A study of standardized regimens of steroid treatment in reactions in leprosy at a referral centre.

It is a well known fact that reactions and nerve function impairment (NFI) account for majority of disabilities and morbidities in leprosy. Steroids are the principal agents administered for treatment of reactions and NFI. In this study, we compared the efficacy of two regimens namely high dose (60 mg) regimen tapered over 28 weeks and low dose (40 mg) regimen tapered over 22 weeks in treatment of reactions and early NFI as regards to incidence of recurrence of reactions in 209 patients. Concerns about the side-effects of steroids were also addressed byfollowing a strict pre-steroid investigation protocol. We observed that the low dose regimen was associated with a higher incidence of recurrence (48.3%) as compared to high dose regimen (16%) signifying the efficacy of longer duration of therapy with a higher starting dose. No patient developed side-effects which necessitated withdrawal of steroids. Early detection with prompt and adequate therapy with proper dose and duration is the key to reduce recurrence of reactions and to minimize deformities due to reactions and NFI in leprosy.

Clinical, histopathological and bacteriological study of 52 referral MB cases relapsing after MDT.

Fifty-two BB-LL relapse cases referred to our centre during 1997-2003 were investigated in detail. Twenty-four cases had been treated with extended MB-MDT [until smear negativity (NON-FDT)]. The remaining 28 cases (54%) had received one of the fixed duration regimens (FDT), of whom 11 had 24 months and 6 had 12 months of WHO MB-MDT. Eleven cases had received rifampicin/ofloxacin (RO) treatment. Follow-up slit skin smear reports were available for 41 cases, all but three cases had been smear negative at some point after release from treatment. None of the cases showed any clinical or bacteriological evidence of upgrading, i.e. LL to BT where as downgrading BB to BL occurred in five cases. The duration between cessation of treatment and reappearance of lesions (DCTR) varied from 2 to 15 years. The mean DCTR was longest (9.4 years) for the NON-FDT and 24 months MB-MDT cases. The mean DCTR was significantly lower in the 12 months MB-MDT and RO treated cases (6.8 and 6.2 years, respectively). Four of RO treated cases and four cases with multiple episodes of reaction had DCTR less than 5 years. Inadequate treatment/poor killing of Mycobacterium leprae results in early onset relapse, whereas 'persisting' or 'drug resistant mutants' contribute to late onset relapse.

Socioeconomics of a global leprosy eradication programme.

In the absence of evidence in the literature on cost factors in the management of leprosy, a reference is made to the sporadic attempts to study costs of case detection and treatment. Such studies indicate that in the currently declining phase of leprosy endemicity, employing a conventionally trained, salaried class of paramedical staff for field surveys is prohibitively expensive if cost per case detected is computed. Involving primary healthcare and community derived workers is cost effective. Likewise, short course chemotherapy with newer drugs under trial, administered under supervision by community volunteers, reduces the expenses considerably. Community-based disability services using inexpensive tools may cut costs by 90%. Operational research on cost effectiveness of rehabilitation comparing 'integrated' with 'vertical' approaches is, unfortunately, still in a primitive stage. It is urged that in view of the changing logistics, manpower costs and financial implications should be given serious consideration by health planners. Post-elimination problems such as: (i) unearthing hidden cases; (ii) community-based supervised treatment with highly promising newer drugs; (iii) identification of reactions and relapses; and (iv) field management of disabilities resulting from acute and silent neuritis etc could be solved in a much cheaper manner. Integration of leprosy into general healthcare services and community-based rehabilitation of leprosy patients along with those disabled by other diseases will be the major task in future as these procedures are expected to reduce management costs and eliminate stigma.

Penile and scrotal lesions in leprosy: case reports.

Six leprosy patients in the Ridley-Jopling spectrum of BT-BL showing lesions on penis and scrotum are presented, as we believe that this common enough clinical feature is not well documented in the literature.

Management of leprosy on the basis of the epidemiology of disabilities.

With the reduction on caseload due to the impact of multidrug therapy (MDT) in most parts of India, we believe that there is a need to understand the epidemiology of disabilities in leprosy which may not necessarily correlate with the distribution pattern of active disease. We present a methodology of data collection and verification taking the district as a unit to calculate the prevalence rate of disability as an exclusive entity in the district population, unrelated to the problems posed by the communicable component of leprosy. This study indicated that the prevalence rate of Grade II disabilities in 14 hyperendemic districts was 0.82/1000, whereas it was 0.22/1000 in low endemic districts. Limb disability data collected from three hyperendemic districts in Andhra Pradesh following task-oriented training enabled the paramedical worker to offer services to 5753 disabled patients after assessing the disability caseload per worker.

Reduction in caseload after multidrug therapy in an urban leprosy control programme--a retrospective study in Bombay.

