title: A multicenter randomized trial comparing rabeprazole and itopride in patients with functional dyspepsia in Japan: the NAGOYA study.
abstract: The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day (n= 69) or ITO 150 mg/day (n= 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962).
authors.affiliation: Department of Medical Innovation, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kamiya
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Michiko
authors.initials: M
authors.lastname: Shikano
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Kubota
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Mizoshita
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Public Health Center, Okazaki City Medical Association, Tatsumi nishi 1-9-1, Okazaki, Aichi 444-0875, Japan.
authors.forename: Tsuneya
authors.initials: T
authors.lastname: Wada
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanida
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Kataoka
authors.affiliation: Adachi Clinic, Yagotoyama 220, Tenpaku-ku, Nagoya 468-0077, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Adachi
authors.affiliation: Fuji Hospital, Nishiyashiki 137-1, Ushida-cho, Chiryu, Aichi 472-0007, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Hirako
authors.affiliation: Okuda Naika Clinic, Hinata-cho 2-9-3, Mizuho-ku, Nagoya 467-0047, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Okuda
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Joh
keywords: epigastric pain syndrome; functional dyspepsia; itopride; postprandial distress syndrome; rabeprazole