Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study.

Abstract

BACKGROUND:

There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)-induced ulcers.

OBJECTIVE:

To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing.

DESIGN:

Randomized, prospective, controlled study; clinical trial.

SETTING:

Five hospitals in a University Medical Center group in Korea.

PATIENTS:

This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer.

INTERVENTION:

PPI and rebamipide combination therapy.

MAIN OUTCOME MEASUREMENTS:

The ulcer healing rate at 4 weeks after ESD.

RESULTS:

The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P < .0001) and in the per-protocol analysis (94.5% vs 91.2%; P = .020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P = .014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P = .027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P = .027; OR 1.933; 95% CI, 1.074-3.481).

LIMITATIONS:

Open-label study.

CONCLUSION:

PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT01167101.).

• Authors: Woon Geon Shin, Sung Jung Kim, Min Ho Choi, Kyoung Oh Kim, Hyun Joo Jang, Cheol Hee Park, Il Hyun Baek, Kyung Ho Kim, Gwang Ho Baik, Sea Hyub Kae, Jong Hyeok Kim, Hak Yang Kim
• Journal: Gastrointestinal endoscopy (Gastrointest Endosc) Vol. 75 Issue 4 Pg. 739-47 (Apr 2012) ISSN: 1097-6779 [Electronic] United States
• PMID: 22281110 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Chemical References

• Anti-Ulcer Agents
• Proton Pump Inhibitors
• Quinolones
• rebamipide
• Alanine

Topics

• Adenoma (surgery)
• Aged
• Alanine (analogs & derivatives, therapeutic use)
• Anti-Ulcer Agents (therapeutic use)
• Carcinoma (surgery)
• Chi-Square Distribution
• Confidence Intervals
• Dissection (adverse effects)
• Drug Therapy, Combination
• Female
• Gastric Mucosa (surgery)
• Gastroscopy
• Humans
• Male
• Middle Aged
• Odds Ratio
• Proton Pump Inhibitors (therapeutic use)
• Quinolones (therapeutic use)
• Stomach Neoplasms (surgery)
• Stomach Ulcer (drug therapy, etiology)