Portal de Periódicos da CAPES

Budesonide enema in pouchitis—a double‐blind, double‐dummy, controlled trial

2002; Wiley; Volume: 16; Issue: 1 Linguagem: Inglês

10.1046/j.1365-2036.2002.01139.x

1365-2036

Alicia M. Sambuelli, Luis A. Boerr, Silvia Negreira, Ángel Gil, G Camartino, Sergio P. Huernos, Zulema Kogan, Ana Cabanne, A Graziano, H.A. Peredo, Ivan Doldan, Ofelia González, Emilia Sugai, M Lumi, Jie Bai,

Helicobacter pylori-related gastroenterology studies

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 ≥ 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 ≥ 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.