Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
Crohn's disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified. We investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn's disease after curative ileocolonic resection in a placebo-controlled double-blind clinical trial.


METHODS
Eighty patients were randomized to ornidazole 1 g/day or placebo started within 1 week of resection and continued for 1 year. The primary end point was the proportion of patients with clinical recurrence at 1 year. Secondary end points were endoscopic recurrence at 3 months and 12 months after resection.


RESULTS
Two patients in the ornidazole group withdrew consent and were not dosed. Ornidazole significantly reduced the clinical recurrence rate at 1 year from 15 of 40 (37.5%) patients in the placebo group to 3 of 38 (7.9%) patients in the ornidazole group (Fisher exact test, 8.03; P = .0046; odds ratio, 0.14; 95% confidence interval, 0.037-0.546). Ornidazole reduced endoscopic recurrence at 12 months from 26 of 33 (79%) in the placebo group to 15 of 28 (53.6%) in the ornidazole group (chi2 , 4.37; P = .037; odds ratio, 0.31; 95% confidence interval, 0.10-0.94). Endoscopic recurrence at 3 and 12 months predicted clinical recurrence. Significantly more patients in the ornidazole group dropped out from the study because of side effects (P = .041).


CONCLUSIONS
Ornidazole 1 g/day is effective for the prevention of recurrence of Crohn's disease after ileocolonic resection.
Rutgeerts
Paul
P
Department of Gastroenterology, University Hospital Gasthuisberg, 3000 Leuven, Belgium. Paul.Rutgeerts@uz.kuleuven.ac.be
Van Assche
Gert
G
Vermeire
Séverine
S
D'Haens
Geert
G
Baert
Filip
F
Noman
Maja
M
Aerden
Isolde
I
De Hertogh
Gert
G
Geboes
Karel
K
Hiele
Martin
M
D'Hoore
Andre
A
Penninckx
Freddy
F
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control* / Q000601:surgery*; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009950:Ornidazole / Q000009:adverse effects / Q000627:therapeutic use*; D011182:Postoperative Care; D011237:Predictive Value of Tests; D011859:Radiography; D055502:Secondary Prevention
D000900:Anti-Bacterial Agents; D009950:Ornidazole