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.
OBJECTIVE
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).
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kazuhiko
K
Nakamura
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Eikichi
E
Ihara
Department of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Hirotada
H
Akiho
Department of Gastroenterology, Aso Iizuka Hospital, Iizuka, Japan.
Kazuya
K
Akahoshi
Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Naohiko
N
Harada
Division of Gastroenterology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Toshiaki
T
Ochiai
Department of Gastroenterology, Harasanshin Hospital, Fukuoka, Japan.
Norimoto
N
Nakamura
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.|Department of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Haruei
H
Ogino
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tsutomu
T
Iwasa
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Akira
A
Aso
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoichiro
Y
Iboshi
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Ryoichi
R
Takayanagi
D000236:Adenoma / Q000601:surgery; D000368:Aged; D000409:Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D000069916:Endoscopic Mucosal Resection / Q000009:adverse effects; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D015363:Quinolones / Q000008:administration & dosage*; D064750:Rabeprazole / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000601:surgery; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D015363:Quinolones; D064750:Rabeprazole; C052785:rebamipide; D000409:Alanine
Antiulcer agents; Endoscopy; Proton pump inhibitors; Stomach ulcer; Therapeutics