International open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results.

OBJECTIVE: To describe the rationale, design and preliminary results of an open trial of 6 months uniform multi-drug therapy (U-MDT) for all types of leprosy patients assuming a cumulative relapse rate not exceeding 5% over 5 years of follow-up. METHODS: We intended to recruit 2500 patients each in multi-bacillary (MB) and pauci-bacillary (PB) groups from India (five centres) and China (two centres). Standardized clinical criteria were used to assess skin lesions in the field. RESULTS: A total of 2912 patients enrolled from November 2003 to May 2007 (India, 2746; China, 166). MB patients constituted 39% and 3% had grade 2 disability. During follow-up, 27 patients (0.9%) developed new lesions. Of these, 78% were on account of reactions. Six patients had clinically confirmed relapse. Clofazimine-related skin pigmentation was short-lived and was acceptable to patients. We analysed data for clinical status of skin lesions. About 2.9% of patients were lost to follow-up; 85.9% completed treatment, of whom 19% had inactive skin lesions. PB patients responded better than MB patients (27%vs. 6%; P < 0.001). At the end of the first (n = 2013) and second year (n = 807) of follow-up post-U-MDT, in 49% and 46% patients, lesions were inactive, respectively (59% and 57% in PB, 37% and 28% in MB; P < 0.001). CONCLUSION: U-MDT appears to be promising with respect to clinical status of skin lesions.

Sustainable leprosy related disability care within integrated general health services: findings from Salem District, India.

The main focus of leprosy control has been case detection and treatment delivery with relative neglect of prevention of disability. Absence of reliable data and lack of research have added to the problem. This raised concerns about the capacity of the general health system to address the needs of people living with leprosy-related disabilities. In this prospective study appropriate services for people living with leprosy-related disabilities were introduced in the form of self-care training, guidance and monitoring by the general health staff facilitated by a non-governmental organisation leprosy centre in a district in south India with a population of 3.1 million (estimated in 2005). The staff identified 1232 people with leprosy-related disabilities and trained them in self-care. Follow-up assessments indicated that 86% were found to be practising self-care regularly and all the 239 general health workers were found to be actively involved. The most heartening outcome was the healing of plantar ulcers in 70% of people at the 1-year follow up. This intervention is sustainable because of the simplicity of the procedures and the involvement of all health staff including supervisors.

Trends in new case-detection leprosy in Bihar, India.

Multi-drug therapy (MDT) has been successfully implemented in all leprosy endemic countries. Prevalence of leprosy has declined remarkably after the introduction of MDT. Detection of new cases did not show expected decline in many endemic and low endemic situations. Bihar in India started implementing MDT in 1993. The Damien Foundation India Trust (DFIT) supported the leprosy control programme in Bihar by providing a district technical support team (DTST) for each district assigned to DFIT. Effective coverage was achieved in 1996-98. Data for the period 1996-2004 from 10 districts are presented in this paper. The total population in these districts was 29.4 million. Deformity among newly detected leprosy patients declined to 1% indicating effective early case-detection. Intensive new case-detection activities were in vogue contributing to high new case-detection rate (NCDR). The NCDR remained high during the 9-year period reported here and did not show any declining trend.

Diagnosis of leprosy.

Of all the diagnoses of dermatological disorders, the leprosy is perhaps the easiest one to be done on one side but difficult also on the other side. Proper history taking in the diagnosis is very important. Clinical examination is intended to find out if the patient has any skin or nerve lesion. The most important is the definite sensory deficit in the skin lesions which if present confirms the diagnosis of leprosy. Nerve examination necessitates to see the involvement of peripheral nerves eg, ulnar, lateral popliteal, posterior tibial, median or facial. In the routine diagnosis of cases, slit-skin smear from skin lesions and ear lobes is generally not required. The presence of any cardinal sign, related to skin patch or nerve, confirms the diagnosis.

"Instant" new leprosy case-detection: an experience in Bihar State in India.

