Thalidomide as therapy for human immunodeficiency virus-related oral ulcers: a double-blind placebo-controlled clinical trial.
A double-blind, randomized, placebo-controlled clinical trial was performed in Mexico City to evaluate the efficacy of thalidomide in treating oral recurrent aphthae in human immunodeficiency virus (HIV)-infected subjects. Sixteen HIV-infected patients with clinical and histological diagnosis of oral recurrent aphthous ulcerations received randomly an 8-week course of either thalidomide or placebo, with an initial oral dosage of 400 mg/d for 1 week, followed by 200 mg/d for 7 weeks. Ten subjects received thalidomide and six received placebo. At 8 weeks, nine subjects (90%) in the thalidomide group had complete healing of their ulcers, compared with two (33.3%) of the six patients in the placebo group (P = .03). There was a significant reduction in largest ulcer diameter in the thalidomide group. Rash was observed in 80% of the thalidomide patients. Although thalidomide demonstrated an unquestionable benefit in treatment of oral ulcers in HIV patients, caution must be taken given the frequent occurrence of side effects.
Ramirez-Amador
V A
VA
Universidad Autonoma Metropolitana-Xochimilco, Department of Health Care, Villa Quietud, Consejo Nacional para la Prevención y Control del Sida, Toriello Guerra, Mexico. rava1863@cueyatl.uam.mx
Esquivel-Pedraza
L
L
Ponce-de-Leon
S
S
Reyes-Teran
G
G
Gonzalez-Guevara
M
M
Ponce-de-Leon
S
S
Sierra-Madero
J G
JG
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D019226:Oral Ulcer / Q000188:drug therapy*; D013792:Thalidomide / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D013792:Thalidomide