title: Effectiveness and safety of clofazimine and pentoxifylline in type 2 lepra reaction: a double-blind, randomized, controlled study.
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.
  
  
  CONCLUSIONS
  Pentoxifylline effectively reduces initial severity; clofazimine provides sustained improvement but acts slowly.
authors.affiliation: Department of Dermatology, Medical College, Kolkata, West Bengal, India.
authors.forename: Kunal
authors.initials: K
authors.lastname: Roy
authors.affiliation: Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Amrita
authors.initials: A
authors.lastname: Sil
authors.affiliation: Department of Dermatology, Medical College, Kolkata, West Bengal, India.
authors.forename: Nilay K
authors.initials: NK
authors.lastname: Das
authors.affiliation: Department of Dermatology, Medical College, Kolkata, West Bengal, India.
authors.forename: Debabrata
authors.initials: D
authors.lastname: Bandyopadhyay
mesh_terms: D000328:Adult; D016918:Arthritis, Reactive / Q000382:microbiology*; D002991:Clofazimine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000382:microbiology; D007917:Leprostatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007918:Leprosy / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000382:microbiology; D010431:Pentoxifylline / Q000009:adverse effects / Q000627:therapeutic use*; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007917:Leprostatic Agents; D010726:Phosphodiesterase Inhibitors; D002991:Clofazimine; D010431:Pentoxifylline