Randomized Controlled Trial Comparing the Efficacy of Sustained-Release Formula of Mosapride-Plus-Esomeprazole Combination Therapy to Esomeprazole Monotherapy in Patients with Gastroesophageal Reflux Disease

Abstract

We aimed to evaluate whether adding a sustained-release (SR) formula of mosapride to proton-pump inhibitors (PPIs) would be more effective in controlling symptoms than PPI alone in patients with gastroesophageal reflux disease (GERD). Sixty patients with heartburn and/or regurgitation were randomly assigned to two groups: mosapride SR 15 mg combined with esomeprazole 20 mg once daily (ME group) and esomeprazole 20 mg once daily alone (E group). The primary endpoint was the complete-resolution rate of GERD symptoms after eight-week medication, and the secondary endpoints were the complete-resolution rate of GERD symptoms after four-week medication, symptom-improvement rates ≥ 50% after four- and eight-week medication, and change in reflux-disease-questionnaire (RDQ) and GERD-health-related quality-of-life (GERD-HRQL) scores from baseline at four- and eight-week medication. No significant differences in complete-symptom-resolution rates at eight weeks and four weeks or in the changes in RDQ and GERD-HRQL scores from baseline at four- and eight-week medication were observed between the ME and E groups. The symptom-improvement rate of ≥50% after four and eight weeks was comparable between both groups. Adding mosapride SR to esomeprazole in patients with GERD provides no additional benefits in controlling GERD symptoms.

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis

“…The GERD-HRQL was validated and considered as an appropriate instrument to evaluate typical GERD symptoms[ 18 ]. Therefore, previous clinical studies performed in South Korea have used the RDQ and GERD-HRQL to evaluate the therapeutic effect in patients with GERD[ 19 , 20 ].…”

Prokinetics‐safety and efficacy: The European Society of Neurogastroenterology and Motility/The American Neurogastroenterology and Motility Society expert review

“…The decrease in symptom score was similar between the lansoprazole and mosapride group and the lansoprazole and placebo group, except for severely symptomatic patients who showed greater symptom reduction with lansoprazole and mosapride. Similarly, a recent trial with 60 GERD patients found no significant differences in symptom resolution, reflux‐disease‐questionnaire (RDQ), and GERD‐health‐related quality‐of‐life (GERD‐HRQL) between the group receiving mosapride and esomeprazole, and the group receiving esomeprazole alone 196 …”