Anita Girdhar

Risk of developing disability in pre and post-multidrug therapy treatment among multibacillary leprosy: Agra MB Cohort study

Objectives If leprosy is a public health problem, it is due to the disabilities it causes. Surprisingly little is known about the risk of disabilities. Even now, mainly cross-sectional studies report disability prevalence. The present study aims to report the risk of disability in pre and post-WHO multidrug therapy (MDT) in multibacillary leprosy patients and to assess the extent of the incidence of disability. Methods The study design is prospective and the setting is an institutional field area. Patients were detected during 2001–6 field surveys. Of the 289 multibacillary patients, 146 completed the study. Both sexes were involved. The primary outcome planned was to study cure of disease, relapses and disability in patients receiving MDT. The secondary outcome was to measure reaction and default. Assessment was done clinically. Data have been analysed using SPSS software, logistic, survival analysis was performed and the χ2 test of significance was used. Results An important risk factor was found to be three or more nerves involved with odds of 3.73 (1.24–11.2), and delay in treatment; 2.27 (1.04–4.96) at the pre-MDT stage and three or more nerves involved with odds of 2.81 (1.0–7.9) at the post-MDT stage. The incidence of disability was found to be 2.74/100 person-years; 2.69 in the MDT arm and 2.84 in defaulters, with slightly higher disability among early defaulters (3.08) than among late defaulters (2.30). The study suggests that the incidence of disability could be slightly higher if treatment is not completed. Conclusion Early treatment for leprosy is a must for reducing the risk of disability, and treatment delay would increase the risk of disability. It is important to note that the incidence of disability between defaulters and those completing treatment was not found to be significantly different.

WHO Multidrug Therapy for Leprosy: Epidemiology of Default in Treatment in Agra District, Uttar Pradesh, India

Aim. To study the magnitude of default, time of default, its causes, and final clinical outcome. Methods. Data collected in active surveys in Agra is analyzed. Patients were given treatment after medical confirmation and were followed up. The treatment default and other clinical outcomes were recorded. Results. Patients who defaulted have comparable demographic characteristics. However, among defaulters more women (62.7% in PB, 42.6% in MB) were seen than those in treatment completers (PB 52.7% and MB 35.9%). Nerve involvement was high in treatment completers: 45.7% in PB and 91.3% in MB leprosy. Overall default rate was lower (14.8%) in ROM than (28.8%) in standard MDT for PB leprosy (χ 1 2 = 11.6, P = 0.001) and also for MB leprosy: 9.1% in ROM compared to 34.5% in MDT (χ 1 2 = 6.0, P = 0.015). Default rate was not different (28.8% versus 34.5%, P > 0.05) in both types of leprosy given MDT. Most patients defaulted at early stage of treatment and mainly due to manageable side effects. Conclusion. The default in standard MDT both for PB and MB leprosy was observed to be significantly higher than in ROM treatment. Most defaults occurred at early stage of treatment and major contribution of default is due to side effects like drowsiness, weakness, vomiting, diarrhea, and so forth, related to poor general health. Although about half of the defaulters were observed to be cured 2.2% in PB-MDT and 10.9% of MB-MDT developed disability. This is an issue due to default. Attempts are needed to increase treatment compliance. The use of specially designed disease related health education along with easily administered drug regimens may help to reduce default.

A randomized controlled trial to compare cure and relapse rate of paucibacillary multidrug therapy with monthly rifampicin, ofloxacin, and minocycline among paucibacillary leprosy patients in Agra District, India

