1I 6^ hitemationa/ Journal of Leprosy^ 200 I

A Plea to Revive Skin Smear Examination

To THE EDITOR:

Leprosy is one of the oldest diseasesknown to mankind, but an effective treat-ment for it could only be made available acouple of decades ago. The credit mostlygoes to the World Health Organization(WHO) which mobilized the expertiseglobally, designed the multidrug therapy(MDT) and recommended its use in 1981. Ithas further convinced the member countriesin which the disease posed a problem toadopt the new strategy. India also readilyresponded to this call for a combined attackon the disease. The magnitude of the lep-rosy problem in India at the time MDT wasbegun was considerably high. Its estimatedcaseload was around 4 million, which con-stituted almost one third of the global prob-lem. Befittingly, the country started imple-menting MDT through one of the largestand best organized programs in the world.More than one and a half decades of the In-dian National Leprosy Program (N,LEP) inthe country have generated voluminous in-formation on the MDT operation, and thecumulative data have helped in modifyiniz.the WHO guidelines from time to time. It isnot wrong to say that the Indian experienceis more or less representative of the entireMDT operation in terms of achievementsand failures.

The most glaring achievement of MDTin India has been the drastic reduction ofthe prevalence rate (PR). A PR of 57/10,000population in the year 1983 had decreasedto 5.2/10,000 by the year 2000 (5)• A spec-tacular PR reduction is not confined to In-dia. It was shared by many countries. Thissuccess led the 44th World Health Assem-bly to urge its member states to eliminatethe disease as a public health problem by2000 A.D. This was historic, because it an-nounced a target year and laid emphasis onthe event of elimination. But setting a targethad both virtues and vices. While itwhipped the program toward optimal activ-ities, it also compelled the adoption of sev-eral compromises in the elimination strat-egy. The important ones are:

Concept of elimination. The 8IstDhalem Workshop on The Eradication ofInfectious Diseases held in Berlin. Ger-many. in 1997 defined four stales of med-ical intervention in a disease. The stagesare: control, elimination, eradication andextinction. Elimination is the state of zeroincidence of a disease at some part of theworld at a given point in time. Eradicationis permanent zero incidence globally, andextinction means total disappearance of thecausative organism. Judged with these cri-teria, the elimination strategy practiced inleprosy appears to suffer from two inade-quacies: a) The presumption of achieving azero incidence is indirect. The prow-amheavily depends upon the reduction of theprevalence rate (PR) in place of the inci-dence rate (IR), also with the objective ofachieving a PR of less than 1/10,000 andnot a PR of zero. It may also be noted herethat initially when elimination was definedin terms of the reduction in PR, dissentingvoices heard scientists, prow-am managersand nongovernmental organizations whosuggested the IR in place of the PR ("). Theviews for inclusion of the IR or its proxy,new case detection rate (NCDR), are oftenforthcoming even today. Unfortunately, thecalculation of the NCDR is another difficulttask in leprosy due to the very insidious na-ture of clinical symptoms, the tendency ofself-healing in a high proportion of cases,and the lingering problem of backlog cases.As per the in available, theNCDR has continued at a fairly high levelover the last few years, and this is a ques-tion mark on the claim of progress towardelimination.

b) Ascertaining the state of cure: There isno second opinion that the MDT is robust.The problem lies generally in deciding thepoint of cure and the cut-off point of treat-ment. The natural expectation of any patientis complete relief of clinical symptoms.Leprosy is such a disease that, even in thedays of MDT, an unambiguous cure cannotbe assured to the patient. Even if he takesregular treatment his skin and nerve lesionstake a rather long time to subside, which

69, 2^ Correspondence^ 117

leads to an important dilemma. lithe pa-tient is treated until complete disappearanceof lesions, the regularity of treatment is dif-ficult to sustain. At the same time, a shortercourse of treatment is regarded as incom-plete, especially if his clinical problem con-tinues. When the MDT program waslaunched, the recommendation was to treatthe cases until the lesions become inactiveor the smear becomes negative (MB pa-tients). Although this was itself a compro-mise, it has some rationale. Then the crite-ria of cure changed rapidly as the year 2000approached and, successively, there fol-lowed the introduction of fixed-durationtreatment (FDT), shorter FDT (12 doses),and single-dose therapy. Added to this, thepractices of active surveillance and skin-smear examination were made optional,which otherwise should have been strength-ened in the post-FDT scenario. The chang-ing criteria on cure adopted from time totime have points both in favor and a2ainst,although there is no consensus on the issueC•3.4. to cite only a few). Although theelimination slogan greatly charged the pa-tients and workers with renewed enthusi-asm, in the technical sense the strategy 1b1-lowed fits more to leprosy control than lep-rosy elimination. The problem with adisease under control is that once there isrelaxation in the intervention efforts, thereoften is a risk of the disease returning withadded complications, such as drug resis-tance.

