Crossover study of thalidomide vs placebo in severe recurrent aphthous stomatitis.
A multicentric crossover randomized trial of 100 mg of thalidomide vs placebo each for 2 months was conducted in patients with severe aphthous stomatitis of more than 6 months' duration. Seventy-three patients were included. Complete remission was obtained in 32 patients who received thalidomide and in 6 patients who received placebo. The confidence interval of the difference between the two treatments ranged from 25% to 53%. Most of the patients who did not achieve a complete remission had a dramatic improvement with regard to the number of aphthae when they were receiving thalidomide. Thirteen of 17 patients who had a complete remission while they were receiving thalidomide had a recurrence with placebo, 19 +/- 9 (mean +/- SD) days after stopping this drug. Side effects were significantly more frequent with thalidomide, especially drowsiness and constipation. We concluded that thalidomide in a dosage of 100 mg/d is an effective treatment of severe aphthous stomatitis but is not without some risk.
Services de Dermatologie, Centre Hôpitalier Universitaire Henri Mondor, Créteil, France.
J
J
Revuz
J C
JC
Guillaume
M
M
Janier
P
P
Hans
C
C
Marchand
P
P
Souteyrand
J M
JM
Bonnetblanc
A
A
Claudy
S
S
Dallac
C
C
Klene
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000473:pathology; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*
D013792:Thalidomide