Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Abstract

Summary Aim : To evaluate efficacy and safety of oral beclometasone dipropionate (BDP) when added to 5‐ASA in the treatment of patients with active ulcerative colitis. Methods : In a 4‐week, placebo‐controlled, double‐blind study, patients with extensive or left‐sided mild to moderate active ulcerative colitis were randomized to receive oral 5‐ASA (3.2 g/day) plus BDP (5 mg/day) or placebo. Clinical, endoscopic and histologic features, and haematochemical parameters were recorded at baseline and at the end of the study. Results : One hundred and nineteen patients were enrolled and randomly treated with BDP plus 5‐ASA ( n = 58) or placebo plus 5‐ASA ( n = 61). Both treatment groups showed a statistically significant decrease of disease activity index (DAI) and histology score at the end of treatment ( P = 0.001, each). DAI score was lower in the BDP group than in the placebo group ( P = 0.014), with more patients in clinical remission in the BDP group (58.6% vs. 34.4%, P = 0.008). Serum cortisol levels significantly decreased in BDP group vs. baseline ( P = 0.002), but without signs of pituitary‐adrenal function depletion. A low incidence of adverse events was observed in both groups. Conclusions : Oral BDP in combination with oral 5‐ASA is significantly more effective than 5‐ASA alone in the treatment of patients with extensive or left‐sided active ulcerative colitis.