The drastic reduction in the PR has re-sulted in a proportional decrease in theworkload. This is the right time to divertmanpower and resources in measuring andmonitoring the results. Well-equipped sur-veillance units can be set up at least on anexperimental basis in selected areas, per-haps for one district in each state, to see thatthe simplified approaches are yielding theexpected results. It may be mentioned herethat the Workshop on Impact of MDT onthe Trend of Leprosy held in 1993 proposeda few sentinel centers to keep watch on thedisease trend (''). Well standardized leprosyinformation systems are also being orga-nized by endemic countries which have ei-ther eliminated the disease or are very nearelimination. This step is appropriate andtimely although sonic difficult, yet impor-

tant, indicators have not been included Theindicators presently included arc: 1) preva-lence rate, 2) case detection rate, 3) per-centage coverage of MDT, 4) cure rate, and5) disability rate (") Of these, indicators 2,3, and 4 are related. Since presently almost100% of registered cases are receivingMDT in a program (") and all are taken ascured after FDT, indicators 3 and 4 are rep-etitions of the same success story. Hence, inplace of them other more important and in-formative indicators can be included. Prob-ably the smear-positivity rate is a well-deserved candidate. We may recollect herethat in the rush for early elimination thisimportant aspect of the program was com-promised first.

In spite of the numerous achievements ofMDT, the issue that makes everyone uneasyis the static or slightly increasing NCDR (").The reasons often cited are: 1) incubatingcases surfacing as clinical disease, 2) detec-tion of hidden cases, 3) increased voluntaryreporting due to increased awareness, etc.Such reasons may be true for the Indianstates of Uttar Pradesh and Bihar, but notfor Tamil Nadu, Andhra Pradesh, Maharas-tra and Orissa where the MDT program waswell organized for a long time and was of-ten appreciated in the past (5.(). The detec-tion of a large number of cases with a highMB rate, high child rate, and low disability(grade 2) in these states during the modifiedleprosy elimination campaigns (MLECs) (`')makes one uneasy in terms of NCDR. Al-though from time to time concern has beenshown for this aspect, the possibility of areservoir of infection and continuing trans-mission failed to draw due attention.

In a microbial disease, if the NCDR isnot corning down and there is a high childcase rate looking for or ruling out the roleof a causative agent appears more relevant.But, due to reasons to be enumerated later,skin-smear examination—the only afford-able laboratory test to detect Mycobac-terium leprae—has gradually been madeoptional in the programs. When a difficultprocedure is made optional it amounts tonear deletion, and today there is no adequateinformation on this issue. To include again anindicator on smear positivity now needs therevival of smear laboratories, a possibility ifthis procedure is made more rational and re-

118^ International Journal of Leprosy^ 2001

alistic. A few modification in the test are asfollows:

. The grading system probably needs tobe (hopped. Almost all infectious diseasesmanage with a positive or negative report,and this is also possible in the managementof leprosy. The smear grading system wasthe most cumbersome exercise, involvingaveraging at two stages. Even if smears arecollected from three sites, as per the guide-lines, 100 fields are to be screened if the or-ganisms are scanty and 25 fields if they arenumerous. Averaging all the fields gives thebacterial index (BI) of the field, and an av-erage of the three fields gives the 131 of thepatient. When there is only one drug regi-men for a positive case, whether 100 fieldsshow 1-10 bacilli (grade 1 ) or one fieldshows more than 1000 bacilli (grade 6, Rid-ley scale), burdening the technician withsuch arithmetic computations seems unwar-ranted. Since isolation of a highly bacillatedpatient is not required, there is probably noneed to know the degree of positivity.Hence, a reliable positive or negative reportwill be adequate.

2. There is evidence that tuberculoid(TT) and indeterminate leprosy cases are al-most always smear negative. If the clinicaldiagnosis is dependable, these cases do notrequire smear examination.

3. The number of sites needs to be lim-ited to 3. If the field worker/clinician isgood at selecting the most active site, evenone site is adequate to give the required in-formation. Examination may be repeated atthe interval of 6 months, and it may be fromthe one site which had the highest BI in theinitial examination.

4. In the NLEP set up in India, PMW andNMS belong exclusively to the leprosycadre. They have no other option than togive their best performance in leprosy. Butthe technicians, at least in the MDT dis-tricts, are mostly from the general healthservice laboratories. Working in a generallaboratory is more attractive and rewardingthan doing monotonous smear reporting.Hence, laboratory technicians posted tosmear labs generally manage a transfer atthe earliest opportunity. This is also some-times reflected in the independent evalua-tion team reports. Hence, it would be idealif the PMW/NMS who are trained in smearreporting were posted to the surveillance

units. Another alternative would be theirtemporary employment by contract.

