Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

Aliment Pharmacol Ther. 2006 Jan 15;23(2):303-12. doi: 10.1111/j.1365-2036.2006.02743.x.


Background: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis.

Aim: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema.

Methods: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol).

Results: A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%).

Conclusion: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Rectal
  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Budesonide / administration & dosage*
  • Budesonide / adverse effects
  • Colitis, Ulcerative / drug therapy
  • Double-Blind Method
  • Enema / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Proctitis / drug therapy*
  • Proctocolitis / drug therapy
  • Treatment Outcome


  • Anti-Inflammatory Agents
  • Budesonide