A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum

Am J Trop Med Hyg. 2005 May;72(5):518-26.

Abstract

In a randomized, double-blind, double-dummy controlled study, 22 men with erythema nodosum leprosum (ENL) received six capsules containing either 100 mg (group A, n = 12) or 300 mg (group B, n = 10) of thalidomide daily for one week. A six-week, four capsules per day taper followed, in which group A received 50 mg/day of thalidomide in weeks 2 and 3, then dummy capsules in weeks 4 through 7, while group B had gradual decrements every two weeks. Both regimens caused comparable improvement in 19 patients at day 7 (group A [12 of 12] versus group B [7 of 10]; P = 0.08), but slower tapering in group B showed less re-emergence of ENL through week 7 (P = 0.02, versus group A). Most patients developed new lesions soon after stopping treatment. Slower tapering from a higher initial thalidomide dose may improve clinical ENL responses, but high recurrence rates after discontinuation indicates further assessment is needed to identify better tapering regimens.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Erythema Nodosum / drug therapy*
  • Humans
  • Interleukin-6 / blood
  • Leprostatic Agents / administration & dosage*
  • Leprostatic Agents / adverse effects
  • Leprosy, Lepromatous / drug therapy*
  • Lymphocytes
  • Male
  • Middle Aged
  • Neopterin / urine
  • Thalidomide / administration & dosage*
  • Thalidomide / adverse effects
  • Tumor Necrosis Factor-alpha / metabolism

Substances

  • Interleukin-6
  • Leprostatic Agents
  • Tumor Necrosis Factor-alpha
  • Thalidomide
  • Neopterin