title: Effects of acotiamide on esophageal motor function and gastroesophageal reflux in healthy volunteers.
abstract: BACKGROUND
  The prevalence of gastroesophageal reflux disease (GERD) has been increasing worldwide, with proton pump inhibitor (PPI) administration the current mainstay therapy for affected individuals. However, PPI efficacy is insufficient especially for non-erosive reflux disease. Although it has been reported that prokinetic drugs improve GERD, their effects on esophageal function remain to be clearly investigated. In the present study, we evaluated the direct effects of acotiamide, a novel prokinetic agent for the treatment of functional dyspepsia, on esophageal motor function and gastroesophageal reflux.
  
  
  METHODS
  Ten adult healthy volunteers (average age 24 years, range 20-36 years; 7 males, 3 females) were enrolled. Esophageal body peristaltic contractions and lower esophageal sphincter (LES) pressure with and without acotiamide administration were recorded using high resolution manometry using a cross-over protocol. Total and acidic reflux levels for 24 h and during the postprandial period were also recorded using a multichannel intraluminal impedance and pH monitoring system. Data were analyzed blind by one observer.
  
  
  RESULTS
  Acotiamide at a standard dose of 300 mg/day did not significantly stimulate esophageal motor function. Although the frequency of swallows with weak contraction tended to decrease with acotiamide administration, the difference as compared to no administration was not statistically significant. In addition, the drug neither decreased total or postprandial gastroesophageal acid/non-acid reflux events nor accelerated esophageal clearance time.
  
  
  CONCLUSIONS
  Acotiamide, a novel gastrointestinal motility modulator, at a standard dose did not significantly affect esophageal motor functions or gastroesophageal reflux in healthy adults. Additional investigations with GERD patients are necessary to elucidate its clinical significance.
  
  
  BACKGROUND
  This study was registered on 1st August 2013 with the University Hospital Medical Information Network (UMIN) clinical trials registry, as number: UMIN000011260.
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. ishimura@med.shimane-u.ac.jp.
authors.forename: Norihisa
authors.initials: N
authors.lastname: Ishimura
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. mami1117@med.shimane-u.ac.jp.
authors.forename: Mami
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. d_h_m202@med.shimane-u.ac.jp.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Mikami
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. shinoshimura@yahoo.co.jp.
authors.forename: Shino
authors.initials: S
authors.lastname: Shimura
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. uno511976@yahoo.co.jp.
authors.forename: Goichi
authors.initials: G
authors.lastname: Uno
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. aimi@med.shimane-u.ac.jp.
authors.forename: Masahito
authors.initials: M
authors.lastname: Aimi
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. n-oshima@med.shimane-u.ac.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Oshima
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. si360405@med.shimane-u.ac.jp.
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. kinosita@med.shimane-u.ac.jp.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
mesh_terms: D000328:Adult; D001549:Benzamides / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D017097:Electric Impedance; D049630:Esophageal Sphincter, Lower / Q000187:drug effects* / Q000502:physiology; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008365:Manometry; D010528:Peristalsis / Q000187:drug effects*; D019518:Postprandial Period; D013844:Thiazoles / Q000494:pharmacology / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D001549:Benzamides; D005765:Gastrointestinal Agents; D013844:Thiazoles; C410959:Z 338