Saffron plus vitamin E versus vitamin E for sexual dysfunction: A randomized controlled trial

Abstract

Abstract Introduction: Prevalence of sexual disorders in women of childbearing age is high. Due to the safety of saffron for medicinal purposes, and the limited evidence related to effect of saffron on sexual function, we aimed to determine the effect of saffron along with vitamin E compared to vitamin E alone on sexual function (primary outcome), and depression, anxiety and stress (secondary outcomes) during two months of the intervention and one month after stopping the intervention in women of reproductive age with sexual dysfunction. Materials and methods: In this double-blind trial, 50 women with sexual dysfunction, no sleep disorder and no severe depression were allocated into two groups using stratified (Moderate or mild/normal depression) block randomization. The intervention group received 15 mg saffron capsule (safrotin) and a capsule containing 15 mg of saffron and 50 mg of vitamin E (safracid), and the control received a placebo capsule (in appearance identical to safrotin) and a 50 mg vitamin E capsule (in appearance identical to safracid), daily for 8 weeks. The participants, the drug prescriber and the outcome assessor were unaware of the type of intervention received by each person. Sexual function was assessed using the Women's Sexual Function Scale (FSFI) and the depression, anxiety and stress were assessed using the Depression, Anxiety and Stress Scale (DASS-21) before the intervention, at 4 and 8 weeks after the intervention, and 4 weeks after stopping the intervention. Repeated measures ANOVA or Mann-Whitney U were used to compare the groups. Results: A total of 25 people allocated in each group were fully followed up for one month. Three women in the intervention group and two women in the control group were lost after the first follow-up. Mean score of the baseline sexual function was 22.9 (SD 3.6) from the attainable range score of 2-36. In general, After the intervention, the mean score of sexual function in the intervention group was significantly higher than the control group (adjusted mean difference (AMD) 4.6, p < 0.001. Also, the mean scores of all domains of sexual function including arousal, desire, orgasm, and satisfaction (except pain) at all time points after the intervention (p < 0.001) and the mean rank of lubrication only in eight weeks after the intervention (p = 0.004) were statistically higher in the intervention group than the control group. After the intervention, the mean rank of depression score was significantly lower in the intervention group compared to the control group at all the three time points; four (p = 0.011) and eight (p = 0.005) weeks of the intervention and four weeks after the end of the intervention (p = 0.007). The mean rank of anxiety score was significantly lower in the intervention group compared to the control group at the four weeks of the intervention (p = 0.016) and four weeks after the end of the intervention (p = 0.002), but there was no statistically significant difference at the eight weeks of the intervention (p = 0.177). Also, after the intervention, the mean stress score in the intervention group was significantly lower than the control group (p < 0.001 in all three time points). Conclusion: Based on the results of this trial, addition of saffron to vitamin E improves the sexual performance of women of reproductive age with sexual dysfunction . Trial registration: Iran's International Clinical Trials Registration Center, ID IRCT20100414003706N36, registered on May 17, 2020, https://fa.irct.ir/trial/45992