Background & Aims: Data indicate that cyclooxygenase-2-specific inhibitors cause less gastroduodenal mucosal damage than nonspecific NSAIDS, but their effects on the small bowel mucosa are less well recognized. In a multicenter, double-blind, placebo-controlled trial with video capsule endoscopy (VCE) we prospectively evaluated the incidence of small bowel injury in healthy subjects treated with celecoxib compared to naproxen plus omeprazole. Methods: We randomly assigned subjects with normal baseline VCEs to celecoxib 200 mg twice daily (n = 120), naproxen 500 mg twice daily plus omeprazole 20 mg once daily (n = 118), or placebo (n = 118) for 2 weeks. The primary end point was the mean number of small bowel mucosal breaks per subject. Results: Baseline VCE found small bowel lesions in 13.8% (57/413) of screened subjects, who became ineligible for randomization. The mean number of small bowel mucosal breaks per subject and the percentage of subjects with these mucosal breaks were 2.99 ± 0.51, 55% for naproxen/omeprazole compared to 0.32 ± 0.10, 16% for celecoxib and 0.11 ± 0.04, 7% for placebo (P
CITATION STYLE
Goldstein, J. L., Eisen, G. M., Lewis, B., Gralnek, I. M., Zlotnick, S., & Fort, J. G. (2005). Video capsule endoscopy to prospectively assess small bowel injury with celecoxib, naproxen plus omeprazole, and placebo. Clinical Gastroenterology and Hepatology, 3(2), 133–141. https://doi.org/10.1016/S1542-3565(04)00619-6
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