Crohn's disease: budesonide promotes remission in active disease less effectively than conventional steroids but does not prevent relapse

Clinical bottom line (level 1a)

  1. Patients with active Crohn's disease who take budesonide compared with placebo (NNT = 5 at 8 weeks) or mesalazine (NNT = 4 at 16 weeks) are more likely to go into remission.
  2. Patients with active Crohn's disease who take budesonide compared with conventional steroids are less likely to go into remission (NNH = 12 at 8 weeks) , but have fewer steroid-related adverse effects (NNT = 5 at 8 weeks) .
  3. Patients with Crohn's disease in remission who take budesonide compared with placebo are not clearly less likely to relapse, nor clearly more likely to have steroid-related adverse effects.
  4. Patients, following surgical resection for Crohn's disease, who take budesonide compared with placebo are not clearly less likely to have a recurrence.
Papi et al: Alimentary Pharmacological Therapy 2000; 14 : 1419-1428
Expires October 2003

The study

Systematic review of all double-blind randomised controlled trials of
  • Patients: active or quiescent Crohn's disease
  • Intervention: oral budesonide
  • Outcome: remission
Articles found in ?all languages using Medline, - (search terms: budesonide and Crohn or inflammatory bowel disease) and and hand-searching using bibliographies, main review articles and proceedings from major gastrointestinal meetings (1993 to 1999)

Selection criteria: see above
Appraisal criteria: by 3 indepedent reviewers: criteria detailed in text
Articles excluded if:
  • patients aged < 18


12 studies found
  • active Crohn's disease: 1 budesonide v. placebo; 1 budesonide v. mesalazine; 4 budesonide v. conventional steroids involving 621 patients
  • Crohn's in remission: 4 studies involving 449 patients
  • post-curative resection: 2 studies involving 212 patients

Heterogeneity was assessed using a L'Abbe plot.

The evidence

Outcome Time to outcome ARR
(95% CI)		 NN T
(95% CI)
budesonide v. placebo: remission 8 weeks 22.5%
(10.6% to 34.3%)		 5
(3 to 9)
budesonide v. mesalazine: remission 16 weeks 27.1%
(13.3% to 40.8%)		 4
(2 to 8)
budesonide v. conventional steroids: remission 8 weeks -8.5%
(-16.4% to -0.7%)		 -12
(-140 to -6)
budesonide v. conventional steroids: steroid-related adverse effects 8 weeks 22.4%
(12.8% to 32.0%)		 5
(3 to 8)
budesonide v. placebo: relapse in Crohn's disease in remission 12 months -0.8%
(-9.9% to 8.3%)		 -130
(NNT = 10 to infinity;
NNH = 12 to infinity)
budesonide v. placebo: steroid-related adverse effects 12 months -5.3%
(-14.5% to 3.9%)		 -19
(NNT = 7 to infinity;
NNH = 26 to infinity)
budesonide v. placebo: post-surgical clinical recurrence 12 months -3.0%
(-15.0% to 8.8%)		 -30
(NNT = 7 to infinity;
NNH = 11 to infinity)

  • 9 mg of budesonide was found to be the optimal dose in active Crohn's disease for promoting remission.
  • Studies of long-term steroid-related adverse effects had significant heterogeneity.

Citation

  1. Papi C, Luchetti R, Gili L, et al: budesonide in the treatment of Crohn's disease: a meta-analysis. Alimentary Pharmacological Therapy 2000; 14 : 1419-1428
Search Terms:
Contributor: Chris Ball, October 2001
Reviewer:

Clinical Question.
Patient active or quiescent Crohn's disease (in remission)
Intervention or Exposure oral budesonide
Comparison placebo, mesalazine, corticosteroids
Outcome relapse, remission