patients is important but emphasis must
be placed on patients discharging and transmitting infection with M. leprae.
Bacteriological and epidemiological studies have clearly established the
infectiousness of multibacillary patients. The frequency of disease is also
highest among contacts of smear positive patients. Hence multibacillary
patients should be the prime target of case detection.
The two principal approaches to case detection are :
- Passive case finding
- Active case finding
Passive Case Finding
Voluntary case reporting forms the main basis of passive case finding.
In recent years there has been a significant increase in the proportion of
self-reporting patients in the programme. Increasing self reporting indicates
not only greater awareness of the disease but also a degree of confidence
on the part of the community regarding the efficacy of available treatment
and a reduction in social stigma. It should be encouraged by utilizing all
available resources including the mass media. Several operational studies
have shown that patients reporting voluntarily tend to be more regular for
treatment compared to those detected by other methods. This fact alone is
sufficient to justify concerted efforts on all fronts to intensify promotion of
health education.
4.1
Contacts should be made with other medical institutions and social
organizations within the district to encourage wide dissemination of infor
mation regarding the leprosy eradication programme.
4.2
Active Case Finding
Surveys constitute important operational activity for active case
finding. Total population surveys should be intensified in all highly endemic
areas. Efforts should be directed at obtaining at least a 90% coverage in all
the villages. The districts should be covered within 3 years. In this connec
tion, family surveys or surveys ol selected groups of population, such as
school children, industrial labourers etc., holding youth camps, skin camps
3
and enlisting the support of students under NSS and NCC may also help in
case detection. Involvement of teachers, private practitioners, medical
studentsand interns can also promote identification of early cases.
The surveys should be time bound and target oriented. Their progress
should be monitored at periodic intervals. Contact surveys should be
organized every year. While contacts of all patients should be examined
annually, highest priority need to be accorded to contacts of multibacillary.
patients. Rapid survey of families and HE will yield good results.
In areas known for higher incidence of leprosy in children, school
surveys should be carried out on priority with appropriate maintenance of
records.
Case detection in urban areas present special problems. Case finding
in these areas should focus on intensive health education with the use of
mass media, such as news papers, radio and television. Contact surveys,
school surveys and mass surveys in slums, tenements and industrial
groups should be regularly undertaken.
DISEASE CLASSIFICATION
The manifestations of leprosy are many and variable. Its classification
is based on clinical and histopathological findings and examination of skin
smears. The two major polar types are lepromatous leprosy and tuberculoid
leprosy. Classification within the borderline region is less precise. In
addition, an early indeterminate form is seen which may develop into one of
the three forms mentioned. However, for the purpose of eradication
programme, leprosy patients are divided into multibacillary (MB) and
paucibacillary (PB) types. The former is infectious while the later is not.
There are several classifications of leprosy in use. The equivalents o<
various types is presented in table - 1 below. It is recommended that the
states/UTs follow the classification endorsed for tne programme.
5.
TABLE 1
Equivalents of Different Classifications of Leprosy
Multibacillary
S. Other Classilication
No.
1. International
(Maidrid 1953)
2. Ridley and
Jopling
3. Indian
4
Current Classilication
Paucibacillary
Lepromatous
i Tuberculoid
Borderline lepromatous li Indeterminate
Smear Positive Indet- in Borderline
-erminate, tuberculoid
tuberculoid
and borderline tuberculoid
I BB.
i I.
ii BL
■ TT
iii LL
i» BT.
IL
I T
i
ii
in
iv
4. Indian Association
of Leprologists
(1981) Consensus
N?L
P under N
Early indeterminate
under N?L
Lepromatous
Borderline
lepromatous
MA
Indeterminate
Tuberculoid
ill Pureneuritic
Iv Borderline
tuberculoid
6.
CLINICAL EXAMINATION
The main objective oj the clinical examination is to diagnose leprosy,
identify the clinical type, and distinguish between paucibacillary and
multibacillary patients. This will enable the field workers to decide on the
proper treatment regimen, the duration of treatment as also the plan of
surveillance.
The clinical examination should be undertaken systematically, pref
erably in day light by a medical officer or a senior paramedical worker. As
for any other disease, it should include history taking and general examina
tion of all systems. It is^ot the purpose of this booklet to document the
manifold signs and symptoms of leprosy. Suffice it to say that the patients
complaints should be checked for the presence of patches on the skin,
anesthesia, sensations of the tingling and numbness, nerve enlargement,
nodules anywhere over the body, shiny, oily skin, loss of sweating and
presence of any ulcers. Complications such as fever, erythematous swel
lings, tenderness along the peripheral nerves and involvement U eye
should be looked for. The clinical findings should be carefully noted in the
performae prescribed in the programme for this purpose.
7.
BACTERIOLOGICAL EXAMINATION
Bacteriological examination is an essential pre-requisite to classifica
tion and for commencing treatment. Subsequently, it is required during the
surveillance period. It should be performed by a person trained for proper
collection, staining and examination of the skin smear.
In stained skin smears, M. laprae can be seen lying singly, in clumps
or in compact masses called globi. the Ziehl-Neelsen method of staining is
recommended. In a properly stained skin smear the leprosy bacilli appear
bright red and everything else takes the blue colour of the counter stain. The
M. leprae retain the property of staining with carbol fuchsin even when
dead. This may mislead the technician in concluding that the patient is not
making progress on treatment, it is, therefore, important to distinguish
between living and dead bacilli. The living bacilli appear as uniformly stained
5
rods while the dead bacilli take irregular staining or appear as granules
(granular bacilli).
The bacteriological index (Bl) should be reported on Ridley's scale
which has a maximum reading of 6. The number of sites from where the
smears are made should not be less than 3, out of which 2 sites should be
from active lesions. The smears should be fixed and transported to the
laboratory within a week.
8.
OTHER LABORATORY INVESTIGATIONS
Facilities for additional laboratory investigations should be available.
These include chemical and microscopic examination of urine, estimation
of haemoglobin and performance of liver function tests. These investiga
tions should be carried out wherever clinical examination indicates the need
for these tests.
9.
9.1
DIAGNOSIS AND DIFFERENTIAL DIAGNOSIS
Diagnosis of leprosy is based on the following cardinal signs ;
- skin lesion either hypopigmented/erythematous patch with or
without infilteration;
- partial or complete loss of sensation;
- thickened nerves with or without tenderness/pain;
- demonstration of M. leprae in skin smear;
Presence of any two of these four cardinal signs will confirm diagnosis
of leprosy.
9.2 A large number of neurological and dermatologic disorders may mimic
leprosy. The scope of this publication does not permit any detailed discus
sions of these diseases. It may, however, be emphasised that the leprologists tend to over-diagnose leprosy (due to lack of knowledge of several of
the skin and some neurological or general medical problems). Under the
pressure of annual targets given to the states for detection of new cases,
the problem of over diagnosis is further accentuated. It cannot be overem
phasised that a combination of a chronic skin disease and peripheral nerve
involvement should always lead to the consideration of leprosy. The skin
lesions of leprosy, especially of paucibacillary disease, are characterized by
hyposthesia, and peripheral nerve involvement can always be demon
strated. The peripheral neuropathy due to diabetes mellitus, collagen •
diseases or syringomyelia may be confused with leprosy, but skin involve
ment is not a feature of these diseases.
With the advent and successful implementation of MDT, there is a
sharp fall in the prevalence rate of leprosy, though the incidence remains
static. The peculiar phenomenon observed is that, most of the new cases
6
are with one or two lesions. Diagnosis of sdch cases is a problem when rt
occurs in children. Sometimes the cardianal criteria for diagnosis also may
not hold good in such circumstances. Many dermatological diseases mimic
leprosy and should be differentiated and if the diagnosis is still doubtful,
should be kept under observation.
The skin lesions with following features should not be considered as
leprosy:
1. Linear pale macular lesions with definite sharp margins since
birth.
2. Hypopigmented, ill defined single or more patches over the face
of children - look for other signs of avitaminosis.
3. Single or more round or oval hypopigmented patches with fine
adherent scales having well defined margins over the cheeks of
children -spontaneously heal with change of climate or respond
well to topical steroids.
4. Hypopigmented or erythematous (red), slightly scaly or itchy,
lesions seen on the seborrhic areas of the body viz : between the
scapulae on the back, retroauricular or nasolabial fold - re
sponds to topical steroids.
5. Severely itchy round lesions with marginal vasicles and central
healing-responds well to antifungal agents.
6. Small round hypopigmented lesions on the neck or trunk with
powdery scales, itches on sweating - respond well to antifungal
agents or simple keratolytic (peeling) agents.
7. Round dry scaly plaques, usually symmetrical on the back of
elbows or on the anterior aspect of knee joints. On removal of
these silvery scales bleeding points can be visible.
8. Annular itchy plain skin lesions on plaques with papular or
smooth nodular edges, usually in the hands of children.
9. Erythematous (red) round or oval itchy plaques with history of
sudden onset - respond well to anti histamines.
10. Single round or oval mildly itchy lesions with (petaloid) fine
scales on the margins, mainly seen on the trunk.
11. Butterfly lesions on the front of face or lesion of any shape on
other parts of the face or sun exposed areas. These lesions are
with raised margins, central atrophy or depigmentation and
scaling.
10.
DISEASE ACTIVITY STATUS
When patients receive only dapsone treatment, there is great reluc
tance in releasing them from control (RFC). Over the years, this has
resulted in substantially increasing the unproductive work load of the
peripheral workers besides integrating prevalence rates. For efficient
operation of the programme, a clear distinction must be made between the
active case and those in whom the disease has become inactive. The later
are of no immediate epidemiologic significance. Timely release of such
patients from control is essential so that the manpower can be released for
greater coverage.
A patient without any sign of clinical activity and with negative
bacteriologic findings should be considered as an "inactive case". The signs
of activity are :
- erythema and infiltration;
- extension or appearance of new skin lesions;
- extension of anaesthesia or paresis/paralysis or development of
new anaesthetic areas;
- tenderness pain of nerves;
- presence of acid fast bacilli; and
- occurrence of reactions.
In the absence of these signs, the patient should be considered
clinically inactive. In clinically inactive cases after dapsone monotherapy,
regular treatment with dapsone should be continued for 1 year in paucibacillary patients and for 5 yrs in muItibacillary cases before their release from
control.
Because of the risk of relapse, the paucibacillary patients should be
under yearly surveillance for several years after the treatment has been
stopped.
In those districts where the treated patients have not yet been
identified as inactive, the paucibacillary cases without any sign of clinical
activity and with negative bacteriology, can be directly released from control
provided.
- they have taken dapsone regularly for at least 3 years and
- the decision is taken by a medical officer or senior paramedical
worker.
11.
CHEMOTHERAPY
It has been estimated by Shepard that in a new untreated multibacil- "
lary patient, the bacterial population is 10’2 organisms, 1/1 Oth of which
are alive ie 10'’. The principles of combined chemotherapy depend
on the fact that if the bacterial population is rapidly reduced from 10”
to 105 or less, the emergence of new resistant mutants can be
minimized or stopped. The evidence based on the chemotherapy of
tuberculosis shows that the more rapid the anti-bacterial effect, the less
8
likely are the persisters to emerge. If a drug has only bacteriostatic activity,
the bacilli resume multiplication as soon as the serum level falls belowthe
minimum inhibitory concentration (MIC). Compliance of treatment, there
fore, becomes critical. When the drug has bactericidal activity, the compli
ance become less critical.
Objectives : The objectives of multi-drug treatment are :
- to sterilize the leprosy lesions in the shortest possible period of
time so as to interrupt the transmission of infection;
- to prevent the emergence of resistant strains of M. leprae;
- to cure the patient, minimize the development of deformities and
prevent treatment failures; and
- to prevent relapse.
»
The three drugs employed in the programme are dapsone, rifampicin
and clofazimine.
Dapsone : Dapsone is cheap, effective and virtually without toxicity. At a
dose of 100 mg daily it is weak bactericidal against /W. leprae in man. Such
a dose results in peak serum levels that exceed the minimum inhibitory
concentration (MIC) of dapsone against leprosy bacilli by a factor of 500.
This large therapeutic margin is exceptional and unique. At this dose the
drug inhibits the multiplication of mutants of M.leprae with low or even
moderate degrees of dapsone resistance. Dapsone has a long half life of
about 24 hours.
Rifampicin ; It is highly potent bactericidal drug and its rapid action in killing
M. leprae is due to inhibition of ribonucleic acid (RNA) synthesis. It is
effecitve against dapsone resistant bacilli.
*
Clofazmine; This is a red Riminophenazine dye which is bacteriostatic in
action. It is virtually non-toxic when administered in doses not greater than
100 mg daily. However higher doses are used to manage type 11 reactions.
Treatment of Multibacillary Leprosy
The treatment of choice for multibacillary leprosy is by combined
chemotherapy. Even though the MDT cover in the Indian programme has
rapidly expanded ever since its commencement in 1983, however, due to
financial constraints and other, it has not been possible for MDT to reach
every district. Still, for sometime to come dapsone alone will continue to be
the main stay in the treatment of leprosy in non-MDT districts.
11.1
9
11.1.1
Dapsone Monotherapy
Because of its safety and effectiveness, dapsone is pre-eminently
suited for domiciliary treatment. Care should, however, be exercised to
prevent the emergence of dapsone resistant strains of M. leprae by
- using the drug in full doses; and
- ensuring un-interrupted, daily treatment.
a. Regimen
Adults
: Dapsone 100 mg daily self-administered.
Children : Dapsone is given in doses of 50 mg daily in children
between 6 to 14 years in age. In the unlikely event ot the child with
multibacillary disease being below 6 years, the dose should be further
reduced to 25 mg daily.
■
$
Duration of Treatment
Treatment should be continued until the patient becomes clinically
inactive and bacteriologically negative for which assessment should be
carried out once every year. Compliance of drug intake should be regularly
monitored by tablet counting and spot test of urine, wherever possible
Once inactivity is achieved, regular dapsone treatment is full dose should
be carried out for a further period of 5 years. Thereafter, the patient should
be kept under yearly surveillance, without treatment, to detect any relapse.
b.
On this regimen, the majority of the patients become clinically inactive
and bacteriologically negative within 5 to 6 years. If at the end of 7 years, this
does not happen, the patient should be comprehensively reviewed clinically
as well as bacteriologically by the medical officer and referred to the
specialist for opinion. Such refractory responders are likely to be dapsone
resistant and, therefore, need to be treated with combined therapy.
If at any time during the course of monotherapy, the patient shows
evidence of clinical and bacteriological deterioration, it is likely that secondary dapsone resistance has supervened.
The reappearance of solid bacilli in the skin smears (Ml) strongly
suggests secondary dapsone resistance. These patients again need to be
referred to the specialist for combined chemotherapy.
11.1.2 Multidrug Treatment
In the NLEP, combined chemotherapy with dapsone, refampicin and
clofazimine is carried out in districts that are under the MDT and modified
MDT programmes. In these districts all the leprosy patients both multibacil
lary and paucibacillary arc to be subjected to the prescribed regimen of
'
T
treatment. In addition, multidrug treatment is resorted to in districts under
dapsone monotherapy for certain categories of patients as described here
under.
The criteria for selection of multibacillary patients in a MDT
district are :
- all skins smear positive patients irrespective of their classifica
tion;
- all clinicially active BB, BL and LL patients whether skin-smear
positive or negative;
- all active BT cases with ten or more lesions including nerve and
skin lesions, irrespective of their smear status;
- all skin smear positive relapse after dapsone monotherapy or
MDT irrespective of the classification;
- multibacillary patients on dapsone monotherapy who have
become bacteriologically negative within the last 24 months;
- paucibacillary patients on MDT, who at the end of 12 months of
therapy shows new lesions or extension of old lesions.
In districts under dapsone monotherapy :
- multibacillary patients who do not show clinical inactivity and/or
gross reduction of bacterial load after 5 years of regular dapsone
monotherapy;
- paucibacillary patients who do not show clinical inactivity after 2
years of regular treatment with dapsone monotherapy.
- relapsed multibacillary or paucibacillary cases during or after
dapsone monotherapy; and
- proved or even suspected patients of dapsone resistance primary or secondary.
Regimen
All the registered cases will receive daily supervised treatment in the
initial 14 days as follows :
Rifampicin
600 mg
Clofazimine
100 mg
Dapsone
100 mg
(This daily intensive therapy for 14 days should however be used only
when separate instruction have been issued).
Patients appearing for the first time on any day of the intensive course
will be given daily supervised doses only for the remaining days of the
intensive 14 day course. Registered cases who missed the intensive
course and new cases detected after the intensive phase of treatment is
over, will receive only pulse treatment as prescribed in the continuation
a.
phase. The supervised doses are meant to be ingested by the patient in the
presence of the medical officer or the non-medical supervisor.
The supervised 14 day intensive phase of treatment is followed in the
districts where the MDT programme functions under the vertical set-up. In
the modified MDT districts, however, the 14 day intensive treatment course
has been dispensed with. In these districts, all the registered patients start
with pulse treatment in the continuation phase, as described below.
Continuation Phase: The treatment is given at least for a period of 2
years with the following drugs :
- Rifampicin
600 mg, once a month supervised.
- Clofazimine
:
300 mg, once in a month supervised
and 50 mg daily self-administered.
-
100 mg daily, self-administered.
Dapsone
Note:
1. Adults less than 35 Kg in body weight should receive 450 mg
rifampicin daily, during the intensive phase and thereafter once
a month in the continuation phase.
2. The daily 50 mg clofazimine is recommended to be self-admini
stered as it helps in patients compliance. If 100 mg capsules only
are available, the drug should be taken on alternate days.
Children : In children, the doses are proportionately reduced. The
recommended schedule for children in the age group 6-14 years is given in
table-2.
TABLE-2
Recommended dose for Children
Phase
6 (o 9 years
10 to 14 years
Intensive for 14 days
Rifampicin 300 mgm daily
Clolazimine 50 mgm daily
Dapsone 25 mgm daily
Rifampicin 300 mgm once
monthly
Clofazimine 100 mgm
once monthly and 50 mgm
twice weekly
Dapsone 25 mgm daily
Rifampicin 450 mgm daily
Clofazimine 50 mgm daily
Dapsone 50 mgm daily
Rifampicin 450 mgm
once monthly
Clofazimine 150 mgm once
monthly and 50 mgm on
alternate days
Dapsone 50 mgm daily
Continuation for
a minimum of
2 years
Duration of Treatment : The treatment should be continued for a
minimum period of 24 months or until skin smear becomes negative,
whichever is later. Smear negativity means absence of M. leprae in skin
smears on 2 consecutive occasions at monthly interval, from at least 3 sites
each time. If there is no favourable response in the disease activity after 3
12
years of treatment, the patient should be referred to the consultant leprologist. By favourable response is meant that either the signs and symptoms
decline as evidence by flattening of raised lesions, subsidence of nodular
lesions and neurites. There should be no extension of infiltration or anesthe
sia or a reduction in Bl.
