薬理と治療

Abstract

Objectives　To investigate the effects of black ginseng extract(BGE)containing ginsenoside Rg3, which is expected to exhibit antifatigue properties, on fatigue in healthy Japanese adults. Methods　A randomized, placebo–controlled, double–blind, parallel–group comparison trial was conducted. The study included healthy Japanese adults with a visual analogue scale(VAS) of fatigue of 50–80 mm on the screening test and a change in VAS of fatigue of 10–20 mm before and after a stressful task using the Uchida–Kraepelin performance test. Participants were randomly assigned to two group(n=64/group)using a computer and given either 3 BGE tablets or placebo. The food intervention lasted 8 weeks. The endpoints were the VAS for fatigue, OSA Sleep Questionnaire MA version, Profile of Mood States 2nd Edition Japanese version, and salivary amylase. The primary outcome was the VAS of fatigue before the stressful task following an 8–week intervention. Results　There were 4 and 2 dropouts in the BGE and placebo groups, respectively, leaving 122 participants(60 and 62 in the BGE and placebo groups, respectively)in the study. The VAS of fatigue before stressful task following the 8–week intervention was significantly lower in the BGE group than in the placebo group( BGE group 39.9±18.6 mm,Placebo group 46.4±17.7 mm, P=0.037), indicating that fatigue was reduced. The other endpoints were unaffected by BGE intake. This study found that no adverse events were associated with the consumption of the test food. Conclusions　The results of the effect of continuous intake of BGE for 8 weeks on reducing the subjective fatigue in healthy Japanese adults suggest that BGE reduces the subjective fatigue that occurs on a daily basis. Trial registration　UMIN000048301 Foundation　NIHON PHARMACEUTICAL CO., LTD.(Jpn Pharmacol Ther 2024;52:801‒18)