Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis: A multicenter, randomized, double-blind study

Abstract

Background Topical beclomethasone diproprionate has shown efficacy in ulcerative colitis. Aim To assess, in a multicenter, randomized, double-blind study, the tolerability and safety of topical beclomethasone diproprionate (3 mg) enema and foam versus mesalazine (2 g) enema and foam in mild–moderate distal ulcerative colitis. Patients In 15 referral gastrointestinal units, 99 patients with distal ulcerative colitis were enrolled. This number was lower than planned according to the statistical analysis, due to a low recruitment rate. Methods Patients were randomly assigned to random preparations (beclomethasone diproprionate enema, beclomethasone diproprionate foam, mesalazine enema, mesalazine foam) once nightly for 8 weeks, with clinical and endoscopical assessment (Disease Activity Index score) at baseline ( T0), 4 ( T4) and 8 weeks ( T8). Results were expressed as median and range (95% confidence interval). The efficacy was assessed by comparing the Disease Activity Index value at T4 and T8 by using the Student's t-test or the Wilcoxon–Mann–Whitney test. Results Efficacy was comparable in the beclomethasone diproprionate or mesalazine groups at both T4 and T8 (response at T4: beclomethasone diproprionate 78% [95% confidence interval 0.6–0.8] versus mesalazine 79% [95% confidence interval 0.6–0.8]; T8: beclomethasone diproprionate 84% [95% confidence interval 0.7–0.9] versus mesalazine 90% [95% confidence interval 0.7–1.0]; p = n.s.; remission at T4: beclomethasone diproprionate 24% [95% confidence interval 0.1–0.3] versus mesalazine 28% [95% confidence interval 0.1–0.3]; remission at T8: beclomethasone diproprionate 36% [95% confidence interval 0.2–0.5] versus mesalazine 52% [95% confidence interval 0.3–0.6]; p = n.s.).The Disease Activity Index lowered at T4 and T8 versus T0 in the four groups ( T4 versus T0: beclomethasone diproprionate foam Disease Activity Index 2 versus 6 p < 0.0001; beclomethasone diproprionate enema 4 versus 6, mesalazine enema 3 versus 6, mesalazine foam 3.5 versus 7, p < 0.001 for all three groups; T8 versus T0: p < 0.01). The Disease Activity Index lowered at T8 versus T4 in the beclomethasone diproprionate enema and foam (Disease Activity Index: 2 versus 4 and 1 versus 4, respectively; p < 0.05) and in the mesalazine enema (Disease Activity Index: 1.5, range 0–4 versus 3, range 0–12; p < 0.01), but not in the mesalazine foam group (Disease Activity Index: 1, range 0–9 versus 3.5, range 0–8; p = n.s.). The safety profile was favourable for all groups. Conclusions Beclomethasone diproprionate and mesalazine enema and foam show a comparable tolerability and efficacy in mild active distal ulcerative colitis.