The National Leprosy Eradication Programme (NLEP) is based on survey, education and treatment, including coverage of all the registered cases with multi-drug therapy (MDT). The Government of India introduced MDT in all leprosy endemic districts through a vertical set-up, and through mobile leprosy treatment units in low endemic districts. Anti-leprosy work has not been uniform in all the states and needed push-start in some, such as Bihar. There have been spurts of leprosy elimination activities and the entire populations of the regions have not been covered because of various administrative reasons and logistic problems. In Singhbhum district of Bihar, a successful attempt was made to cover the maximum population by campaign approach. The strategy was to involve all the field workers of the leprosy programme in the district, supported by a small group of experienced personnel. The campaign, lasting for 39 working days, resulted in detecting leprosy cases equivalent to 64% of cases detected during the previous one full year. The entire operation helped the local staff to gain experience that would be useful for the future of the NLEP, and also provide an insight into working practices. Similar campaign approach can be used in situations where case-detection activities are feeble and the implementation of MDT is slow. If such campaigns are repeated at appropriate intervals, it will be a great support to achieving the goal of leprosy elimination.

Evaluation of the modified leprosy elimination campaign in a high leprosy endemic district of Jharkhand.

An evaluation of the third Modified Leprosy Eradication Campaign (MLEC) was carried out in Potka block in the high endemic district of East Singhbhum, Jharkhand State, India, by our external evaluation team, from 29 October to 8 November 2001. The searchers in this block detected 389 suspects during the MLEC; of these, 181 (46%) were examined, and 69 (38%) of them were confirmed as cases by the Programme staff. The evaluators examined 189 (48.5%) of the total 389 suspects detected by the searchers, including 31 of the 69 cases confirmed by the Programme staff. Concordance of diagnosis of leprosy cases by the Programme staff and the evaluators was found to be high (90%). However, concordance of the type of leprosy was found to be variable (PB 38%, MB 72%, SSL 100%). Specificity and sensitivity of diagnosis by the Programme staff (as against those by the evaluators) were found to be 85.7% and 79.2% respectively. There was no case of re-registration. The evaluators examined 108 of the suspects detected by the Search Team, but not screened by the Programme staff, and diagnosed 47 cases (44%; PB 20, MB 9, SSL 18) from among them. The evaluators also diagnosed additional 30 new cases (PB 18, MB 5, SSL 7), during their visit. An assessment of knowledge about the disease and treatment among confirmed cases revealed that most of the patients did not know correctly about their disease. All the cases were referred by the searchers. About 45% of cases were aware of the duration for which they needed to take the treatment, 97% of cases showed the blister calendar packs and had taken the supervised dose. Availability of MDT to the patients and drug compliance were found to be adequate. Assessment of the impact of IEC activities on the awareness of leprosy among the community showed that about 50% of those interviewed were aware of the campaign. Most of them had information about the availability of leprosy drugs and knew that treatment was free. A majority of those aware of the disease said that they would refer suspects, if they come across any, to PHC centres for treatment.

Chemoprophylaxis against leprosy: expectations and methodology of a trial.

Because of the great efficacy of multidrug therapy (MDT), it had been hoped that the widespread use of MDT would bring about a rapid decrease of the incidence of leprosy. To the present, a decrease of incidence has not been observed, possibly because of the long incubation period of the disease, and because general implementation of MDT is still recent. Other reasons, such as environmental sources of infection or the role of healthy carriers in transmitting Mycobacterium leprae, cannot be excluded. Therefore, one must seek alternative or supplementary strategies, such as chemoprophylaxis. Household contacts of leprosy patients are at greater risk of developing leprosy than is the general population. Therefore, a randomized, controlled trial of chemoprophylaxis, using a single 10 mg/kg dose of rifampicin, or a placebo, is planned in nine projects in India, among the household contacts of newly detected leprosy patients. Based upon assumptions of a protective efficacy of the chemoprophylaxis of 50%, an annual incidence of 2 per 1000 contacts, a desired power of the study of 90%, and a level of significance of 95%, 15,000 household contacts will be allocated randomly by household to each arm of the study, and followed for 5 years. Considered as household contacts will be all persons living in the same household as an index case and sharing the same kitchen. Pregnant women and infants will be excluded. To be certain that transmission of the organisms from the index case cannot occur once the prophylaxis is administered, rifampicin will be administered 2 months after diagnosis of the index case. Diagnosis of leprosy will be clinical, and confirmed independently. Although household contacts usually constitute only a small proportion of the new patients detected in a control programme, their high-risk status makes them particularly appropriate for a study of the potential effect of chemoprophylaxis. Following the trial, one could evaluate the usefulness and feasibility of using the same strategy in other population-groups, based on the number of persons necessary to treat to prevent one case.

