Randomized, Triple-Blinded, Placebo-Controlled Trial of SA3X (Spilanthes acmella) for the Management of Erectile Dysfunction

Introduction Spilanthes acmella has been used as an aphrodisiac in India and other countries. However, studies concerning humans have been limited. This randomized controlled trial was carried out to evaluate the effect of SA3X capsules containing 500 mg of S. acmella on sexual function domain scores in sexually active men with symptoms of erectile dysfunction (ED) using the Men's Sexual Health Questionnaire (MSHQ). Materials and methods This triple-blind, placebo-controlled, parallel-group was conducted at two centres in Hyderabad and Secunderabad from May to December 2021. Patients were randomized 1:1 to SA3X therapy or placebo for one month along with an observational cohort. The change of MSHQ score and its subdomains from baseline to month 1 (primary endpoint) and one-month post-treatment (secondary outcome) was assessed using a mixed model repeated measures analysis. Additional secondary outcomes measured were the change in the International Index of Erectile Function (IIEF) and duration of penile erection. Safety was evaluated. Results The intention-to-treat population included 448 patients (152 - SA3X therapy; 146 - placebo; 150 - observational cohort). A significant increase was observed with SA3X therapy versus placebo on the total MSHQ score (17.24 vs 4.72; SE: 2.11, 1.98; P<0.001) along with the sub-domains at the end of one month of therapy. At one-month post-treatment, the increase in MSHQ score with SA3X therapy was significant (18.48 vs 3.78; SE 2.81, 1.39; P<0.001). The IIEF scores and duration of penile erection also increased significantly in the SA3X therapy group. Dysgeusia (3.94%) was the most common drug-related adverse effect. No serious adverse effects were noted. Conclusion SA3X was concluded to be safe and effective as a potential treatment for ED.