PMID- 26362795 OWN - NLM STAT- MEDLINE DCOM- 20160512 LR - 20220316 IS - 1471-230X (Electronic) IS - 1471-230X (Linking) VI - 15 DP - 2015 Sep 11 TI - Effects of acotiamide on esophageal motor function and gastroesophageal reflux in healthy volunteers. PG - 117 LID - 10.1186/s12876-015-0346-7 [doi] LID - 117 AB - 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. TRIAL REGISTRATION: This study was registered on 1st August 2013 with the University Hospital Medical Information Network (UMIN) clinical trials registry, as number: UMIN000011260. FAU - Ishimura, Norihisa AU - Ishimura N AD - 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. FAU - Mori, Mami AU - Mori M AD - 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. FAU - Mikami, Hironobu AU - Mikami H AD - 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. FAU - Shimura, Shino AU - Shimura S AD - Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. shinoshimura@yahoo.co.jp. FAU - Uno, Goichi AU - Uno G AD - Department of Gastroenterology and Hepatology, Shimane University School of Medicine, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. uno511976@yahoo.co.jp. FAU - Aimi, Masahito AU - Aimi M AD - 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. FAU - Oshima, Naoki AU - Oshima N AD - 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. FAU - Ishihara, Shunji AU - Ishihara S AD - 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. FAU - Kinoshita, Yoshikazu AU - Kinoshita Y AD - 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. LA - eng SI - JPRN/UMIN000011260 PT - Clinical Study PT - Journal Article DEP - 20150911 PL - England TA - BMC Gastroenterol JT - BMC gastroenterology JID - 100968547 RN - 0 (Benzamides) RN - 0 (Gastrointestinal Agents) RN - 0 (Thiazoles) RN - D42OWK5383 (Z 338) SB - IM MH - Adult MH - Benzamides/pharmacology/*therapeutic use MH - Cross-Over Studies MH - Electric Impedance MH - Esophageal Sphincter, Lower/*drug effects/physiology MH - Esophageal pH Monitoring MH - Female MH - Gastroesophageal Reflux/*drug therapy MH - Gastrointestinal Agents/pharmacology/*therapeutic use MH - Healthy Volunteers MH - Humans MH - Male MH - Manometry MH - Peristalsis/*drug effects MH - Postprandial Period MH - Thiazoles/pharmacology/*therapeutic use MH - Young Adult PMC - PMC4567836 EDAT- 2015/09/13 06:00 MHDA- 2016/05/14 06:00 PMCR- 2015/09/11 CRDT- 2015/09/13 06:00 PHST- 2015/04/13 00:00 [received] PHST- 2015/09/07 00:00 [accepted] PHST- 2015/09/13 06:00 [entrez] PHST- 2015/09/13 06:00 [pubmed] PHST- 2016/05/14 06:00 [medline] PHST- 2015/09/11 00:00 [pmc-release] AID - 10.1186/s12876-015-0346-7 [pii] AID - 346 [pii] AID - 10.1186/s12876-015-0346-7 [doi] PST - epublish SO - BMC Gastroenterol. 2015 Sep 11;15:117. doi: 10.1186/s12876-015-0346-7.