Combined budesonide and antibiotic therapy for active Crohn's disease: a randomized controlled trial.
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.
Steinhart
A Hillary
AH
Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada. hsteinhart@mtsinai.on.ca
Feagan
Brian G
BG
Wong
Cindy J
CJ
Vandervoort
Margaret
M
Mikolainis
Shelley
S
Croitoru
Kenneth
K
Seidman
Ernest
E
Leddin
Desmond J
DJ
Bitton
Alain
A
Drouin
Eric
E
Cohen
Albert
A
Greenberg
Gordon R
GR
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
D000890:Anti-Infective Agents; D008795:Metronidazole; D019819:Budesonide; D002939:Ciprofloxacin