title: Budesonide for induction of remission in Crohn's disease.
abstract: BACKGROUND
  Corticosteroids play a key role in the induction of remission in Crohn's disease. However, corticosteroids can cause significant adverse events. Budesonide is an alternate enteral glucocorticoid with limited systemic bioavailability.
  
  
  OBJECTIVE
  The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in Crohn's disease.
  
  
  METHODS
  The following electronic databases were searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched. Pharmaceutical companies were also contacted.
  
  
  METHODS
  Randomized controlled trials comparing budesonide to a control treatment were included. The study population included patients of any age with active Crohn's disease (CDAI > 150). The primary outcome was induction of remission (CDAI < 150) by week 8 to 16 of treatment. Secondary outcomes included: time to remission, mean change in CDAI, clinical, histological or endoscopic improvement, improvement in quality of life, adverse events and early withdrawal.
  
  
  METHODS
  Two independent investigators reviewed studies for eligibility, extracted the data and assessed study quality. A random effects model was used and studies were weighted using the DerSimonian & Laird method. Meta-analysis was performed using RevMan 4.2.10 software.
  
  
  RESULTS
  Twelve studies were included: 9 compared budesonide with conventional corticosteroids, 2 were placebo-controlled, and 1 compared budesonide with mesalamine. After 8 weeks of treatment, budesonide was significantly more effective than placebo (RR 1.96, 95% CI 1.19 to 3.23) or mesalamine (RR 1.63; 95% CI 1.23 to 2.16) for induction of remission. Budesonide was significantly less effective than conventional steroids for induction of remission (RR 0.86, 95% CI 0.76 to 0.98), particularly among patients with severe disease (CDAI > 300) (RR 0.52, 95% CI 0.28 to 0.95). Fewer adverse events occurred in those treated with budesonide compared to conventional steroids (RR 0.64, 95% CI 0.54 to 0.76) and budesonide was better able to preserve adrenal function (RR for abnormal ACTH test 0.65, 95% CI 0.55 to 0.78).
  
  
  CONCLUSIONS
  Budesonide is more effective than placebo or mesalamine for induction of remission in Crohn's disease. Although short-term efficacy with budesonide is less than with conventional steroids, particularly in those with severe disease or more extensive colonic involvement, the likelihood of adverse events and adrenal suppression is lower.
authors.affiliation: C/O Room 445, Mount Sinai Hospital, 600 University Ave, Toronto, Ontario, Canada, M5G 1X5. cynthia.seow@utoronto.ca
authors.forename: Cynthia H
authors.initials: CH
authors.lastname: Seow
authors.forename: Eric I
authors.initials: EI
authors.lastname: Benchimol
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Griffiths
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Otley
authors.forename: A Hillary
authors.initials: AH
authors.lastname: Steinhart
mesh_terms: D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide