A randomized, double-blinded, placebo-controlled, multicenter trial, healing effect of rebamipide in patients with low-dose aspirin and/or non-steroidal anti-inflammatory drug induced small bowel injury

• Published in: Journal of gastroenterology Vol. 49; no. 2; pp. 239 - 244
• Main Authors: Kurokawa, Sei, Katsuki, Shinichi, Fujita, Tomoki, Saitoh, Yusuke, Ohta, Hidetoshi, Nishikawa, Kouji, Sato, Yasushi, Sato, Yasuhiro, Ohira, Koji, Yamada, Masataka, Kato, Mototsugu
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01.02.2014; Springer; Springer Nature B.V
• Subjects: Abdominal Surgery; Aged; Alanine - analogs & derivatives; Alanine - therapeutic use; Analysis; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Ulcer Agents - therapeutic use; Aspirin - administration & dosage; Aspirin - adverse effects; Capsule Endoscopy; Clinical trials; Colorectal Surgery; Complications and side effects; Dietary Proteins - blood; Dosage and administration; Double-Blind Method; Female; Gastroenterology; Hepatology; Humans; Intestinal Diseases - chemically induced; Intestinal Diseases - drug therapy; Intestinal Diseases - pathology; Intestinal Mucosa - drug effects; Intestinal Mucosa - injuries; Intestinal Mucosa - pathology; Intestine, Small - drug effects; Intestine, Small - injuries; Intestine, Small - pathology; Male; Medical colleges; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Nonsteroidal anti-inflammatory drugs; Original Article—Alimentary Tract; Prostaglandins; Quinolones - therapeutic use; Surgical Oncology; Wound Healing; Aspirin; Nutritional parameter; Small intestinal injury; Capsule endoscopy; NSAID
• ISSN: 0944-1174; 1435-5922; 1435-5922
• DOI: 10.1007/s00535-013-0805-2

Background It is not clear what kind of drug is appropriate to heal NSAID-induced enteropathy. Several reports showed the preventive effect of prostaglandin analogue or inducer using healthy subjects who took NSAIDs. However there was no report for healing effect and for patients. The aim of this study was to evaluate the healing effect of rebamipide in patients with NSAIDs-induced enteropathy. In addition, we evaluated for nutritional parameter. Methods This study was conducted as a randomized, double-blinded, placebo-controlled, multicenter trial. Study protocol was approved by each hospital’s ethical committees. Patients with LDA and/or NSAID more than 3 months were enrolled. Patients with enteropathy were divided into the placebo and the rebamipide groups. Rebamipide 100 mg three times daily was administered during 4 weeks. Capsule endoscopies were performed at 0 and 4 week. The number of small intestinal ulcer and erosion were evaluated. Total protein was analyzed as nutritional parameter. Results Sixty one participants were completed this study. Change in number of small intestinal erosion in the rebamipide group was −2.5 ± 3.4, and 2.1 ± 3.9 in the placebo group ( P  < 0.0001). Change in number of small intestinal ulcer in the rebamipide group was −0.5 ± 1.6, and 0.1 ± 0.7 in the placebo group ( P  = 0.024). Change in serum total protein levels in the rebamipide group was 0.06 ± 0.36, and −0.27 ± 0.34 in the placebo group ( P  = 0.0005). Conclusions Rebamipide has not only the healing effect for NSAIDs-induced enteropathy compared with placebo, but the improvement of nutritional condition. These results showed a tentative therapeutical strategy for chronic NSAIDs users.