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

Abstract

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.

• Authors: F Rizzello, P Gionchetti, A D'Arienzo, F Manguso, G Di Matteo, V Annese, D Valpiani, T Casetti, S Adamo, A Prada, G N Castiglione, G Varoli, M Campieri
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 6 Pg. 1109-16 (Jun 2002) ISSN: 0269-2813 [Print] England
• PMID: 12030952 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Placebos
• Beclomethasone
• Hydrocortisone

Topics

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