Crohn's disease: budesonide was more likely to induce remission than mesalamine.

Clinical bottom line (level 1b)

  1. Patients with active Crohn's disease who were given budesonide were more likely to have remission than those given mesalamine (NNT = 4 at 16 weeks) .
  2. Patients given mesalamine were more likely to withdraw from the trial (NNH = 4 at 16 weeks) .
Thomsen et al: New England Journal of Medicine 1998; 339 (6): 370-374
Expires May 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 25 centres, Denmark, France, UK, Norway, Italy, Spain, Portugal, Greece, South Africa, Austria, Australia, Ireland

182 patients (aged range 18 to 74 years; mean 33, 68% female) confirmed diagnosis (colonoscopy, small-bowel follow-through or barium enema within 24 hours) of active Crohn's disease, as defined by a score of 200-400 on the Crohn's Disease Activity Index

Excluded if
  • <18 years old
  • disease not confined to distal ileum, ileococcal region and ascending colon
  • active Crohn's disease in rectum
  • septic complications, abscess, perforation or active fistulas, ileostomy, or colostomy
  • undergone resection of >100 cm of the ileum
  • required immediate surgery
  • diabetes mellitus, active peptic ulcer disease, systemic infection, or clinically significant renal , hepatic or cardiovascular disease or asthma
  • pregnant or breast-feeding
  • allergic to glucocorticoids or mesalamine


    • Control Group: (n = 93, 77 analysed): budesonide 9 mg once daily
    Experimental Group: (n = 89, 50 analysed): mesalamine 2 g twice daily

    99% followed for 16 weeks
    Outcome notes:
    • withdrawal : due to adverse effects or worsening disease

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no remission 16 weeks 35
    (37.6%)    		 57
    (64.0%)    		 -70%
    (-131% to -26%)    		 -26.4%
    (-40.4% to -12.4%)    		 -4
    (-8 to -2)
    withdrawal 16 weeks 13
    (14.0%)    		 36
    (40.5%)    		 -190%
    (-410% to -65%)    		 -26.5%
    (-38.9% to -14.1%)    		 -4
    (-7 to -3)

    Comments

    1. All patients took at least one dose of trial medication.

    Citation

    1. Thomsen OO, Cortot A, Jewell D, et al: A comparison of budesonide and mesalamine for active Crohn's disease. New England Journal of Medicine 1998; 339 (6): 370-374
    Contributor: Clare Wotton, November 2000
    Reviewer:

    Clinical Question.
    Patient active Crohn's disease
    Intervention or Exposure budesonide
    Comparison mesalamine
    Outcome remission, withdrawal