OBJECTIVES To study cure rate and relapse rate of standard World Health Organization paucibacillary multidrug therapy (PB-MDT) with monthly rifampicin, ofloxacin, and minocycline for six months (ROM-6) among paucibacillary leprosy patients. METHODS A total of 268 patients, detected during active search in Agra district during 2001-2004, who had paucibacillary (PB) leprosy having 1-5 skin lesions and/or one nerve thickening/tenderness, were allocated, using random number tables, to two treatment groups; PB-MDT and ROM-6. On the first day of the month, dose of PB-MDT and of the ROM were given under supervision for 6 months. After completion of drug therapy, patients were followed every 6 months for first 5 years and later annually for next 3 years for monitoring disease status, cure rates, reactions and relapses. Cηi σθuαρε test was used to compare relapse rates. RESULTS The cure rate at 2 years was 99% in ROM-6 and 97.0% in PB-MDT group, of those who completed treatment and the difference was statistically not significant. At 5 years, only 88 patients in PB-MDT group and 90 patients in ROM-6 group could be followed; all were observed to be cured. However, during the period of 5-8 years, 3 of 67 patients in PB-MDT group and 1 of 73 in ROM-6 group were observed to have relapsed. In all, 10 relapses were noted (3 in ROM-6 and 7 in PB-MDT group) giving a relapse rate of 1.10/100 person years in PB-MDT and 0.435/100 person years in ROM groups (P = 0.053 ; statistically not significant). Of the 10 relapses, 5 occurred within 5 years (3 in PB-MDT group and 2 in ROM-6), 4 during 5-8 years (3 in PB-MDT and 1 in ROM-6), and 1 occurred in MDT group after 8 years. LIMITATION A number of patients were lost to follow up after release from treatment and thus actual number of relapses in the study could not be assessed. Additionally, diagnosis was purely clinical and histology could not be done for reasons related to functional difficulties in the field. CONCLUSION The study shows that PB-MDT and ROM-6 have almost similar acceptability, cure rate and relapse rate.

Increase of leprosy cases in Firozabad District of India ‐ A two time cross‐sectional survey

DEAR EDITOR, On 31 December 2014, India declared the elimination of leprosy after reaching a reported prevalence of < 1 per 10 000 population. Recent World Health Organization (WHO) data indicate a 21 2% decline in the number of new cases in the period 2005–09, from 169 709 cases in 2005, and a further 5 9% decline in the period 2009–14. This has led to several policy issues, rendering leprosy a disease of less importance and thus reducing the attention of public health programme managers in India with regard to the disease. However, independent reports from several Indian states, as well as from Brazil, Indonesia, Bangladesh and Madagascar, have revealed that cases of leprosy are on the increase, questioning the claim of disease elimination. A recent Indian study has revealed that the actual case detection rate for leprosy may be 4–5 times higher than is being reported (unpublished National Sample Survey data). In a week-long awareness campaign, another study, from Vadodara, India, discovered a large number of undetected cases of leprosy. A study examining spatial heterogeneity in order to project leprosy trends in India revealed large variations and concluded that the data do not support a hypothesis of rapid progress in leprosy control. Another study, which examined the basis of elimination claims made by the national programme, did not find that any additional efforts had been made in terms of inputs to support such claims. Therefore, the question is: has leprosy endemicity declined and, as a result, also the new case detection rate (NCDR)? If so, is this happening naturally or as a result of developmental efforts, or could there be unrealistic reasons for it, such as the stopping of field activities? It has been reported that the prevalence of leprosy has fallen solely as a result of stopping active field-based case detection. In the present study, we examined the change in NCDR (per 10 000 population) from a survey carried out in 2006– 09 (survey 1) to a survey carried out from March 2011 to December 2012 (survey 2) at a microlevel (village or urban). We utilized leprosy survey data available from the district of Firozabad, India, from two points in time, with an average gap of 4 11 years. Firozabad is one of 70 districts in India, located to the north-east of Agra in Uttar Pradesh. Survey 1 revealed an NCDR of 7 57. Of the total cases of leprosy detected, 58% were of single skin lesions, indicating a high disease transmission. This was in contrast to the reported annual NCDR (ANCDR) of 0 345–0 587 for 2006–09. Using survey 1 NCDR data and assuming a 20% expected variation, a sample size of 129 099 persons was required. It was assumed that the survey would cover 50% of the target population; owing to high-scale labour migration, the inflated sample size was 258 198 persons. Assuming survey 1 data to be universal, 259 units (230 rural, 29 urban) were randomly sampled. During survey 2, the total population examined was 219 609, and included people from survey 1 plus 68 750 new participants. Physical examination was used to find leprosy, which was then confirmed clinically. The endemicity of leprosy is defined as the number of leprosy cases per unit (0, 1, 2, 3–5 and > 5) and computed NCDR (number of leprosy cases detected/population examined), and the proportion compared using the Gaussian Z test of significance. The results revealed that in 151 rural units, where no leprosy was detected during survey 1, the NCDR increased significantly from 0 to 14 72 (Z = 12 1; P < 0 001) during the study period. The NCDR also increased significantly in 42 village units where only one case was detected during survey 1, from 10 89 to 18 37 (Z = 2 6; P < 0 05), and in 17 village units with 3–5 cases detected earlier, from 25 41 to 44 01 (Z = 3 4; P < 0 001); however, in 16 village units with two cases each and in units with more than five cases, the NCDR did not change significantly. The combined NCDR data suggested a significant increase in village units, from 7 9 to 20 23 (Z = 9 9; P < 0 001), and in urban units from 14 3 to 20 37 (Z = 2 4; P < 0 05). In the combined population, the NCDR was observed to increase significantly with endemicity levels of 0, 1 and 3–5, except in units with endemicity levels of 2 and > 5 (Table 1). These data suggest that 76 of 154 disease-free units (49 3%) gained disease during the period between survey 1 and survey 2. The gain of disease in units with initially only one case was observed to be 36 0%, 27 3% in units with two cases, 38 1% in units with 3–5 cases and none in units with more than five cases (Table 2). The loss of disease status (1 becoming 0 or 2 becoming 0 or 1, etc.) was observed in 38 0% of units with one initial case, 54 5% in units with two cases, 28 6% in units with 3–5 initial cases and 66 7% in units with more than five cases. Overall, a gain in disease status was seen in 41 7% and a loss in 17 4% of units. Therefore, the net change results in an increase in the NCDR. Although reported ANCDR data in India have shown a continuous decline in cases of leprosy, the present study contradicts these findings. The NCDR in survey 2 has significantly increased both in rural and urban areas of Firozabad.

