A Multicenter Open-Label Randomized Trial Comparing Rabeprazole Versus Itopride in Japanese Functional Dyspepsia: The NAGOYA Study

Abstract

BACKGROUND&AIMS: The efficacy of proton pump inhibitor (PPI) for functional dyspepsia (FD) in Japan, in which the acid secretion is thought to be less than Western people, is unknown. The aims of this study was to compare the therapeutic effects of Rabeprazole (RPZ) and Itopride (ITO), and to investigate the randomized open-labeled trial in Japanese FD patients. METHODS: 151 consecutive patients diagnosed as FD by Rome III criteria, were randomly assigned to either 4-week treatment with RPZ or with ITO. Dyspeptic symptoms were evaluated with questionnaires, additional abdominal pain and indigestion score in Gastrointestinal Symptom Rating Scale as a FD symptom score (FD score) at pretreatment and 1, 2, and 4 weeks after the treatment. The efficacy endpoint is the change rates based on pretreatment in FD score at each time-points. We also conducted sub-analysis of epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). RESULTS: At all time-points, RPZ group was more higher improvement rates than ITO group significantly (Figure). RPZ group showed significant rapid improvement in FD score within 1 week, and persisted until after 4 weeks, but, significant improvement in FD score was only seen after 4 weeks with ITO. With RPZ improved FD symptoms in both EPS and PDS, significantly, whereas the significant improvement with ITO was only seen in PDS. CONCLUSIONS: These results showed that acid suppressive therapy with PPI is more useful than with PDS as well as with EPS in Japanese FD patients.