Effect of SA3X (Spilanthes acmella) Supplementation on Serum Testosterone Levels in Males with Erectile Dysfunction - A Parallel Double-Blind Randomized Controlled Trial.

Abstract

Objectives:To determine whether SA3X (Spilanthes acmella) supplementation improves serum testosterone levels, in comparison with placebo, in participants with erectile dysfunction (ED) and low testosterone levels. Material and methods:This double-blind placebo-controlled parallel-group was conducted in Hyderabad, India, among male participants who were randomized to SA3X therapy or placebo (1:1) for three months. The change of serum testosterone levels from baseline to months 1, 2, 3 and 6 (three months after completion of the intervention) were assessed using a mixed model repeated measures analysis. Additional secondary outcomes were the change in the Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and the duration of penile erection. Stratifying the effect of SA3X on testosterone levels was done to account for potential confounders and effect modifiers. Safety was evaluated. Results:The intention-to-treat population included 215 patients (105 - SA3X therapy; 110 - placebo). SA3X intervention increased the testosterone levels significantly (21.85 vs. 1.89 ng/dL; P<0.001) at the end of month 3. The elevated testosterone levels were maintained at month 6 (18.69 vs. 1.79; P<0.001) even after discontinuation of the intervention. The MSHQ scores, IIEF scores, and duration of penile erection also increased significantly in the SA3X group. Sensitivity analysis showed that the effect of SA3X on testosterone significantly differed by BMI, presence of comorbid conditions and intake of phosphodiesterase-5 inhibitors. Dysgeusia (7.61%) was the significant drug-related adverse effect. Conclusion:Supplementation with SA3X for people with ED and low testosterone is a safe option as it significantly increases testosterone levels along with erectile function.