Crossover study of thalidomide vs placebo in severe recurrent aphthous stomatitis.

Abstract

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.

• Authors: J Revuz, J C Guillaume, M Janier, P Hans, C Marchand, P Souteyrand, J M Bonnetblanc, A Claudy, S Dallac, C Klene
• Journal: Archives of dermatology (Arch Dermatol) Vol. 126 Issue 7 Pg. 923-7 (Jul 1990) ISSN: 0003-987X [Print] United States
• PMID: 2193629 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Thalidomide

Topics

• Adult
• Double-Blind Method
• Female
• Humans
• Male
• Multicenter Studies as Topic
• Randomized Controlled Trials as Topic
• Recurrence
• Stomatitis, Aphthous (drug therapy, pathology)
• Thalidomide (adverse effects, therapeutic use)