BACKGROUND: Previous studies have shown that non-erosive reflux disease (NERD) patients are less sensitive to proton pump inhibitor (PPI) treatment than patients with erosive reflux disease. The aim of this study was to investigate whether treatment with prokinetics in addition to omeprazole therapy would improve clinical symptoms, gastric emptying and esophageal peristalsis in PPI-resistant NERD patients with or without delayed gastric emptying. METHODS: Subjects were 64 consecutive patients presenting with typical symptoms of PPl-resistant NERD (n = 44) and 20 healthy volunteers. PPI-resistant NERD patients underwent mosapride citrate (15 mg/day) and omeprazole (20 mg/day) co-therapy for 12 weeks. We evaluated the clinical symptoms as well as gastric emptying and esophageal manometry before and after combined therapy. We measured both acylated- and des-acylated plasma ghrelin levels by the ELISA method. The primary endopoint was to investigate whether co-administration of mosapride citrate and omeprazole would improve clinical symptoms and gastric emptying in PPI-resistant NERD patients with delayed gastric emptying. RESULTS: T (max) value in PPI-resistant NERD patients was significantly higher than in healthy volunteers. Combination therapy with the prokinetic agent mosapride citrate and omeprazole significantly improved reflux symptoms and T (max) value in T (max) > 65 min NERD patients. Co-therapy also significantly reduced des-acylated-ghrelin levels in NERD patients with delayed gastric emptying. CONCLUSIONS: Administration of mosapride citrate in addition to omeprazole improved gastro-esophageal reflux and gastric emptying in PPI-resistant NERD patients with delayed gastric emptying.
BACKGROUND: Previous studies have shown that non-erosive reflux disease (NERD) patients are less sensitive to proton pump inhibitor (PPI) treatment than patients with erosive reflux disease. The aim of this study was to investigate whether treatment with prokinetics in addition to omeprazole therapy would improve clinical symptoms, gastric emptying and esophageal peristalsis in PPI-resistant NERD patients with or without delayed gastric emptying. METHODS: Subjects were 64 consecutive patients presenting with typical symptoms of PPl-resistant NERD (n = 44) and 20 healthy volunteers. PPI-resistant NERD patients underwent mosapride citrate (15 mg/day) and omeprazole (20 mg/day) co-therapy for 12 weeks. We evaluated the clinical symptoms as well as gastric emptying and esophageal manometry before and after combined therapy. We measured both acylated- and des-acylated plasma ghrelin levels by the ELISA method. The primary endopoint was to investigate whether co-administration of mosapride citrate and omeprazole would improve clinical symptoms and gastric emptying in PPI-resistant NERD patients with delayed gastric emptying. RESULTS: T (max) value in PPI-resistant NERD patients was significantly higher than in healthy volunteers. Combination therapy with the prokinetic agent mosapride citrate and omeprazole significantly improved reflux symptoms and T (max) value in T (max) > 65 min NERD patients. Co-therapy also significantly reduced des-acylated-ghrelin levels in NERD patients with delayed gastric emptying. CONCLUSIONS: Administration of mosapride citrate in addition to omeprazole improved gastro-esophageal reflux and gastric emptying in PPI-resistant NERD patients with delayed gastric emptying.