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: gastroesophageal reflux; mosapride; proton pump inhibitors.
Conflict of interest statement
The authors declare that they have no competing interests in this work.
Randomized Controlled Trial Comparing the Efficacy of Mosapride Plus Omeprazole Combination Therapy to Omeprazole Monotherapy in Gastroesophageal Reflux DiseaseY Yamaji et al. J Dig Dis 15 (9), 469-76. PMID 24957863. - Randomized Controlled TrialCombining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone. Both regimens provided less relief from reflux symptoms in NERD …
Characteristics of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms -Is Switching Proton Pump Inhibitors Based on the Patient's CYP2C19 Genotype an Effective Management Strategy?T Takeuchi et al. Intern Med 54 (2), 97-105. PMID 25742999. - Clinical TrialOur findings suggest that switching the PPI from omeprazole (20 mg once daily) to rabeprazole (20 mg once daily) is not a significant effective therapeutic strategy for i …
Investigation of Pretreatment Prediction of Proton Pump Inhibitor (PPI)-resistant Patients With Gastroesophageal Reflux Disease and the Dose Escalation Challenge of PPIs-TORNADO Study: A Multicenter Prospective Study by the Acid-Related Symptom Research Group in JapanT Furuta et al. J Gastroenterol 46 (11), 1273-83. PMID 21861141. - Clinical TrialFSSG could predict response to a PPI for symptomatic GERD. Increase of RPZ dose is useful for treatment of GERD refractory to the standard dose of RPZ.
Efficacy of Mosapride Plus Proton Pump Inhibitors for Treatment of Gastroesophageal Reflux Disease: A Systematic ReviewQ Liu et al. World J Gastroenterol 19 (47), 9111-8. PMID 24379638. - ReviewMosapride combined therapy is not more effective than PPI alone as first-line therapy. Whether it is effective in PPI-resistant patients needs to be determined.
ARE THE PERSISTENT SYMPTOMS TO PROTON PUMP INHIBITOR THERAPY DUE TO REFRACTORY GASTROESOPHAGEAL REFLUX DISEASE OR TO OTHER DISORDERS?RS Azzam. Arq Gastroenterol 55Suppl 1 (Suppl 1), 85-91. PMID 30304291. - ReviewInitially, the management of PPI refractoriness consists in correcting low adherence to PPI therapy, adjusting the PPI dosage and emphasizing the recommendations on lifes …