A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum.
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.
Villahermosa
Laarni G
LG
Leonard Wood Memorial Center for Leprosy Research (American Leprosy Foundation) Cebu City, The Philippines.
Fajardo
Tranquilino T
TT
Abalos
Rodolfo M
RM
Balagon
Maria V
MV
Tan
Esterlina V
EV
Cellona
Roland V
RV
Palmer
Jeffrey P
JP
Wittes
Janet
J
Thomas
Steven D
SD
Kook
Karin A
KA
Walsh
Gerald P
GP
Walsh
Douglas S
DS
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
D015850:Interleukin-6; D007917:Leprostatic Agents; D014409:Tumor Necrosis Factor-alpha; D013792:Thalidomide; D019798:Neopterin