title: 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.
abstract: 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.
authors.affiliation: Department of Gastroenterology, Sapporo-Kosei General Hospital, Sapporo, Japan.
authors.forename: Sei
authors.initials: S
authors.lastname: Kurokawa
authors.forename: Shinichi
authors.initials: S
authors.lastname: Katsuki
authors.forename: Tomoki
authors.initials: T
authors.lastname: Fujita
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Saitoh
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Ohta
authors.forename: Kouji
authors.initials: K
authors.lastname: Nishikawa
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Sato
authors.forename: Koji
authors.initials: K
authors.lastname: Ohira
authors.forename: Masataka
authors.initials: M
authors.lastname: Yamada
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kato
mesh_terms: D000368:Aged; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D053704:Capsule Endoscopy; D004044:Dietary Proteins / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007410:Intestinal Diseases / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000293:injuries / Q000473:pathology; D007421:Intestine, Small / Q000187:drug effects* / Q000293:injuries / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D014945:Wound Healing
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D004044:Dietary Proteins; D015363:Quinolones; C052785:rebamipide; D000409:Alanine; D001241:Aspirin