Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial.

Abstract

BACKGROUND & AIMS:

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.

• Authors: Paul Rutgeerts, Gert Van Assche, Séverine Vermeire, Geert D'Haens, Filip Baert, Maja Noman, Isolde Aerden, Gert De Hertogh, Karel Geboes, Martin Hiele, Andre D'Hoore, Freddy Penninckx
• Journal: Gastroenterology (Gastroenterology) Vol. 128 Issue 4 Pg. 856-61 (Apr 2005) ISSN: 0016-5085 [Print] United States
• PMID: 15825069 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Ornidazole

Topics

• Adult
• Aged
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Crohn Disease (diagnostic imaging, pathology, prevention & control, surgery)
• Double-Blind Method
• Endoscopy, Gastrointestinal
• Female
• Humans
• Male
• Middle Aged
• Ornidazole (adverse effects, therapeutic use)
• Postoperative Care
• Predictive Value of Tests
• Radiography
• Secondary Prevention