Management of simple plantar ulcers by home based self-care.

Seeking a solution to bring down the prevalence of simple plantar ulcers in the field, Damien Foundation India Trust (DFIT), Chennai, developed a curriculum to teach the field staff of all its projects. The purpose was to make patients self-reliant in the care of their plantar ulcers in their homes. The strategy used was to make patients take care of their ulcers using tools found in their homes and surroundings and become responsible for the care of their limbs. This strategy was implemented in eight projects of DFIT and the programme was followed regularly for one year. Regular monitoring and evaluation showed that under this strategy the prevalence of plantar ulcers was reduced by about 50%.

Pace of leprosy elimination and support teams in Bihar state, India.

Despite the extensive implementation of multiple drug therapy (MDT) in most leprosy-endemic countries world-wide since 1982, bringing about a remarkable reduction in prevalence, there are still regions at the sub-national level where the implementation of MDT remains difficult. The state of Bihar (population 86.3 million) in India is a good example of such a region. Previously rated as one of the most highly endemic states, it still contributes about 21% of the total caseload in India and about 12% of the global caseload. For various reasons, case-finding and drug treatment have lagged behind the progress made in most other states in the country and in 1996, the Damien Foundation India Trust (DFIT) volunteered technical support to increase the pace of elimination. Sixteen out of the 39 districts in the state were allocated, with a population of 41.8 million. Support teams, including a Medical Advisor and a Non-Medical Supervisor, both with over 10 years experience of leprosy work and control programmes, were provided to assist and work alongside government staff in case detection, treatment delivery, case-holding and discharge in their respective areas of operation. New case detection by intensive survey increased by 394% and total new case detection by 226% during the year 1996-1997, with similar trends in the following year. Striking improvements were also observed in MDT coverage, treatment regularity, monitoring and discharge of patients and in the training of local staff. This collaboration between a non-government agency (DFIT) and the staff of the National Leprosy Eradication Programme in 16 out of 39 districts in the State of Bihar has clearly been extremely successful. Similar approaches in the remaining districts of Bihar, and in other parts of India, where the infrastructure is available but inadequate, may contribute significantly to achieving the elimination goal at national and sub-national levels.

Utilizing primary health care workers for case detection.

Under the National Leprosy Elimination Programme it takes at least one year for the paramedical worker to survey the allotted population for case detection. An alternative strategy in warranted for States like Bihar still having a high case load and poorly functioning leprosy programme. An intensive case finding programme using Primary Health Care (PHC) workers was organized in Bhojpur district, Bihar State, India. The whole population (3, 173, 701 in 1996) of the district was screened within a period of four days and confirmation of suspected cases was carried out in four days. During this screening procedure, 1586 new leprosy cases were detected (NCDR = 5 cases per 10,000) and all were started on MDT. The new cases constituted 26.4% of active cases existing on record before the screening. After this experience, the prevalence rate of active cases increased from 19 to 24 10,000. If such rapid screening programmes are done at least twice a year, it will greatly hasten the process of elimination of leprosy.

A comparative study of the cost and effectiveness of a modified system of MDT drug delivery system in a high endemic district (Nalagonda) of South India.

