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Effectiveness and safety of clofazimine and pentoxifylline in type 2 lepra reaction: a double‐blind, randomized, controlled study
Author(s) -
Roy Kunal,
Sil Amrita,
Das Nilay K.,
Bandyopadhyay Debabrata
Publication year - 2015
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/ijd.12793
Subject(s) - medicine , pentoxifylline , clofazimine , double blind , randomized controlled trial , leprosy , dermatology , surgery , pathology , alternative medicine , placebo
Background Type 2 lepra reaction (T2R) is a difficult‐to‐manage condition in leprosy, and an effective and safe steroid‐sparing agent is needed for its management. The World Health Organization proposes clofazimine and recommends pentoxifylline for T2R. Our study was done to compare the effectiveness and safety of clofazimine and pentoxifylline therapy in patients with T2R. Methods Twenty patients with T2R were randomized equally. Group A received pentoxifylline 400 mg t.d.s, group B received clofazimine 100 mg t.d.s. for 12 weeks. Both groups received prednisolone 40 mg o.d., tapered over 12 weeks. The effectiveness parameters were days needed for resolution of cutaneous and systemic manifestations, relapses, cutaneous score, systemic score, and average daily prednisolone intake. Safety parameters were spontaneously appearing adverse events and laboratory parameter changes. Results The cutaneous scores in the clofazimine ( P < 0.001) and pentoxifylline groups ( P < 0.001) showed a progressive decline in subsequent follow‐ups. Individual follow‐ups were significantly lower than baseline in both groups ( P < 0.05). Systemic scores fared similarly. There were no significant intergroup changes. Average daily prednisolone intake progressively decreased in group B ( P < 0.001). Cutaneous and systemic manifestations took a comparable time to resolve. Both drugs were safe. Conclusion Pentoxifylline effectively reduces initial severity; clofazimine provides sustained improvement but acts slowly.