Regularity of Treatment
Adequate treatment implies that the patient has taken 24 monthly
supervised doses of combined therapy in 36 months. A patient may be
considered on regular treatment, if the combined therapy has been taken
for at least two-thirds of the period at any interval of time. For example, if the
patient has had 8 full months of combined treatment during the 12 month
period, he or she can be considered to have received regular treatment.
The above multidrug treatment is designed for all categories of
multibacillary patients, including
- freshly diagnosed untreated cases;
- patients not responding satisfactorily to previous dapsone
monotherapy;
- dapsone resistant patients; and
- patients who have relapsed while on oapsone monotherapy or
after its cessation.
b.
11.2
Treatment of Paucibacillary Leprosy
11.2.1 Dapsone Monotherapy
Regimen :
Adults : Dapsone 100 mg daily self-administered
Children .-The dose should be proportionately reduced to 50 mg daily
for children in the age group of 6-14 years. In children 5 years old or less in
age, dapsone should be given in a dose of 25 mg daily.
Duration of Treatment; The treatment should be continued till the
patient is declared “inactive". Once inactivity is achieved, treatment should
be continued for 1 year before the patient is release from control (RFC).
Surveillance is not required, but the patient should be advised to report to
the clinic if symptoms recur or lesions develop.
The vast majority of patients will become clinicaily inactive within 3
years and no purpose is served in treating these patients beyond 3 years.
If inactivity is not achieved within this period, these patients should be
carefully reassessed by medical officer to ensure that the diagnosis and
classification are correct.This refractory response is presumptive evidence
of primary resistance and these patients may need combined chemother
apy. They shoud be referred to the consultant leprologist.
13
' 11.2.2 Multidrug Treatment of Paucibacillary Patients
Paucibacillary multidrug regimen is required for Indeterminate, TT and
BT cases as well as for pure neuritic patients, provided they are smear
negative.
Regimen :
Adults : Rifampicin is given once a month in a dose 600 mg under
supervision and dapsone 100 mg daily, self-administered For adults below
35 Kg in weight the dose of rifampicin should be 450 mg once monthly and
dapsone 50 mg daily.
Children : The dose should be proportionately reduced as shown in
table - 3.
TABLE-3
Dose for Children with Paucibacillary Leprosy
Drugs
O-5 years
6-14 years
Dapsone daily
Rifampicin monthly
25 mgm
300 mgm
50 mgm
450 mgm
Duration of Treatment: Treatment should be continued till 6 of the
monthly doses have been administered. If the treatment is interrupted for
some reasons, the regimen should be recommended from where it was left
off to complete the full course, provided that 6 monthly doses are given
within a period of 9 months. Clinical and bacteriological assessment must
be under-taken by a medical officer or a non-medical supervisor. Treatment
can then be terminated if:
- there is no extension of existing lesions or appearance of new
lesions; and
- there is no new nerve involvement or paresis/paralysis.
Before discharge, the patient should be informed that the reduction or
disappearance of the lesions would occur gradually and that, if at any time,
new lesions appear, he must report for advice immediately; also, that it was
not necessary to seek treatment elsewhere.
It takes nearly 6 months for clinical inactivity to be achieved with
chemotherapy. The purpose of the short term course is to render the patient
free from viable bacilli and to initiate regression of the disease. Resolution
of skin and nerve lesions takes place gradually, brought about by the high
cell-mediated immunity. It should also be remembered that some lesions
are only partially reversible or even irreversible and may, therefore, persist.
Rarely, lesions of a trophic or degenerative nature may occur much later
and should be ignored.
14
,
Occassionally on completion of adequate treatment (6 supervised
doses of rifampicin), the lesion may not show regression This is liable to
occur especially in patients who are smear negative and have multiple
lesions, widely disseminated symmetrically or bilaterally. The diagnosis
then, should be carefully reviewed by the medical officer after detailed
clinical and bacteriological examination for any error in classification. If the
classification was correct, the treatment should be continued with rifampicin
and dapsone in the same doses for a further period of 6 months. If the
disease was wrongly classified, the treatment should be changed to that
recommended for multibacillary disease.
11.2.3 Regularity of Treatment
For paucibacillary patients, adequate treatment implies intake of 6
doses of combined therapy at monthly interval within a period of 9 months.
Such patients when taken off the drugs will be said to have 'completed
treatment'.
Type of patients: The proposed regimen is designed for the treatment
of all categories of paucibacillary patients including :
- newly diagnosed and previously untreated patients;
primary dapsone resistant patients; and
dapsone treated paucibacillary patients who relapse.
ASSESSMENT AND SURVEILLANCE
At periodic monthly contacts for supervised administration of drugs,
the MO/NMS should
- elicit information regarding any side effect of drugs:
- monitor occurrence of adverse reactions; and
- take appropriate action such as,referral if required
12.
Periodic clinical and bacteriological examination of the patients are
required during and after treatment.
Clinical: Clinical assessment should be undertaken by a MO/NMS, at
the end of the month following the administration of the sixth supervised
dose of rifampicin in paucibacillary patients to decide on termination of
treatment. For multibacillary patients, clinical review should be carried out
annually for a minimum period of 2 years or until smear negativity is
attained, whichever is later Patients who do not show the anticipated
favourable response after 3 years of treatment should be referred to the
consultant leprologist for comprehensive review
Bacteriological : Skin smear examination is necessary before the
commencement of MDT in multibacillary patients. Thereafter, it should be
under-taken annually until the smear becomes negative. After the treat-
15
ment is discontinued, smear examinations should be repeated every year
for 5 years during the surveillance period.
In paucibacillary patients, smear examination should be undertaken
prior to the commencement of MDT and at the end of the prescribed course
of treatment, before discharge only if the work load permits.
13.
CASE HOLDING
Regularity of Treatment : The success of multidrug therapy pro
gramme depends no less on operational efficiency as on technical factors.
Any interruption in the regular system of treatment, whether supervised or
self-administered, will increase the risk of failure. It calls for the highest
degree of patience, tact and tolerance in those responsible for seeing that
the treatment is carried out. It means winning the confidence of the patient
and his family. As long as the organizers of treatment services do not
shoulder the responsibility of promoting regular drug intake, even the best
of drug regimens will fail to induce therapeutic and epidemiological sue cess they are capable of.
Regularity of attendance should be promoted by :
pre-clinic motivation drives; and
intensive health education, explaining to the patients, particularly,
the development of deformities following incomplete or irregular
treatment.
Scrupulous attention must be paid to the recording of clinic atten
dance. The treatment card should be carefully maintained. The dates when
the patient has to attend should be recorded in advance on the treatment
card or registered in accordance with the individual attendance schedule.
Monitoring drug intake: Irregularity in taking self-administered clofaz
imine and dapsone is more difficult to detect and may take several weeks
before it becomes known. Regularity of drug intake should be promoted by:
- emphasising its importance on the patient at the very first visit
and reinforcing this information at periodic intervals;
- dispensing the tablets and capsules in air tight plastic containers
which makes counting much easier besides protecting the drug;
- intensive health education to the patient and his family members
to generate family pressures, promoting regularity in drug in
take; and
- spot testing of urine for detection of DDS.
It cannot be overstated that continuity, regularity and completion of
chemotherapy are keys to the success of disease control.
■ 16
DEFAULTER RETRIEVAL ACTION
Absentee follow up action may be by direct contact or indirectly
through messages sent by post or delivered through friends and relatives.
Needless to say that direct action, though more expensive and time
consuming, is liable to be more effective.
It is easy to identify the causes of default than to remedy them.
Treatment default has many of its roots outside the health system. They
may be for loss of working time or other competing activities of daily life or
social and cultural traditions. Many health professionals believe that health
education is required to ensure patient compliance. Experience, however,
does not support this view. Successive evaluations of NLEP have revealed
that many a patient give no reason to explain absenteeism. Some are
reluctant to accept the diagnosis in the absence of deformities. It is, how
ever, that with the extension of MDT to larger areas, the beneficial effects
of the treatment have built community faith regarding the cure of their
disease. This has resulted both in increased self-reporting of patients and
in greater regularity of treatment.
14.
15.
CRITERIA FOR DISCHARGE
Multibacillary Leprosy : A multibacillary patient who is clinically inac
tive and bacteriologically negative at the commencement of MDT, should
continue treatment for 2 years (24, monthly supervised doses within 36
months). Thereafter, the treatment should be discontinued provided the
patient continued to remain clinically inactive and bacteriologically negative
at the end of this period.
Multibacillary, smear positive patients should be treated until they
become clinically inactive and bacteriologically negative, or administration
of 24 supervisory pulses maximum in 36 months, whichever is later. If after
the treatment for more than 36 months, the Bl remains the same, or
increases, the patient should be assessed again clinically and bacteriologi
cally for deciding the course of treatment.
Paucibacillary Leprosy: These patients should continue treatment till
6 supervised monthly doses have been administered. If the treatment was
interrupted, the regimen should be recommenced where it was left off to
complete 6 doses within 9 months. If the lesions show extension or new
lesions appears at the end of the prescribed course of treatment, the same
schedule must be continued for a further period of 6 months to complete 1
year, provided the classification is reviewed and found correct. Patients
refractory after 1 year of treatment should be referred to the consultant
leprologist for evaluation and advice.
Surveillance : Case released from treatment after MDT shall be on
surveillance as follows :
- MB cases for 5 years with yearly clinical and bacteriological
assessment;
- PB cases for 2 years with yearly clinical assessment.
RELAPSE
A patient released from treatment after completing and adequate
course of multi-drug therapy, monotherapy but who subseqently develops
new signs and symptoms of the disease either during the period of
surveillance or thereafter, is considered to have'relapsed’.
In paucibacillary patients, it is very often difficult to distinguish be
tween relapse and type I reactions. Nevertheless, it is essential that the
distinction is made correctly so that appropriate treatment can be given.
The differences between the two are summarized in table-4.
16.
TABLE-4
Differences between TYPE I Reaction and Relapse
Relapse
Type 1 Reactions
Time interval
Generally occurs during
chemotherapy or within
6 months ol stopping
treatment
Onset
Old lesions
Abrupt and sudden
Existing lesions become
erythematous and consi
derably swollen and
edematousSeveral new lesions appear.
Lesions usually ulcerate
Multiple nerve involvement
common, painful and tender.
New lesions
Ulceration
Nerve involvement
Fever, joint pains, malaise
General condition
Response to treatment Rapid may occur
Occurs only when chemo
therapy has been
discontinued alter
an interval of al
least 6 months.
Slow & insidious
Only the margin of the
lesion may show
erythema and infiltration.
New lesions are minimal.
Ulceration does not occur.
Nerve involvement may
occur only in a single nerve.
no pain or tenderness.
Not affected
Slow
16.1 Precautions and Side-effects of Drugs
16.1.1 Dapsone
The Contra indications for the induction of dapsone therapy are :
- the presence of anaemia, a haemoglobin value of less than 8.0
g%;
- debilitating illnesses;
- evidence of renal or hepatic damage;
- hypersensitivity to dapsone.
18
There is no other contra indication to the use of dapsone. In patients
with anaemia, it should be corrected with haematinics before commencing
treatment.
Side-effects
1. Anaemia : The drug is known to cause haemolysis in the early part of
treatment. This is generally self-limiting. Rarely, however, acute haemoly
sis may be precipitated by dapsone.
2.
Hepatitis : Genuine cases of dapsone hepatitis have been documented.
Detection of hepatitis during dapsorie therapy calls for
its cessation.
Specific treatment
can be restored once
the icterus has
cleared.
3.
4.
5.
Allergic dermatitis.
Hypermelanosis or fixed drug eruption.
Psychosis : It is reversible once the drug is withdrawn.
16.1.2. Rifampicin
It is available in the form of capsules. The drug should be given on
empty stomach to exert its therapeutic effect. The drug should not be given
if the patient has hepatic or renal dysfunction.
Side-effects
a. Flushing or pruritis with or without rash often on the face and
scalp. There may be redness and watering of the eyes.
b. Abdominal pain and nausea sometimes accompanied by vomit
ing and diarrhea.
c. Fever, chills, malaise, headache and bone and joint pains.
d. Rarely shortness of breath may occur.
e. Purpura, acute hemolytic anaemia, shock and renal failure are
also rare.
f. Elevated serum transaminase levels with risk of hepatitis.
The first few symptoms occur within 2-3 hours of the first dose.
Flushing and pruritis may occurduring the first month, nausea and vomiting
during the first 6 months and breathlessness between the 3rd and the 6th
months of the treatment.
Half the patients with adverse reactions require no modification of the
regimen since the symptoms are mild and self-limiting. Symptomatic
treatment should be given where the reactions trouble the patients and
persist. In patients with respiratory syndrome, caution is necessary and
19
such patient may require hospitalization. If shock is followed by renal failure,
rifampicin should not be given again. This is true of haemolytic anaemia as
well. Likewise, if purpura occurs, the drug should be stopped. Whenever the
reaction persists and bother the patient, the dose should be reduced to 450
mg. If no improvement occurs, rifampicin may be discontinued.
It should be remembered that the effectiveness of steroid is reduced
if given to a patient receiving daily rifampicin. Similarly, the effectiveness of
oral contraceptives is impaired.
16.1.3. Clofazimine
Clofazimine is well tolerated and virtually non-toxic in the doses used.
The following side-effects are described :
a. Skin : Reversible dose related reddish to brown black discolouration, especially on the exposed parts of the body, Discolouration of sweat,
tears, hair, sputum, urine and faeces may occur during the administration
of the drug. General dryness of the skin (xeroderma), ichthyosis and pruritis
can be troublesome side-effects. Photo-toxicity, acneform eruptions and
non-specific skin rashes have also been reported.
b. Gastro-intestinal: Symptoms reported include nausea, vomiting,
abdominal pain, intermittent loose stools, diarrhoea anorexia and weight
loss. There are two separate entities :
i) An early syndrome commencing within a few days of the
treatment, possibly related to the direct irritating effect of the
drug. The symptoms subside when the dose is reduced.
ii) A late syndrome observed after some months of high dose
therapy with persistent dianhoealoss of weight and abdominal
pain. The syndrome is associated with deposition of clofazimine
crystals in the tissues, usually in the sub-mucosae of the small
intestine and the mesenteric lymph nodes.
iii) Eyes : But for conjunctival pigmentation that does not affect
acuity of vision, no other ocular side effects have been reported.
REPORTS
The progress of the activities under the programme is reported
monthly, quarterly and annually.
The year starts on 1st of April and ends by 31st March. Accordingly the
quarterly and monthly reports are also to be submitted. Completeness,
accuracy and regularity in the submission of reports are important. The
monthly and annual reporting forms are given in Annexure I and Annexure
11. For quarterly report, replace the annual in the Annexure II with the quarter
18.
20
;
>,
i
ending June, September, December and March as applicable. Monthly
reports should be submitted by Leprosy Control Unit and other existing setup
under NLEP to the District Leprosy Unit/Zonal Leprosy Office by the 10th of
succeeding month. The DLO/ZLO will compile the report for the district and
send it to the state by the 20th-of the succeeding month. In the districts
where DLO/ZLO are not available, the State Leprosy Officer would give
suitable instructions as to who shall compile report from those districts. The
State/Union Territory Leprosy Officer (SLO) would send a compiled report
for the month to the Leprosy Division, Directorate General of Health
Services, Nirman Bhavan, New Delhi by the 28th of the succeeding month.
The quarterly reports also may be timed as above. The annual report for the
year from 1st April of the preceding year to 31st March of the current year
should be compiled by the LCUs/SETs etc. functioning under NLEP in the
districts to the DLO/ZLO by the 20th of April of the current year. The DLO/
ZLO would compile the report from the different components and submit it
to the SLO by 30th April. The SLO would send the consolidated annual
reports for the year to the Leprosy Division of the Directorate General of
Health Services so as to reach on or before 10th May of the year.
21
ANNEXUREI
NATIONAL LEPROSY ERADICATION PROGRAMME
MONTHLY REPORTING FORM
*
Name of the state
Period under report since beginning of
1st April of new financial year.
3. Total no of districts
i)
Districts under regular MDT
ii) Districts under regular MMDT
iii) Districts under low endemic MDT
iv) Districts under Monotherapy
v) Total districts
MB
**
4. No. of cases on record at the beginning
of the year i.e. 1st April.
5. No. of cases under treatment on 1 st April
i)
Under MDT
ii) Under monotherapy
Iii) Total Patients under treatment
by all means
6. No. of new cases detected between 1st
April and period under report
7. No. of new cases brought under treat
ment between 1st April and period under
report
a. New patients under MDT
b. New patients under monotherapy
c. Total
8.
No. of cases deleted from records (dis
charge by all means including release
from treatment)
9.
No. of child cases below 14 years among
new cases detected between 1st April
and period under report
10. No. of new cases with deformity (grade II
and more) among cases detected in
the current year
11. Balance No. of active cases on record on 31.3.92
12. Balance No. of leprosy cases remained under
antneprotic treatment as on 31.3.92
- Monotherapy
- MDT
1.
2.
•
Form for use at state level
*'
•*• PB - Stands for Paucibacillary
22
PB
***
MB - Stands for Multibacillary
Total
X
ANNEXURE II
ANNUAL REPORTING FORM
NATIONAL LEPROSY ERADICATION PROGRAMME
State/UT
Year :_______________________________________________________
PART-A
Urban Rural
Total
1.
Estimated total population for the year
2.
Population covered under NLEP during
the year.
3.
Population examined during the year.
MB
PB
Total
4.
Number of new cases detected during
the year.
i. By surveys
ii. By other methods
5.
Number of child cases (0-14 yrs) newly
registered during the year.
6.
Total number of patients registered at
the end of previous year.
7.
Total number of registered in-patients
at the end of the reporting year.
9.
Bacteriological status of total registered
patients at the end of the reporting year.
9.1. Number of patients bacteriologically
positive.
9.2. Number of patients bacteriologically
negative.
9.3. Number of patients with bacteriological
status unknown.
10.
Treatment administered to the cases
registered during the year.
10.1. Number ol patients who received dap
sone monotherapy
10.2. Number of patients who received mul
tidrug therapy.
11. Number of patients under surveillance
after completion of treatment.
12. Number of patients registered relapses
during the year.
13. Regularity of treatment
MT
13.1. Number of patientstaking regular treat
ment (more than 9 months) in a year.
13.2. Number of patients not taking regular
treatment (less than 9 months).
13.3. Number of unknown.
14. Number of patients released from treat
ment.
MB
MDT
Total
PB
Total
Number of patient referred for surgical
procedures like
15.1. Reconstruction surgery.
15.2. Eye complications.
15.3. Amputation.
16. Number of cases provided with
Foot wear.
Artificial limbs.
Crutches.
15.
PART-B (LOGISTICS)
Infrastructure
No. at the
beginning of
year
Current Year
Target
Achievement
1.
