Antibiotics have been widely used in the treatment of active CD, but only two randomized controlled trials are available to support their use for maintenance of postoperative remission. Rutgeerts et al. assigned postoperative patients to 20 mg/kg per day of metronidazole for a total of 12 weeks. One-year recurrence rates were 25% for the placebo group and only 4% for the treated group, a difference that was statistically significant. After 3 years, however, the endoscopic recurrence rates were the same between the two groups, and clinical recurrence rates showed only a non-significant trend favouring therapy .
In a second study by Rutgeerts et al. assessing the use of nitroimidazole antibiotics in this setting, 80 postoperative patients were randomized to placebo or ornidazole 500 mg (Tiberal; Roche, Basel, Switzerland) twice daily for 1 year. The primary endpoint was clinical recurrence 1 year after surgery. A significantly lower rate was found in the treated group compared to those receiving placebo (37.5% vs. 7.9%). Ornidazole was used because it was thought to have side effects which were similar to those of metronidazole, but of a lesser severity. Unfortunately, in this study, more than 30% of patients in the ornidazole group dropped out as a result of side effects, the most common being nausea, vomiting, and metallic taste. This is also a major problem with long-term use of metronidazole .
These two well-designed studies support the effectiveness of nitroimidazole antibiotics in the maintenance of surgically induced remission of CD, however, there is a lack of clarity with regards to the dosing and duration of therapy given the significant side-effect profile.
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