Effect of vitamin E with and without saffron on the sexual function in women of reproductive age with sexual dysfunction: a randomized controlled trial

Abstract Background Sexual satisfaction is a crucial part of a fulfilled life, and the ability to have satisfying sexual function is crucial to one’s sexual health. This study investigated the effect of the combined administration of saffron and vitamin E and vitamin E alone on the sexual function of women in their reproductive years. Methods A triple-blind randomized controlled trial was conducted with 50 participants experiencing sexual dysfunction without comorbid sleep disorders or severe depression. They were allocated into two groups using a block randomization method (stratified based on the severity of moderate or mild/normal depression). During the 8-week intervention period, participants in the experimental group were administered a 15 mg saffron capsule (safrotin) in the morning and a combination capsule containing 15 mg saffron and 50 mg vitamin E (safradide) in the evening. During the same period, the control group consumed one saffron placebo capsule in the morning and one capsule containing 50 mg of vitamin E and saffron placebo in the evening (in identical appearance to safradide). The Female Sexual Function Index was used to assess sexual function, and the Depression, Anxiety, and Stress Scale-21 (DASS-21) was used to measure levels of depression, anxiety, and stress. These measures were administered at baseline as well as four and eight weeks post-intervention, with an additional measurement taken four weeks after the intervention ceased. The repeated measures ANOVA, ANCOVA, and Mann-Whitney U tests were used to compare the groups. Results Following the intervention, the experimental group (saffron and vitamin E) demonstrated a statistically significant increase in the overall mean score of sexual function compared to the control group (placebo of saffron and vitamin E) (adjusted mean difference (AMD): 4.6; 95%CI: 3.1 to 6.1; p