Establishment
a.
b.
c.
d.
e.
f.
g.
h.
I.
2.
L.C.U.
U.L.C.
S.E.T. Centres
T.H. Ws/No. of Beds.
Rec. Surg. Unit.
LR.P.Us.
Other (Specify)
No. of Leprosy beds.
No. of Voluntary Orgns. working in leprosy.Vehicles Positions
Total Number
No.
3.
working
condition
Staff Position
Category
24
in
No. at
the end
of the
year
No. sanctioned
No. in
position
No. Trained
1. S.L.O.
2
Z.L.O./D.L.Os.
3. M.Os.
4. N.M.S.
5. Health Educators
6. Physiotherapists
7. Statistical Asstt.
8. PMW/NMA/LI, etc.
9. Lab. Technician.
10. Dispensers.
11. Clerical Staff.
12. Drivers.
13. Group D.
14. Others
4. Stock Position of Drugs :
Drugs
Quantity at
the beginning
of the year
100 mgm
50 mgm
Rifampicin
300 mgm
150 mgm
Clofazimine 100 mgm
50 mgm
5. Microscope facilities
No. of Microscopes
6. Building position.
Quantity
consumed
during the
year
Quantity
required
for next
year
Dapsone
No. in working condition
Building constructed/acquired
Specify
Signature of the Reporting Officer
Name
Date :
Designation
Place :
Postal Address
25
■I
•"jAf‘
• A?' u
■ (’ „•
A' !'
■:
NATIONAL LEPROSY ERADICATION
PROGRAMME
STATUS REPORT
1992
LEPROSY DIVISION
DIRECTOR GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH & FAMILY. WELFARE
NIRMAN BHAWAN, NEW DELHI - 11001 T.
FOREWORD
The Indian Programme for leprosy control is the largest of its kind in
the world. It is time-bound and target oriented, aiming at disease elimination
by the end of the century.
Leprosy continues to engage urgent attention of health planners in
this country. There is need for making available comprehensive data on the
National Leprosy Eradication Programme for all those interested in leprosy
control. This status report traces the evolution of organised leprosy control
in India, the factors behind the disease which constrain an effective
programme; the programme (NLCP/NLEP) itsgrowth, performance, imbal
ances and measures to strengthen the same. An attempt has been made
to provide an understanding of the problems and perspectives of leprosy
control work in India.
We are grateful to World Health Organisation for providing the serv
ices of Dr. Sharad Kumar for assistance in preparing this document.
(Dr. A.K. Mukherjee)
ABBREVIATION
NLEP
VO
MB
DB
MDT
MT
MMDT
RFT
MO
NMS
PMW
Lab. T
DLO
ZLO
SLO
LOU
SET
ULC
UT
ZLO
CHC
PHO
HE
PT
AM
AF
CM
CF
IEC
DDP
MCR
RFC
CMO
POL
OTC
HA
NGO
GOI
Ut
Dt or
Distt.
Q & A
National Leprosy Eradication Programme
Voluntary Organisation
Multibacillary
Paucibacillary
Multidrug Therapy
Mono Therapy
Modified Multidrug Therapy
Release From Treatment
Medical Officer
Non Medical Supervisor
Para Medical Worker
Laboratory Technician
District Leprosy Officer
Zonal Leprosy Olficer
State Leprosy Officer
Leprosy Control Unit
Survey, Education and Treatment Centre
Urban Leprosy Centre
Union Territory
Zonal Leprosy Officer
Community Health Centre
Primary Health Centre
Health Educator
Physiotherapist
Adult Male
Adult Female
Child Male
Child Female
Information, Education & Communication
Drug Delivery Point
Micro Cellular Rubber
Release From Control
Chief Medical Officer
Petrol, Oil & Lubricants
Orientation Training Camp
Health Assistant
Non Government Organisation
Government of India
Unit
District
Question & Answers
CONTENTS
SNo.
TOPIC
PAGE NO
1
INTRODUCTION ........................... .......................................................... 1
2
CASE LOAD.............................................................................................. 1
3
INTER STATE VARIATION ................................................................... 4
4
LEPROSY CONTROL BEFORE 1955 .............................................. 12
5
NATIONAL LEPROSY CONTROUERADICATION
PROGRAMME ....................................................................................... 13
i
Objectives ............................................... .................................. 13
ii Strategy........................................................................................ 15
iii Organisational Structure............................................................ 16
iv Infrastructure ............................................................................... 21
v
Population Coverage ................................................................ 26
vi Case Detection and treatment ................................................ 27
vii Progress of Multidrug Therapy................................................ 30
6
TRAINING OF PERSONAL ................................................................ 41
7
VACANCY OF POSTS.......................................................................... 43
8
PERFORMANCE ...................................................................................
i Disease Detection and Treatment .........................................
ii Programme Monitoring..............................................................
iii Management ..............................................................................
9
EXPENDITURE ...................................................................................... 46
10
HEALTH EDUCATION ......................................................................... 47
11
REHABILITATION ................................................................................ 49
12
VOLUNTARY & INTERNATIONAL AGENCIES
tN'.ANTI-LEPROSY WORK................................................................... 49
13
TENTATIVE PLAN FOR LEPROSY ELIMINATION
IN THE COUNTRY................................................................................. 51
43
43
45
46
APPENDIX............................................................................................... 56
INTRODUCTION
Leprosy is a disease of great antiquity; its origin and early spread is
largely a matter of surmise. Possibly it originated in Africa and spread very
early to India and from there to China There is no doubt that in Africa, India
and China, the disease has been prevalent for many centuries. There are
Biblical references to leprosy. Reference to leprosy is found in the ancient
medical writings of India. The most ancient are those of Charaka, Sushruta
and Vaghbata.
Leprosy is unique in many respects. It has.the maximum social stigma
attached to it. A common belief is that leprosy is due to sins committed.
There is also a belief that leprosy is hereditary and incurable. There are
many misconceptions about this disease. These combined with the high
deformity and very low mortality rates in leprosy patients have led to the
development of social aversion and ostracism against leprosy patients.
It is now accepted that leprosy is completely curable at any stage, that
it is only an infection, that it is least communicable and the deformities that
arise in leprosy patients can be completely prevented by early detection and
treatment.
Until a few decades ago, the disease was one of neglect; the affected
were interned in leprasoriums mainly managed by charitable trusts and vol
untary organisations. The establishment of the Indian council of the British
Empire Leprosy Relief Association in 1925 (Renamed as Hind Kusht
Nivaran Sangh in 1947), laid the foundation of organised leprosy work in
India. A committee appointed by Government of India in 1941 reviewed the
extent of leprosy problem in the country and made specific recommenda
tions for initiating anti-leprosy measures. This was followed by another
expert committee in 1954 that gave rise to concrete plans for leprosy control
in India including legislations.
The middle of the present century witnessed a breakthrough in the
knowledge regarding the causation, spread and treatment of leprosy.
Organised efforts, supported by national government, were launched in
India to cure the affected and contain its further spread and impart
education to the people on the disease. The present book-let traces the
development of this anti-leprosy work, leading to national leprosy eradica
tion programme (NLEP) announced in 1983, with the avowed goal of its
eradication by the year 2000 AD.
1.
z
2.
CASE LOAD
Leprosy survey was included for the first time in India as a part of
British Imperial Census in the year 1871-72. Later, it was extended in the
country in 1890-91. The prevalence rate of leprosy in India during the period
prior to 1950 was essentially obtained as a part of decennial population
census. According to the subsequent census in 1931, about 136 thousand
cases were there, giving a prevalence rate of 0.49 per 1000 population'.
This was, however, a gross underestimate because of several rea
sons, namely :
- it included cases with severe forms of the disease only;
- all cases might not have been reported because of social stigma
attached to the disease;
- latent cases and those with minor symptoms were not recog
nized; and
- errors in coverage of population.
Similar estimates based on successive censuses may be seen in
Table -1.
Asa result of the surveys carried out in different parts of the country
during nineteen twenties and thirties and by multiplying the detected
number of cases by a certain factor, it was estimated that the number of
cases in the country would be 10 lakhs. Since the anti-leprosy work in the
country intensified in the post independence years after 1948, and particu
larly after the initiation of the national leprosy control programme in 1955 by
Government of India, the number of cases of leprosy rose from 10 lakhs to
20 lakhs to 25 lakhs and in 1981 it stood at 39 lakhs.
The progressive increase in the estimated number of cases may give
rise to the erroneous idea that leprosy was on an increase
TABLE-1
Prevalence of Leprosy in India
s.
Year
Population
(millions)
Estimated number
of leprosy
patients ('000)
Prevalence rate
(per 1000 popu
lation)
1871
1881
1891
1901
1911
1921
1931
1951
1961
1971
1981
1991
198.291
216.679
274.334
294.361
315.156
318.942
324.753
360.958
439.118
574.958
685.185
847.421
108.81
128.09
126.24
97.36
109.09
102.51
159.80
1374.01
2561.60
3200.90
3919.337
2764.00
0.55
0.59
0.46
0.33
0.35
0.32
0.49
3.81
5.83
5.84
5.72
3.26
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
1.1.
12.
Source : For data prior to 1971 Mohammed Ali, P (1963) Factsand Figures about Leprosy
in India.
1. Government ol India, Ministry o! Health (1955) Report ol Committee for Control of
Leprosy, Govt, of India Press Calcutta.
WHO 9/075
Figure 1 : Prevalence of Registered Leprosy Cases. June 1990
3
in uie country. This was, however, not so. In some areas where systematic
surveys were carried out on a long term basis, there was no evidence of any
increase in the disease. Apart from increase in population, the other reason
for rise in the number of estimated cases was intensification of case finding
programme. Increased voluntary reporting consequent upon the availa
bility of potent drugs also served to increase the known number of cases.
On the other hand, it would appear that the estimated figures were on
the higher side because they represented the cumulated number of cases
at a point of time, ignoring the patients in whom the disease was 'arrested'
or 'cured'. Moreover, the surveys were usually carried out in endemic areas
with high prevalence rates and this prevalence was interpolated to the
whole country. It is well-known that the prevalence rate of leorosy varies
from state to state and from district to district and even in different pockets
of the same district.
The trend of increase in the estimated leprosy cases through succes
sive decades got arrested after 1983, when the MDT programme was
introduced. It affected a profound change in the leprosy epidemiology and
control. Intensified casefinding'and establishment of reliable information
was stipulated as an essential pre-requisite before starting multi-drug
therapy (MDT) in a district. Further, it resulted in discharging from existing
■registers, patients no longer in need of treatment. Both, due to intensified
detection activities and the curative appeal of MDT, it was generally
observed that the number of 'new case' detected increased phenomenally
during the first three years before leveling off or even starting a slow decline.
This upsurge comprised.
- new cases representing recent transmission, (1-3 yrs);
- cases resulting from infection acquired a long time ago (10-30
yrs); and
- the backlog of cases that had failed to report during the earlier
years.
The pattern of new case detection rates during the first three years of
MDT strongly suggested that most of the backlog of earlier undetected
cases would now be on record. Cases registered for MDT approximated to
the true load of leprosy cases needing treatment.
The estimated case load for the country in June 1990 was around
27,64,000 giving a prevalence rate of 3.26 per 1000 population against the
registered cases numbering 23,70,687. Present estimales indicated that 15
to 20 per cent of the leprosy cases were in children below 14 years, 6 to 12
percent suffered from deformities and about one-fifth of the cases were
infectious.
Inter-State Variations
Variations in the prevalence of leprosy in the different states of India
4
are shown in the map at figure 1. It would be seen from the map that
although the disease was found throughout the country, it was not equally
distributed in the sub-continent. There was a wide variation in the preva
lence, even in low endemicity areas there existed pockets of high preval
ance. However, a definite pattern could be established demarcating high
(prevalence rate of more than 5), moderate (2 to 5) and low (<2) endemicity
areas.
The high endemicity areas were found mainly in the south eastern and
central parts of the country. These included the states of Tamil Nadu,
Andhra Pradesh, Orissa, Bihar, Madhya Pradesh, Uttar Pradesh, Mahar
ashtra and West Bengal as reviewed in June 1990. These 8 states
accounted for approximately 90 percent of the total registered case load
jand an equal percentage of population at risk in the country (Table 2).
TABLE- 2
States of High Prevalence
State/ur
Population
Cases on record
Prevalence
1990
June 1990 .
rate per 1000
64311
83946
65096
78773
31669
58138
138410
65548
283866
465553
203250
181459
182487
378444
367234
287296
4.41
5.55
3.12
2.30
5.76
6.51
2.C5
4 39
Andhra Pradesh
Bihar
Madhya Pradesh
Maharashtra
Orissa
Tamil Nadu
Uttar Pradesh
West Bengal
The Prevalence rates mentioned above were average figures for the
entire state. The geographical distribution as well as population at risk of
leprosy differed substantially, not only from state to state but also at district
and village levels. The latest data as compiled :n March 1991 provided
complete information on all the states (Table - 3).
TABLE- 3
Prevalence of Registered Leprosy Cases
by State - March 1991
S. Sla.j/UT
No.
1. Andhra Pradesh
2. Arunachal Pradesh
3. Assam
4. Bihar
5. Goa
6. Gujarat
Population
1991 (lakhs)
Cases on record
March 1991
Prevalence
rate per
1000
663.00
8.58
222.94
863.38
11.68
411.74
203521
1305
18215
451357
1228
22316
3.07(11.8)
1.52(3.6)
0.81(1.5)
5.22(5.4)
1.05(5.0)
0.54(2.9)
7. Haryana
8. Himachal Pradesh
9. Jammu & Kashmir
10. Karnataka
11. Kerala
12. Madhya Pradesh
13. Maharashtra
14. Manipur
15. Meghalaya
16. Mizoram
17. Nagaland
18. Orissa
19. Punjab
20. Rajasthan
21. Sikkim
22. Tamil Nadu
23. Tripura
24. Uttar Pradesh
25. West Bengal
26. Andaman & Nicobar
27. Chandigarh
28. Dadar & Nagar Haveli
29. Daman & Diu
30. Delhi
31. Lakshadweep
32. Pondicherry
TOTAL
163.17
51.11
77.18
448.17
290.11
661.35
787.16
18.26
17.61
6.86
12.15
315.12
201.90
438.89
4.03
556.38
27.44
1387.60
679.82
2.77
6.40
1.38
1.01
93.70
0.51
7.89
680
3956
3720
72071
53932
279286
147866
1369
1552
363
2026
153267
550
19911
109
176027
2193
356285
203852
1280
2049
280
252
1363
151
1962
0.04(0.08)
0.77(1.6)
1.22(2.2)
1.60(6.0)
1.85 (5.8)
4.22(2.3)
1.96(6.2)
0.74(4.5)
1.20(4.6)
0.52(1.0)
1.66(3.9)
4.86(12.1)
0.02(0.1)
0.45(1.6)
0.27(7.8)
3.16(12.9)
0.80(4.9)
2.56(3.7)
3.00(6.9)
4.60(4.9)
4.54(4.7)
2.02(1.0)
2.49(3.8)
0.14(0.4)
2.92(25.0)
2.48(15.0)
8439.30
2184299
2.5
-j)
NB : Figures in parenthesis give the estimated prevalence rate)
Of the 455 districts in the country, 201 were high endemic for leprosy
with a prevalence of 5 or more per 1000 population. Another 77 districts had
prevalence varying between 2 and 5 while the remaining 177 districts had
prevalence below 2/1000. These districts were distributed among the 32
states and union territories of the country. The stratification of leprosy
according to the districts may be seen in Table - 4. Nearly 450 million .
population lived in endemic areas. Districts with high and moderate preva*'
lence of leprosy are shown state-wise in Table - 5 and Table - 6.
TABLE-4
Stratification of Districts According to Prevalence Rate
No. ol Districts
Cases ('000)
Less than 2/1000
Between 2 - 4.9/1000
5 or 5-1/1000
177
77
201
150
400
1500
TOTAL
455
2050
S. No. Prevalence Rate
1.
2.
3.
6
TABLE -5
List of High Endemic Districts with Prevalence
Rate 5 to 5+/1000
s.
No
Under modified
MDT setup
Under vertical
MDT setup
Name of State/
UT
4
3
1
2
1.
Andhra
Pradesh
1. Ananthapur
2. Guntur
3. Rangareddy
4. Mohbubnagar
5. Niziamabad
6. Khammam
7. Sirkakulum
8. Vizianagram
9. Visakhapatnam
10. Chittor
11. East Godavari
12. Krishna
13. Warangal
14. Nalgonda
15. Cuddapah
16. West Godavari
17. Karim Nagar
18. Medak
19. Nellore
20. Kurnool
21. Prakasam
22. Adilabad
23. Hyderabad
2.
3
Assam
Bihar
1.
1.
2.
3.
4.
Karbi Anglong
Deogarh
Singhbhum
Bhagalpur
Rohtas
1.
2.
3.
4,
5.
6.
7.
8.
9.
10.
11.
12.
13.
Gaya
Hazaribagh
Girith
Ranchi
Dhanbad
Siwan
Patna
Aurangabad
Nawadah
Bhojpur
Purunia
Katihar
Muzaffarpur
7
1
3
2
4
14.
15.
16.
17.
4.
Gujarat
5. Karnataka
6.
Kerala
7.
Madhya Pradesh
8.
Manipur
9.
Maharashtra
8
1.
2.
3.
4.
5.
6.
Dangs
Panchmahal
Surat
Bharuch
Baroda
Vai sad
1.
2.
3.
4.
5.
6.
7.
8.
Belgaum
Dharwad
Bidar
Gulbarga
Raichur
Bijapur
Bellary
Mysore
1. Alleppey
2. Trichur
3. Trivandrum
4. Quilon
5. Palghat
1. Durg
2. Rajnandgaon
3. Bilaspur
4. Bastar
5. Raipur
6. Bhind
7. Gwalior
8. Rewa
9. Ujjain
10. Raigarh
11. Sagar
1.
2.
3.
4.
5.
6.
7.
8.
9.
Wardha
Amaravati
Chandrapur
Nanded
Osmanabad
Yuvatmal
Latur
Gadchirori
Bhandara
Sitamarhi
Darbhanga
West Champaran
Santhal Pargana
—
1.
2.
3.
4.
5.
1.
2.
3.
4.
5.
6.
7.
8.
9.
to.
11.
1.
2.
Kasargode
Ernakulam
Cannannore
Mallapuram
Kozikode
Bhopal
Indore
Khadwa
Satna
Datia
Tikamgarh
Chhattarpur
Jabalpur
Bolaghat
Shahdol
Surguja
Tamemglung
Chandel
■4
1
10. Nagaland
11. Orissa
12. Sikkim
13. Tamil Nadu
4
3
2
10. Nagpur
11. Thane
12. Sholapur
13. Satara
14. Parbhani
15. Raigad
16. Akola
17. Buldhana
18. Beed
19. Bombay
1. Mon
1
1. Ganjam
2.
