Oral versus combination mesalazine therapy in active ulcerative colitis: adouble-blind, double-dummy, randomized multicentre study

Background: Oral and topical mesalazine formulations are effective in activ e ulcerative colitis, but little is known on the efficacy of combined treat ment. Aim: To compare the efficacy of oral mesalazine vs. combined oral and topic al mesalazine in mildly to moderately active ulcerative colitis. Methods: Patients with mildly to moderately active ulcerative colitis (Clin ical 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 en ema for 6 weeks. The rate of clinical remission (CAI < 4) or clinical remis sion/improvement (reduction of CAI of 50% from baseline) at 6 weeks and tim e to clinical remission/improvement were primary end-points; the rate of en doscopic remission was a secondary end-point. Results: 67 patients were assigned to oral treatment and 63 to combined tre atment. One patient in the oral group and 2 in the combined group discontin ued the treatment due to adverse events. Following an intention-to-treat an alysis, the rate of clinical remission was 82% for oral treatment and 87% f or combined treatment (P=0.56); the mean time to remission 22.2 and 20.2 da ys, respectively (P=0.29); the rate of clinical remission/improvement and t he 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 di sease remission.