Budesonide enema in pouchitis--a double-blind, double-dummy, controlled trial.

Abstract

BACKGROUND:

Pouchitis has been suggested to be a recurrence of ulcerative colitis in a colon-like mucosa. Topical steroids are a valid therapeutic alternative for distal forms of ulcerative colitis.

AIM:

To investigate the efficacy and tolerability of budesonide enema in the treatment of pouchitis compared with oral metronidazole.

MATERIALS AND METHODS:

Twenty-six patients with an active episode of pouchitis (defined as a pouchitis disease activity index score >or= 7) and no treatment during the previous month were randomized to receive either budesonide enema (2 mg/100 mL at bedtime) plus placebo tablets or oral metronidazole (0.5 g b.d.) plus placebo enema in a prospective, double-blind, double-dummy, 6-week, controlled trial.

RESULTS:

Based on the intention-to-treat principle, we detected a significant improvement in disease activity at the end of the first week with both drugs (P < 0.01). After that, improvement was moderated until stabilization at 4 weeks in both treatments. The per protocol analysis showed that both drugs had similar efficacy in terms of disease activity, clinical and endoscopic findings. Fifty-eight per cent and 50% of patients improved (decrease in pouchitis disease activity index >or= 3) with budesonide enema and metronidazole, respectively (odds ratio, 1.4; confidence interval, 0.2-8.9). Adverse effects were observed in 57% of patients given metronidazole and in 25% of patients given budesonide.

CONCLUSIONS:

Budesonide enemas are an alternative treatment for active pouchitis, with similar efficacy but better tolerability than oral metronidazole.

• Authors: A Sambuelli, L Boerr, S Negreira, A Gil, G Camartino, S Huernos, Z Kogan, A Cabanne, A Graziano, H Peredo, I Doldán, O Gonzalez, E Sugai, M Lumi, J C Bai
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 1 Pg. 27-34 (Jan 2002) ISSN: 0269-2813 [Print] England
• PMID: 11856075 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Anti-Inflammatory Agents
• Metronidazole
• Budesonide

Topics

• Administration, Oral
• Adolescent
• Adult
• Anti-Infective Agents (administration & dosage, adverse effects, pharmacology)
• Anti-Inflammatory Agents (administration & dosage, adverse effects, pharmacology)
• Budesonide (administration & dosage, adverse effects, pharmacology)
• Double-Blind Method
• Enema
• Female
• Humans
• Male
• Metronidazole (administration & dosage, adverse effects, pharmacology)
• Middle Aged
• Pouchitis (drug therapy)
• Treatment Outcome