A fall in the active registered case prevalence rate together with a fall in the active caseload per worker after the introduction of multidrug therapy (MDT) is becoming a managerial issue in leprosy control. A retrospective analysis was undertaken to assess the caseload per paramedical worker with reference to active cases for treatment (3341), cases for surveillance (2227) and cases for care after cure (165) at the end of December 1989. All these cases were under the care of 24 paramedical workers. The analysis showed that the caseload per worker was 239 (active cases 139, plus surveillance cases 93, plus care after cure cases 7), though active registered case prevalence rate declined from 1.82/1000 (before starting MDT) to 0.79/1000 by the end of December 1989. The case detection rate was 0.49/1000 by the end of 1989. So, although the active registered case prevalence rate declines, the worker will have enough to do because of the need for surveillance and the detection of relapses, early neuritis, early disabilities and care after cure. Simultaneously, new case detection and treatment must be continued. All these aspects need to be considered when programme managers are reviewing leprosy control strategy.

A comparative study of the efficacy of WHO and IAL multidrug therapy regimens for leprosy--an in-vivo and in-vitro study.

In the absence of definite evidence on utility of intensive therapy with rifampicin in multibacillary leprosy cases, a laboratory based investigation was undertaken basically to compare the efficacy of WHO and IAL regimens. In each group 4 untreated BL-LL patients were included and their skin biopsies were subjected for viability test both in vitro and in vivo systems. A consistant fall in BI with good clinical improvement was observed in both the groups. However good viability was maintained till about third pulse dose in WHO group whereas under IAL group rapid fall in viability was observed after intensive phase. Viable bacilli were seen even after 12,15,18 and 24 doses in both groups. These findings question the need for additional 21 doses of rifampicin in IAL schedule. However such studies are to be repeated on larger samples.

Thalidomide in leprosy--study of 94 cases.

Thalidomide has a beneficial effect on type II Lepra reaction especially chronic and recurrent reaction. It helps to minimise steroid dependency. Thalidomide was given to 94 cases of type II lepra reaction, who had not responded to steroids or had repeated reactions. This clinical data was analysed regarding clinical improvement, relapse of reaction, side effects of the drug, etc. The analysis showed that all the patients improved remarkably and steroids could be withdrawn. If the competence of staff using this drug is enhanced, morbidity due to leprosy can considerably be reduced.

Three years assessment of multidrug therapy in multibacillary leprosy cases.

Analysis of Bacteriological Index (BI) of 584 multibacillary leprosy patients who had completed multidrug therapy (MDT) as per the recommendations of World Health Organization (WHO) and Indian Association of Leprologists (IAL) showed smear conversion rates of 56% at 24 doses and 66% at 36 doses. Taking BI as a parameter of judgement, the results indicate distinct improvement over the performance achieved through dapsone monotherapy during earlier period. IAL regimen consisting of daily initial administration of rifampicin for 21 days did not show any distinct advantage over WHO regimen. Bacteriological decline was uniformally noticeable in all patients though in cases with high initial BI, smear conversion rate was much less. All the six patients with BI more than 5, and 59 patients (70%) with BI 1 to 4.9 and 87 patients (64%) with BI 3 to 3.9 have not been rendered negative even after three years of treatment. On the contrary seventeen patients whose skin smears were still positive after receiving 24 supervised doses became bacteriologically negative subsequently, and remained so though chemotherapy was stopped. Such studies on large number of patients for a longer period is essential to establish whether chemotherapy should necessarily be continued up to the point of negativity.

An approach to leprosy work in south Bombay--a preliminary communication.

The city of Bombay with its teeming eight million citizens is characterised by varied types of living pattern in its different parts and the approach to leprosy control work should be flexible to suit these facets of living conditions. Earlier reports (Ganapati and Girija 1979) have indicated the possibility of the successful application of techniques based on mass surveys in North Bombay where people belonging to low socio-economic strata live in somewhat organised slums or shanty towns. However, extreme South Bombay is marked by the paucity of such vast slums and one is struck by the more permanent multistoreyed housing structures. Living in commercial establishments as well as footpath dwelling are common. This presentation consists of an attempt to gauge the leprosy problems in this part of the city taking advantage of 425 patients registered at a leprosy clinic run in conjunction with the dermatology out patient department of a big general hospital over a period of 40 months. 212 cases (50%) hailing from South Bombay proper were the subject matter for analysis. 66% (140) belonged to progressive types of leprosy classifiable as BT through LL and of the Ridley-Jopling classification and 30.7% were bacteriologically positive. 42.9% of the patients had some degree of deformity. Males formed 80% of the sample and 76% were above 15 years of age. Analysis of duration of residence revealed that 68% were living in Bombay for over six years and 53.5% were residing in the city for 11 years or more. This finding is contrary to the expectation of leprosy patients in Bombay belonging to a "floating population". Attempts at field work revealed the following findings: Slum pockets being few (only four), patients were expected to live in residential buildings; but it was found that 25% of population were staying in work places. 17% were footpath dwellers and 18.9% shared their accommodation with people other than family members. 10.4% were domestic servants staying in the residences of their employees. The labour class constituted 50.5% the unemployed housewives group formed 21.7% and beggers 0.9%. 4.2% only were slum dwellers. Locating and examining contacts of patients was difficult as 42.9% could not be traced owing to faulty addresses or patients having changed residences or shifted to native places. Of the 111 patients (52.3%) contacted, 26.4% were living with families and 26.1% were staying alone or with others.(ABSTRACT TRUNCATED AT 400 WORDS)

