Comparative study of uniform-MDT and WHO MDT in Pauci and Multi bacillary leprosy patients over 24 months of observation.

STUDY
DESIGN: An open comparative study between WHO MDT and U-MDT regimen in all types of leprosy over 24 months of observation was carried out at Gandhi Hospital, Secunderabad, India. Periodic assessment of clinical and histopathological parameters at 6 monthly intervals was performed in both groups of patients for grading response to the treatment regimens. PATIENTS AND METHODS: One hundred and twenty-seven newly diagnosed, untreated leprosy patients classified into PB (< or = 5 skin lesions) and MB leprosy (> 5 skin lesions) were alternately allocated into Study (U-MDT for 6 months) and Control groups (WHO MDT) at entry. Out of the 127 patients included, 64 patients (M-44, F-20; PB leprosy 32 & MB leprosy 32) could be followed-up regularly. These 64 patients were clinically assessed and graded into Good, Moderate and Poor response at 6, 12 and 18 months of the study, and 44 of these patients were also assessed at 24 months of the study. Histopathological assessments were also done at the above intervals.
RESULTS: PB PATIENTS: The control and study groups comprised of 14 and 18 patients respectively. When clinical grades were compared, the numbers of Moderate and Good responses were 78% and 61% at 6 months, 86% and 94% at 18 months and 82% and 100% at 24 months in the PB Control and Study groups respectively, suggesting better progressive improvement in the Study group compared to Control group, but the differences were not significant (At 6 months P = 02195, at 18 months 0.7305, at 24 months P = 0.3500) Histopathological assessment at 12 months, showed higher percentage of Good responses (100%) in the PB-Study group than in the PB-Control group (86%). MB PATIENTS: The MB Control and Study groups comprised of 22 and 10 patients respectively. In clinical improvement grades, Good responses in the Control group was 36%, 45% and 77% at 12, 18 and 24 months of study, whereas the Study group did not have a single Good response at 12 and 18 months with the Poor responses being 50%, 67% and 75% at 12, 18 and 24 months. These differences between the groups were significant at all periods of assessment. (At 12 months P = 0.0465, at 18 months P = 0.0014, at 24 months P = 0.0064). Histopathological assessment showed higher the percentage of Good responses in Control group (100%) compared to Study group (50%) at 18 months.
CONCLUSION: U-MDT of 6 months duration was well tolerated and effective in patients with PB leprosy but was too short a regimen adequately to treat patients with MB leprosy.