Rebamipide has the potential to reduce the intensity of NSAID-induced small intestinal injury: a double-blind, randomized, controlled trial evaluated by capsule endoscopy

J Gastroenterol. 2011 Jan;46(1):57-64. doi: 10.1007/s00535-010-0332-3. Epub 2010 Oct 6.

Abstract

Background: A study reported that rebamipide was effective at reducing short-term nonsteroidal anti-inflammatory drug (NSAID)-induced enteropathy. The purpose of this study was to re-evaluate the effect of the co-administration of rebamipide on small intestinal injuries induced by short-term NSAID treatment.

Methods: Eighty healthy male volunteers were randomly assigned to two study groups: a control group (N = 40), which received NSAID (diclofenac sodium, 75 mg/day) and omeprazole (20 mg/day) treatment along with a placebo; and a rebamipide group, which received NSAID, omeprazole and rebamipide (300 mg/day). Small intestinal injuries (mucosal breaks plus denuded areas) were evaluated by capsule endoscopy before and after 14 days of treatment.

Results: A total of 38 control subjects and 34 rebamipide subjects completed the treatment and were evaluated by capsule endoscopy. NSAID therapy increased the mean number of mucosal injuries per subject from a basal level of 0.1 ± 0.3 to 16 ± 71 and 4.2 ± 7.8 in the control and rebamipide groups, respectively, but the difference was not significant. The difference in the percentage of subjects with at least one mucosal injury post-treatment was also not significant (control 63%; rebamipide 47%). Limiting our analysis to subjects with mucosal injuries, rebamipide co-treatment had the tendency to reduce the mean number of mucosal injuries per subject from 25 in the control group to 8.9 in the rebamipide group (multiple comparisons test; p = 0.088, Mann-Whitney U test; p = 0.038).

Conclusions: Rebamipide co-therapy had the potential to reduce the intensity of small intestinal injury induced by 2-week administration of diclofenac.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alanine / analogs & derivatives*
  • Alanine / pharmacology
  • Alanine / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Ulcer Agents / pharmacology*
  • Anti-Ulcer Agents / therapeutic use*
  • Capsule Endoscopy
  • Diclofenac / adverse effects
  • Double-Blind Method
  • Humans
  • Intestinal Mucosa / drug effects*
  • Intestinal Mucosa / pathology*
  • Intestine, Small / drug effects*
  • Intestine, Small / pathology*
  • Male
  • Middle Aged
  • Omeprazole / adverse effects
  • Quinolones / pharmacology*
  • Quinolones / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Anti-Ulcer Agents
  • Quinolones
  • Diclofenac
  • Omeprazole
  • rebamipide
  • Alanine

Associated data

  • ISRCTN/ISRCTN50390099