Field follow-up of leprosy cases in an urban area.

To achieve effective case holding in SET programme "treatment reminder" through home visits by field personnel is of much importance as drug compliance of leprosy cases is known to be very poor in general. A field study was undertaken to followup (A) school detected 158 leprosy cases (B) patients residing within project area especially 350 infectious cases as well as those 329 patients taking treatment elsewhere (C) 28 infectious patients from outside control area. (A) 70% Children diagnosed as leprosy through earlier surveys were available. 14% were believed to be regular for treatment 78% patients did not go for treatment. From this untreated group 73% showed features ranging from marked improvement to total regression of lesions. (B) 22% smear positive leprosy cases registered for treatment who dropped out from treatment over a period of 5 years were followed up. 21% dropped out cases had left the control area and their whereabouts were not known. From a group of 329 patients living in the control area of the same project who were believed to be taking treatment elsewhere only 48% could be contacted. The rest of them could not be contacted for various reasons. (C) During home visits to 28 infectious leprosy cases coming from far away places 21% said that they were taking treatment elsewhere. The figures in this study indicate the need for planning priority oriented home visit programme according to local situations to maintain at least infectious cases under regular treatment in view of the multiplicity of drugs as per the recent recommendations from experts.

Prevalence of leprosy in slums in Bombay including a leprosy colony.

Transmission of leprosy which is related directly to the total quantum of infection in the community as a whole is decided by the existence of patients suffering from progressive and infectious forms of leprosy and their movement from place to place. This information is of great importance in cities like Bombay to identify the priority areas as targets towards which control efforts should be directed. In this presentation an attempt has been made to compare the leprosy survey figures from three different situations in the city. Selection is arbitrary, not made on statistical basis. The data of particular importance is from a leprosy colony located in North Bombay representing a hyperendemic situation and a normal slum adjacent to this colony, movement of population between these two colonies being free. Age specific prevalence rates of leprosy after examining more than 80% of population from these colonies are compared with data derived from normal slums situated elsewhere in the city. The figures reveal varying prevalence rates marked by an increasing trend in the prevalence figures, leprosy colony representing the largest pool of infection. These figures indicate that wider statistically planned investigations on similar lines in urban areas may provide epidemiological data useful for planning control measures on a more rational basis.

A bacteriological assessment of multibacillary cases in leprosy colonies after 4 1/2 years of multidrug therapy.

In this presentation we have devised a novel way of calculating the total bacterial quantum in 100 (78 LL and 22 BL) multibacillary leprosy patients living in leprosy colonies. The calculation is based on Ridley's logarithmic scale. We have also attempted to assess the reduction in the bacterial quantum as a result of intervention through multidrug therapy (MDT). 53% of the patients rendered bacteriologically negative within two years of treatment of MDT and 94% at 54th pulse dose i.e. at 54th month. The bacterial quantum in human source as leprosy patients was calculated thus--Average BI of the group X Number of patients in each group X Multiplication factor devised as per Ridley's Bacterial Index (BI). By applying this purely arithmetic formula, it was found that 99.8% of the bacterial load is harboured in leprosy patients having BI more than 3. The introduction of MDT initiated the reduction in total bacterial quantum "based on above arithmetic scale" was achieved very fast i.e., from 100% to 5% at 12 months and to 0.4% at 24 months. We believe that if one wants to achieve leprosy control through a reduction in total bacterial quantum within a specific period, leprosy cases with BI more than 3 should be treated on priority basis.

The simultaneous inoculation of Mycobacterium leprae and M. intracellulare into nude mice: development of cutaneous leproma and accelleration of foot pad swelling.

Organisms of the non-pathogenic Mycobacterium intracellulare serotype 19 Darden enhanced the pathogenicity of M. leprae when inoculated together into the foot pads of nude mice. This supporting effect could be demonstrated by an accelleration of foot pad swelling, beginning 4 months after inoculation and by the development of cutaneous leproma on dorsal and lateral body sites within 6 months after inoculation. These leproma increased in number and size during the 9 months they were under observation and demonstrated micromorphological characteristics similar to those of human leprosy.

