PMID- 22281110 OWN - NLM STAT- MEDLINE DCOM- 20120814 LR - 20220311 IS - 1097-6779 (Electronic) IS - 0016-5107 (Linking) VI - 75 IP - 4 DP - 2012 Apr TI - Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. PG - 739-47 LID - 10.1016/j.gie.2011.11.004 [doi] AB - 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.). CI - Copyright A(c) 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. FAU - Shin, Woon Geon AU - Shin WG AD - Department of Internal Medicine, Kangdong Sacred Heart Hospital, Seoul, Korea. FAU - Kim, Sung Jung AU - Kim SJ FAU - Choi, Min Ho AU - Choi MH FAU - Kim, Kyoung Oh AU - Kim KO FAU - Jang, Hyun Joo AU - Jang HJ FAU - Park, Cheol Hee AU - Park CH FAU - Baek, Il Hyun AU - Baek IH FAU - Kim, Kyung Ho AU - Kim KH FAU - Baik, Gwang Ho AU - Baik GH FAU - Kae, Sea Hyub AU - Kae SH FAU - Kim, Jong Hyeok AU - Kim JH FAU - Kim, Hak Yang AU - Kim HY LA - eng SI - ClinicalTrials.gov/NCT01167101 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20120126 PL - United States TA - Gastrointest Endosc JT - Gastrointestinal endoscopy JID - 0010505 RN - 0 (Anti-Ulcer Agents) RN - 0 (Proton Pump Inhibitors) RN - 0 (Quinolones) RN - LR583V32ZR (rebamipide) RN - OF5P57N2ZX (Alanine) SB - IM MH - Adenoma/*surgery MH - Aged MH - Alanine/*analogs & derivatives/therapeutic use MH - Anti-Ulcer Agents/*therapeutic use MH - Carcinoma/*surgery MH - Chi-Square Distribution MH - Confidence Intervals MH - Dissection/adverse effects MH - Drug Therapy, Combination MH - Female MH - Gastric Mucosa/surgery MH - Gastroscopy MH - Humans MH - Male MH - Middle Aged MH - Odds Ratio MH - Proton Pump Inhibitors/*therapeutic use MH - Quinolones/*therapeutic use MH - Stomach Neoplasms/*surgery MH - Stomach Ulcer/*drug therapy/etiology EDAT- 2012/01/28 06:00 MHDA- 2012/08/15 06:00 CRDT- 2012/01/28 06:00 PHST- 2011/06/17 00:00 [received] PHST- 2011/11/03 00:00 [accepted] PHST- 2012/01/28 06:00 [entrez] PHST- 2012/01/28 06:00 [pubmed] PHST- 2012/08/15 06:00 [medline] AID - S0016-5107(11)02393-5 [pii] AID - 10.1016/j.gie.2011.11.004 [doi] PST - ppublish SO - Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.