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Title: Antimycobacterial therapy in Crohn's disease: results of a controlled, double-blind trial with a multiple antibiotic regimen.
Title Abreviation: Am J Gastroenterol Date of Pub: 1994 Apr
Author: Prantera C; Kohn A; Mangiarotti R; Andreoli A; Luzi C;
Issue/Part/Supplement: 4 Volume Issue: 89 Pagination: 513-8
MESH Headings: Adult; Antibiotics, Combined (*TU); Antitubercular Agents (*TU); Clofazimine (TU); Crohn Disease (*DT/EP/*MI); Dapsone (TU); Double-Blind Method; Ethambutol (TU); Female; Human; Male; Mycobacterium Infections, Atypical (*DT); Prospective Studies; Rifampin (TU); Time Factors; -RN-;
Journal Title Code: 3HE Publication Type: CLINICAL TRIAL
Date of Entry: 940505NEntry Month: 9407
Country: UNITED STATES Index Priority: 1
Language: Eng Unique Identifier: 94197151
Unique Identifier: 94197151 ISSN: 0002-9270
Abstract: Several recent reports have suggested an association of atypical mycobacteria with Crohn's disease. OBJECTIVES: The goal of this double-blind, placebo-controlled trial was to determine the efficacy of treatment with antimycobacterial drugs in maintaining clinical remission and in reducing active inflammatory lesions. METHODS: Forty patients (15 male) with refractory, steroid-dependent Crohn's disease were randomized to receive 2 months of tapering steroids plus either a 9-month regimen of ethambutol, clofazimine, dapsone and 1-day dose only of rifampicin (n = 22), or identical placebo. RESULTS: Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months. Three of the remaining 19 patients on active drug relapsed during the study period, compared with 11 of 17 on placebo (log likelihood ratio = 4.6; p = 0.03). Another patient was withdrawn in remission at 5 months for anemia related to dapsone. Nine patients whose disease relapsed or persisted on placebo were crossed over to active drug; five achieved sustained remission, two failed, and two were withdrawn for side effects. Substantial endoscopic or radiologic healing did not occur. CONCLUSION: This study suggests that the treatment regimen with rifampicin, ethambutol, clofazimine, and dapsone is effective in relief of symptoms and maintenance of remission in some Crohn's disease patients.
Abstract By: Author
Address: Department of Gastroenterology, Ospedale Nuovo Regina Margherita, Rome, Italy.