Fall in the case load (from 17,000 to 4,500), has changed the disease profile and introduction of fixed duration Therapy (FDT) has made management of leprosy cases rather easy in Nalgonda, a backward district in Andhra Pradesh. The system of drug delivery which was conceived for managing large case load, however, remains unchanged, thereby resulting not only in considerable wastage of resources but also in hampering other activities like case detection and patient care. This study was undertaken to develop and assess a modified system of drug delivery in terms of the cost and effectiveness, its overall effect on other activities in the programme and its acceptability by the field staff. Four Leprosy Control Units (LCUs) were selected and were randomly assigned either to study (Gudibanda, Suryapet) or control (Nalgonda, Bhuvanagiri) group. In the study group the modified drug delivery system replaced the existing system. The modified system consisted of the para medical worker being made responsible for patients at all the DDPs in his subcentre. The clinics were managed alternately by medical officers and non medical supervisors every month. In the control group each clinic was managed by medical officers every month and it covered two sub centers with each drug delivery point being assisted by a para medical worker. The study revealed that the modified system resulted in a saving of 130 man-days a month, a 30% saving in use of vehicle, a 30% saving in POL and improvement in case detection. There was no change in the clinic attendance and drug consumption compliance in the units where modified system was introduced.

A study on the effect of patient and community education in prevention of disability programme.

The effect of self-care learning by leprosy patients in prevention of disabilities was studied by adapting two strategies in two subcentres of a project in South India, one through patient education by trained field staff and the other through community education involving trained animators and health committees. One of the subcentres was taken as control where neither of the strategies was employed. In terms of results, though both the strategies were found to be effective in containing occurrence of new deformities among high risk patients and healing of trophic ulcers in hands and feet, strategy I i.e. self-care education of patients by concerned field personnel without prejudice to their routine work is recommended because of ease in diffusion of strategy.

The influence of operational factors in the profile of monolesional leprosy cases in south India.

A comparison of the profile of monolesional cases among new PB cases detected in a Government Leprosy Control Unit (GLCU) and the field area of a Central Leprosy Teaching and Research Institute (CLTRI), both located in South India, demonstrates that the proportion of monolesional cases among new cases detected between 1987 and 1991 was higher in children than adults, higher in females than males (only in the CLTRI)--over 95% were the tuberculoid type. A significantly increasing trend in this proportion could be seen in the GLCU but not in the CLTRI; an explanation of this is based on the difference in operational aspects in case detection methodology adopted by the 2 areas--e.g. intersurvey interval and mode of case detection. Such studies, focusing on single skin lesions, help us in understanding the role of various possible operational factors in influencing the behaviour of the disease.

Mycobacterium leprae soluble antigen (Rees) skin test responses in an endemic population in India.

The response to intradermal administration of Rees soluble skin test antigen was studied in 12,142 randomly selected individuals living in a highly endemic area in South India. Taking a cut-off point of 12 mm induration as the criterion for 'positivity', 73% of PB cases, 45% of MB cases and 63% of noncase population (67% in contacts and 63% in non-contacts) were found to be positive. Age-specific positivity rates were higher in males than in females and in adults than in children. The difference in age-adjusted positivity rates between cases, contacts an noncontacts in the female population was found to be significant. However, the differences in reaction response are not sufficient to identify the sub-populations of cases, contacts and noncontacts and as such this antigen is not likely to be useful in epidemiological studies of infection and evolution of clinical disease in high endemic populations.

Initial intensive therapy for multibacillary leprosy patients--in retrospect.

We analysed the results of 4845 multibacillary (MB) patients being treated with multidrug treatment (MDT) in the Srikakulam District of Andhra Pradesh, India. Of these, 2309 (47.7%) patients were given an initial 14-day intensive therapy with rifampicin, clofazimine and dapsone, followed by the WHO recommended pulse therapy. The rest of the cases were given only pulse therapy. The improvement in terms of bacteriological clearance and the proportion of cases declared released from treatment (RFT) was found to be significantly higher among patients treated with only pulse therapy. Clinic attendance was found to be better and more regular in patients treated with intensive therapy, and no relapses were seen with either therapy. The implications of these findings on the operational aspects of programme implementation are discussed.