Crohn's disease: remission: budesonide has no clear effect on relapse rates

Clinical bottom line (level 1a)

  1. Patients with Crohn's disease in remission who take oral budesonide (at 3 mg or 6 mg daily) compared with placebo are not clearly less likely to have a relapse in the next 12 months.
Simms and Steinhart: Cochrane Library 2001; 1 : -
Expires October 2003

The study

Systematic review of all randomised controlled trials of
  • Patients: Crohn's disease in remission (CDAI < 150); disease restricted to ileum and colon
  • Intervention: oral budesomide 6 mg or 3 mg daily compared with placebo
  • Outcome: relapse

    Articles found in English, Spanish, French, German, Italian, Japanese using Medline, Cochrane controlled trials register, inflammatory bowel disease review group trials register, 1966 to September 2000 (search terms: oral budesonide, Crohn's disease, Crohn disease and inflammatory bowel disease ) and reviewed bibliographies of retrieved articles. Proceedings from the American Gastroenterology Association conference (1980 to1998) were hand-searched, and the manufacturer of budesonide and some authors contacted.

    Selection criteria: see above
    Appraisal criteria: 3 independent unblinded reviewers based on 3 criteria - randomisation, double-blind, placebo-control
    Articles excluded if: see above

    3 RCTs found involving 270 patients followed for 12 months

    The evidence

    Outcome Time to outcome CER OR
    (95% CI)    		 NN T
    (95% CI)
    relapse: budesonide 6 mg v. placebo 12 months 58/90
    (64.4%)    		 0.75
    (0.41 to 1.36)     		15
    (NNT = 5 to infinity;
    NNH = 15 to infinity)
    relapse: budesonide 6 mg v. 3 mg 12 months 58/90
    (64.4%)    		 0.73
    (0.40 to 1.33)     		13
    (NNT = 4 to infinity;
    NNH = 16 to infinity)
    relapse: budesonide 3 mg v. placebo 12 months 58/90
    (64.4%)    		 0.99
    (0.54 to 1.83)     		430
    (NNT = 7 to infinity;
    NNH = 8 to infinity)

    Citation

    1. Simms L, and Steinhart AH: budesonide for maintenance of remission in Crohn's disease. Cochrane Library 2001; 1 : -
    Search Terms: Crohn* in Cochrane Library
    Contributor: Chris Ball, October 2001
    Reviewer:

    Clinical Question.
    Patient Crohn's disease in remission
    Intervention or Exposure oral budesonide
    Comparison placebo
    Outcome relapse
    		•