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

• Published in: Gut and liver Vol. 10; no. 6; pp. 917 - 924
• Main Authors: Kazuhiko Nakamura, Eikichi Ihara, Hirotada Akiho, Kazuya Akahoshi, Naohiko Harada, Toshiaki Ochiai, Norimoto Nakamura, Haruei Ogino, Tsutomu Iwasa, Akira Aso, Yoichiro Iboshi, Ryoichi Takayanagi
• Format: Journal Article
• Language: Korean
• Published: 대한소화기기능성질환·운동학회 30.11.2016
• Subjects: Antiul-cer agents; Endoscopy; Proton pump inhibitors; Stomach ulcer; Therapeutics
• ISSN: 1976-2283; 2005-1212

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). (Gut Liver 2016;10:917-924)