Crohn's disease: budesonide was less effective but less toxic than prednisolone in active disease.

Clinical bottom line (level 1b)

  1. Patients with active Crohn's disease who took budesonide compared with prednisolone were not clearly less likely to go into remission.
  2. Patients on budesonide had a small decrease in their Crohn's activity index score compared with patients on prednisolone.
  3. Patients on budesonide had fewer corticosteroid-related side-effects than patients on prednisolone (NNT = 5 at 10 weeks) .
Rutgeerts et al: New England Journal of Medicine 1994; 331: 842-845
Expires May 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 11 university hospitals, North-West Europe

176 patients (aged mean 36 years, 62% female) active Crohn's disease (CDAI score > 200)

Excluded if
  • aged <18
  • ileostomy or small bowel resection exceeding 100 cm
  • complication of disease: abscesses, perforations, active fistulas
  • discontinued corticosteroids within previous two weeks
  • active peptic ulcer, clinically-important hepatic , renal, cardiovascular or psychiatric conditions
  • candidates for immediate surgery (e.g. fibrous intestinal strictures)


    • Note:
  • Patients were randomised in blocks of four.


    • Control Group: (n = 88, 88 analysed): prednisolone 40 mg po once daily for 2 weeks, then 30 mg for 2 weeks, then 25 mg for 2 weeks, then decreased by 5 mg per week for the final four weeks; and placebo
    Experimental Group: (n = 88, 88 analysed): budesonide 9 mg po once daily for 8 weeks, then 6 mg po once daily for the final 4 weeks; and placebo.

    100% followed for 10 weeks
    Outcome notes:
    • no remission : remission: CDAI <150
    • treatment failure : success: CDAI < 150, or fall of > 100 points

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    withdrawal from study 10 weeks 15
    (17.1%)    		 16
    (18.2%)    		 -7%
    (-102% to 44%)    		 -1.14%
    (-12.4% to 10.1%)    		 -88
    (NNT = 10 to infinity;
    NNH = 8 to infinity)
    no remission 10 weeks 41
    (46.6%)    		 30
    (34.1%)    		 27%
    (-6% to 49%)    		 12.5%
    (-1.88% to 26.9%)    		 8
    (NNT = 4 to infinity;
    NNH = 53 to infinity)
    treatment failure 10 weeks 24
    (27.3%)    		 36
    (40.9%)    		 -50%
    (-129% to 2%)    		 -13.6%
    (-27.5% to 0.22%)    		 -7
    (NNT = 450 to infinity;
    NNH = 4 to infinity)
    side effects 10 weeks 48
    (54.6%)    		 29
    (33.0%)    		 40%
    (14% to 58%)    		 21.6%
    (7.28% to 35.9%)    		 5
    (3 to 14)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    fall in Crohn's disease activity score (CDAI) 143
    ()     		100
    ()     		p=0.001
    ( to )

  • 82% completed medication.

    • Comments

    1. The study is too small to show any clear difference in the therapeutic effects of prednisolone and budesonide.

    Citation

    1. Rutgeerts P, et al: A comparison of budesonide with prednisolone for active Crohn's disease. New England Journal of Medicine 1994; 331: 842-845
    Search Terms: Crohns in Best Evidence
    Contributor: David Ford and Chris Ball, October 2000
    Reviewer:

    Clinical Question.
    Patient Crohn's disease
    Intervention or Exposure budesonide
    Comparison prednisolone
    Outcome remission, side effects