Therapeutics · Supplements and Botanicals

Dietary Supplements for Erectile Dysfunction: Analysis of Marketed Products, Systematic Review, Meta-Analysis and Rational Use

Petre GC, Francini-Pesenti F, Vitagliano A, Grande G, Ferlin A, Garolla A

Published August 22, 2023 Nutrients
DOI 10.3390/nu15173677 PMID 37686709 PMC PMC10490034

RRM Academy Synopsis

Most Italian erectile dysfunction supplements had no expected efficacy

A review of 23 randomized trials and 27 supplements sold in Italy found that 20 of 25 scored supplements for erectile dysfunction had no expected efficacy. Pooled trial results favored ginseng, Tribulus and L-arginine, though the trials carried some risk of bias.

Key Findings

  • The review included 23 randomized controlled trials. Of 41 active ingredients used by manufacturers, 33 had no reported efficacy on erectile dysfunction and eight had recognized clinical evidence of efficacy.
  • Pooled mean differences in erectile function favored L-arginine (3.22, 95% CI 1.80, 4.63), Tribulus terrestris (3.88, 95% CI 1.31, 6.45) and Panax ginseng (2.67, 95% CI 1.10, 4.25).
  • Heterogeneity between trials was I2 = 71% for L-arginine, I2 = 76% for Tribulus terrestris and I2 = 39% for Panax ginseng.
  • Of 27 supplements sold in Italy, 25 were scored. Of these, 2 (8%) matched the higher expected efficacy cluster, 3 (12%) the lower group and 20 (80%) the no expected efficacy criterion.
  • Every one of the 27 supplements held at least one ingredient lacking evidence. In 24 formulations (88.8%), some ingredients were dosed below the minimal effective daily dose.

Interpretation

The work is a systematic review and meta-analysis of randomized trials, each testing one ingredient, joined to a scoring system built by the authors. Only single-ingredient trials were eligible, so no trial of a finished product was included. The authors report some risk of bias in the trials for each ingredient, generally low for L-arginine, and high heterogeneity among the Tribulus terrestris trials. They state only that the ingredients are potentially effective on average. For Withania somnifera, the pooled result of two studies did not favor the ingredient, and the authors draw no conclusion against it. Products came from online retailers and Italy's register of notified supplements.

RRM Context

The authors note that trouble with erections can signal underlying endocrine disease. They list obesity, diabetes, high blood pressure and smoking as main risk factors. Restorative reproductive medicine includes the male partner in a couple's evaluation. It looks for the cause of a symptom before treating the symptom.

Abstract

The use of nutraceutical products to enhance male sexual performance has a long history, especially with regard to the treatment of erectile dysfunction (ED). Alternative treatments for ED are becoming increasingly popular, with growing interest from consumers, as well as increased revenue for manufacturers. Dietary supplements (DSs), which are a mixture of active ingredients, are mainly sold online. In randomized controlled trials, the molecules contained in DSs have demonstrated varying degrees of effectiveness, or even have no evidence to support their use. However, none of the studies carried out provided sufficient evidence to consider these products a first-line therapy. Therefore, the combination of the various active ingredients, especially in relation to the daily dose, leaves doubts about the real effectiveness. In order to evaluate the potential efficacy of DS formulations, we analyzed the products marketed in Italy using a scoring approach. A systematic review of the literature was performed to evaluate the effect of DS and to detect the active ingredients able to improve erectile function-called effective ingredients (EIs)-and their minimal effective daily dose (mED). A metanalysis identified some nutraceuticals, such as Panax ginseng, Tribulus terrestris and L-arginine, that are able to improve male sexual function. Based on the scoring system, 2 (8%) supplements matched with the cluster of higher expected efficacy, 3 (12%) with the lower efficacy cluster and 20 (80%) matched with the criterion of no expected efficacy. DSs marketed in Italy are usually blends of many substances that are frequently employed at a negligible dose or without any evidence.

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Therapeutics › Supplements and Botanicals › Herbal and Botanical Products · Research Methods › Evidence Synthesis › Meta-Analysis
Gabriel Cosmin Petre, Francesco Francini-Pesenti, Amerigo Vitagliano, Giuseppe Grande, Alberto Ferlin, Andrea Garolla
G Petre, F Francini-Pesenti, A Vitagliano, G Grande, A Ferlin, A Garolla
PMID 37686709 37686709 DOI 10.3390/nu15173677 10.3390/nu15173677 Petre et al. 2023, Petre 2023