Trial reportThe Indian journal of medical research2016
International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programmes.
Trial report in The Indian journal of medical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 18 citations in OpenAlex.
- Approaches to quantifying acceptability of pharmaceutical interventions for neglected tropical diseases: A scoping review.PLoS neglected tropical diseases · 2026Article
- Programmatic Addition of Clofazimine to Multidrug Therapy for Paucibacillary Leprosy in India: A One-Size-Fits-All Approach in Absence of Sound Clinical Evidence.The American journal of tropical medicine and hygiene · 2025Article
- Leprosy.Nature reviews. Disease primers · 2024Review
- Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy.PLoS neglected tropical diseases · 2024Article
- Global leprosy scenario: Eradication, elimination or control?The Indian journal of medical research · 2023Article
- Low risk of relapse and deformity among leprosy patients who completed multi-drug therapy regimen from 2005 to 2010: A cohort study from four districts in South India.PLoS neglected tropical diseases · 2021Article
- Article
- Uniform multidrug therapy for leprosy - time for a rethink?The Indian journal of medical research · 2016Article
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Authors and funding
15 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
objectivesUniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance.
methodsNewly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated.
resultsA total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable. INTERPRETATION &
conclusionsWe observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696].
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