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

Aliment Pharmacol Ther. 2002 Jun;16(6):1109-16. doi: 10.1046/j.1365-2036.2002.01298.x.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / pharmacology*
  • Beclomethasone / administration & dosage
  • Beclomethasone / pharmacology*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / pathology
  • Double-Blind Method
  • Female
  • Humans
  • Hydrocortisone / blood
  • Male
  • Middle Aged
  • Placebos
  • Severity of Illness Index
  • Treatment Outcome


  • Anti-Inflammatory Agents
  • Placebos
  • Beclomethasone
  • Hydrocortisone