2. Puri
3. Cuttack
4. Dhenkanal
5. Mayurbhani
6. Balasore
7. Sambalpur
8. Balangir
9. Koraput
10. Phulbani
11. Sundergarh
1. East District
2. South District
1. North Arcot
2. Anna Chengi
3. Salem
4. Pasumpon PTT
(PMR Shivranga)
5. Kamarajar
6. Ramanathpuram
7. Dharmapuri
8. Thanjavur
9. Periyar
10. Anna Duidigul
11. Madurai
12. South Arcot
13. Puddukkotai
14. Tiruchirapalli
15. Neilai
Konabomman
16. VO Chidambaranar
17. Coimbotore
18. Nilgiris
19.
20.
Kanyakumari
Madras
Kalahandi
Keonjhar
1
14. Uttar Pradesh
15. West Bengal
16. Andaman &
Nicobar
17. Lakshadweep
18. Pondicherry
4
3
2
1. Varanasi
2. Barabanki
3. Dehradun
4. Faizabad
5. Sitapur
6. Kheri
7. Kanpur(urban)
8. Kanpur Dehat
9. Utlarkashi
10. Pilibhit
11. Baharaich
12. Deoria
13. Hardoi
14. Raebarely
15. Azamarh
16. Ballia
17. Ghazipur
18. Mirzapur
1. Purulia
2. Bankura
3. Bardhaman
4. Midanapur
5. Birbhum
1.
1.
1.
2.
3.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Gorakhpur
Lucknow
Unnao
Rampur
Badaun
Shahjahanpur
Etawah
Fatehpur
Banda
Hamirpur
Jalaun
Basti
Gonda
Bareilly
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Cooch Bihar
Howrah
Hooghly
Jalpaiguri
Maida
24 Parganas (S)
Nadia
24 Parganas (N)
West Dinajpur
Murshidabad
Andaman ■
Lakshadweep
Pondicherry
Karaikal
Yanam
TABLE-6
Moderately Endemic 77 Districts (PR - 2 - 5/'000)
S.No. District
1. Gaya
2. Hazaribagh
3. Giridih
4. Ranchi
5. Monghyr
6. Begusarai
State
Bihar
Bihar
Bihar
Bihar
Bihar
Bihar
1981 (Lakhs)
Estd. PR/
1000 (81)
21.38
21.95
17.30
30.59
33.14
14.56
4.8
4.5
4.4
3.1
3.6
4.7
Population
*
■-
v
r.
7. East
Champaran
8. Madhubani
9. Samastipur
10. Nalanda
11. Palamu
12. Saharsa
13. Saran
14. Gopalganj
15. Daman
16. Bangalore(U)
17. Kolar
18. Mandya
19. D. Kannada
20. Pathanamthita
21. Kottayam
22. Idukki
23. Wynad
24. Hoshangabad
25. Ratlam
26. Dhar
27. Jhabua
28. Barwani
29. Guna
30. Damoh
31. Chhindwara
32. Mandla
33. Sidhi
34. Betul
35. Rajgarh
36. Dewas
37. Shajapur
38. Shivpuri
39. Morena
40. Seoni
41. Panna
42. Narsingpur
43. Jalna
44. J’algaon
45. Kohlapur
46. Sangli
47. Ratnagiri
48. Dhule
49. Ahmad Nagar
50. Pune
51. Aurangabad
52. Farrukhabad
53. Jhansi
54. Pratapgarh
Bihar
Bihar
Bihar
Bihar
Bihar
Bihar
Bihar
Bihar
Daman & Diu
Karnataka
Karnataka
Karnataka
Karnataka
Kerala
Kerala
Kerala
Kerala
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Madhya Pradesh
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Maharashtra
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
24.27
23.24
21.16
16.38
19.16
29.52
20.74
13.61
0.48
34.92
19.05
14.18
23.36
10.76
16.97
9.71
0.55
10.03
7.82
10.57.
7.95.
16.30
10.01
7.21
12.33
10.37
9.90
9.25
8.01
7.95
8.40
8.65
13 03
8.09
5.39
6.50
11.85
20.04
28.18
20.59
14 54
23.53
30.51
49.49
18.23
20.02
11.33
18.07
3.1
4.8
4.3
2.9
2.6
2.2
2.3
2.8
4.1
3.1
3.7
3.8
2.8
3.3
3.3
3.3
3.0
3.6
4.6
3.8
3.2
4.0
3.2
4.3
4.3
3.8
4.2
2.7
2.7
2.3
2.3
2.7
2.0
2.1
2.9
2.1
3.4
4.1
3.4
4.0
2.2
2.6
2.8
2.2
2.8
3.8
3.2
3.3
1 1
55. Sultanpur
56. Chamoli
57. Nanital
58. Moradabad
59. Jaunpur
60. Aligarh
61. Allahabad
62. Lalitpur
63. Tehri Garwal
64. Pithoragarh
65. Calcutta
66. Darjeeling
67. Chamba
68. Shimla
69. Sirmur
70. Ajmer
71. Bharatpur
72. Ganga Nagar
73. Jaipur
74. Jodhpur
75. S. Madhopur
76. Sirohi
77. Udaipur
4.
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
Uttar Pradesh
West Bengal
West Bengal
Himachal Pradesh
Himachal Pradesh
Himachal Pradesh
Rajasthan
Rajasthan
Rajasthan
Rajasthan
Rajasthan
Rajasthan
Rajasthan
Rajasthan
20.38
3 64
11.23
31.51
25.27
25.65
37.81
5.87
4.99
4.80
42.56
11.49
3.11
5.10
3.06
14.40
12.99
20.29
34.20
16.67
15.35
5.42
3.56
3.6
3.2
3.2
4.2
4.1
2.1
2.7
2.6
2.9
2.7
4.0
4.0
2.7
2.0
2.6
2.5
2.6
2.6
2.0
2.0
2.7
2.2
2.4
LEPROSY CONTROL BEFORE 1955
Prior to the beginning of national leprosy eradication programme in
1955, anti-leprosy activities were wide spread in the country. However,
these measures were primarily concerned with the treatment of patients,
and organised by charitable missions and non-governmental agencies.
The physical facilities available were far from satisfactory. There were
152 institutions with in-patient provision for admitting and treating patients
with a total bed strength of 19600. In other words, there were 142.6 beds per
1000 estimated cases.
The inter-state availability of beds was grossly uneven, the largest •<
number being provided by then Madras state (1 : 1260), followed by
Manipur (1 :3666) and Himachal Pradesh (1 :4675). When viewed against
the estimated number of cases, the picture was really dismal in most of the
states, Uttar Pradesh being at the bottom with 1 bed for 40,435 estimated
cases.
In addition to 152 institutions with in patient care provision, 1203
clinics in the country operated out-patient services for leprosy patients. It is
estimated that on an average, there was one clinic per 300 thousand
population, which again varied greatly from state to state. This, however,
was understandable since most of anti-leprosy activities were being under
taken by several independent agencies such as voluntary organisations,
religious institutions and charitable trusts, without any plan and co-ordina
tion to provide services on a rational basis. Lack of any organised effort led
to the governmental action to control the disease through the establishment
of national leprosy control programme based on the recommendation of an
expert committee1.
NATIONAL LEPROSY CONTROL/ERADICATION PROGRAMME
The NLEP was launched in 1955, the last year of the first five year
plan, with the main objective of controlling leprosy through domiciliary
treatment with sulphone. It started as a centrally aided scheme with its
focus on the rural areas of high and moderate endemicity. In the low
endemic states the expectation was to provide leprosy services through the
existing infrastructural facilities meant for general health services. To give
impetus to control work, the scheme was converted into a centrally
sponsored programme in 1969-70. with total expenditure on it being
chargeable to the central government.
5.
Objectives
To begin with the programme did not have a clearly defined policy or
operational objectives for nearly two decades. The plan documents (1951,
1956, 1961 and 1969-70) only stated ‘.he problem and described the inputs
that would be made available to strengthen the programme. This meant that
the programme was all along input oriented and not performance oriented.
This was necessitated because of several factors.
a. lack of primary prevention (vaccination) against the disease;
b. non-availability of potent drugs for early and complete cure;
c. isolation of all patients was not feasible as the benefits were not
commensurate with costs involved;
d. lack of community cooperation due to social stigma attached to
the disease; and
e. the existing legislation on leprosy were negative and had unsci
entific approach.
It was only in 1976 that the programme was made performance
orientedI2. Each of the states was given certain targets by the Government
of India in respect of :
a. new cases to be detected and brought under treatment and
b. number of patients to be discharged as disease arrested or
cured during each year. The targets, however, were based on
certain assumptions (Appendix 1).
i)
Government ol India, Ministry ol Health (1955), Report ol Uro Committee for the
Control Leprosy. Government ol India Press, Calcutta.
2 Government ol India (1976). Ministry of Health fl Family Planning Report of the
Central Councils of Health & Family Planning, 15-17, April 1976.
I
13
NLEP focused on the rural areas since 80.0 percent of the population
lived there and even a larger percentage of cases were expected there. It
was further considered that leprosy being a disease of rural incidence and
urban prevalence, its control in the rural areas will automatically reduce the
migration of cases. However, several indigenous foci were observed in
urban areas. Hence, during the fifth five year plan, the programme was
extended to the urban areas as well. It was envisaged that by detecting all
cases and bringing at least 90 percent of them under continuous treatment
with sulphones, it would be possible to bring down the load of infection by
80 percent and there by making disease control effective.
While there was considerable expansion of the control activities and
good results were obtained in selected centres, the impact of the pro
gramme on the country as a whole was far below expectations. Even with
well-organised and effectively implemented programme based on dapsone
monotherapy, although substantial decline was achieved in the prevalence’
of the disease, it was not possible to demonstrate a parallel decline in its
incidence, which was sine qua non arresting for disease transmission in the
country.
The monotherapy strategy further suffered from both operational and
technical limitations. It relied mainly on long-continued, self administered
dapsone. The treatment remained meagre, rudimentary and restrictive,
relying solely on pill distribution to the maximum number of patients
possible. The emphasis, thus, was on quantitive rather than qualitative cure.
Besides, resistance to dapsone was emerging as a serious phenomenon to
contend with.
Large geographic variations in the same state still existed in the
prevalence ot the disease. For example, in Tamil Nadu, the range of
variation was from 5.0 to 28.7 perthousand and in West Bengal from 4 0 to
25.0 per thousand. All these factors called for an effective strategy for
leprosy control in the high endemicity districts on a priority basis.
With the availability of a number of highly effective bactericidal drugs
and better understanding of the disease, a radical change in the approach-’'
to arrest the disease within a specified period of time appeared possible
Simultaneously, there also developed in the country a new political will to
control leprosy.
The Prime Minister of India in her address to the World Health
Assembly in May, 1981, made an appeal to all the developed countries to
help in leprosy eradication. While addressing a joint meeting of the Cabinet
Committee on Science and Technology and Science Advisory Committee
to the cabinet in May, 1981, the Prime Minister again asked the Indian
scientists to develop a leprosy eradication strategy. The Ministry of Health
14
and Family Welfare constituted a working group to devise a new strategy
and action plan for the control and ultimate eradication of leprosy. Dr. M.S.
Swaminathan, member, Planning Commission, was the chairman and
eminent scientists, leprologists and social scientists were the members of
the committee.
The recommendations of this group1 brought about changes in the
programme administration and strategy namely.
- NLCP was changed into a time bound programme with the
specific goal of arresting the disease activity in all leprosy cases
by the turn of the century;
- tfie existing sulphone monotherapy was supplemented with one
or more bactericidal drugs for treatment of the disease in the
form of a campaign with a view to achieve its effective control;
- efforts were to be made to obtain self-sufficiency in the require
ment of anti-leprosy drugs;
- measures were initiated to attract and retain medical officers in
leprosy control services;
- activities of voluntary organisations in leprosy control were reor
ganised and supported;
- the process of repealing leprosy act of 1898 to be expedited;
- community based rehabilitation of disabled leprosy patients was
planned on a priority basis;
- screening of pre-school children and youth emphasized for early
detection of disease;
- setting up National Leprosy Eradication Commission (NLEC)
under the chairmahship of Union Minister of Health and Family
Welfare for programme policy guidance and National Leprosy
Eradication Board (NLEB) under the chairmanship of Union
Health Secretary for monitoring tfie activities of the programme.
ii
Strategy
The strategy of the programme was to control the disease through
reduction in the quantum of infection in the population, reduction of infective
sources and breaking the chain of disease transmission. Four basic
activities were envisaged namely.
early detection and regular treatment of patients,
- providing multi-drug therapy (MDT) to all the patients on domiciallary basis; and
- education of the patients, their families and the community
1 Government ol India (1982), Ministry ol Health fi Family Welfare. Report ol the
Working Group on the Eradication ol Leprosy. Publication S Information Directorate
(CSIR) Hillside Road, New Delhi.
members in general on leprosy and its curability: and
- social and economic rehabilitation of the patients.
The objectives of MDT were :
- to sterilize the leprosy lesions in the shortest possible period of
time so as to Interrput the transmission of infection;
- to prevent the emergence of resistant strains of M. leprae;
- to cure the patient, minimize the development of deformities and
prevent treatment failures; and
- to prevent relapse.
The bactericidal drugs recommended in the programme were dap
sone, rifampicin, and clofazimine in the following doses (Table-7)
An intensive course of 14 daily doses and subsequently monthly
doses were given under the direct supervision of the medical officer. Cases
detected on any day of intensive treatment were given supervised doses
only for the remaining days of the 14 day course, followed by monthly
supervised and daily unsupervised treatment for a minimum of 24 months.
Mu It ibaci llary (MB) cases detected after administration of 14 intensive daily
doses received only monthly supervised and daily unsupervised doses for
at least 24 months.
Until 1984, rifampicin was being administered to MB patients on two
consecutive days every month, one supervised and other unsupervised.
Since January 1985, however, the administration of second unsupervised
doses of rifampicin was discontinued. Likewise, in Paucibacillary (PB) cases,
initially three supervised daily doses of rifampicin and dapsone were given
until 1984. From January 1985, only single monthly dose of rifampicin was
given under supervision for a mininum of six months.
The supervisedl 4 days intensive phase of treatment was followed in
the districts where the MDT programme functioned as a vertical set-up. In
the modified MDT districts the 14 days intensive, supervised treatment was
dispensed with. In these districts all the registered patients started with
pulse treatment in the continuation phase.
Organisational Structure
A five tier organisational structure was created over the years as a part
of NLCP/NLEP. The present basic elements of the structure are given in an
organisational chart (fig. 2).
National Leprosy Eradication Commission functions as the policy
making body for the guidance and surveillance of the programme. It is the
responsibility of the National Leprosy Eradication Board (NLEB) to imple
ment the plan and policies as laid down by the NLEC An officer of the rank
of a deputy director general of health services is the director of the
programme. He is basically responsible for planning, programming, organ-
iii)
16
TABLE-7
Multidrug Therapy Regimen in Leprosy*1
2
Period
Drugs
Age Group
6-9 yrs
MB Cases
Intensive
for 14 days
Continualion phase
for a minimum of two
years
PB Cases
Continualion phase
for a mini
mum of 6
months
• Once in a month
" Twice a week
1 Daily
2 Alternate days
10-14 yrs
Rifampicin
Clofazimine
Dapsone
Rifampicin
Clofazimine
300mg
50mg
25mg
300mg ’
100mg ’
50mg ”
450mg
50mg
50mg
450mg *
150mg *
50mg 2
Dapsone
25mg ’
Rifampicin
Dapsone
300mg *
25mg 1
MB ■ Multibacillary
.PB - Paucibacillary
Remarks
15yrs
Supervised
Supervised
Supervised
Supervised
Supervised
Unsupervised
50mg 1
600mg
100mg
100mg
600mg *
300mg *
50mq ’
100 mg 2
100mg ’
450mg *
50mg 1
600mg *
100mg '
Supervised
Unsupervised
Unsupervised
NATIONAL LEPROSY ERADICATE;I COMMISSION
NATIONAL LEPROSY ERADICATION BOARD
----- —---------------------------------------------------- 1
N
| MINISTRY OF HEALTH AND FAMILY WELFARE |
R
| DIRECTORATE GENERAL OF HEALTH SERVICES |
E
| LEPROSY DIVISION |
Figure 2 : Organisation Structure of NLEP at the Centre, State
and District Levels
18
isation and implementation as per the policy decisions of NLEC and under
the direction of NLEB. The programme director is assisted by technical
officers of the rank of assistant director general (ADG) and deputy assistant
director general (DADG) of health services.
Additional/joinl/deputy director of health services a' the state level is
the state leprosy offficer (SLO). He performs the same functions at the state
level as DDG (leprosy) does at the centre
For many years under NLCP, the district medical officer of health
looked after the leprosy work in his district, in addition to his many other
duties. During the fifth five year plan, however, leprosy officers were made
available at the district/zonal levels also at the rate of one per district where
the disease was of moderate endemicity. With NLEP coming into being, one
DLO was planned to be provided for every district where tlie prevalence rate
was 5 per thousand or more.
Two types of units were in operation at the periphery. In areas of high
endemicity, a subsidiary centre was created, one for every 80,000 popula
tion. After initial experimentation, however, the subsidiary centre was
renamed as leprosy control unit (LOU) during the third five year plan and
was given a population of 150 thousands With the Introduction of effective
,control in the fourth plan period, districts with prevalence of 5 or more per
/thousand were provided with LOU at the rate of one per 4 - 5 lakh population.
The present staffing pattern of LCU besides ancillary staff is :
Medical officer
1
Non-medical supervisors (NMS)
4
Paramedical workers (PMW)
20
In areas of moderate endemicity, the suivey, education and treatment
(SET) centres were established commencing with the second five year
plan. In 1982, these were extended also to areas with endemicity of less
than 5 per thousand. A SET centre was to serve a population of 25,000. A
PMW or a non-medical assistant wasgiven for each centre. The SET centre
was attached to a Primary Health Centre (PHC) or a dispensary or a
hospital located in the area. The PMW worked under the supervision of a
NMS who was made available one for every five PMWs. SET centres were
established also in known moderately endemic areas in highly endemic
districts.
When tire programme was extended to urban areas during the fifth
plan period, urban leprosy centres (ULC) came into existence, one for every
50,000 population. Each ULC was manned by a PMW who functioned
under tlie supervision and guidance of a medical officer in charge of the
dispcnsary/hospital to which the ULC was attached.
In addition, facilities for those who needed hospitalization were
19
planned. These were supplemented by a limited number of reconstructive
surgery units.
a.
