SUMMARYAim: 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 ¼ 58) or placebo plus 5-ASA (n ¼ 61). Both treatment groups showed a statistically significant decrease of disease activity index (DAI) and histology score at the end of treatment (P ¼ 0.001, each). DAI score was lower in the BDP group than in the placebo group (P ¼ 0.014), with more patients in clinical remission in the BDP group (58.6% vs. 34.4%, P ¼ 0.008). Serum cortisol levels significantly decreased in BDP group vs. baseline (P ¼ 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.

SUMMARYAim: To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis. Methods: In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function.Results: One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n ¼ 90) or 5-ASA (n ¼ 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion. Conclusion: Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.

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