Efficacy of rebamipide for diclofenac-induced small-intestinal mucosal injuries in healthy subjects: A prospective, randomized, double-blinded, placebo-controlled, cross-over study

Yasumasa Niwa, Masanao Nakamura, Naoki Omiya, Osamu Maeda, Takafumi Ando, Akihiro Itoh, Yoshiki Hirooka, Hidemi Goto

Research output: Contribution to journalArticle

111 Citations (Scopus)

Abstract

Background: Although obscure gastrointestinal bleeding cannot be detected by colonoscopy or upper endoscopy, wireless video capsule endoscopy (VCE) is capable of imaging it. Few data are available on medical therapy for patients with nonsteroidal anti-inflammatory drug (NSAID)-induced small-intestinal mucosal injuries. The aim of this study was to compare prevention by rebamipide and placebo of NSAID-induced smallintestinal injury in healthy subjects. Methods: Ten healthy subjects who provided written informed consent were enrolled. Rebamipide or placebo plus diclofenac was administered with omeprazole for 7 days, and for an additional 7-day period with treatments reversed in the same subjects, with a 4-week washout period between treatments. VCE of the small intestine was performed four times, before and after each of the two study periods. Results: The number of subjects with small-intestinal mucosal injuries was higher in the placebo group (8/10) than in the rebamipide group (2/10) (P = 0.023). Two cases of ulcer and one of bleeding were observed in the placebo group, while no ulcer or bleeding was observed in the rebamipide group. Conclusions: Rebamipide had significantly higher efficacy than placebo in preventing NSAID-induced small-intestinal mucosal injury.

Original languageEnglish
Pages (from-to)270-276
Number of pages7
JournalJournal of Gastroenterology
Volume43
Issue number4
DOIs
Publication statusPublished - 01-04-2008
Externally publishedYes

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Diclofenac
Cross-Over Studies
Healthy Volunteers
Capsule Endoscopy
Placebos
Wounds and Injuries
Anti-Inflammatory Agents
Hemorrhage
Ulcer
Pharmaceutical Preparations
Omeprazole
Colonoscopy
Informed Consent
Endoscopy
Small Intestine
Therapeutics
rebamipide

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Niwa, Yasumasa ; Nakamura, Masanao ; Omiya, Naoki ; Maeda, Osamu ; Ando, Takafumi ; Itoh, Akihiro ; Hirooka, Yoshiki ; Goto, Hidemi. / Efficacy of rebamipide for diclofenac-induced small-intestinal mucosal injuries in healthy subjects : A prospective, randomized, double-blinded, placebo-controlled, cross-over study. In: Journal of Gastroenterology. 2008 ; Vol. 43, No. 4. pp. 270-276.
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abstract = "Background: Although obscure gastrointestinal bleeding cannot be detected by colonoscopy or upper endoscopy, wireless video capsule endoscopy (VCE) is capable of imaging it. Few data are available on medical therapy for patients with nonsteroidal anti-inflammatory drug (NSAID)-induced small-intestinal mucosal injuries. The aim of this study was to compare prevention by rebamipide and placebo of NSAID-induced smallintestinal injury in healthy subjects. Methods: Ten healthy subjects who provided written informed consent were enrolled. Rebamipide or placebo plus diclofenac was administered with omeprazole for 7 days, and for an additional 7-day period with treatments reversed in the same subjects, with a 4-week washout period between treatments. VCE of the small intestine was performed four times, before and after each of the two study periods. Results: The number of subjects with small-intestinal mucosal injuries was higher in the placebo group (8/10) than in the rebamipide group (2/10) (P = 0.023). Two cases of ulcer and one of bleeding were observed in the placebo group, while no ulcer or bleeding was observed in the rebamipide group. Conclusions: Rebamipide had significantly higher efficacy than placebo in preventing NSAID-induced small-intestinal mucosal injury.",
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Efficacy of rebamipide for diclofenac-induced small-intestinal mucosal injuries in healthy subjects : A prospective, randomized, double-blinded, placebo-controlled, cross-over study. / Niwa, Yasumasa; Nakamura, Masanao; Omiya, Naoki; Maeda, Osamu; Ando, Takafumi; Itoh, Akihiro; Hirooka, Yoshiki; Goto, Hidemi.

In: Journal of Gastroenterology, Vol. 43, No. 4, 01.04.2008, p. 270-276.

Research output: Contribution to journalArticle

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T1 - Efficacy of rebamipide for diclofenac-induced small-intestinal mucosal injuries in healthy subjects

T2 - A prospective, randomized, double-blinded, placebo-controlled, cross-over study

AU - Niwa, Yasumasa

AU - Nakamura, Masanao

AU - Omiya, Naoki

AU - Maeda, Osamu

AU - Ando, Takafumi

AU - Itoh, Akihiro

AU - Hirooka, Yoshiki

AU - Goto, Hidemi

PY - 2008/4/1

Y1 - 2008/4/1

N2 - Background: Although obscure gastrointestinal bleeding cannot be detected by colonoscopy or upper endoscopy, wireless video capsule endoscopy (VCE) is capable of imaging it. Few data are available on medical therapy for patients with nonsteroidal anti-inflammatory drug (NSAID)-induced small-intestinal mucosal injuries. The aim of this study was to compare prevention by rebamipide and placebo of NSAID-induced smallintestinal injury in healthy subjects. Methods: Ten healthy subjects who provided written informed consent were enrolled. Rebamipide or placebo plus diclofenac was administered with omeprazole for 7 days, and for an additional 7-day period with treatments reversed in the same subjects, with a 4-week washout period between treatments. VCE of the small intestine was performed four times, before and after each of the two study periods. Results: The number of subjects with small-intestinal mucosal injuries was higher in the placebo group (8/10) than in the rebamipide group (2/10) (P = 0.023). Two cases of ulcer and one of bleeding were observed in the placebo group, while no ulcer or bleeding was observed in the rebamipide group. Conclusions: Rebamipide had significantly higher efficacy than placebo in preventing NSAID-induced small-intestinal mucosal injury.

AB - Background: Although obscure gastrointestinal bleeding cannot be detected by colonoscopy or upper endoscopy, wireless video capsule endoscopy (VCE) is capable of imaging it. Few data are available on medical therapy for patients with nonsteroidal anti-inflammatory drug (NSAID)-induced small-intestinal mucosal injuries. The aim of this study was to compare prevention by rebamipide and placebo of NSAID-induced smallintestinal injury in healthy subjects. Methods: Ten healthy subjects who provided written informed consent were enrolled. Rebamipide or placebo plus diclofenac was administered with omeprazole for 7 days, and for an additional 7-day period with treatments reversed in the same subjects, with a 4-week washout period between treatments. VCE of the small intestine was performed four times, before and after each of the two study periods. Results: The number of subjects with small-intestinal mucosal injuries was higher in the placebo group (8/10) than in the rebamipide group (2/10) (P = 0.023). Two cases of ulcer and one of bleeding were observed in the placebo group, while no ulcer or bleeding was observed in the rebamipide group. Conclusions: Rebamipide had significantly higher efficacy than placebo in preventing NSAID-induced small-intestinal mucosal injury.

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