MDT Under Vertical Setup
Over the years, a separate cadre of health workers were trained to
provide anti-leprosy services. In 1983 MDT was started in two districts. To
ensure the satisfactory implementation of Multi-drug treatment in the district
both with regard to its quality and coverage, certain pre-requisites wer4
laid down before the district was selected. These included :
- the selection of districts was confined to those having preva
lence rate of 5 or more per 1000 in the year immediately
preceding the sanction of MDT;
- the districts selected should have been cover IbyLCUs, ULCs
and SET centres and there was to be no unsurveyed virgin
population;
- the districts was to have a full-time functioning DLO supported
by other recommended staff;
- the district should have adequate referral facilities for attending
complications; and
- the district was to have detected at least 80 percent of the
estimated cases, evolved a system of regular treatment and also
possessed a laboratory attached to each unit.
High endemic districts with leprosy prevalence of 5 or more per 1000
numbered201 (Table-5).MDTwasextendedtothesedistrictsina phased
manner. By 1991, 135 of the districts were covered. Presently, these
districts were at various stages of MDT implementation and provided MDT
umbrella to 75 percent of all the recorded cases, numbering 1.5 to 1.6
million.
Modified MDT Setup
Besides 135 of the 201 endemic districts where MDT operated, there
still remained 66 districts where leprosy services were provided by the '
existing health services. These districts did not possess the requisite
infrastructure for establishing the vertical MDT setup. At the same time it
was necessary to extend the benefit of multidrug treatment to nearly 0.6 to
0.7 million patients in these districts. The Government of India, in 1990
developed the modified multidrug therapy approach.
The modified approach differed from the vertical programme essen
tially in the following respects :
- district leprosy unit functioned under the overall charge of the
district medical officer;
- the leprosy services were delivered through the primary health
b.
20
care staff supplemented by leprosy workers to the extent available in the district;
- the medical officer of the PHC was to be the overall incharge of
MOT operations in the area;
- the treatment points were to coincide with the PHC, the subsidi
ary health centre, the dispensaries and hospitals; and
- Cash assistance was envisaged to leprosy patients for collecting
drugs from the treatment points with further incentive to those
completing treatment.'
The organisational chart for modified MDT at the state level and below
may be seen in figure 3.
In order to facilitate understanding of the programme, its components,
Vactivities and responsibilities equally well by all concerned and to ensure
that the peripheral workers performed their jobs in an uniform and compre
hensive manner, an operational guide' was developed earlier. After MDT
was introduced into the programme, 2 other manuals detailing guidelines on
case detection, classification, treatment. Follow up and reporting in MDT
districts1
2and for modified MDT scheme3 were brought out in 1985 respec
tively.
iv.
Infrastructure
As the NLCP progressed after its establishment in 1955, the number
of infrastructural facilities developing during the successive five year plans
are presented in Table - 8.
The physical infrastructural components as on 1/4/1991 by state and
union territories are given in Table - 9. Certain salient features of the
infrastructure development were as follows ;
• Creation of LCU started in file very first year of the programme,
though the achievement of the target was only 77.5 percent
during the first plan. It recorded a growth of 103 percent during
the second plan. During the succeeding plans the achievements
were short of the targets, each between 87.5 and 95.3 percent.
In the seventh plan, however, the achievement exceeded the
target by 12.4 percent.
- SET centres whose establishment commenced during the 2nd
1. Government ol India. Ministry of Health. Family Planning & Urban Development
(1969), Guide and Operational Guidelines for Assessment of Leprosy Work in India.
Government of India Press. Faridabad.
2. Government of India, DGHS (1985) Leprosy, Guidelines for Case Detection,
Treatment, Followup and Reporting ■ Ashok Printers, Delhi.
3. Government of India, DGHS (1990). Guidelines lor Modified MDT Scheme in
Selected Districts - TPS. New Delhi.
TABLE-8
Establishment of Infrastructure by Plan Period
Leprosy
Control
Unit
SET
Centres
Urban
Leprosy
Centre
Temporary
Hospital
Ward
Reconst
Surgery
Units
District
Leprosy
Units
SSAU/ESU
Leprosy
Training
Centres
Total
Plan Period
Type of
IV
V
61-66
Ann
ual
66-69
69-74
103
4G
1
4
194
564
0
0
0
VI
VII
74-79
Ann
ual
79-80
80-85
85-90
70
126
0
26
355
758
379
363
462
0
861
0
6985
0
0
53
411
0
197
241
902
0
0
0
0
166
0
87
38
291
0
0
0
0
0
68
0
7
0
75
0
0
0
0
0
0
0
0
0
0
97
0
0
0
93
17
87
24
277
41
10
0
10
0
1
19
0
3
6
49
/
II
III
51-56
56-61
31
TABLE-9
Physical Infrastructure under NLEP by States
as on March 1991
S. No. S'ate/UT
1.
2.
3.
4.
5.
6,
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Andhra Pradesh
Arunachal P.udesh
Assam
Bihar
Goa
Gujarat
Haryana
Himachal Pradesh
Jammu & Kashmir
Karnataka
Kerala
Madhya Pradesh
Maharashtra
Manipur
Meghalaya
Mizoram
Nagaland
Orissa
LCU
ULC
SET
DLO
THW
SSAU
VO
94
2
9
85
1
21
0
6
8
41
20
54
42
91
0
16
69
2
21
3
1
2
43
15
72
258
1
1
164
31
250
1044
31
369
2
15
37
673
254
530
970
17
16
7
30
140
31
0
6
21
1
7
0
5
0
20
8
23
24
4
0
2
3
10
50
1
5
29
1
9
0
1
2
22
5
14
23
1
2
1
2
11
3
0
1
4
0
2
1
1
0
3
3
5
1
0
0
1
0
1
45
3
6
18
0
17
1
1
1
22
11
7
27
2
1
0
0
2
2
1
2
2
55
16
■
LCU
ULC
SET
DLO
THW
SSAU
VO
Punjab
Rajasthan
Sikkim
Tamil Nadu
Tripura
Uttar Pradesh
West Bengal
A & N Islands
Chandigarh
D & N Haveli
Daman & Diu
Delhi
Lakshadweep
Pondicherry
2
5
2
102
3
122
73
0
0
0
0
0
0
1
16
5
6
82
4
60
71
3
0
0
0
3
0
3
0
8
13
26
20
1023
395
10
0
0
0
0
0
24
1
4
1
22
1
65
15
1
0
0
0
0
0
2
1
4
1
52
1
17
30
1
0
0
0
1
0
1
1
0
0
7
1
1
4
1
0
0
0
0
0
0
1
7
1
31
1
48
14
0
1
0
0
3
0
1
Total
758
902
6099
277
291
41
287
S. No. State/UT
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
STATE
DIRECTOR OF HEALTH SERVICES assisted by
STATE LEVEL OFFICER
DISTRICT
CHIEF MEDICAL OFFICER assisted by
DlfTIHIC I 1 FI’UOF.Y OFFICER
1,00,000
POP.
COMMUNITY HEALTH CENTRE assisted by
LEPROSY NON MEDICAL SUPERVISOR
30,000
POP.
PRIMARY HEALTH CENTRE assisted by
PARA MEDICAL WORKER
25,000
POP.
MULTI PURPOSE HEALTH ASSISTANT (MALE)
assisted by HEALTH ASSISTANT (FEMALE)
5,000
POP.
MULTI PURPOSE WORKER (MALE) assisted by
MULTI PURPOSE WORKER (FEMALE)
1,000
COMMUNITY HEALTH GUIDE/WORKER
Figure 3 : Organisational Structure for Modified MDT Setup at the State Level
and Below.
plan recorded shortfalls in target achievement during each of the
plan periods though their number increased with each succes
sive plan. In the 7th plan a number of SET centres were
converted into modified LCUs.
- Other facilities which started during the 5th plan period showed
varying degrees of success in the establishment of targets
ranging between 68.0 percent for reconstructive surgery units to
87.0 percent for upgradation of subsidiary centres into LCUs.
- During'the 6th plan period, with the change in strategy and
provision of additional funds, the achievement of all targets shot
up from 17.3 percent to 400 percent except for reconstructive ,
surgery units.
Inclusion of MDT in the programme called for an'augmentat,ioH in the
infrastructural facilities to be met with in a phased manner. It was envisaged'
that by the end of 1990, in all the 201 districts with prevalence rate of ovei
5 per 1000, these facilities will be established. By the end of the 7th plan,
there was a further augmentation in the establishment of all facilities, ;
25
starting with a 14 percent increase in leprosy training centres to 36.4 in
ULCs and 88.0 percent in LCUs.
It can be said that only after the 4th plan period did the programme
acquire a significant thrust with allround development in infrastructural
facilities to meet the patient needs. It received a further major filling
following the introduction of MDT as a programme component in 1983.
Population Coverage
The population coverage by infrastructural facilities since the start of
NLCP is given in Table -10.
The total population covered upto 1966 was 54.724 million, constitut
ing 14.7 percent of the endemic population of the country. About 16.3
percent additional population was covered in the 4th five year plan, 35.99
percent during 1974-77 and 64.2 percent by the end of 1985. Currently,
(March 1991) the infrastructural facilities extend to 568.5 million represent
ing 67.4 percent of the endemic population.
V).
TABLE-10
Population Covered and Cases Detected Since the Inception of
NLCP by Plan Periods (Figures in Lakhs)
Plan
I
II
HI
IV
V
VI
VII
Period
1951-56
1956-61
1961-66
Annual Plan
(1966-69)
1969-74
1974-79
Annual Plan
(1979-80)
1980-85
1985-90
Cumulative
Population
Covered
Cases Detected
20.00
147.00
572.00
818.00
0 17
1467.00
3548.00
3618.00
4.56
10.90
2.60
4399.00
5685.00
21.44
29.12
0.95
4 56
2.10
Marked variations did exist amongst different states and union territo
ries in the percent endemic population provided with infrastructural facili
ties. However, highly endemic states with large patient load were accorded
complete coverage. The extent of endemic population extended the protec
tion by March 1991 in 8 of the states that accounted for approximately 90
percent of the total registered case load in the country is shown in
Table -11.
26
TABLE - 11
Endemic Population Provided Cover in
Certain Selected States
State/UT
Andhra Pradesh
Bihar
Madhya Pradesh
Maharashtra
Orissa
Tamil Nadu
Uttar Pradesh
West Bengal
Population, 1991
(Lakhs)
Porcont Population
Provided Cover
663.00
863.38
661.35
787.16
201.90
556.38
1387.60
679.82
10.0
48.6
59.3
79.0
100.0
100.0
55.0
86.2
But for Bihar, Madhya Pradesh and Uttar Pradesh, 80.0 Percent or
more of the population had been covered.
Case Detection and Treatment
The number of leprosy cases on record and those brought under
treatment in successive plan periods since the beginning of NLCP in 1955
is shown in fig. 4.
The number of cases on record in the country progressively increased
through the years-from 1.12 iakhs during the II plan to 32.46 lakhs between
1980-85. This was to be expected with increasing coverage of population
and establishment of more and more infrastructural facilities. The number
of recorded cases that was 20.4 lakh in March 1991, showed a decline for
the first time in years. This was, no doubt, due to incorporation of MDT in the
programme. By 1991, the MDT had reached all the 201 districts with endemicity of 5 per thousand or more. The introduction of MDT entailed large
scale elimination of cases at initial screening (Table-12), resulting in a
precipitous fall in the number of cases on record. This was supplemented
by actual decrease in the number of cases in areas where MDT had been
in operation for more than 3 years.
The performance during the present decade showed that on an
average 0.4 to 0.5 million new cases were being detected annually. The
number of cases discharged as cured progressively increased every year
(Fig-5). At the end of March 1991,2 0 million leprosy cases were on record,
of which a proportion were on treatment Over 5 0 million patients had been
discharged as disease cured/migraled/dcad since the inception of the pro
gramme.
Case detection, treatment and discharge by states/union territories
for 1990-91 is presented in Table-13. Performance in this regard was being
measured by the programme on the basis of two indices, namely
vi.
Figure 4 tNumber of Cases on Record and Under Treatment since Programme Inception
28
percent of the allotted cases detected annually, and
• per cent of the detected cases treated in the same period.
It would be seen that most of the states and union territories, not only
met their targets but exceeded them by 9.0 to 192.0 per cent of the allotted
number, the exceptions being Himachal Pradesh, Madhya Pradesh, the
eastern states of Meghalaya, Mizoram and Nagaland, Sikkim, West Bengal
and union territories of Delhi and Pondicherry. Even these states detected
80 per cent or more of the allotted cases save for Nagaland and Sikkim.
Since nearly all the detected cases were brought under treatment, thenumber of treated cases also overshot the allotted targets.
TABLE12
Total Number of Leprosy Cases on Record, Under Treatment and
Discharged by States as on March 1991.
S.No. State/U. T.
1. Andhra Pradesh
2. Arunachal Pradesh
3. Assam
4. Bihar
5. Goa
6. Gujarat
7. Haryana
0. Himachal Pradesh
9. J & K
10. Karnataka
11. Kerala
12. Madhya Pradesh
13. Maharashtra
14. Manipur
15. Meghalaya
16. Mizoram
17. Nagaland
18. Orissa
19. Punjab
20. Rajasthan
21 Sikkim
22. Tamil Nadu
23. Tripura
24. Uttar Pradesh
25. West Bengal
26. A & N Island
27. Chandigarh
28. D & N Haveli
29. Daman & Diu
Cases on
record
Cases under
treatment
Cases
discharged
214235
1301
18766
462710
1245
24901
1282
3957
6356
39470
65817
159850
166619
1365
1394
201
2030
157621
3291
15549
225
207116
2706
361568
114349
1347
936
383
192
214235
1301
18446
418689
1245
24864
1282
3957
5456
39470
53544
124598
166619
• 1365
1394
193
2030
156966
2991
13961
225
202897
2706
316939
92974
1347
878
368
192
1190031
813
13179
264080
3917
128230
918
3299
1873
263859
79209
188864
839561
4667
1199
680
583
330106
4651
8026
248
1171891
2446
368712
529566
1243
13
64
96
29
30.
31.
32.
Lzeiru
Lakshadweep
Pondicherry
4232
159
1963
3945
159
1963
1097
443
12320
______ Tola!___________________ 2043136_________ 1877199_______ 5415884
If treatment of all the cases was inescapable in the interest of
programme efficiency, it was even more important that they complete
treatment. Against 4.81 lakh new cases detected during the 1990-91 those
discharged numbered 9.84 lakhs. The latter included besides those who
completed treatment, cases in the backlog and others who migrated or died.
Some of the reasons why achievement exceeded the targets may be
found in a massive increase in NLEP infrastructure simultaneous with the
extension of MDT and adoption of rapid methods of screening leading to
increasing case detection.
Drug defaulting was the bane of many a leprosy control programmes.
The NLEP, however, maintained a high rate of treatment regularity. The
proportion of MB patients taking regular treatment was 88.6 per cent, while
73.0 per cent of the paucibacillary were regularly taking drugs, with an
overall treatment compliance of 75.0 per cent in all the patients'.
vii) Progress of Multidrug Therapy (MDT)
a. Leprosy Profile
Currently 201 districts with leprosy prevalence of 5 or more per 1000
.- population were under MDT (Table-5). These included 137 districts where *
the MDT operated under the vertical setup, while in the remaining 64,
modified MDT was introduced in 1991. These districts were in various
stages of MDT implementation. In addition, in 45 low endemicity districts,
MDT was being given with the help of existing health services. The Total C
population under cover of combined therapy was 568.5 million.
At the end of March 1991, nearly 75.0 percent of the recorded leprosy
'cases i.e. 1.5 to 1.6 million were receiving multidrug treatment. Over a
million cases had been discharged since 1985 as disease cured.
The disease profile in 100 of the MDT districts for which complete data
was available is shown in Table-14.
It showed that M DT had been in progress for 5 or more years in 17 of
the districts; in 19 it had operated for 4 years, in 52 for 2 to 3 years while in
the remaining 12 it was launched only in 1990. The case load in these
districts at the commencement of MDT stood at 1.7 million. This number
came down to 0.55 million at the end of December, 1991.
1. .Ministry ol Health. DGHS (1991), Fourth Independent Evaluation ol National
Leprosy Eradicaton Programme.
30
zou-
U
00-81
Figure 5 :
|
|
|
|
81-82
82-83
83-84
84-85
|---------------- 1----------------- 1----------------- 1----------------
85-86
86-87
87-88
88-89
89-90
Annual New Leprosy Case Detection and Discharge Performance, 19801990
31
TABLE 13
Case detection, Treatment and Discharge of Leprosy Cases 1990-91
State/
U.T.
Annual
target
tor
case detection A treat
ment (1990-1991)
New
cases deteded as on March
%
1991
Number .chievement
2
1
Cases brought un Annual
der treatment
target lor
%
case disch a r g e
Number Achievement
(1990
1991)
Cases discha- Cases on
rged up to March record al
% the end ol
1991
Number Arrhievement month
Cases under
treatment at
the end of
month
3
4
5
6
7
8
9
10
11
12
214234
1.
Andhra Pradesh
50000
85795
171.59
85795
100.00
200000
141351
70.68
214235
2.
Arunachal Pradeshi
100
109
109.00
109
100.00
100
57
57.00
1301
1301
3.
Assam
1500
1647
109.80
1647
100.00
1500
1185
79.00
18766
18448
4.
Bihar
25000
26107
104.43
25404
97.31
30000
29934
99.78
462710
418685
5.
Goa
200
505
252.50
505
100.0
500
937
187.40
1245
1245
6.
Gujarat
8000
9721
121.51
9700
99.78
25000
13396
53.58
24901
24864
7.
Haryana
100
263
263.00
263
100.00
100
325
325.00
1282
1282
8.
Himachal Pradesh
200
169
84.50
169
100.00
200
530
265.00
3957
3957
200
265
132.50
265
100.00
200
253
126.50
6356
5454
18000
19786
109.92
19786
100.00
60000
76195
126.99
39470
39470
9.
J&K
10.
Karnataka
11.
Kerala
6000
7318
121.97
6174
84.37
9000
10061
111.79
65817
53544
12.
Madhya Pradesh
27000
26520
98.22
26520
100.00
30000
35491
118.30
159850
124590
13.
Maharashtra
55000
89696
163.08
89696
100.00
190000
118323
62.28
166619
166619
14.
Manipur
80
124
155.00
124
100.00
100
136
136.00
1365
1365
15.
Meghalaya
50
39
78.00
39
100.00
50
46
92.00
1394
1394
16.
Mizoram
50
42
84.00
42
100.00
50
224
448.00
201
190
17.
Nagaland
100
34
34.00
34
100.00
100
11
1100
2030
2030
18.
Orissa
30000
47326
157.75
47326
100.00
50000
68202
136.40
157621
156960
1
2
4
5
6
7
8
9
11
10
12
19.
Punjab
200
550
275.00
550
100.00
200
736
368.00
3291
2990
20.
Rajasthan
800
1006
125 75
1006
100.00
800
2641
330.13
15549
13940
21.
Sikkim
22.
Tamil Nadu
23.
Tripura
24.
Ullar Pradesh
25.
West Bengal
25000
26.
A & N Islands
100
27.
