Dongre S, Langade D, Bhattacharyya S. Efficacy and safety of ashwagandha (Withania somnifera) root extract in improving sexual function in women: A pilot study. BioMed Research Int. 2015;2015:284154.doi: 10.1155/2015/284154.
A double-blind, randomized, placebo-controlled trial
Women aged 21 to 50 who were in a steady heterosexual relationship for over one year, and previously or presently engaged in sexual activity for several years. Participants had to have a male partner who was either not impotent or minimally impotent on a single question self-report of erectile dysfunction questionnaire. Women also had to meet the following criteria:
- baseline score of <26 on the Female Sexual Function Index (FSFI)
- baseline score of >11 on the Female Sexual Distress Scale (FSDS)
- diagnosis of female sexual dysfunction (FSD) with one or more of the following:
- hypoactive sexual desire disorder (HSDD)
- female sexual arousal disorder (FSAD)
- female orgasmic disorder (FOD)
- combined genital and subjective arousal disorder
- willingness to engage in sexual intercourse with an intent to attain orgasm at least twice a week
- willingness to provide written informed consent and ability to meet all the study requirements
- willingness to use a condom
- ability to speak, read, and write English
Fifty women who met the selection criteria were randomly divided into 2 groups. Group A (n=25) were given a high concentration ashwagandha root extract (HCARE), 300 mg 2 times a day for 8 weeks. Group B (n=25) received a placebo identical in size, shape, color, and texture.
The primary outcome was the Female Sexual Function Index (FSFI). The FSFI is a 19- item, self-report form that includes scores for desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score is a weighted sum of these. The FSFI was used at baseline, 4 weeks, and 8 weeks.
Study Parameters Assessed
The primary efficacy outcomes used the FSFI as stated above. Secondary outcomes used the Female Sexual Distress Scale (FSDS), the Sexual Activity Record (SAR), the Patient’s Global Assessment of Response to Therapy (PGART), the Patient’s Global Assessment of Tolerability to Therapy (PGATT), and compliance.
While many parameters did improve, the most difficult one in clinical practice, low desire, was not improved with ashwagandha in this study.
None of the women enrolled in the study withdrew. All the women in the study had total FSFI scores suggestive of female sexual dysfunction (FSD), with scores of 13.57+/-0.9 and 13.63+/-0.95 for Group A and Group B respectively. Initial scores suggested problems of desire, orgasm, lubrication, satisfaction, arousal, and pain. The mean FSFI score at week 4 was 20.25 in Group A and 17.69 in Group B. At week 8, the mean total FSFI score was 23.86 in Group A and 20.06 in Group B. The increase in the FSFI total score was significantly higher in the ashwagandha group than in the placebo group at both weeks 4 and 8 (P<0.001). There was no significant difference between ashwagandha and placebo in the desire domain at weeks 4 and 8. The mean FSFI arousal domain scores relative to baseline were significantly higher in Group A than in Group B at weeks 4 and 8 (P<0.001). For lubrication scores, the effects of ashwagandha were also strong with greater improvement than placebo at weeks 4 and 8. For the orgasm score, the improvement was significantly higher in the ashwagandha group than placebo at week 4 (P<0.01) and week 8 (P<0.001). The difference was not statistically different for pain scores but the mean FSDS score increased statistically significantly more in the ashwagandha group than in the placebo group both at weeks 4 and 8 (P<0.001). There was improvement in the sexual activity record of Group A (P<0.01) as well as the number of successful sexual encounters in group A versus Group B at week 8 (P<0.001). Lastly, of the 25 women in Group A, 15 scored the response to the therapy as excellent, 9 as good, and 1 as moderate. The treatment was well-tolerated with no adverse effects observed.
In animal models, ashwagandha has been found to be effective in stress-induced sexual dysfunctions.1 Ashwagandha may improve female sexual dysfunction due to its role in reducing stress, but possibly in its role in increasing androgens in women.2 Limitations of the study include the sample size, which limits this to a pilot study. Also, the women are not postmenopausal, when sexual dysfunction is more common and arguably tougher to treat. While this product had some positive effects, the search needs to continue for safe and effective botanical approaches to female sexual dysfunction, especially in the domain of desire.