Efficacy of the four weeks treatment of omeprazole plus mosapride combination therapy compared with that of omeprazole monotherapy in patients with proton pump inhibitor-refractory gastroesophageal reflux disease: a randomized controlled trial

PURPOSE: The aim of this study was to compare the effect of omeprazole plus mosapride combination therapy with that of omeprazole monotherapy in proton pump inhibitor (PPI) refractory gastroesophageal reflux disease (GERD) patients. PATIENTS AND METHODS: Patients were eligible to participate in this study if they had experienced symptoms of heartburn and/or regurgitation more than twice weekly and were unresponsive to at least 8 weeks of a standard dose of PPI. A total of 44 consecutive patients were randomized to receive omeprazole 20 mg once daily plus either mosapride 5 mg or placebo three times daily for 4 weeks. We evaluated their clinical symptoms by means of frequency scale for symptoms of GERD (FSSG) questionnaires completed at the beginning and the end of the study. The primary outcome was to compare changes in FSSG scores between treatment groups during the study period. RESULTS: Most of the study population had non-erosive reflux disease (91.0% in the combination group and 81.8% in the control group). The minority of patients had Los Angeles grade A or B erosive esophagitis (9% in the combination group and 18.2% in the control group). None of the patients had Los Angeles grade C or D erosive esophagitis. FSSG total scores significantly decreased both in the combination group and the control group, with no significant differences in improvement between the groups (−8.00±7.18 for the combination group versus −5.68±6.29 for the control group, p=0.129). As a secondary outcome, our data showed that the effect of combination therapy on a number of symptom-free days (heartburn-free days, regurgitation-free days, and night-time heartburn-free days) was not superior to PPI monotherapy. CONCLUSION: Combining mosapride for four weeks with a standard dose of PPI is not more effective than PPI alone in patients with PPI-refractory GERD.