Chandigarh
28.
80
20
25.00
20
100.00
50
125
250.00
225
225
75000
94794
126.39
90575
95.55
200000
249331
124.67
207116
202890
150
355
236.67
355
100.00
100
591
591.00
2706
2706
45000
50963
113 25
49563
97.25
50000
42032
84.06
361568
31690
17134
68 54
17134
100.000
30000
190683
635.61
114349
92970
165
165.00
165
100.00
100
55
55.00
1347
1347
50
146
292.00
114
78.08
50
7
14.00
936
870
D & N Haveli
50
105
210.00
105
100.00
50
64
128 00
383
383
29.
Daman & Diu
20
22
110.00
22
100.00
20
29
145.00
30.
Delhi
500
383
76.60
374
97.65
200
136
68.00
31.
Lakshadweep
50
54
108.00
54
100.00
50
88
176.00
159
159
32.
Pondicherry
500
473
94.60
473
100.00
2500
1655
66.20
1963
1963
369080
481636
130.50 •474108
98.44
881020
984830
111.78 2043136
1877190
Total
co
co
3
'
192
192
4232
3940
TABLE-14
Leprosy Profile in 100 Selected MDT Districts
Year of
No. ol Cases
Prevalence Rate
Childhood MB:PB
MDT
At MDT Dec 91 At MDT Dec 91 % Fall
Rate
Ratio
commen commen
commen
Among
in Net
cement
cement
cement
New
Cases
Cases Dec 1991
S.No.
Districts
1
2
3
1. Anantapur
2. Guntur
3. Nellore
4. Karimnagar
5. Krishna
6. Cuddapah
7. Warangal
8. Chittoor
9. West Godavari
10. Vishakhapatnam
11. Medak
12. Prakasam
13. East Godavari
14. Nizamabad
15. Nalqonda
16. Adilabad
17. Khammam
18. Kurnool
19. Srikakulam
20. Vizianagaram
1989
1989
1989
1988
1987
1988
1987
1987
1987
1985
1989
1990
1985
1990
1988
1989
1388
1990
1983
1987
4
27022
27196
27022
26910
28036
29069
38216
32669
191.38
24155
16268
13626
43945
8273
30456
13718
11732
36371
30740
23643
5
Disability
Rate
Among
New
Cases
6
7
8
9
10
11
10260
10.60
9057
9.00
9410
13.40
7675
10.43
7532
9.20
5297
15.30
3389
21.70
3767
8.80
4472
6.66
2492
9.37
4895
9.00
10946
7.50
10.90
9982
2761
5.30
5289
9.60
8970
6.59
9393
6.65
11566
15.00
2559 . 16.20
2668
13.20
3.22
2.20
4.67
2.50
2.04
2.73
1.60
1.15
1.27
0.76
2.16
4.60
2.69
1.76
2.40
4.30
5.30
4.80
1.10
1.27
78.2
31.8
65.3
76.0
77.8
82.1
92.6
82.9
91.8
76.0
38.6
38.6
75.3
66.7
75.0
34.7
20.3
68.0
93.2
90.3
4?
30.88
33.53
26.19
32.24
33.69
30.09
24.68
28.56
32.42
31.20
16.90
30.25
37.13
17.13
30.42
25.49
30.69
26.30
21.40
15.52
17.48
13.22
23.22
24.82
17.50
14.44
27.65
17.16
17.80
16.87
33.65
14.47
18.78
38.45
18.26
26.71
24.61
15.08
22.77
19.96
0.70
1.50
2.55
1.69
3.72
1.82
1.90
2.57
2.27
2.59
3.42
2.78
3.33
0.29
1.66
3.53
2.85
1.51
1.61
5.54
1
CO
CD
2
21. Mahabubnagar
22. Karbi Anglong
23. Deogarh
24. Valsad
25. Dangs
26. Panchmahal
27. Surat
28. Bharuch
29. Vadodra
30. Gulbarga
31. Raichur
32. Bidar
33. Rajnand Gaon
34. Durg
35. Bilas pur
36. Bastar
37. Raigarh
38. Gadchiroli
39. Nanded
40. Osmanabad
41. Shblapur
42. Yuvatmal
43. Nagpur
44. Thane
45. Bhandara
46. Akola
47. Satara
48. Raigarh
49. Buidana
3
4
5
6
7
8
9
10
11
1989
1990
1985
1987
1987
1988
1989
1989
1984
1988
1988
1988
1987
1987
1989
1989
1989
1938
1987
1987
1987
1987
1988
1988
1988
1990
1989
1989
1939
20593
1901
11069
11683
668
11765
6920
6231
11975
17357
17767
7390
9683
16155
14607
4253
12162
6817
20329
10965
14712
13506
10825
25704
12920
10631
6139
6114
7638
16784
1828
1951
2718
179
2765
3675
3503
1459
3257
6103
1825
2385
4947
10256
1060
9643
1835
3480
1564
4138
3009
2261
6252
3036
3602
3006
3618
3178
6.70
3.52
10.88
6.90
5.80
5.17
6.20
4.76
4.68
8.30
8.96
7.40
8.30
10.00
6.60
6.00
8.97
11.64
11.63
10.84
5.64
7.77
7.90
7.67
7.06
5.80
5.50
7.00
5.06
4.90
0.29
1.91
1.53
1.55
1.19
1.47
2.70
0.57
1.56
3.40
1.80
1.65
2.60
3.47
1.53
6.68
2.29
1.98
1.91
1.28
1.45
1.65
1.19
1.46
1.97
1.50
4.10
1.68
26.8
91.7
82.3
77.8
73.2
76.9
76.2
43.2
87.8
81.2
65.8
75.6
80.1
74.0
47.4
74.5
24.4
80.3
82.9
82.3
77.3
81.3
79.1
84.4
79.3
66.0
72.7
41.4
66.7
13.39
28.52
7.31
45.35
31.74
45.09
34.93
40.04
37.40
31.15
15.47
23.86
20.51
43.44
41.29
31.80
51.39
37.69
8.75
5.46
8.69
7.28
9.16
11.58
14.49
19.86
8.38
11.41
30.14
13.59
12.14
12.23
29.47
14.01
13.39
23.09
54.58
12.96
29.71
27.34
22.85
17.15
17.92
10.69
10.82
13.79
32.45
31.92
32.76
7.94
10.05
16.43
42.89
18.73
25.90
35.89
25.95
29.88
10.00
3.79
3.73
6.48
6.80
6.46
4.44
3.21
4.95
5.16
8.17
8.74
4.07
12.66
4.72
0.54
0.34
0.04
0.79
0.23
0.14
0.63
0.71
0.04
0.29
2.55
0.45
CD
O)
2
3
4
5
6
7
8
9
10
11
50. Beed
51. Parbhani
52. Amravati
53. Wardha
54. Chandrapur
55. Mon
56. Puri
57. Cunack
58. Dhankenal
59. Mayurbhanj
60. Balasore
61. Sambalpur
62. Ganjam
63. Salem
64. Chengai Anna
65. Dharampuri
66. Madurai
67. Ramnathapuram
68. Periyar
69. OEM Dinndigul
70. Sinaganga PTT
71. Kamarajar
72. Thanjavur
73. Madras
74. South Arcot
75. North Arcot
76. Coimbotore
77. Varanasi
78. Barabanki
79. Faizabad
80. Unar Kashi
81. Kanpur Dehat
1990
1989
1985
1981
1987
1988
1985
1987
1988
1988
1989
1991
1983
1987
1985
1988
1988
1988
1988
1987
1988
1988
1988
1990
1990
1983
1989
1985
1987
1989
1990
1988
7461
9944
10487
8973
19737
940
33227
45897
13903
17791
21284
29231
36704
44497
43701
10213
27614
6333
25249
15366
13938
14903
26696
13193
34787
35213
15196
14984
10292
7700
563
18056
4521
4150
2405
1578
3466
288
7368
11338
6706
6933
14090
19985
4939
7531
10955
3512
10156
2549
8652
3460
5080
4305
7298
4191
22423
3295
8263
7013
2772
4334
186
5266
6.25
7.10
5.68
9.30
13.92
8.50
10.50
9.60
12.7Q
10.50
8.10
10.87
13.57
20.20
12.10
12.45
20.00
6.20
12.27
16.20
14.32
10.80
6.50
6.90
8.28
13.90
8.90
6.40
6.30
5.00
8.87
13.37
3.20
2.22
1.10
1.70
2.44
3.09
2.52
2.06
5.72
3.70
6.25
8.76
1.85
2.10
3.02
1.76
3.36
2.25
3.65
1.95
4.73
2.77
1.60
1.10
4.17
1.10
2.68
1.90
1.39
1.82
0.94
2.93
48.8
68.7
80.6
81.7
82.4
00.0
63.6
78.5
54.9
64.7
22.8
19.4
86.3
89.6
75.0
85.0
83.2
63.7
70.2
87.9
66.9
74.3
75.3
84.0
49.6
92.0
69.8
70.3
77.9
63.6
89.4
78.0
17.35
23.59
35.11
26.52
27.69
11.94
10.70
6.50
10.16
9.86
56.49
25.21
23.79
36.97
24.01
34.86
42.63
13.57
9.18
9.95
16.86
8.61
13.75
10.89
12.94
23.22
13.70
10.09
6.65
9.16
11.63
8.71
42.96
34.97
53.34
28.22
38.70
1.11
0.26
0.17
0.23
0.17
1
29.82
19.96
21.50
14.15
25.86
16.37
3.91
30.83
32.03
28.37
19.63
20.20
25.23
32.44
31.51
31.88
31.45
49.01
28.15
33.62
36.24
18.66
7.39
6.42
1.61
4.22
1.03
3.40
1.30
2.65
6.50
4.13
26.70
2.71
1.96
3.33
3.69
1.13
2.44
2.45
2.43
4.88
2.68
1.71
1.52
5.11
1.40
10.04
5.92
8.04
12.90
5.72
82. Pilbhit
83. Mirzapur
84. Deoria
85. Sitapur
86. Bankura
87. Purulia
88. Lakshadweep
89. Pondicherry
Total
3
4
5
6
7
8
9
10
11
1990
1990
1989
1990
1988
1982
1986
1989
11276
8156
9020
17150
26304
27254
406
4210
10766
4669
5249
12504
6561
8830
73
1801
11.58
6.90
6.10
8.00
12.00
33.75
10.50
7.00
10.67
3.69
3.48
5.34
2.76
4.17
1.43
2.32
7.8
46.5
42.9
33.2
77.0
87.6
86.3
66.8
13.05
12.50
8.08
3.93
23.99
17.60
32.35
37.58
16.94
34.59
36.43
22.89
32.76
21.83
6.33
13.05
9.98
10.90
5.78
2.68
4.65
6.87
1702935 554217
2.05
The incidence of the disease in children varied widely as did the MB
ratio. The former ranged between 1.61 and 54.5 per cent of all the new
cases with an average of 23.9 per cent, while 6.5 to 56.4 per cent of the
cases were multibacillary. Deformity affected about 5.0 per cent of the
patients. The unusually high childhood rate was due to detection of children
in large numbers at the surveys that focused primarily on schools. At the
aggregate level nearly 40.0 per cent of the all cases were detected through
school surveys during 1990-91.
Independent evaluations carried out in 1987, 1989 and 1991 showed
that MDT was very well accepted by the patients, the tolerance was good
and the side effects minimal. The drug compliance was excellent as seen
by high attendance rate. Over 80.0 per cent of the patients took treatment
regularly and the relapse rate was less than 1.0 per cent, indicating that the^j
treatment was effective. Voluntary reporting of patients in the MDT districts
was 35.0 per cent on an average.
b. Bacteriological Examination
Examination of skin smears for bacilli was an essential pre-requisite of
MDT programme. Such examination was carried out to supplement disease
classification before starting treatment and later as a follow up measure.
Currently the bacteriological services constituted a weak link in the MDT
programme. On an average, 60.0 per cent of the patients were subjected to
bacteriological examination. Between the two disease types, however, bac
teriological cover was available to-72.5 per cent of the multibacillary cases
against 47.6 per cent given to paucibacillary type.
c. Impact of MDT
The MDT programme profoundly changed the leprosy picture in the
affected districts. The numberof cases decreased by more than 67 percent
(from 1.7 to 0.55 million). Each one of the 100 districts registered a
significant decline in the prevalence rate, ranging between 7.8 per cent^.
observed in Pilibhit to 95.7 per cent of the rate at the commencement of
MDT in Alleppey.
The effect of MDT on the epidemiological profile in 10 of the districts
completing intensive phase of MDT operations is presented in Tables 15.
16, 17, 18. The epidemiological indices employed were :
- prevalence rate per 1000
- annual case detection rate per 1000
- proportion of MB cases among the new cases per 100
- childhood leprosy rate among new cases per 100
- deformity rate in new cases per 100
38
- relapse rate per 1000
- voluntary reporting rate per 100
Prevalence Rate : A dramatic decline in the prevalence rate charac
terized all the districts, the average fall being 71.6 percent from its pre-MDT
value. The maximum decrease of 89.2 per cent was v/itnessed in
Vishakhapatnam while the least that occurred was 13.5 per cent inf
Balasore. Since the detection of new cases in the districts was through, the
prevalence rate denoted the actual number of cases. There was no doubt
that the case load in these districts declined simultaneously.
Annual Case Detection Rate : Like the prevalence rate, the annual
case detection rate also decreased uniformly in all the districts. The
average decline was 44.5 per cent.
MB Ratio in New Cases : The proportion of multibacillany cases
increased in 7 of the 10 districts, while in the remaining 3 it showed an
average decline of 11.0 per cent. As some of the paucibacillary cases
resolved on their own, the duration of the disease in the PB cases was, on
an average, shorter comparecLlg, MB cases. This accounted for the
increase in the MB cases. The backlog of cases prevalent during the early
stages of MDT also disproportionately increased the number of multibacillary cases.
Childhood Leprosy Rate : An increase in the proportion of children
among the new cases was seen in all the districts compared to what it was
at the commencement of MDT, the increase varying widely from 9.3 in
Purulia to 285 per cent in Balasore.
TABLE-15
Prevalence & Annual Case Detection Rates in Selected Districts
Completing Intensive MDT Phase
District
Prev. rate
Prev. Current.
BALASORE
CHENGAI MGR
*DUMKA
DEOGARH
DHARWAD
DURG
MAYURBHANJ
PURI
PURULIA
VISHAKHAPATNAM
WEST GODAVARI
8.1
12.8
10.8
6.2
9.0
11.4
10.5
33.7
9.3
6.6
7.0
3.3
1.9
1.0
2.7
4.5
2.0
4.4
1.0
1.7
%
Vari.
-13.5
-74.2
-82.4
-83.8
-70.0
■60.5
■80.9
■86.9
-89 2
-74.2
Annual Case
Detection rate
Prev. Current
0.8
2.4
2.3
2.4
2.8
5.7
1.9
2.6
4.9
2.7
0.6
1.6
1.7
1.2
2.0
2.0
1.0
1.7
1.0
1.2
%
Vari.
-25.0
-33.3
-26 0
-50.0
•28.5
•64.9
■47.3
•34.6
■79.5
-55.5
39
TABLE-16
MB Ratio & Childhood Leprosy Rate in Selected Districts Complet
ing Intensive MDT Phase
District
MB ratio in
new cases
Prev. Current
BALASORE
CHENGAI MGR
DEOGARH+DUMKA
DHARWAD
DURG
MAYURBHANJ
PURI
PURULIA
VISHAKHAPATNAM
WEST GODAVARI
35
32.8
31.0
27.8
29.0
32
19.0
29
33.0
12
33.0
27.6
45.0
25.6
38
50
23.0
31
35.8
14
°z
/o
Vari.
Childhood
%
Prev. Current
-7.1
-15.8
+48.4
-8.8
+31.0
+56.2
+21.0
+6.8
+8.4
+ 16.6
12.7
14.5
16.0
13.0
18.6
15.0
18.0
16.0
14.2
15.6
49.0
19.2
12.0
20.0
21.0
19.0
23.0
17.5
31.0
38.0
%
Vari.
+ 285
+32.4
-25.0
+53.8
+ 12.9
+26.6
+27.7
+9.3
+ 118.3
+ 143.5
TABLE-17
Disability & Relapse Rates in New Leprosy Cases in Selected
Districts Completing Intensive MDT Phase
District
BALASORE
CHENGAI MGR
DEOGARH+DUMKA
DHARWAD
DURG
MAYURBHANJ
PURI
PURULIA
VISHAKHAPATNAM
WEST GODAVARI
MB ratio in
new cases
Prev. Current
12.2
6.8
15.4
2.0
11.6
NA
6.4
9.6
3.4
5.4
NA
2.4
10.1
1.4
8
NA
1.0
6.8
2.0
1
%
Vari.
NA
-64.7
-34.4
-30.0
-31.0
NA
-84.3
-29.1
-41.1
-81.4
Childhood
%
Prev. Current
Vari.
0
0.8
0.3
.02
0.5
0
0.2
1.6
0
0
NA
•12.5
-•
■50
-60
-10
-12.5
-
%
0
0.7
0.3
.01
0.2
0
0.18
1.4
0
0
TABLE-18
Voluntary Case Reporting Rate in Selected districts Completing
intensive MDT Phase
Districts
BALASORE
CHENGAI MGR
DEOGARH+DUMKA
DHARWAD
DURG
40
Voluntary Reporting rate
Prev.
Current
20
23
26
46
22
60
36
35
53
30
Vari.
+ 40
+ 13
+9
+8
+8
MAYURBHANJ
PURI
PURULIA
VISHAKHAPATNAM
WEST GODAVARI
15
21
19
33
36
25
34
27
27
51
+ 10
+ 13
+8
-6
+ 15
Prev. = Before MDT
Vari. = Variation
Disability Rate: The disability rate also showed a decrease in 8 of the
10 districts; in the remaining two no information was available. The decline
in the disability rate was difficult to explain. No doubt, it was partly due to the
effect of M DT, as in these districts the M DT had been in progress for several
years. On the other hand, it was also influenced by a large scale elimination
of disabled patients during initial screening at the commencement of MDT.
Relapse Rate : The relapse rate showed a decrease in all the 5
districts for which information was available.
Voluntary Reporting Rate : An increase in self reporting varying from
8 to 40 per cent in different districts was in fact a measure of the confidence
of people reposed in the effectiveness of MDT and an increasing aware
ness of the availability of cure against leprosy.
6. TRAINING OF PERSONNEL
NLEP maintained its own cadre of leprosy workers for the training of
which 49 training centres were established during the successive five year
plans. These leprosy training centres were spread over 12 states in the
country (Table-19).
