title: Combined budesonide and antibiotic therapy for active Crohn's disease: a randomized controlled trial.
abstract: OBJECTIVE
  Although antibiotics are frequently used to treat Crohn's disease, this practice is not supported by strong evidence from randomized trials.
  
  
  METHODS
  We conducted a double-blind multicenter study of patients with active Crohn's disease of the ileum, right colon, or both. Patients were randomized to receive oral ciprofloxacin and metronidazole, both 500 mg twice daily, or placebo for 8 weeks. All patients received oral budesonide 9 mg once daily. The primary efficacy measure was the proportion of patients in remission at week 8.
  
  
  RESULTS
  Of the 134 patients who were randomized, 130 were evaluated for efficacy; 66 received placebo, and 64 received antibiotics. At week 8, 21 patients (33%) assigned to antibiotics were in remission as compared with 25 patients (38%) in the placebo group (P = 0.55; absolute difference, -5%; 95% confidence interval, -21% to 11%). An interaction (P = 0.025) between treatment allocation and disease location on treatment response was identified. Among patients with disease of the colon, 9 of 17 (53%) were in remission after treatment with antibiotics, compared with 4 of 16 (25%) of those who received placebo (P = 0.10). Discontinuation of therapy because of adverse events occurred in 13 of 66 (20%) patients treated with antibiotics, compared with 0 of 68 in the group who received placebo (P < 0.001).
  
  
  CONCLUSIONS
  In patients with active Crohn's disease of the ileum, the addition of ciprofloxacin and metronidazole to budesonide is an ineffective intervention, but this antibiotic combination may improve outcome when there is involvement of the colon.
authors.affiliation: Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada. hsteinhart@mtsinai.on.ca
authors.forename: A Hillary
authors.initials: AH
authors.lastname: Steinhart
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: Cindy J
authors.initials: CJ
authors.lastname: Wong
authors.forename: Margaret
authors.initials: M
authors.lastname: Vandervoort
authors.forename: Shelley
authors.initials: S
authors.lastname: Mikolainis
authors.forename: Kenneth
authors.initials: K
authors.lastname: Croitoru
authors.forename: Ernest
authors.initials: E
authors.lastname: Seidman
authors.forename: Desmond J
authors.initials: DJ
authors.lastname: Leddin
authors.forename: Alain
authors.initials: A
authors.lastname: Bitton
authors.forename: Eric
authors.initials: E
authors.lastname: Drouin
authors.forename: Albert
authors.initials: A
authors.lastname: Cohen
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Greenberg
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D003106:Colon / Q000187:drug effects; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007082:Ileum / Q000187:drug effects; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole; D019819:Budesonide; D002939:Ciprofloxacin