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Title: Controlled trial of antimycobacterial therapy in Crohn's disease. Clofazimine versus placebo.
Title Abreviation: Dig Dis Sci Date of Pub: 1991 Apr
Author: Afdhal NH; Long A; Lennon J; Crowe J; O'Donoghue DP;
Issue/Part/Supplement: 4 Volume Issue: 36 Pagination: 449-53
MESH Headings: Adult; Clofazimine (AE/*TU); Crohn Disease (*DT); Double-Blind Method; Drug Evaluation; Female; Human; Male; Middle Age; Recurrence; Remission Induction; -RN-;
Journal Title Code: EAD Publication Type: CLINICAL TRIAL
Date of Entry: 910502NEntry Month: 9107
Country: UNITED STATES Index Priority: 1
Language: Eng Unique Identifier: 91176827
Unique Identifier: 91176827 ISSN: 0163-2116
Abstract: In order to study the effect of clofazimine, a powerful antimycobacterial and antiinflammatory agent, 49 patients with active Crohn's disease were randomized to either corticosteroids plus clofazimine 100 mg daily (N = 25) or to steroids and matching placebo (N = 24). A total of 28 patients (58%) went into disease remission (clofazimine 16, placebo 12; P = NS) with a fall in disease activity score from 10.5 +/- 4.4 to 3.3 +/- 3.5. Patients were treated for a further eight months with clofazimine or placebo and 18 of 28 maintained their remission and completed the study (clofazimine 12, placebo 6; P = NS). Side effects were minor and consisted of skin rash and increased pigmentation. Clofazimine as a solitary antimycobacterial agent appears ineffective in inducing remission in Crohn's disease but may have a role in either disease maintenance or combination chemotherapy.
Abstract By: Author
Address: Department of Gastroenterology, St. Vincents Hospital, Dublin, Ireland.