Possible effects of Saffron (Crocus sativus) in the treatment of erectile dysfunction: A randomized, double-blind, placebo-controlled trial

Aim of the study A significant portion of erectile dysfunction (ED) patients, receiving available treatments, fails to respond. This study aims to evaluate efficacy of saffron in improving erectile function compared with placebo in men with erectile dysfunction. Materials and methods Men with ED of at least a mild severity participated in a 6-week, parallel-group, double-blind, placebo-controlled trial. Participants were randomized to receive 15 mg saffron or placebo capsules twice daily. The trial continued for six weeks, and participants were evaluated every two weeks. The primary outcome of interest was the change in the erectile function. The results were analyzed using t-test, linear regression, and repeated-measures ANOVA. Results Sixty-two participants were equally randomized into two groups, and 29 participants in each group completed the trial. Participants had a mean age of 41years, and the majority suffered from mild erectile dysfunction. Positive changes in erectile function scores reached 6.14 (95% CI [4.97, 7.30]) points in the saffron group, which was superior to the placebo. The confidence interval excluded the minimal clinically important difference of the scale. The adverse events were similar between the two groups and saffron showed a clinically acceptable profile. Conclusion Our findings suggest saffron might be an effective and safe option to ameliorate erectile dysfunction among ED patients, especially those who decline or are unwilling to use phosphodiesterase type 5 inhibitors.