UNLABELLED: 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 RESULTS: Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months.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 Another patient was withdrawn in remission at 5 months for anemia related to dapsone.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or persisted on placebo were crossed over to active drug; five achieved sustained remission, two failed, and two were withdrawn for side effects.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.
RCT Entities:
UNLABELLED: 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 RESULTS: Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months.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 Another patient was withdrawn in remission at 5 months for anemia related to dapsone.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 diseasepatients.
Authors: S P L Travis; E F Stange; M Lémann; T Oresland; Y Chowers; A Forbes; G D'Haens; G Kitis; A Cortot; C Prantera; P Marteau; J-F Colombel; P Gionchetti; Y Bouhnik; E Tiret; J Kroesen; M Starlinger; N J Mortensen Journal: Gut Date: 2006-03 Impact factor: 23.059
Authors: William S Mow; Carol J Landers; A Hillary Steinhart; Brian G Feagan; Ken Croitoru; Ernest Seidman; Gordon R Greenberg; Stephan R Targan Journal: Dig Dis Sci Date: 2004-08 Impact factor: 3.199
Authors: G A Thomas; G L Swift; J T Green; R G Newcombe; C Braniff-Mathews; J Rhodes; S Wilkinson; G Strohmeyer; G Kreuzpainter Journal: Gut Date: 1998-04 Impact factor: 23.059
Authors: J M Dumonceau; A Van Gossum; M Adler; P A Fonteyne; J P Van Vooren; J Deviere; F Portaels Journal: Dig Dis Sci Date: 1996-02 Impact factor: 3.199