5. Past experience shows that most of theleprosy programs failed to attract techni-cians; therefore this area deserves some in-centive. In addition, there is also a need toprovide good working conditions in theform of a well-lighted room, good binocu-lar microscope and quality reagents. Smearreporting is probably the most difficult testdue to the varied morphology of M. lepme.A pink rod, a fragment and a granule, any-thing can be a bacillus. A good binocularmicroscope reduces eye strain considerably.

6. Other issues which complicate and de-value smear examination are: a) the variedforms of the organism as stated above, b)relating living and death status to morpho-logical forms, c) dead bacilli lying in thetissue for a long thne due to the body's in-effective macrophage disposal machineryand resulting smear positivity, d) smearnegativity in as much as 80% of leprosycases (smear negativity does not excludeleprosy) and, lastly, e) the availability ofeasily countable skin lesions (alternate wayof classification). All probably added to theargument for making this examination op-tional; but then these are the biologic char-acteristics of M. leprae and we have to dealwith them. It is a bit odd to think the sur-veillance/monitoring of an infectious dis-ease, without ascertaining the status of thecausative agent, even for public health con-sideration.

7. M. leprae and NI. tuberculosis sharesimilarities in susceptibility of rifampin,tendency to develop resistance to mono-therapy, and manifesting in MB and PBforms ('). Hence, MDT for leprosy is de-signed more or less on the basis of a strat-egy already in use for the control of tuber-culosis, which is a comparable publichealth problem. The directly observed treat-ment (DOT) schedule followed in tubercu-losis control heavily depends on the resultof three consecutive sputum reports (2).Compared to M. tuberculosis, M. leprae ismore problematic a bacterium. It has so fardefied culture in artificial media, and thisprevented the development of a vaccineagainst it. Its principal host tissue is thenerve—a structure risky for invasive tech-niques. In short, the biology of M. lepme isless explored and its long-term behavior de-

69,2^ Correspondence^ 1 I 9

serves to be carefully watched. Hence, the 4.affordable skin-smear examination needs tohe included in the surveillance system.^

5.—I). Porichha, M.D.

&film; Kush! Villashak^ 6.

Hind K,,/ii ^Sang!!New Delhi 110 001, hulia^ 7.

REFERENCES1. Guossur, J. Whither short-term chemotherapy or8.

leprosy? Indian J. kept. 69 (200(1) 119-120.2. FIARRis, A., MAin4:, D. and Lli,kfkvit, M. TB—A

Clinical Manual for South East Asia. Geneva:World I lealth Organization. 1997.^9.

3. Ii. H. Why multidrug therapy or MB leprosy canhe shortened to 12 non is. Lepr. Rev. 69 (1998)106-109.

Kviocii, V. M. Is there a microbiological rationalefor single-dose treatment of leprosy? (Editorial)Lepr. Rev. 69)199S) 2-5.Report on MLEC under NLEP. New Delhi: DGHS.Leprosy Division. 1999.Report on the Workshop on Impact of MDT on theTrend of Leprosy. Gupte, M. D.. ed. Madras: IndianAssociation of Leprologists. 1994.WATERS, NI. Is it safe to shorten multidrug therapyIon lepromatous (LL-B14 leprosy to 12 inonths?Lepr. Rev. 69 ( 1 99i) 110-111.WHO AcrioN PROGRAN1ME FOR ELIMINATION OFLEPROSY. Shortening duration of treatment formultibacillary leprosy. Indian J. Lepr. 69 (1997)267-270.Woitkp HEALTH ORGANIZATION. Leprosy elimina-tion projects: remaining challenges towards theelimination of leprosy. Indian J. Lepr. 72 (2000)33-35.

Leprosy with Peripheral T-Cell Lymphoma:a Rare Association

To THE EDITOR:

An 85-year-old male presented withotherwise asymptomatic skin lesions overthe face of 8 months' duration. He did nothave any other cutaneous or systemic com-plaints. He had undergone rectal surgery 15years earlier, but details of the disease orthe surgery were not available. Examina-tion revealed numerous, tirm-to-hard, skin-colored and erythematous papules and nod-ules predominantly over the face, giving riseto "leonine facies," with a few lesions alsoover the trunk (Fig. 1). One lesion over theface (Fig. 1) and another over the back werefun2ating. In addition, his skin showed dif-fuse leathery induration over the trunk andextremities. He was fairly well built and notanemic. The axillary lymph nodes were 2-3cm in diameter, firm in consistency andwere not fixed to the underlyin1J, structures.Systemic examination did not reveal anyabnormalities. Peripheral nerves were notthickened. A hemogram and liver and renalfunction tests were normal. USG-abdomenshowed fatty liver. No para-aortic nodeswere seen. A slit-skin smear by the standardtechnique demonstrated acid-fast bacilli oc- FIG.^NIultiple papules and nodules over the

face.

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