<p>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</p>

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.

A Systematic Review and Meta-analysis of Randomized Control Trials: Combination Treatment With Proton Pump Inhibitor Plus Prokinetic for Gastroesophageal Reflux Disease

“…The remaining 40 articles were subjected to full reviews, and after assessing the eligibility, we excluded a further 24 articles ( Fig. 1 ), leaving 16 articles 10 , 19 - 33 for meta-analysis ( Table 1 ). These 16 studies presented details on 1446 participants, among whom 719 were included in the PPI plus prokinetics group (mosapride, 10 , 21 , 22 , 24 , 25 , 29 - 32 , 34 domperidone, 23 , 27 , 28 revexepride, 19 , 20 and acotiamide 26 ) and 727 were included in the PPI monotherapy group.…”

“…Nine studies indicated global symptom improvement of GERD in terms of a binary outcome (yes or no), 10 , 19 , 22 , 24 - 26 , 28 - 30 whereas the other 7 studies 20 , 21 , 23 , 27 , 31 - 33 reported continuous measures (ie, a change in symptom improvement). Among the 9 studies that rated global symptom improvement of GERD in terms of a binary outcome, the average percentage symptom improvement was 63.8% in the PPI plus prokinetics group, compared with 50.6% in the PPI monotherapy group.…”

Pathophysiology and treatment options for gastroesophageal reflux disease: looking beyond acid

“…Some studies have shown that mosapride, a selective 5-HT 4 receptor agonist, may augment the effects of PPIs when coadministered in certain patient populations, such as those with erosive esophagitis; 73,74 however, many other studies have not been able to reproduce this significant synergistic effect with mosapride. 75,76 Rikkunshito, a traditional Japanese medicine that promotes gastric motility through the release of ghrelin, may have some effectiveness in treating refractory GERD as it also has synergistic effects on gastric motility when combined with PPIs and may be effective as monotherapy for GERD. [77][78][79][80] Further study of prokinetic agents in the setting of GERD may give light to future advances in the management of refractory GERD.…”

Additional Mosapride to Proton Pump Inhibitor for Gastroesophageal Reflux Disease: A Meta-Analysis

“…The remaining 12 studies were scrutinized, after which three more studies were rejected [ 32 , 33 , 34 ] because subjects in the control groups did not use PPIs. Finally, we included nine RCTs in our meta-analysis [ 12 , 13 , 14 , 15 , 17 , 18 , 19 , 20 , 21 ]. The details of the included RCTs are presented in Table 1 .…”

“…In 2013, a systematic review concluded that mosapride combined with a PPI was not more effective than a PPI alone [ 16 ]. Since then, several RCTs have been conducted [ 17 , 18 , 19 , 20 , 21 ], and most RCTs showed that the improvement in GERD patients who received mosapride was not statistically significant, although mosapride seemed to offer a favorable result in these patients. The reason is that the sample size was not large enough to reach statistical significance.…”