A double-blind placebo controlled study of acotiamide hydrochloride for efficacy on gastrointestinal motility of patients with functional dyspepsia

• Published in: Journal of gastroenterology 2017-05, Vol.52 (5), p.602-610
• Main Authors: Nakamura, Kumiko, Tomita, Toshihiko, Oshima, Tadayuki, Asano, Haruki, Yamasaki, Takahisa, Okugawa, Takuya, Kondo, Takashi, Kono, Tomoaki, Tozawa, Katsuyuki, Ohda, Yoshio, Fukui, Hirokazu, Kazuhito, Fukushima, Hirota, Shozo, Watari, Jiro, Miwa, Hiroto
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adult; Aged; Analysis; Anxiety - etiology; Anxiety - prevention & control; Benzamides - pharmacology; Benzamides - therapeutic use; Colorectal Surgery; Double-Blind Method; Dyspepsia; Dyspepsia - diagnostic imaging; Dyspepsia - drug therapy; Dyspepsia - physiopathology; Dyspepsia - psychology; Female; Gastric Emptying - drug effects; Gastroenterology; Gastrointestinal Motility - drug effects; Hepatology; Humans; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Original Article–Alimentary Tract; Psychiatric Status Rating Scales; Psychometrics; Quality of Life; Radionuclide Imaging; Severity of Illness Index; Stomach - diagnostic imaging; Surgical Oncology; Thiazoles - pharmacology; Thiazoles - therapeutic use; Treatment Outcome
• ISSN: 0944-1174; 1435-5922
• DOI: 10.1007/s00535-016-1260-7

Background Acotiamide is widely used to improve symptoms in patients with functional dyspepsia (FD) in multiple large-scale clinical studies, but there are few reports about the drug’s mechanism of action. The aim of this study was to assess the effects of acotiamide on gastric accommodation and gastric emptying, gastrointestinal symptoms, and health-related quality of life (HR-QOL) in a placebo-controlled study. Methods We conducted a randomized, double-blind placebo-controlled study. Fifty Japanese FD patients were randomly assigned to either placebo ( n  = 25) or acotiamide 100 mg × 3/day for 2 weeks ( n  = 25). At baseline and at 2 weeks of treatment, we evaluated the patients’ gastric motility using scintigraphy to determine the accommodation and emptying values, gastrointestinal symptom rating scale (GSRS), HR-QOL (SF-8), and anxiety and depression scale (HADS). Results Four patients failed to complete the medication regimen and were omitted from analysis; data from 24 placebo patients and 22 acotiamide patients were analyzed. Acotiamide significantly increased gastric accommodation compared to the placebo ( p  = 0.04 vs. p  = 0.08; respectively). Acotiamide significantly accelerated gastric emptying (50 % half-emptying time) ( p  = 0.02 vs. p  = 0.59). Acotiamide significantly improved the total GSRS scores compared to placebo ( p  = 0.0007 vs. p  = 0.14). HR-QOL did not differ significantly between the two groups, but acotiamide significantly improved the HADS anxiety score compared to placebo ( p  = 0.04 vs. p  = 0.20). Conclusions Our placebo-controlled study demonstrated that acotiamide significantly increased both gastric accommodation and gastric emptying in Japanese FD patients. Acotiamide also improved the patients’ dyspeptic symptoms and anxiety score. Clinical Trials Registry no: UMIN000013544.