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Oral versus combination mesalazine therapy in active ulcerative colitis: a double‐blind, double‐dummy, randomized multicentre study
Author(s) -
Vecchi M.,
Meucci G.,
Gionchetti P.,
Beltrami M.,
Di Maurizio P.,
Beretta L.,
Ganio E.,
Usai P.,
Campieri M.,
Fornaciari G.,
De Franchis R.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.00913.x
Subject(s) - mesalazine , medicine , ulcerative colitis , enema , gastroenterology , adverse effect , randomized controlled trial , sulfasalazine , placebo , clinical endpoint , colonoscopy , colorectal cancer , cancer , pathology , alternative medicine , disease
Background: Oral and topical mesalazine formulations are effective in active ulcerative colitis, but little is known on the efficacy of combined treatment. Aim: To compare the efficacy of oral mesalazine vs. combined oral and topical mesalazine in mildly to moderately active ulcerative colitis. Methods: Patients with mildly to moderately active ulcerative colitis (Clinical Activity Index, CAI 4–12) were identified at 15 participating centres. They were randomized to receive either mesalazine 4 g orally plus placebo enema, or mesalazine 2 g orally plus mesalazine 2 g rectally as a liquid enema for 6 weeks. The rate of clinical remission (CAI < 4) or clinical remission/improvement (reduction of CAI of 50% from baseline) at 6 weeks and time to clinical remission/improvement were primary end‐points; the rate of endoscopic remission was a secondary end‐point. Results: 67 patients were assigned to oral treatment and 63 to combined treatment. One patient in the oral group and 2 in the combined group discontinued the treatment due to adverse events. Following an intention‐to‐treat analysis, the rate of clinical remission was 82% for oral treatment and 87% for combined treatment ( P =0.56); the mean time to remission 22.2 and 20.2 days, respectively ( P =0.29); the rate of clinical remission/improvement and the rate of endoscopic remission were 85% and 91% ( P =0.503) and 58% and 71% ( P =0.21), respectively. Conclusions: In patients with mild active ulcerative colitis, mesalazine 4 g orally and 2 g orally plus 2 g enema are equally effective in inducing disease remission.