A team from Buenos Aires, Argentina, investigated the efficacy and tolerability of budesonide enema in the treatment of pouchitis, compared with oral metronidazole.
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.
A total of 26 patients with an active episode of pouchitis (defined as a pouchitis disease activity index score ≥ 7) and no treatment during the previous month were included in the prospective double-blind, double-dummy trial.
Each was randomized to receive either budesonide enema (2 mg/100 ml at bedtime) plus placebo tablets, or oral metronidazole (0.5 g twice daily) plus placebo enema, over a 6-week period.
Based on the intention-to-treat principle, the researchers detected a significant improvement in disease activity at the end of the first week with both drugs.
|Proportion of patients that improved:|
| Alimentary Pharmacology & Therapeutics |
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.
The investigators found that 58% and 50% of patients improved (decrease in pouchitis disease activity index ≥ 3) with budesonide enema and metronidazole, respectively (odds ratio, 1.4).
Adverse effects were observed in 57% of patients given metronidazole and in 25% of patients given budesonide.
Dr A. Sambuelli, of the ‘Dr Carlos Bonorino Udaondo' Gastroenterology Hospital, Buenos Aires, concluded on behalf of colleagues, "Budesonide enemas are an alternative treatment for active pouchitis, with similar efficacy but better tolerability than oral metronidazole."