Kunal Roy1, Amrita Sil2, Nilay K Das1, Debabrata Bandyopadhyay1. 1. Department of Dermatology, Medical College, Kolkata, West Bengal, India. 2. Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Abstract
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.
RCT Entities:
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.
Authors: Stephen L Walker; Anna M Sales; C Ruth Butlin; Mahesh Shah; Armi Maghanoy; Saba M Lambert; Joydeepa Darlong; Benjamin Jewel Rozario; Vivek V Pai; Marivic Balagon; Shimelis N Doni; Deanna A Hagge; José A C Nery; Kapil D Neupane; Suwash Baral; Biliom A Sangma; Digafe T Alembo; Abeba M Yetaye; Belaynesh A Hassan; Mohammed B Shelemo; Peter G Nicholls; Diana N J Lockwood Journal: PLoS Negl Trop Dis Date: 2017-07-03
Authors: Barbara de Barros; Saba M Lambert; Mahesh Shah; Vivek V Pai; Joydeepa Darlong; Benjamin Jewel Rozario; Medhi Denisa Alinda; Anna M Sales; Shimelis Doni; Deanna A Hagge; Dilip Shrestha; M Yulianto Listiawan; Abeba M Yitaye; Jose A C Nery; Kapil D Neupane; Vivianne L A Dias; C Ruth Butlin; Peter G Nicholls; Diana Lockwood; Stephen L Walker Journal: BMJ Open Date: 2020-11-17 Impact factor: 2.692