Safety and efficacy of a dietary supplement containing functional food ingredients for erectile dysfunction

Abstract

Functional food ingredients are widely used for erectile dysfunction. We conducted 2 clinical studies to evaluate the safety and efficacy of a commercialized dietary supplement containing Panax ginseng C.A. Meyer extract, Lepidium meyenii root extract, yeast extract, egg white peptide, Mucuna pruriens extract, black ginger extract, polyphenol, l-arginine, l-carnitine, coenzyme Q10, vitamin E, black pepper extract, and zinc. In the first study, after providing informed consent, 15 healthy men (mean age, 35.3 ± 1.9 years) participated. A dietary supplement, EDiSON was administered for 8 weeks. Adverse events were recorded daily. In the second study, 14 men diagnosed with mild-to-moderate erectile dysfunction participated in an 8-week randomized, double-blind, placebo-controlled study. They were assigned to the dietary supplement group (n = 8) or the placebo group (n = 6). The primary outcome was the quality of life, as assessed by the International Index of Erectile Function-5 (IIEF-5) questionnaire. All patients completed the studies. In the first study, the intake of the dietary supplement was not associated with any adverse events. In the second study, the intake of the supplement was associated with significant improvement of the IIEF-5 score at 4 weeks and at 8 weeks of the trial, compared to the baseline. Our initial findings support the safety of the EDiSON dietary supplement. The results from the randomized, double blind, placebo-controlled trial support the use of the EDiSON dietary supplement for the treatment of mild-to-moderate erectile dysfunction. This study was registered at http://www.umin.ac.jp, as UMIN000009405.