Fennel for postmenopausal sexual dysfunction

Relation

Abedi P, Najafian M, Yaralizadeh M, Namjoyan F. Effect of fennel vaginal cream on sexual function in postmenopausal women: a double-blind, randomized, controlled trial.J Med Life. 2018;11(1):24-28.

Objective

To evaluate the effect of fennel vaginal cream on symptoms of sexual dysfunction in postmenopausal women

Draft

Randomized, double-blind, placebo-controlled trial

Participant

Sixty Iranian women aged 45 to 65 years with confirmed natural postmenopausal status (absence of menstruation > 1 year; FSH > 40 IU/L). All participants were married/sexually active and had a Female Sexual Function Index [FSFI]<26; Women with vaginal bleeding or infections and women receiving hormone replacement therapy (HRT) or phytoestrogens were excluded from the study.

intervention

Patients in the experimental group (n=30) were instructed to use the 5% fennel vaginal cream (5 g) every night for 8 weeks, while patients in the control group (n=30) were instructed to use a placebo cream every night.

The fennel cream was made from an 80% ethanol extraction of fennel seeds that were stored for 3 days and then freeze-dried. This dried extract was then mixed with a 5% emulsion cream base preserved with methyl and propyl parabens and mixed with a “proper” carrier (unspecified) to a concentration of 5%. The placebo cream was made with the same excipient and had a “similar color and appearance” to the fennel cream. Details about what “similar color and appearance” means were not provided.

Study parameters assessed

FSFI assessed for all participants at baseline and after 8 weeks

Primary outcome measures

Changes in FSFI and individual markers such as arousal, lubrication, orgasm ability, sexual satisfaction and pain after 8 weeks of fennel cream or placebo

Key insights

All domains of FSFI sexual function, including arousal, lubrication, orgasm, sexual satisfaction, and pain, improved in both the fennel and placebo groups. However, the total FSFI score was higher in the fennel group than in the placebo group (P<0.001). No adverse effects of the vaginal preparations were reported by either group. There were no withdrawals from this study.

Practice implications

The FSFI is a clinical self-report tool that assesses multiple dimensions of female sexual function and is commonly used in clinical trials to assess female sexual function disorders.^1.2It was developed as a diagnostic tool to assess women's specific dysfunctions regardless of socioeconomic status, age, ethnicity or sexual orientation.¹It has been found to have high validity and reliability for both diagnosing female sexual disorders and monitoring changes with treatment.

Menopause, defined as the absence of menstruation for at least 1 full year, is often associated with physical and symptomatic changes in sexual function related to genitourinary symptoms of menopause (GSM), including dryness, dyspareunia, and bleeding. By some estimates, approximately 50% of women experience atrophic vulvovaginal changes within 7 to 10 years of menopause, along with commonly reported changes in physical sexual function, including decreased arousal, sexual response, and dryness or pain during intercourse.^3.4However, in clinical practice, presenting symptoms may or may not correlate well with objective signs such as vulvovaginal atrophy and/or prolapse; Therefore, a clinically sensitive approach to questions about stress, sleep, relationship and personal well-being, and other factors is required. Many women may also believe that these changes are a natural part of aging and therefore may not be aware that effective treatments exist.^5.6

This raises the question of whether there are clinical effects of a local topical preparation for menopausal sexual dysfunction outside of its objective effects on local vaginal cytology and pH - essentially a positive placebo effect.

Oral and/or topical applications of synthetic or bioidentical estrogens are standard for conventional therapeutics, but as data from the Women's Health Initiative showed, oral estrogen therapies carried increased risks of coronary heart disease, breast cancer, and endometrial cancer over a 5-year period. high.⁵While topical vulvovaginal estrogen therapy is thought to pose fewer of these risks, there are concerns about the ingredients in many commercial preparations, and customized preparations can be expensive and increasingly difficult to cover through health insurance or private insurance.⁵

Phytoestrogens such as fennel are believed to have a negligible to slightly beneficial effect on menopausal symptoms such as hot flashes, GSMs, and sexual function.^6.7However, to date, little attention has been paid to the use of phytoestrogenic compounds in local topical preparations, either for GSMs or for sexual function in postmenopausal women.

Using the same treatment and placebo groups, the authors of this study had previously found that nightly application of the topical 5% fennel compound to the vulvovaginal area resulted in statistically significant changes in the vaginal maturation index and reduced vaginal pH, indicating reduced signs of atrophy, in the treated subjects over a period of 8 weeks compared to the treated subjects Controls.⁸

However, in this larger study of sexual function, both the placebo and treatment groups reported improvements in all measured areas of sexual dysfunction, although the effects were greater in the treatment group. This raises the question of whether there are clinical effects of a local topical preparation on menopausal sexual dysfunction outside of themObjectiveEffects on local vaginal cytology and pH – essentially a positive placebo effect.

However, an important potential confounder could be the presence of an active ingredient in the placebo preparation. Given that the authors did not provide any details about the placebo preparation other than that it was prepared using "the correct carrier" and had "a similar odor, color and appearance to the fennel cream," the question arises as to whether a partial effect could be achieved by an active ingredient in the placebo cream that was not specified in this study. In their methods section, the authors stated that details of the placebo preparation had been previously published; however, the reference cited was only available as an abstract and did not contain the relevant details.⁸

Overall, this study raises some very interesting questions about whether the positive benefits ofanytopical treatments for postmenopausal sexual dysfunction (as opposed to effects on cellular vaginal atrophy).per se) are at least partly placebo effects. For patients who may be at higher risk for pelvic pathology, who may be unable to tolerate vaginal estrogens, or who wish to avoid prescription hormonal therapies, the use of a 5% topical phytoestrogen compound for compounding either in the office or through a pharmacy familiar with dispensing natural products seems appropriate.