Six months fixed duration multidrug therapy in paucibacillary leprosy: risk of relapse and disability in Agra PB cohort study

Background Many studies have focused on multidrug therapy (MDT) for multibacillary (MB) leprosy and rarely on long-term outcome of paucibacillary (PB) leprosy having recommendation of therapy for 6 months fixed duration therapy for PB patients. Studies on measuring risk of disability are rare. The present study is to assess the cure; default, relapse and disability in a prospective cohort of PB leprosy during follow-up of >4 years after treatment. Design Prospective. Setting Primary in our field area of Agra District. Participants 920 PB leprosy patients entered the study, 621 completed treatment, 599 followed finally including 271 males, no ethnic differentiation, patients of all age groups except for children below 5 years and old persons above 70 years were not included. Treatment 6 months fixed duration MDT as recommended by WHO. Primary and secondary outcomes Treatment completion, cure, relapse and development of disability based on clinical assessment by well-experienced doctors. Statistical methods Data have been analysed using SPSS software, risk is computed as incidence per 100 person–years (PY) and test of significance used. Results Study reports 91% cure rate. Incidence of relapse was 1.3/100 PY with no significant variation by age, sex, delay in detection, patches and nerves. Crude incidence of disability was 2.2% and varied significantly by age and nerve thickening but not by sex, number of patches, nerves and delay in treatment. Incidence of disability was 0.50/100 PY in treatment completed and 0.43 among defaulters. Conclusion The study concludes that relapses do occur after MDT treatment but at the level of 1–2%, incidence of disability remains low (<1/100 PY) in PB leprosy. Low incidence of relapse and disability suggests that 6 months therapy is quite effective. However, further improvement may help to improve its efficacy. Longer follow-up may add to efficacy measures.