J Neurogastroenterol Motil  
A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease
Ju Yup Lee,1 Sung Kook Kim,2,* Kwang Bum Cho,1 Kyung Sik Park,1 Joong Goo Kwon,3 Jin Tae Jung,3 Eun Young Kim,3 Byung Ik Jang,4 Si Hyung Lee,4 and Daegu-Gyeongbuk Gastrointestinal Study Group (DGSG)
1Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea; 2Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea; 3Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea; and 4Department of Internal Medicine, Yeungnam University Cellege of Medicine, Daegu, Korea
Correspondence to: Sung Kook Kim, MD, PhD
Department of Internal Medicine, Kyungpook National University Hospital, 130 Dongdeokro, Jung-gu, Daegu 41944, Korea
Tel: + 82-53-420-5517, Fax: + 82-53-426-8873, E-mail: knuhkim@gmail.com
Received: June 13, 2016; Revised: December 6, 2016; Accepted: January 2, 2017; Published online: February 13, 2017.
© The Korean Society of Neurogastroenterology and Motility. All rights reserved.

cc This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background/Aims
We aimed to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rate according to the Los Angeles classification for esomeprazole alone and esomeprazole plus mosapride.
Methods
A total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at week 4 and 8. The primary endpoint was endoscopic healing rate of ERD after 8 weeks of treatment.
Results
Endoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, a total GERD symptom score changes relative to baseline significantly improved in E+M group than that of E only group (-13.4 ± 14.7 vs -8.0 ± 12.3, P = 0.041) and upper abdominal pain and belching score changes showed significantly improved in E+M group than that of E only group (P = 0.018 and P = 0.013, respectively).
Conclusions
The combination proton pump inhibitor with mosapride showed a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms such as upper abdominal pain and belching in ERD patients.
Keywords: Gastroesophageal reflux; Gastrointestinal motility; Proton pump inhibitors; Therapeutics


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