PMID- 27282261 OWN - NLM STAT- MEDLINE DCOM- 20170801 LR - 20220310 IS - 2005-1212 (Electronic) IS - 1976-2283 (Print) IS - 1976-2283 (Linking) VI - 10 IP - 6 DP - 2016 Nov 15 TI - Limited Effect of Rebamipide in Addition to Proton Pump Inhibitor (PPI) in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers: A Randomized Controlled Trial Comparing PPI Plus Rebamipide Combination Therapy with PPI Monotherapy. PG - 917-924 LID - 10.5009/gnl15486 [doi] AB - BACKGROUND/AIMS: The ability of endoscopic submucosal dissection (ESD) to resect large early gastric cancers (EGCs) results in the need to treat large artificial gastric ulcers. This study assessed whether the combination therapy of rebamipide plus a proton pump inhibitor (PPI) offered benefits over PPI monotherapy. METHODS: In this prospective, randomized, multicenter, open-label, and comparative study, patients who had undergone ESD for EGC or gastric adenoma were randomized into groups receiving either rabeprazole monotherapy (10 mg/day, n=64) or a combination of rabeprazole plus rebamipide (300 mg/day, n=66). The Scar stage (S stage) ratio after treatment was compared, and factors independently associated with ulcer healing were identified by using multivariate analyses. RESULTS: The S stage rates at 4 and 8 weeks were similar in the two groups, even in the subgroups of patients with large amounts of tissue resected and regardless of CYP2C19 genotype. Independent factors for ulcer healing were circumferential location of the tumor and resected tissue size; the type of treatment did not affect ulcer healing. CONCLUSIONS: Combination therapy with rebamipide and PPI had limited benefits compared with PPI monotherapy in the treatment of post-ESD gastric ulcer (UMIN Clinical Trials Registry, UMIN000007435). FAU - Nakamura, Kazuhiko AU - Nakamura K AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Ihara, Eikichi AU - Ihara E AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Akiho, Hirotada AU - Akiho H AD - Department of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. FAU - Akahoshi, Kazuya AU - Akahoshi K AD - Department of Gastroenterology, Aso Iizuka Hospital, Iizuka, Japan. FAU - Harada, Naohiko AU - Harada N AD - Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. FAU - Ochiai, Toshiaki AU - Ochiai T AD - Division of Gastroenterology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. FAU - Nakamura, Norimoto AU - Nakamura N AD - Department of Gastroenterology, Harasanshin Hospital, Fukuoka, Japan. FAU - Ogino, Haruei AU - Ogino H AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. AD - Department of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. FAU - Iwasa, Tsutomu AU - Iwasa T AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Aso, Akira AU - Aso A AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Iboshi, Yoichiro AU - Iboshi Y AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Takayanagi, Ryoichi AU - Takayanagi R AD - Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - Korea (South) TA - Gut Liver JT - Gut and liver JID - 101316452 RN - 0 (Anti-Ulcer Agents) RN - 0 (Proton Pump Inhibitors) RN - 0 (Quinolones) RN - 32828355LL (Rabeprazole) RN - LR583V32ZR (rebamipide) RN - OF5P57N2ZX (Alanine) SB - IM MH - Adenoma/surgery MH - Aged MH - Alanine/administration & dosage/*analogs & derivatives MH - Anti-Ulcer Agents/*administration & dosage MH - Drug Therapy, Combination MH - Endoscopic Mucosal Resection/adverse effects MH - Female MH - Gastric Mucosa/surgery MH - Humans MH - Male MH - Middle Aged MH - Postoperative Complications/*drug therapy/etiology MH - Prospective Studies MH - Proton Pump Inhibitors/*administration & dosage MH - Quinolones/*administration & dosage MH - Rabeprazole/*administration & dosage MH - Stomach Neoplasms/surgery MH - Stomach Ulcer/*drug therapy/etiology MH - Treatment Outcome PMC - PMC5087931 OTO - NOTNLM OT - Antiulcer agents OT - Endoscopy OT - Proton pump inhibitors OT - Stomach ulcer OT - Therapeutics EDAT- 2016/10/28 06:00 MHDA- 2017/08/02 06:00 PMCR- 2016/11/01 CRDT- 2016/06/11 06:00 PHST- 2015/09/24 00:00 [received] PHST- 2015/12/14 00:00 [revised] PHST- 2016/01/13 00:00 [accepted] PHST- 2016/10/28 06:00 [pubmed] PHST- 2017/08/02 06:00 [medline] PHST- 2016/06/11 06:00 [entrez] PHST- 2016/11/01 00:00 [pmc-release] AID - gnl15486 [pii] AID - gnl-10-917 [pii] AID - 10.5009/gnl15486 [doi] PST - ppublish SO - Gut Liver. 2016 Nov 15;10(6):917-924. doi: 10.5009/gnl15486.