Small bowel injury induced by selective cyclooxygenase-2 inhibitors: a prospective, double-blind, randomized clinical trial comparing celecoxib and meloxicam.

Background: Selective cyclooxygenase (COX)-2 inhibitors are less harmful to the small bowel mucosa than non-selective anti-inflammatory drugs. We aimed to compare the severity of small bowel mucosal injury in healthy volunteers induced by two selective COX-2 inhibitors, celecoxib and meloxicam, in a randomized, double-blind trial, using capsule endoscopy (CE).

Methods: Twenty-nine healthy subjects were randomized to take either celecoxib (200 mg twice daily) or meloxicam (10 mg once daily) for 2 weeks. The incidence and the number of small bowel mucosal injuries (bleeding, ulcers, and erosions) observed by CE were compared between the two groups.

Results: The overall incidence of small bowel mucosal injury was not different between the celecoxib group (6 of 14 subjects, 42.9%) and the meloxicam group (4 of 15 subjects, 26.7%, P = 0.45). In subjects with positive CE findings, the number of ulcers was greater in the meloxicam group than in the celecoxib group (P = 0.02), while such a trend was not found with regard to erosions (P = 0.52). The distribution of mucosal lesions within the small bowel was similar in the two groups.

Conclusions: Selective COX-2 inhibitors are not completely safe for the small bowel. The mucosal lesions may be less severe with celecoxib than with meloxicam.