Crohn's disease: 6 mg budesonide reduced symptomatic relapse.

Clinical bottom line (level 2b)

  1. Patients with Crohn's disease in remission who took 6 mg of budesonide compared with placebo were less likely to have a symptomatic relapse (NNT = 4 at 3 months) .
  2. 3 mg budesonide was not clearly better than placebo at preventing relapse.
Lofberg et al: Gut 1996; 39: 82-86
Expires October 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 11 acute hospitals in Europe

90 patients (aged 18 to 71; mean 35, 60% female) with Crohn's disease in remission (CDAI score < 150 after 10 weeks of therapy with prednisolone or budesonide)

Excluded if
  • aged < 18
  • ileostomy or previous small bowel resection exceeding 100 cm
  • septic complications
  • active inflammation of the rectum
  • active systemic infection
  • peptic ulcer disease
  • receiving total parenteral, enteric or polymeric nutrition
  • disease not localised to terminal ileum or ileocaecal region


    • Control Group: (n = 27, 27 analysed): placebo
    Experimental Group: (n = 31, 31 analysed): budesonide 3 mg daily for 12 months
    Experimental Group: (n = 32, 32 analysed): budesonide 6 mg daily for 12 months

    30% followed for 12 months
    Outcome notes:
    • symptomatic relapse : increase in CDAI score - budesonide 3 mg v. placebo
    • symptomatic relapse : budesonide 6 mg v. placebo

    The evidence

    3 mg budesonide v. placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    symptomatic relapse 3 months 12
    (44.4%)    		 14
    (45.2%)    		 -2%
    (-80% to 43%)    		 -0.72%
    (-26.4% to 24.9%)    		 -140
    (NNT = 4 to infinity;
    NNH = 4 to infinity)

    6 mg budesonide v. placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    symptomatic relapse 3 months 12
    (44.4%)    		 6
    (18.8%)    		 58%
    (3% to 82%)    		 25.7%
    (2.58% to 48.8%)    		 4
    (2 to 39)

    Comments

    1. The study was too small to show any difference between 3 mg budesonide and placebo.
    2. Most patients withdrew due to therapeutic failure - there was no clear difference in the rate between the 3 groups.
    3. Patients on 6 mg of budesonide were slightly more likely to have steroid-induced side-effects (mainly moon-face and acne) (no data given).

    Citation

    1. Lofberg R, Rutgeerts P, Malchow H, et al: Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo-controlled one year study. Gut 1996; 39: 82-86
    Search Terms: ?
    Contributor: Chris Ball and Clare Wotton, October 1999
    Reviewer:

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