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.

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.

J Neurogastroenterol Motil. 2017 Feb 13;:

Authors: Lee JY, Kim SK, Cho KB, Park KS, Kwon JG, Jung JT, Kim EY, Jang BI, Lee SH, Daegu-Gyeongbuk Gastrointestinal Study Group (DGSG)

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.

PMID: 28192647 [PubMed - as supplied by publisher]

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