Anti-Fatigue Effects of Enzyme-Modified Ginseng Extract: A Randomized, Double-Blind, Placebo-Controlled Trial

J Altern Complement Med. 2016 Nov;22(11):859-864. doi: 10.1089/acm.2016.0057. Epub 2016 Oct 18.

Abstract

Objectives: Ginseng saponin is known to have biological activities in maintaining homeostasis and enhancing vital energy. Enzyme-modified ginseng extract (EMGE) was designed to increase the content of its active constituents and to intensify biological activity. The present study investigated the anti-fatigue effects of EMGE in healthy adults in a randomized, double-blind, placebo-controlled trial.

Design: Fifty-two healthy subjects met the diagnostic criteria and were randomly allocated into one of two groups: EMGE (2,000 mg/day) or placebo. EMGE or placebo were administered to each group for 4 weeks. Fatigue scores using the Visual Analogue Fatigue Scale (VAFS) and Revised Piper Fatigue Scale (RPFS) were considered as the primary outcome measure. Life-quality scores were investigated using the Short-Form Health Survey (SF-36). The safety and adverse effects of EMGE were also assessed.

Results: A repeated-measures analysis of variance showed that there was a significant difference in the VAFS scores VAFS between the treatment and placebo groups after 4 weeks. The treatment group's score decreased more than that of the placebo group. There was no difference in the RPFS and SF-36 scores between the two groups. There were no fatal adverse effects.

Conclusion: EMGE treatment for 4 weeks decreased fatigue severity in a healthy population. Adverse effects were rare, and EMGE was generally well tolerated. Randomized, placebo-controlled trials of EMGE are justified in order to elucidate the underlying mechanism of EMGE in combating fatigue.

Keywords: anti-fatigue; enzyme-modified ginseng extract; randomized controlled trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Fatigue / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Panax / chemistry*
  • Plant Extracts / therapeutic use*

Substances

  • Plant Extracts