Leprosy teaching in medical colleges in Bombay--a questionnaire study.

An attempt was made to study the adequacy of leprosy teaching at the undergraduate level of the four medical colleges in Bombay, and to suggest possible routes towards the reorientation of leprosy teaching. Over 55% of the medical faculty contacted expressed dissatisfaction with the existing pattern of leprosy teaching. The survey reveals ample evidence pointing to the necessity of redesigning the curriculum at the undergraduate level, so as to provide increased weightage to both the theoretical and the practical aspects of leprosy. A heartening feature of the study is the inclination shown by a majority of medical teachers to associate themselves with the PSM Department in order to help improve leprosy teaching and thereby help in leprosy control. This offer should definitely be taken advantage of for furthering the cause of leprosy eradication as a part of achievement of "Health for All by 2000 AD".

Leprosy detection through non-survey techniques.

Most practical and cheap techniques other than mass surveys to detect leprosy in urban slums are still not known. The population inhabiting a large somewhat isolated slum in North Bombay was exposed to intensive health education programmes over a period of two years. Leprosy cases reporting as a result of these measures as well as those detected by trained workers casually or through contact examination were registered at two weekly clinics conducted within the slum. A total of 184 patients out of whom 27 were smear +ve, were identifiable by these means. The population of the slum was found to be 18228. Total prevalence rate of leprosy after examining 14723 subjects in the colony was revealed to be 24 per 1000 (smear +ve cases: 2.2. per 1000) out of which a prevalence of 12.4 per 1000 (smear +ve cases: 1.8 per 1000) had actually come to our knowledge even before instituting mass surveys. The results of this study indicate that in comparable urban situation it should be possible to identify 54% of total leprosy cases by techniques other than surveys. More significantly a striking feature of this study is that 82% of cases of true public health significance namely smear +ve patients could be unearthed by these means.

Survey of leprosy in unapproachable and uncovered areas.

Leprosy surveys in tribal population, fishermen and labourers engaged in construction work revealed prevalence rates of 32/10,000, 109/10,000 and 20/10,000 respectively, suggesting that systematic surveys have to be carried out in such population groups, to reach the goal of a "World without leprosy".

Clinical assessment of paucibacillary leprosy under multidrug therapy-three years followup study.

408 skin smear negative paucibacillary leprosy cases who had completed six months MDT were kept under surveillance for three years. The clinical assessment at the end of surveillance showed that 276 (82%) of all the cases attained inactivity. Two patients who were inactive showed signs of relapse. Five patients showed more activity though they were regressing under treatment. The inactivity rate was much higher amongst the patients with 1 to 3 skin lesions (88%) as compared to the patients with greater than or equal to 4 lesions (60%). The difference was statistically significant (P less than 0.001). The past treatment before MDT did not appear to influence the clinical course of the disease. 17% of the patients essentially border-line type continued to show signs of activity even after 3 years surveillance indicating the need for triple drug therapy (to be treated as multibacillary). However large scale data on relapse rate would be essential before the efficacy of WHO short-term therapy for paucibacillary leprosy is evaluated.

An evaluation of the contribution of the Swedish International Development Authority (SIDA) to leprosy control in India based on the implementation of multiple drug therapy (MDT) 1981-1993.

The Swedish International Development Authority (SIDA) first supported the National Leprosy Control Programme in India in 1978. In 1981/82 priority was given to the implementation of multiple drug therapy (MDT), starting in two high-endemic districts, and gradually extending to a total of 19 districts in the years by 1993. SIDA then decided to undertake a detailed evaluation of its 12-year contribution and this was carried out by an international team between November 1993 and April 1994. In terms of epidemiological and public health impact, the main results were impressive and clear-cut; 837,519 cases (old and newly arising) were successfully treated, with few complications and a low rate of relapse. The voluntary reporting rate had improved significantly. Data relating to new case detection, child and disability rates were, however, less clear and difficult to interpret. Deficiencies were also identified in the areas of health education, community participation, gender issues, disability prevention and management, rehabilitation, operational research and assessment of cost-effectiveness. These problems should not, however, detract from the contribution of SIDA, from 1981 onwards, in establishing the implementation of MDT in two 'pilot' districts at an early and important stage in the history of the MDT programme in India. SIDA also made significant contributions in other areas, namely pre-MDT 'screening' of registers in 45 endemic districts in 1990-1993, appointment of consultant leprologists at district level, group education activities, annual meetings of voluntary agencies and the development of a monitoring and information system, with computer facilities, at national level. This paper describes the design and methodology, main findings and conclusions of the evaluation, based on the final report and the appendices submitted to SIDA in Stockholm in April 1994.