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

Abstract

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.

Keywords:

• mosapride
• proton pump inhibitors
• gastroesophageal reflux

Acknowledgments

The authors greatly appreciate Dr. Bancha Ovartlarnporn, NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand, for his fruitful scientific discussion on this study. The authors would like to thank Ms. Wannakorn Homsuwan, research assistant of Rajavithi Hospital, for her kind help in statistical analysis and our sincere gratitude also goes to all patients in this study.

Data sharing statement

The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request and were received permission for use by the ethics committee of Rajavithi Hospital.

Ethics approval and consent to participate

The experimental protocols were performed after approval and in accordance with the guidelines set by the ethics committee of Rajavithi Hospital (No. 055/2559). Written informed consent was obtained from all participants included in the present study.

Supplementary materials

Table S1 FSSG questionnaire

Table S2 Diary

Author contributions

All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no competing interests in this work.