Geranylgeranylacetone protects against diclofenac-induced gastric and small intestinal mucosal injuries in healthy subjects: a prospective randomized placebo-controlled double-blind cross-over study.

Author(s): Niwa Y, Nakamura M, Miyahara R, Ohmiya N, Watanabe O, Ando T, Kawashima H, Itoh A, Hirooka Y, Goto H

Affiliation(s): Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya, Japan. yniwa@med.nagoya-u.ac.jp

Publication date & source: 2009, Digestion., 80(4):260-6. Epub 2009 Oct 16.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND AND AIMS: Little information is available regarding the prevention and treatment of small intestinal mucosal injuries caused by non-steroidal anti-inflammatory drugs (NSAIDs). We planned a pilot study to investigate the protective effects of geranylgeranylacetone (GGA) against NSAID-induced small intestinal injuries using video capsule endoscopy (VCE). SUBJECTS AND METHODS: Ten healthy male volunteers took oral GGA 300 mg/day (regimen A) or placebo (regimen B) in addition to diclofenac 75 mg/day + rabeprazole 20 mg/day for 7 days. We conducted a cross-over trial of regimens A and B with a 2-week washout period. All subjects underwent VCE before and after each administration period, and were evaluated for NSAID-induced gastric and small intestinal mucosal lesions. RESULTS: The number of mucosal lesions (erosions, ulcers and a red spot with possible bleeding) detected in both stomach and small bowel changed between prior to and immediately after administration period, with significantly fewer lesions for regimen A after administration period (mean +/- SD A:B = 2.6 +/- 3.2:9.5 +/- 8.5; p = 0.027). CONCLUSIONS: Combination therapy with GGA and rabeprazole reduced the incidence of gastroenteropathy induced by 1-week administration of diclofenac. Our findings suggest this therapy as a candidate for protecting patients on long-term NSAID therapy. 2009 S. Karger AG, Basel.