title: Randomized controlled trial comparing the efficacy of mosapride plus omeprazole combination therapy to omeprazole monotherapy in gastroesophageal reflux disease.
abstract: OBJECTIVE
  We investigated whether the prokinetic activity of mosapride, a 5-hydroxytryptamine 4 receptor agonist, in combination with proton pump inhibitor (PPI) would ameliorate symptoms of gastroesophageal reflux disease (GERD) in Japanese patients.
  
  
  METHODS
  Patients who experienced reflux symptoms more than twice weekly were eligible for this study. In all, 60 patients were randomized to receive mosapride 5 mg thrice daily combined with omeprazole 10 mg once daily (GO group), or omeprazole alone (O group) for 4 weeks. The patients completed the frequency scale for the symptoms of GERD (FSSG) at the beginning and the end of the study. The primary outcome compared changes in the FSSG reflux-related symptom (RS) score between treatment groups during the study period.
  
  
  RESULTS
  The FSSG RS scores significantly decreased both in the GO group and the O group, with no differences in improvement between the groups (-5.86 for the GO group vs -4.89 for the O group, P = 0.49). In non-erosive reflux disease (NERD) patients the improvement was significantly lower than that in erosive GERD patients (-4.00 vs -7.67, P = 0.02). However, the addition of mosapride was effective in subgroup analyses of specific symptoms, such as burping.
  
  
  CONCLUSIONS
  Combining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone. Both regimens provided less relief from reflux symptoms in NERD than in erosive GERD patients. The addition of mosapride ameliorated reflux in patients with symptoms like burping.
authors: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors: Yutaka
authors: Y
authors: Yamaji
authors: Yoshihiro
authors: Y
authors: Isomura
authors: Shuntaro
authors: S
authors: Yoshida
authors: Atsuo
authors: A
authors: Yamada
authors: Yoshihiro
authors: Y
authors: Hirata
authors: Kazuhiko
authors: K
authors: Koike
mesh_terms: D000368:Aged; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000503:physiopathology; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005769:Gastrointestinal Motility / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; D005765:Gastrointestinal Agents; D009025:Morpholines; D054328:Proton Pump Inhibitors; C062720:mosapride; D009853:Omeprazole
keywords: gastroesophageal reflux; gastrointestinal motility; prokinetic agent; proton pump inhibitors; quality of life; questionnaire