title: A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum.
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.
authors.affiliation: Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation) Cebu City, The Philippines.
authors.forename: Laarni G
authors.initials: LG
authors.lastname: Villahermosa
authors.forename: Tranquilino T
authors.initials: TT
authors.lastname: Fajardo
authors.forename: Rodolfo M
authors.initials: RM
authors.lastname: Abalos
authors.forename: Maria V
authors.initials: MV
authors.lastname: Balagon
authors.forename: Esterlina V
authors.initials: EV
authors.lastname: Tan
authors.forename: Roland V
authors.initials: RV
authors.lastname: Cellona
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Palmer
authors.forename: Janet
authors.initials: J
authors.lastname: Wittes
authors.forename: Steven D
authors.initials: SD
authors.lastname: Thomas
authors.forename: Karin A
authors.initials: KA
authors.lastname: Kook
authors.forename: Gerald P
authors.initials: GP
authors.lastname: Walsh
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Walsh
mesh_terms: D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004893:Erythema Nodosum / Q000188:drug therapy*; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D007917:Leprostatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015440:Leprosy, Lepromatous / Q000188:drug therapy*; D008214:Lymphocytes; D008297:Male; D008875:Middle Aged; D019798:Neopterin / Q000652:urine; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
chemical_list: D015850:Interleukin-6; D007917:Leprostatic Agents; D014409:Tumor Necrosis Factor-alpha; D013792:Thalidomide; D019798:Neopterin