Budesonide enema in pouchitis--a double-blind, double-dummy, controlled trial.
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.
Sambuelli
A
A
Inflammatory Bowel Disease Section, Clinical Service, Clinical Department, Dr Carlos Bonorino Udaondo Gastroenterology Hospital, Buenos Aires, Argentina. asambu@intramed.net.ar
Boerr
L
L
Negreira
S
S
Gil
A
A
Camartino
G
G
Huernos
S
S
Kogan
Z
Z
Cabanne
A
A
Graziano
A
A
Peredo
H
H
Doldán
I
I
Gonzalez
O
O
Sugai
E
E
Lumi
M
M
Bai
J C
JC
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
D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D008795:Metronidazole; D019819:Budesonide