Crohn's disease: budesonide helped induce remission in patients with active disease.

Clinical bottom line (level 1b)

  1. Budesonide in doses of 9 mg daily or higher was effective at inducing remission in patients with active Crohn's disease (NNT = 3 at 10 weeks) .
  2. There was no clear increase compared with placebo in the number of patients with corticosteroid-associated adverse effects.
Greenberg et al: New England Journal of Medicine 1994; 331: 836-841
Expires May 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 27 acute hospitals, Canada

258 patients (aged range 16 to 66 years, 62% female) active Crohn's disease (Crohn's disease activity index score > 200) involving the ileum or ileum and colon and not extending beyond the hepatic flexure

Excluded if
  • previous ileostomy
  • severe disease requiring imminent surgery
  • diabetes mellitus
  • active infection
  • peptic ulcer disease
  • cancer, cardiac or hepatic disease
  • pregnant or breast-feeding


    • Note:
  • Patients were stratified for corticosteroid use > 2 weeks in the previous year.


    • Control Group: (n = 66, 66 analysed): placebo
    Experimental Group: (n = 67, 67 analysed): budesonide 3 mg po once daily; after 8 weeks placebo
    Experimental Group: (n = 61, 61 analysed): budesonide 9 mg po once daily; after 8 weeks 6 mg po once daily
    Experimental Group: (n = 64, 64 analysed): budesonide 15 mg po once daily; after 8 weeks 6 mg po once daily

    100% followed for 10 weeks
    Outcome notes:
    • no remission : remission: CDAI < 150
    • adverse effects : corticosteroid-related adverse events

    The evidence

    3 mg budesonide vs placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 10 weeks 53
    (80.3%)    		 45
    (67.2%)    		 16%
    (-3% to 32%)    		 13.1%
    (-1.64% to 27.9%)    		 8
    (NNT = 4 to infinity;
    NNH = 61 to infinity)
    adverse effects 10 weeks 17
    (25.8%)    		 10
    (14.9%)    		 42%
    (-17% to 71%)    		 10.8%
    (-2.74% to 24.4%)    		 9
    (NNT = 4 to infinity;
    NNH = 37 to infinity)

    9 mg vs placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 10 weeks 53
    (80.3%)    		 30
    (49.2%)    		 39%
    (19% to 54%)    		 31.1%
    (15.3% to 46.9%)    		 3
    (2 to 7)
    adverse effects 10 weeks 17
    (25.8%)    		 16
    (26.2%)    		 -2%
    (-83% to 43%)    		 -0.47%
    (-15.7% to 14.8%)    		 -212
    (NNT = 7 to infinity;
    NNH = 6 to infinity)

    15 mg vs placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 10 weeks 53
    (80.3%)    		 36
    (56.3%)    		 30%
    (10% to 45%)    		 24.1%
    (8.57% to 39.5%)    		 4
    (3 to 12)
    adverse effects 10 weeks 17
    (25.8%)    		 24
    (37.5%)    		 -46%
    (-144% to 13%)    		 -11.7%
    (-27.6% to 4.13%)    		 -9
    (NNT = 24 to infinity;
    NNH = 4 to infinity)

  • 54% completed medication.

    • Comments

    1. The majority of withdrawals from the study were due to insufficient therapeutic effect.
    2. The study is not large enough to show any clear differences in adverse effects between budesonide and placebo.

    Citation

    1. Greenberg GR, et al: Oral budesonide for active Crohn's disease. New England Journal of Medicine 1994; 331: 836-841
    Search Terms: Crohns in Best Evidence
    Contributor: David Ford and Chris Ball, September 2000
    Reviewer:

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