title: 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.
  
  
  OBJECTIVE
  To investigate the efficacy and tolerability of budesonide enema in the treatment of pouchitis compared with oral metronidazole.
  
  
  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.affiliation: Inflammatory Bowel Disease Section, Clinical Service, Clinical Department, Dr Carlos Bonorino Udaondo Gastroenterology Hospital, Buenos Aires, Argentina. asambu@intramed.net.ar
authors.forename: A
authors.initials: A
authors.lastname: Sambuelli
authors.forename: L
authors.initials: L
authors.lastname: Boerr
authors.forename: S
authors.initials: S
authors.lastname: Negreira
authors.forename: A
authors.initials: A
authors.lastname: Gil
authors.forename: G
authors.initials: G
authors.lastname: Camartino
authors.forename: S
authors.initials: S
authors.lastname: Huernos
authors.forename: Z
authors.initials: Z
authors.lastname: Kogan
authors.forename: A
authors.initials: A
authors.lastname: Cabanne
authors.forename: A
authors.initials: A
authors.lastname: Graziano
authors.forename: H
authors.initials: H
authors.lastname: Peredo
authors.forename: I
authors.initials: I
authors.lastname: Doldán
authors.forename: O
authors.initials: O
authors.lastname: Gonzalez
authors.forename: E
authors.initials: E
authors.lastname: Sugai
authors.forename: M
authors.initials: M
authors.lastname: Lumi
authors.forename: J C
authors.initials: JC
authors.lastname: Bai
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D008875:Middle Aged; D019449:Pouchitis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D008795:Metronidazole; D019819:Budesonide