A Randomized, Double-Blind, Pilot Study of the Effect of Famotidine on Acotiamide Treatment for Functional Dyspepsia

Digestion. 2017;96(1):5-12. doi: 10.1159/000477345. Epub 2017 Jun 13.

Abstract

Background/aims: Acotiamide, a prokinetic drug, is used to treat functional dyspepsia (FD), especially postprandial distress syndrome (PDS). However, a treatment for FD patients with PDS and/or epigastric pain syndrome (EPS) has not been established. We investigated the efficacy of famotidine in combination with acotiamide for FD.

Methods: Fifty blindly randomized FD patients received placebo with acotiamide, or famotidine with acotiamide, for 4 weeks. Treatment efficacy was assessed by overall treatment effects (OTE), total, PDS and EPS symptom scores, and impairment of quality of life (QOL).

Results: After OTE assessment, patients who felt affected by treatment comprised 40.9 and 57.9% of famotidine and placebo groups, respectively, after 4 weeks' treatment, with no significant difference between groups. A significant decrease was seen in total, PDS, and EPS symptom scores, and in QOL impairment, after 4 weeks' treatment compared with pretreatment scores for famotidine and placebo groups, but was not observed between groups. The proportion of patients showing a ≥50% decrease in EPS symptom scores was greater in the famotidine than that in the placebo group for every observation point, with the greatest difference observed after 2 weeks' treatment.

Conclusion: The effectiveness of famotidine and acotiamide combination therapy in FD was similar to the effectiveness of acotiamide therapy alone.

Keywords: Acotiamide; Epigastric pain syndrome; Famotidine; Functional dyspepsia; Postprandial distress syndrome.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Abdominal Pain / drug therapy*
  • Adult
  • Benzamides / pharmacology
  • Benzamides / therapeutic use
  • Cholinesterase Inhibitors / pharmacology*
  • Cholinesterase Inhibitors / therapeutic use
  • Double-Blind Method
  • Drug Synergism
  • Drug Therapy, Combination / methods
  • Dyspepsia / drug therapy*
  • Famotidine / pharmacology
  • Famotidine / therapeutic use
  • Female
  • Histamine H2 Antagonists / pharmacology
  • Histamine H2 Antagonists / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Placebos
  • Postprandial Period / drug effects*
  • Proton Pump Inhibitors / pharmacology*
  • Proton Pump Inhibitors / therapeutic use
  • Quality of Life
  • Thiazoles / pharmacology
  • Thiazoles / therapeutic use
  • Treatment Outcome

Substances

  • Benzamides
  • Cholinesterase Inhibitors
  • Histamine H2 Antagonists
  • Placebos
  • Proton Pump Inhibitors
  • Thiazoles
  • Famotidine
  • Z 338