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.
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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)
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Chemical References |
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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)
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