TABLE-19
Distribution of Leprosy Training Centres by States
S.No. State
1 Andhra Pradesh
2 Assam
3 Bihar
4 Gujarat
5 Karnataka
6 Kerala
7 Madhya Pradesh
8 Maharashtra
9 Orissa
10 Tamil Nadu
11 Uttar Pradesh
12 West Bengal
Total
Number of leprosy Training centre
7
1
4
1
4
2
3
7
2
8
5
5
49
Institutional data available on the number of personnel of different
categories trained and their annual training capacity will provide some
insight into the performance of these institutions (Table-20)
TABLE-20
Number of Training Centres, Their Annual Training Capacity and
the Number Trained by Category
S.No. Category
1.
2.
3.
4.
5.
6.
Para-meoical worker
Non-medical supervisors
Lab. technician
Physiotherapy technician
Health educator
Medical officer
No. of
Training
Centres
39
9
8
7
2
11
Annual
Training
Capacity
No. Trained
Till March
1992
2048
111
130
73
20
274
17265
2061
1975
529
401
3161
Only 11 of the 49 centres were engaged in the training of medical
officers while those that trained non-medical supervisors, laboratory tech
nicians and physiotherapists numbered nine, eight and seven. Only 2 of the
institutions provided training in health education.
The above training capacity should be viewed in the background of
current training needs as well as the anticipated requirements in the near
future in the country. Amongst the existing personnel, over 5000 para
medical workers, 1000 non-medical supervisors, 739 doctors, 508 labora
torytechnicians were without training. In addition, 281 physiotherapists and
246 health educators were untrained (Table-21). The extension of MDT
services to 77 moderately endemic districts having prevalence rates be
tween 2 to 5 per 1000 population added its own training load.
In 1986-87, a WHO consultant appointed to recommend steps for
NLEP staff development in view of the Switch over to the MDT programme,
concluded that while the recruitment and training of para-medical workers
TABLE-21
Current Training Status of Personnel in the Programme
Personnel
Medical officers
Non-medical supervisors
Para-medical workers
Laboratory technicians
Physio-therapists
Health educators
42
Sanctioned
Strength
Training
Number
Trained
Number
Requiring
Training
1403
4034
19327
1383
641
409
664
2137
14200
875
360
163
739
1087
5127
508
281
246
was on the whole satisfactory, the same could not be said of medical
officers, non-medical supervisors, laboratory technicians, physiotherapists
and health educators'. It was felt that top priority was required to be given
to the training of over 800 medical officers, 2500 non-medical supervisors,
7000 para-medical workers and 1500 smear technicians.
In order to cater to this need either the existing institutions would be
required to accelerate their activity or nej/v training centres established. In
this context, it must be noted that the current utilization of the training
capacity of the existing institutions was only 36.0 per cent for medical
officers and 39.0 per cent for non-medical supervisors.
VACANCY OF POSTS
The overall vacancy position by category of staff may be seen in
Table-22. The sanctioned post for the programme varied from about 19500
to 27000 between 1985 and 1991 and about 15 to 25 per cent of them lay
vacant at any point of time.
An analysis of the data showed that the worst affected states were
Bihar, West Bengal, Karnataka and Madhya Pradesh. The most affected
category was that of physiotherapists in which 35.0 per cent of the posts
were unoccupied.
7.
r
PERFORMANCE
The recorded evidence indicated that NLCP/NLEP performance dur
ing the last four decades of its existence was creditable. The programme
came into being in 1955 and did not take off until the end of 3rd five year plan^
that is for over 10 years of its birth. Several constraints-social, epidemiologi
cal, therapeutic and technical impeded its progress. It was only during the
5th plan period that the programme got activated. The programme received
a further boost after inclusion of MDT as the main strategy for disease
control as indicated by the investments made and infrastructural facilities
created.
8.
i) Disease Detection and Treatment
One of the most important activities of NLEP was that of surveying
households and examination of family members in the endemic areas to
detect cases. The performance in this respect could be assessed on the
basis of
- per cent of endemic population surveyed ; and
- per cent of estimated cases detected
Population survey was a continuous on-going activity at the LCU and
SET centres. It was expected that the total population examination would
1 Tranining lor National Leprosy eradication Programme Needs-lndia. WHO Project.
ICP LEP001,31st August, 1987. New Delhi.
43
TABLE -22'
Vacant Posts in NLEP
Category
of Post
1985
Sanctioned
%
Vacant
1987
Sanctioned
%
Vacant
1989
Sanctioned
%
1991
Sanctioned
Vacant
%
Vacant
ZLO/DLO
MO
NMS
PMW
Lab. technician
Physiotherapist
HE
NA
1069
2754
14212
553
746
NA
18.9
15.6
11.7
32.4
39.5
234
1009
3324
17043
813
556
410
17.9
28.3
24.4
22.6
39.7
48.4
42.0
238
1076
3654
17683
1036
616
NA
14.7
14.6
17.1
18.9
34.2
50.0
NA
271
1132
4034
19327
1383
641
409
27.6
28.2
17.7
21.9
30.8
35.5
23.2
Total
19334
14.3
23339
24.6
24303
19.9
27152
22.5
' Source : Ministry ot Health & Family Welfare, DGHS (1985, 1987, 1989, 1991), NLEP, 1st 2nd, 3rd and 4th independent
evaluations.
be completed once in 5 years. Programme evaluation in 1991 showed that
more than 87.0 per cent of the para-medical workers were engaged in
survey, spending on an average 28 days in the field in the preceding 3
months. Average population examined by a para-medical workers in the
last 3 months was 3280 in the 33 MDT districts.
The second indicator used for performance assessment was the per
cent of estimated cases detected. There were 3.9527 million cases of
leprosy in India, out of which 2.584 million (65.37%) had been detected by
Dec. 1980. There was a remarkable increase in case detection during thfi.
6th plan period accounting for 41.5 per cent of the total case detection till
that time (21.44 lakhs out off 51.70 lakhs). The case detection shot up
further in the 7th plan period numbering 29.12 lakhs (Table-10).
Another, perhaps even more important, NLEP activity was to bring the
detected.cases under treatment to eliminate the foci of infection. As on 31
’March, 1991, there were 20,43,136 cases on record, of which 1877199
(91.9%) had been brought under treatment. A total of 5.41 million cases had
been discharged as cured or eliminated due to death since the inception of
the programme.
ii) Programme Monitoring
A well developed system of programme monitoring and reporting
existed under the NLEP. It operated at all levels of administrative hierarchy.
The data orginated at the peripheral level of the units and was
reported to the district headquarters which, in turn, forwarded it for aggre
gation to the state. An efficient management of the programme depended
on continuous monitoring and initiating remedial measures in time. For this
reason, an elaborate system of data collection, recording and reporting was
prescribed in the programme. Monthly, quarterly and yearly reports were
envisaged. Certain MDT districts were required to send special report on
their progress. Even the highest level of administrative control in the
Government of India set a great store by regular programme monitoring
•^The Leprosy Commission, under the chairmanship of Health Minister met
at least once a year to lay down policies, for the implementation of which the
Leprosy Eradication Board met once in six months.
Despite such an elaborate system, the programme suffered set backs
as many of the health workers did not have understanding of why the
reports were required. Many of them did not receive training in filling up the
forms’, development of skills in interpreting data and using information for
programme management. These inadequacies came to light during the 4th
independent evaluation of NLEP in,1991. It was, however, to the credit of
the programme that the data originating in the field was found to be reliable
45
and the reports from 90.0 per cent of peripheral units were sent regularly
and in time.
Hi) Management
NLEP had considerable inputs that were vital to its functioning. A vast
network of infrastructure existed under it. The programme presently moni
tored a cadre of 26788 technical persons. Centres were maintained to train
manpower and facilities had been created in the form of temporary hospi
talization units and reconstructive surgery units to provide specialized care.
These called for considerable managerial skills for their optimal utilization.
In addition, it was necessary to ensure continuous supply of adequate anti
leprosy drugs, equipment and transport at all levels.
The programme suffered for want of an optimal management. Nearly
one-fourth of the sanctioned posts remained unutilized and were filled, the^
incumbents suffered for want of training. Half of the health educators had
not received any training while more than one-third of the medical officers
and non-medical supervisors were untrained.
Cadre management presented its own lacunae, the Swaminathan
Commission recommended that the state leprosy officer being the chief
coordinator and technical advisor to the state government on NLEP, his
post should be held by a senior officer with adequate administrative
experience, holding at least the rank of a deputy director of health services.
He should remain in position for a minimum period of 10 years to enable him
to take a long view of the problem. However, only 13 of the 24 SLOs
interviewed during the 4th evaluation possessed earlier experience of work
in leprosy. The average stay of the SLO at his post was only 1 year and 8
months.
9.
EXPENDITURE
At what cost were the foregoing infrastructural facilities for providing
leprosy services established. A simple question like this was difficult to
answer. Analysis of the available data may throw some light on this.
question.
The NLEP had been a centrally aided programme upto 1968-69 when
it was developed, managed and financed by the state governments with
assistance from Government of India. However, during the 4th plan period
commencing 1969-70, the programme was fully supported by Government
of India as a centrally sponsored scheme and the total expenditure on it
became chargeable to Government of India, while the programme was
implemented by state governments according to the guidelines of the
centre.
It would be seen from Tabel-23 that expenditure on NLCP suddenly
46
increased during the 5th plan period when a large number of institutions
came into being. This constituted more than 50 per cent of the estimated
expenditure of NLCP. The expenditure during the 6th plan doubled that of
the 5th plan expenditure and that of the 7th plan was twice as much as in the
6th plan. Large infrastructural facilities were established during the 6th and
7th plan periods due to extension of multi-drug treatment programme to
more and more districts in the country.
Utilization of development budget for 1990-91 by the states showed
that while the utilization of total budget provision was more than 90.0 per
cent in as many as 19 states/UTs, it was not so in the case of another 7. No
information was available in respect of 6 states. Not all the states, however,
utilized the non-revenue budget provision. Bihar surrendered the entire
(.amount of Rs. 107 lakhs. Likewise, expenditure was about 50.0 per cent of
the plan outlay in the states of Andhra Pradesh, Kerala, Maharashtra,
Rajasthan and Tripura.
Table-23
Expenditure on NLCP/NLEP During Successive Five Year Plan
Periods
Period
Expenditure
Pattern ol Assistance
1st Plan (1955-56)
2nd Plan (1956-61)
3rd Plan (1961-66)
Annual Plan (1966-69)
4th Plan (1969-74)
5th Plan (1974-79)
Annual Plan (1979-80)
6th Plan (1980-85)
7th Plan (1985-90)
1990-91
1991-92
35.00
529.00
425.00
63.00
286.00
2023.00
232.00
4004.43
8582.00
2193.57
2280.00 (BE)
Centrally aided
Centrally aided
Centrally aided
Centrally aided
100%
50:50
50:50
100%
100%
100%
100%
HEALTH EDUCATION
Serious recognition of the fact that health education formed an
effective means of promoting leprosy control programme was relatively
recent Age-long prejudice and ignorance in the society regarding the
nature of the disease and tlie possibility of arresting and curing it came in
the way of leprosy control. A change in the general prevailing attitude would
immediately sharpen the cutting edge of our available weapons against
leprosy.
With the acceptance of MDT as a sheet anchor for arresting the
disease, it became all the more important to prepare the community on the
10.
47
curative role of these drugs, the need for regular treatment for prolonged
periods, assistance in default retrieval and social integration of the general
patients.
Every worker under the NLEP was expected to be a health educator.
Inspite of educational component incorporated in the methodology of
leprosy control since the inception of NLEP, necessary messages failed to
reach the people to the desired extent. Financial out-lays were simultane
ously enhanced under NLEP towards health education from 1984-85.
Health education in the programme aimed at:
- creating awareness on the availability of free treatment;
- developing knowledge on the nature of leprosy, its amenability
to cure, recognition of early signs of the disease and prevention
of deformities:
- promoting social integration of the leprosy patients; and
,
- promoting community's commitment to the programme.
The impact of health education on the programme was gone into
some detail by the 4th Independent Evaluation It would be relevant to
discuss some of its findings.
A high degree of programme awareness prevailed in the community.
A great majority of the villagers (71.2% out of 425 interviewed) were aware
of the leprosy workers visiting the villages. Nearly half of them knew the
workers by name. As many as 65 per cent were familiar with the work the
paramedical workers performed in the villages.
Nearly 60.0 per cent of the respondents believed that leprosy did not
spread easily while more than 70.0 per cent knew that tfie disease was
curable. A high proportion of them (67.0%) knew that a leprosy patient could
be safely kept at home. The majority was knowledgeable on the nonhereditary nature of leprosy.
The general belief that the leprosy patients were shunned by one and
all was not borne out by facts. More than 90.0 per cent of the 466 patients
lived with their families and half of the patients were occupied in one .
vocation or the other.
It was obvious that the programme had percolated to the people. The
general attitude of the community towards the disease was positive. The
proportion of self-reporting cases had gone up substantially overthe years.
Among 466 patients interviewed, 255 (48.2%) had reported to the medical
officer on their own.
Undoubtedly, wide variations existed from state to state in respect of
health education component of the programme but the overall picture was
quite satisfactory. It was in the states of Gujarat, Orissa and Maharashtra
that the health education seemed to have made the maximum impact.
48
with extensive field centres comprehensively engaged in antileprosy activi
ties. Thus, the resources of the several of the voluntary agencies were
directed to converge on a single focus of leprosy eradication. It is for the
programme managers now to ensure that these efforts became mutually
supportive with a clear understanding and appreciation of each others role.
It can be facilitated by forming a consortium or a similar structure to develop
linkages between various agencies at the state and central levels for the
purpose of imaginative utilization of all existing facilities.
b. International and Bilateral Agencies
Following the announcement of the Government of India to eradicate
leprosy in a time bound manner, there was wide spread international
interest in the national leprosy eradication programme. Several interna
tional agencies such as UNDP, World Bank, SIDA, DANIDA, WHO,
UNICEF etc. were cooperating with the government in leprosy control. The
most significant role had been played by WHO in evolving a global
programme for leprosy control and providing technical guidance in formu
lating newer strategies from time to time.
WHO’s special programme for research and training in tropical dis
eases covered leprosy and focused on certain significant areas of research
such as:
- development of better diagnostic tests;
- determination of the prevalence of resistance to dapsone;
- development of improved methods of treatment including MDT;
and
- development of vaccine and new drugs.
SIDA was assisting the NLEP since 1978 The first MDT projects in 2
districts viz Wardha and Purulia were launched with SIDA support. SIDA
provided assistance to 15 endemic districts through WHO. These districts
included Srikakulam, Vizianagaram, Ganjam, Deogarh, Varanasi, Purulia,
Krishna, Chandrapur and Thanjavur. The first 10 districts had since gone
'■'into the maintenance phase. In addition, financial assistance for the
services of 40 consultant leprologists was made available.
Implementation of MDT and promotion of health educaiton were the
two main foci of assistance of most of the international agencies. These
activities received assistance from DANIDA in 8 of the districts, by LEPRA
in 6, by NORAD in 3 and by Italian Leprosy Association and Damien
Foundation in 2 each.
13. TENTATIVE PLAN FOR LEPROSY ELIMINATION IN THE COUN
TRY
The Government of India are committed to eradicate leprosy by the
year 2000 AD. The strategy is to provide rapid universal MDT coverage in
51
all the endemic districts. The count down of affected cases and villages has
already begun.
There are 450 districts in India; 201 are high endemic for leprosy with
a prevalence to 5 or more per 1000 population. Another 77 districts have
prevalence varying between 2 and 5. The remaining 177 districts have
prevalence below 2/'000.
Presently the 201 districts have been brought under MDT. These
districts have 85.0 per cent of the total cases in the country. However 66 of
these districts have very recently been sanctioned MDT with a modified
pattern of services. It is proposed to establish vertical MDT services to
these districts by March 1993 with the assistance of World Bank.
Following an in-depth analysis of leprosy situation, 77 districts have
been identified having leprosy prevalence of 2 to 5 per 1000 population
These districts are intended to be covered under modified MDT scheme in
the proposed World Bank project.
M DT was very well accepted by the patients, the tolerance was good
and side effects were minimal. The drug compliance as observed by
attendance rate was high. There was marked reduction in the reactive
episodes. MDT had improved the motivation among patient, staff and
community. There was increased awareness and knowledge about leprosy
in the community as reflected by more and more self reporting of new
patients.
Annual performance of NLEP in the 6th and 7th plans, after MDT had
been introduced as presented in Table-24 shows that for the first time in
1987, the number of cases discharged were 10 per cent more than the
newly detected cases. The ti end is noticeable in subsequent years as well.
This has undoubtedly been possible due to larger and larger number of
patients being brought under multi-drug therapy. The programme is, thus,
moving in the right direction of control. It is expected that the absolute
number of leprosy cases would come down to less than 1.0 per cent of the ,
present case load in the next five years.
TABLE-24
Year
1991
1992
1993
1994
1995
52
No. ol
cases at
the begining
ol the year
New
cases
MDT
2120
1770
1290
990
760
+ 450
<420
+ 400
+370
+320
•500
•650
-500
■500
-500
Discharges
Monotherapy
death, other
reasons
•300
•250
-200
-100
-50
No. ol
cases at
the end
the year
1770
1290
990
760
530
1996
1997
1998
1999
2000
530
330
170
120
60
-450
-380
-250
-200
-150
+280
+240
+ 220
+ 150
+ 120
330
170
120
60
20
-30
-20
•20
-10
-10
The proposed annual targets for case detection and cure and number
of cases at the end of each year upto the year 2000 as worked out by the
Leprosy Division, Directorate General of Health Services in presented in
Table-25.
14. ISSUES
The issues in leprosy should be examined in the context of incomplete
scientific knowledge on many facets of the disease and the limitation of the
> available chemotherapy. Despite these limitaitions, there is evidence to
suggest that the disease is on decline.
TABLE-25
Targeted Achievements Under NLEP by Years
(Cases in Millions)
Year
No ol cases
at the beginning
ol the year
New
cases
Discharges
Monotherapy
death, other
reasons
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2.043
1.743
1.453
1.173
0.839
0.623
0.323
0 093
0.073
0.023
0.003
+0.45
+ 0.43
+0.40
+0.37
+ 0.35
+0.30
+0.25
+ 0.23
+0.15
+0.10
+ 0.10
-0.75
-0.72
-0.68
-0.65
■0.62
-0.60
•0.48
-0.25
■0.20
-0.12
-0.103
No. ol Cases
at the end
ol the
year
1.743
1.453
1.173
0.893
0.623
0.323
0.093
0.073
0.023
0.003
0.000
On the basis of the work done over a period of 12 years, it was
observed that the prevalence rate in an observed area fell from 2.16 to 1.1
per cent; the total infectiousness declined from 149 to 36 with an average
reduction of 9.0 per cent per year, though the incidence of the disease
apparently did not appreciably come down. Another study carried out by
Gandhi Memorial Leprosy Foundation in Bobbilli area of Andhra Pradesh
indicated that the number of new cases and the incidence rate per 1000
population decreased from 144 and 7.2 in 1964-65 to 34 and 1.63 respec
tively in 1972-73. In yet another area, the incidence declined from 3.11 per
1000 in 1957 to 1.50 per 1000 in 1972.
53
There is no doubt that there has been substantial progress in the
control of leprosy in the country. The achievements ot MDT so far have
been impressive. The situation in districts which have completed more than
5 years of MDT seems to prove that elimination of leprosy from India is
within sight. However, the successive evaluations of NLEP performed
between 1986 to 1991 have drawn attention on certain issues affecting the
programme. These are:
- lack of interest and support by medical men in general to work in
leprosy;
- lack of motivation of workers and lack of enthusiasm in govern
ment officials;
- presence of untrained staff in sufficient numbers within the
programme at all levels;
- the training centres remained under-utilized;
- indadequate training in leprosy of under-graduates, laborotary
technicians and non-medical supervisors;
- full complement of staff sanctioned has not been in position;
- inadequate bacteriological surveillance and sub-standard qual
ity of laboratory work;
- lack of desired emphasis on health education
- inadequate facilities of temporary hospitalization wards and suboptimal utilization of the existing ones;
- lack of rehabilitaiton facilities;
- inadequacy of vehicles and disrepair and poor maintenance of
available vehicles;
- inadequate coverage of entire population by SSAUs for long
periods;
- lack of operational research in leprosy to solve problems arising
in the field.
It would be seen that many of the limitations have been in respect of
managerial inputs. However, recent years have witnessed heightened
expression of activities on various facets, of NLEP. It is matter of satisfac
tion that the governments both central and states have been alive to these
weaknesses in the programme. Administrative supervision has been
strengthened to solve on the spot problems by appointing 45 consultant
leprologistswith SIDA assistance in selected districts. A system of monitor
ing has already been built into the programme to provide regular feed back
for corrective measures. There is growing concern for the timely achieve
ment of targets for disease control and the political will for elimination of the
disease by the turn of the century remains unshaken. There has been
substantial increase in financial outlays for NLEP.
54
It is envisaged that as the prevalence rate of leprosy declines to less
than 1/1000 population, the leprosy services would be integrated into
general health services. The paramedical workers would work under the
supervision and guidance of medical officers of primary health centres.
While at some stage the integration of the two will have to take place, the
questions that arise at this stage are:
- will the general health services be able to maintain leprosy
control in the face of competing priorities for family planning and
other health programmes diseases; and
- do the general health services staff possess the necessary
competence, knowledge and skills and above all the commit
ment for leprosy control.
NLEP remains largely a vertical programme. If the goal of disease
cgntrol is achieved as planned, it would be a great success for the vertical
programme. The success of small pox eradication in the country is an
example of the operational efficiency of vertical disease control pro
gramme, unlike malaria that was integrated at crucial stages of its low
prevalence.
There is a need for caution in integrating leprosy services with general
health care services. The operation of modified MDT scheme in selected
districts should be viewed as an experimental field trial towards integra'ion.
Its results should be carefully evaluated before embarking on dismanting
the existing structure of NLEP.
55
Appendix-1
FOLLOWING FACTS HAVE BEEN KEPT IN MIND IN FIXING THE
STATEWISE TARGETS - 1976-77, NLCP
1.
For high endemic States/UTs namely, Andhra Pradesh, Bihar, Maharashtra,
Nagaland, Orissa, Tamilnadu, West Bengal and Pondicherry, the preva
lence rate of leprosy in Leprosy Control Unit area and SET Centre area is
taken, on an average, as 1.5 per cent and 0.7 per cent respectively. For
other States/UTs, these figures are 1.0 per cent and 0.4 per cent respec
tively.
2.
Targets are based on the number of sanctioned staff with the units/centres^t
3.
It is presumed that a PMW surveys a minimum population of about 5000 in
a year.
4.
For the units/centres established upto IV Plan, calculation has been made
on the fact that about 15 per cent of the estimated number of cases in their
respective areas should be brought under treatment in addition during 197677. Because including new cases and the undetected cases the total number
per year will exceed 20 per cent of the estimated cases of an area for some
times.
5.
For the units/centres established or due to be established during 1976-77
during Fifth Plan, calculation has been made on the fact that about 20-30 per
cent of the estimated cases in their respective areas should be brought
under treatment during 1976-77.
6.
It is assumed that units/centres of 1976-77 will be working for about 3-4
months during 1976-77.
7.
About 15 percent of the total cases brought and remained under treatment
till the end of previous year i.e., 1975-76 should be made bacteriological
negative and disease-arrested or cured during 1976-77 by treatment.
Source:
Government of India, Ministry of Health and Family Planning (Department of
Health)-A communication issued to States vide T. 11023/11/75-MTP (C &
CD) dated 7.6.1976, under National Leprosy Control Programme-Targets
for the year 1976-77.
56
Printed at T.P.S,, New Dpi),;
11. REHABILITATION
Rehabilitation of leprosy patients was the joint responsibility of Minis
try of Health and Family Welfare as well as Social Welfare Ministry. It
included physical, vocational and social rehabilitation. Physical rehabilita
tion depended heavily on tire health ministry, involving as it did care of the
ulcers, correction jaf deformities, physiotherapy and health education.
However, the existing facilities for physical rehabilitation were far too
meagre considering the programme needs. There existed 75 recon
structive surgery units and 13 leprosy rehabilitation promotion units
(LRPUs) under the NLEP. The LRPUs aimed at providing vocational
rehabilitation besides facilities for surgical correction of deformed/disabled
patients.
Now that MDT was being implemented in 201 districts and the disease
^prevalence had substantially come down, rehabilitation and prevention of
dehabilitation assumed great importance. Deformities were more com
monly associated with long standing disease. MDT, which reduced the
duration of treatment was expected to make a definite impact in reducing
the occurrence of deformities. However, deformities would still occur due to
reactionary episodes, such as neuritis. An accelerated programme of
rehabilitation was, therefore, an immediate need of NLEP
It was understood that the World Bank had agreed to support a project
of the Government of India to provide rehabilitation including prevention of
dehabilitation in the 66 endemic districts showing leprosy prevalence of
more than 5 per 1000 and in another 77 districts where the prevalence rate
was between 2 and 5. The project was expected to cater to an estimated
case load of 600000 in the former set of districts and to 900000 in the latter
It was proposed to establish rehabilitation promotion and training units
with the World Bank assistance at 15 places in the country as indicated
below :
1. Kanpur
11. Midnapur
6. Patna
2. Puri
7. Bhopal
12. Vishakhapatnam
8. Trivendrum
3. Chengalput
13. Banglore
4. Baroda
9. Shimla
14. Thane
5. Guwahati
10. Jaipur
15. Hyderabad
12. VOLUNTARY AND INTERNATIONAL AGENCIES IN ANTI-LEPROSY WORK
A large number of organizations were involved in various activities
pertaining to control of leprosy in India. While some of tiiem were engaged
in training, education and monarch, others were engaged, in addition, in
case detection, treatment a'V-?ehabilitation to promote leprosy control A
large number of them were voluntary, some were governmental organisa
tions and some others international agencies.
49
a. Voluntary Organisations
Voluntary organisations played a pioneering role throughout the
history of leprosy control in the country. The first known leper asylum was
established in Calcutta early in the 19th century followed by another in
Varanasi. Mission to Lepers, started in 1875 at Chamba, was by far the
biggest single agency engaged in leprosy work.
The earlier focus of these agencies was through out-patient’s clinics
in the country. With the introduction of dapsone for the treatment of leprosy,
the focus changed from an individual patient to the entire population.
After 1951, there occurred an extensive expansion of voluntary
services for leprosy all over the country. Presently, about 285 voluntary
organisations were actively engaged in leprosy relief.
Some of the prominent organisations in the field were :
<
Gandhi Memorial Leprosy Foundation, Wardha, Maharashtra
Hind Kusht Nivaran Sangh, New Delhi
Bharat Sevashram Sangh, Jamshedpur, Bihar
Kashi Kusht Seva Sangh, Varanasi, Uttar Pradesh
Anandvan, Warora, Maharashtra
Tapovan, Amravati, Maharashtra
Hindu Mission, Madras, Tamil Nadu
In addition to institutions establihsed by NLEP, a number of voluntary
agencies contributing a great deal towards leprosy control were subse-'
quently taken over by the government. Prominent among them were :
- Central JALMA Institute for Leprosy, Agra
- Belgium Leprosy Centre, Dharmapuri, Tamil Nadu
- The Danish Leprosy Mission, Aska, Orissa.
Recognizing the great potential of voluntary agencies, the DGHS
evolved in 1985 a mechanism for annual meetings with them with a view to
establish communication and exchange of information and also to under- stand the nature of their work.
The majority of these organisations were multi-functional in nature,
rendering curative-rehabilitative services, besides organising the training of
medical and health auxiliaries. With a bed strength of 14,409 in 1990 in 127
organisations, these institutions vocationally rehabilitated 35275 leprosy
affected persons and nearly 20,000 suffers or were medically rehabilitated.
About 5.0 crore population was covered under SET activities. Nearly a
million cases were detected so far and 1,25,000 cases were discharged.
International voluntary agencies were the pioneers in leprosy relief
work in India. They continued to play a major role in NLEP activities. The
Leprosy Mission, German Leprosy Relief Association, Swiss Emusus,
Damein Foundation and Italian Leprosy Association were organisations
50
Reprinted from “Indian Journal of Leprosy"
Vol. 56 No. 1, Jan-Mar 1984
THE MOUSE FOOTPAD TEST—SENSITIVE TO SMALL
PROPORTIONS OF DRUG-RESISTANT BACILLI
IN A SAMPLE OF M. LEPRAE
J.G. Almeida, P.S. Joseph, G. Sarangapanj, and C.J.G. Chacko
Vol. 56
No. 1
INDIAN JOURNAL OF LEPROSY
Jan-Mar 1984
THE MOUSE FOOTPAD TEST—SENSITIVE TO SMALL
PROPORTIONS OF DRUG-RESISTANT BACILLI
IN A SAMPLE OF M. LEPRAE
J.G. Almeida1, P.S. Joseph1, G. SarangapaniI.
23, and C.J.G. Chacko4
Abstract : In experiments at the Radda Barnen Research
Laboratories of the SLR & TC Karigiri, the mouse footpad test
was demonstrated to detect DDS-resistant M.leprae even if as
few as 0.1% (J in 1000) of the M. leprae tested were DDSresistant. The mouse footpad test appears to be sensitive to
minute proportions of drug-resistant bacilli in samples of
M. leprae tested.
The demonstration of drug-resistant M. leprae by the mouse footpad
test (Pettit et al, 1964) is commonly interpreted to mean that a majority of
the M. leprae in the sample tested are drug-resistant (Almeida et al 1983 ;
Baquillon et al 1980, 1983 ; Pearson et al, 1980, 1981, Pettit et al 1964).
Samples of M. leprae with only small proportions of drug-resistant M.
leprae would presumably escape being labelled “drug-resistant” by the
mouse footpad test. The objective of this study was to test directly
w hether the assumption is valid.
The study was carried out in the Radda Barnen Research Laborato
ries of the SchielTelin Leprosy Research and Training Centre, Karigiri,
where a large mouse footpad laboratory has been in operation since 1970.
MATERIALS AND METHODS
Two separate populations of M. leprae labelled “R” and “S” respec
tively, were taken from mouse footpad culture. “R” was obtained from
mice continuously fed DDS from the day of inoculation, at a concentration
of 0.01% w/w DDS in mouse diet. “S” was obtained from mice fed &n
DDS, and had already been shown to be completely inhibited by 0.01 %
w/w DDS in mouse diet.
Each of the populations was processed for inoculation into mouse
footpads by routine methods previously published (Rees, 1964). The
I.
10
Dr. J.G. Almeida, M.B., B.S., Research Fellow,
2.
Mr. P. Samuel Joseph, Tutor Technician,
3.
Mr. G. Sarangapani, Technician-,
4.
Dr. C.J.G. Chacko, M.D., Ph. D., Professor of Pathology, CMC&H, Vellore,
Head, Radda Barnen Research Laboratories, SchiefTelin Leprosy Research and
Training Centre, Karigiri 632106, India.
ALMEIDA ET AL—MOUSE FOOTPAD TEST
separate suspension of “R” and “S” bacilli that resulted, were then mixed
in five different proportions of “R” to “S” bacilli : IOO%“R” + O%“S”,
10%“R” + 90%“S”, 1%“R” + 99%“S”, 0.l%“R” + 99.9%“S”, and
0%“R” + 100%‘'S". These will be referred to as 100%R, 10%R. 1%R,
0.1 %R and I00%S respectively.
Each of the five was diluted to give 3.3 X IO5 M. leprae per ml, and
0.03 ml was inoculated into each hind footpad of CBA mice. The mice
were then maintained in two groups : One (control mice) fed normal
mouse diet, and the other (treated mice) fed the same diet mixed with
0.01 % w/w DDS from the day of inoculation. Samples of the diet were
tested to ensure that the required concentration of DDS was achieved
(Ellard, 19S0). Mice treated with DDS in the diet will be referred to as
“treated" mice and those on normal diet as “control” mice.
Foot by foot harvests were performed from “control'’ mice at 1
week after inoculation, and on both “treated” and “control” mice
and 4th months after inoculation. Footpads were processed by routine
methods to detect M. leprae (Rees, 1964). “Positive” harvests are those
in which M. leprae were found. No bacilli could be found in footpads
yielding <0.5X IO4 M. leprae.
RESULTS
Tables 1 and 2 show the results of harvests in control and treated
mice respectively. The most remarkable finding is that the inoculum of
0.1 %R yielded positive footpads in treated mice.
Table 1 :
Mouse footpad harvest results from control mice
Inoculum
I
No. of Footpads (Positive/Harvested) at
3RD MONTH
4th month
WEEK
100%R
0/4
I0%R
0/4
8/8
4/4
1%R
0/4
8/8
4/4
0.1 %R
0/4
2/2
8/8
100%S
0/4
8/8
4/4
8/8
4/4
Vol. 56
No. I
Table 2 :
Inoculum
Jan-Mar 1984
INDIAN JOURNAL OF LEPROSY
Mouse footpad harvest results from treated mice
No. of Footpads (Positive/Harvested) at
3rd month
4th month
8/8
4/4
10%R
2/8
4/4
1%R
0/8
4/4
0.1 %R
*
ND
10/12
100%S
0/8
0/4
100%R
’ Not done
“R” bacilli were taken from mice continuously fed on 0.01% DDS
mixed with the diet from the day of inoculation, and may be regarded as j
predominantly DDS-resistant. “S” bacilli were taken from mice fed §8
DDS, and are seen to be completely inhibited by 0.01% DDS in the mouse
diet (Table 2). They may be regarded as predominantly DDS-sensitive.
The inoculum "0.1%R
*
‘ therefore contained as few as 1 resistant M. leprae
in 1000. np
Yet harvest of treated mice in the 4th month after inoculation
found 10 to 12 footpads positive.
There are several noteworthy features in the results. None of the
control mice harvested 1 week after inoculation yielded a positive food
pad. At each harvest of control mice, the proportion of positives among
harvested footpads was identical for inocula “IG0%R” and “IOG%S".
None of the treated mice with inoculum “IOO%S" yielded a positive foot
pad at any harvest. Between the 3rd and 4th month harvests of treated I
mice, the proportion of positives among harvested footpads apparently
increased. In the third month after inoculation, harvest of treated mice
suggests that as the proportion of“R” bacilli in the inoculum decreased,
the proportion of positives among harvested footpads also decreased.
DISCUSSION
In the light of the observations made, one must account for the
demonstration of drug-resistant M. leprae from an inoculum containing
as few as 1 resistant M. leprae in 1000 (0.1%). The mouse footpad test
12
Vol. 56
No.!
Indian journal of leprosy
Jan-Mar 1984
appears sufficiently sensitive to demonstrate drug resistant M. leprae even
when they form only 0.1% of the bacillary population. This minute pro
portion constitutes persuasive evidence of the sensitivity of the mouse
footpad test to drug-resistant M. leprae. The point can probably be
further emphasized by testing even smaller proportions of drug-resistant
M. leprae.
A common practice in the diagnosis of drug-resistance by the mouse
footpad test is to harvest treated mice from the sixth month after inocula
tion (Almeida et al 1983a, 1983b: Baquillon et al, 1980, 1983; Pearson
et al, 1980, Pearson et al, 1981 ; Pettit et al, 1964). If a positive footpad
is found, the M. leprae are declared to be “drug-resistant”. By these
criteria, it is difficult to see how a strain of M. leprae with only I resis
tant bacillus in 1000 can escape being labelled “drug-resistant.”
This report does not in any way detract from the intrinsic worth Bp
the mouse footpad as a model for the experimental study of leprosy. It
must be viewed rather as a sharpening of the valuable technique, that
hopefully will help shed new light on some of the puzzling questions that
remain in leprosy.
ACKNOWLEDGEMENT
We thank Dr. Mary Jacob for her help and suggestions.
Rao typed the manuscript.
Mr. Raja
REFERENCES
1. Almeida, J.G., Christian, M., Chacko, C.J.G., Taylor, P.M. and FrikTSCHI, E.P. (1983a). Studies on dapsone-resistant M. leprae in leprosy patients of
fciudiyatbam Taluk, the leprosy control area of the Schieffelin Leprosy Research and
Training Centre. Karigiri. 2. A progress report. Lepr. Rev., 54 : 185-191.
2. Almeida, LG., Chacko, C.J.G., Christian, M. (1983d). The significance
of DDS-resistanl M. leprae in untreated patients, hit. J. Lepr. (in press).
3. Baquillon, G„ Ferracci, C., Saintandre, R. and Pattyn, S.R. (1980).
Dapsone-resistant leprosy in a population of Bamako (Mali). Lepr. Rev., 51 : 315-319.
4. Baquillon, G., Ferracci, C., Van Loo, G„ and Pattyn, S.R. (1983).
Further results on dapsone-resistant leprosy in Bamako (Mali). Lepr. Rev., 54 : 19-21.
5.
Ellard, G.A. (1980).
Assaying dapsonc in mouse diets.
Lepr. Rev., 51 :
ALMEIDA ET AL—THE MOUSE FOOTPAD TEST
6.
(1980).
Pearson, J.M.I-L, Haile, G.S., Barnbtson, R. St. C., and Rees, R.J.W.
Dapsone-resistant leprosy in Ethiopia. Lepr. Rev., 51 : 315-319.
7. Pearson, J.M.H. (1981). The problem of dapsone-resistant leprosy. Int. J.
Lepr., 49 ; 417-420.
8. Pettit,
Lancet., ii : 673-674.
and Rees,
R.J.W. (1964). Sulphone resistance in leprosy.
9. Rees, R.J.W. (1964). Limited multiplication of acid fast bacilli in the foot
pads of mice inoculated with M. leprae, Brit. J. Exp. Path., 45 : 207-218.
14
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