Fennel Cream for Vaginal Atrophy in Postmenopausal Women
Tori Hudson, ND
Author: Yaralizadeh M, Abedi P, Najar S, at al.
Reference: Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas 2016;84:75-80
Design: This double-blind placebo-controlled randomized trial contained two groups, and included 60 postmenopausal women in Iran. Women were randomized into two groups with one group using a fennel 5% vaginal cream (5gm/day) (n=30), or placebo (n=30), for 8 weeks.
The fennel cream was made with an extract of fennel seeds mixed with ethanol 80% and stored for 72 hours. The extract was then dried and then mixed with 5% final concentration with oil in water emulsion cream base. The base included stearic acid, spermaceti, glycerin and water. Propyl paraben and methyl paraben were added to the oil and aqueous phases. One application of either the fennel cream or the placebo cream (5 g/day) was given for 8 weeks.
Participants: Postmenopausal women studied were those between the ages of 45 and 65, had natural menopause, no menses for 12 months or an elevated FSH and LH and had symptoms of vaginal atrophy. Women were excluded if they had a vaginal infection, used hormones during the 8 weeks prior to the study, smoker, alcohol use, postmenopausal bleeding or used phytoestrogens in the previous month.
The mean age of the women was approximately 53 years old. The mean ages of menopause onset were 49-49.5 years.
Primary outcome: The vaginal pH and maturation vaginal index (MVI) were measured at baseline and after the intervention of 8 weeks and the vaginal atrophy symptoms were measured at baseline and at 2,4 and 8 weeks.
Key findings: No women withdrew from the study. The number of superficial cells increased in the fennel group after 8 weeks compared to the control group (76.1 vs 11.9). The number of intermediate and parabasal cells decreased significantly in the fennel group as compared to the control group. Women in the fennel group showed significant improvements in symptoms including itching (100% in fennel group vs 43% placebo), dryness (100% without dryness in fennel group vs 3.3% in placebo group), pallor (100% without pallor in fennel group vs 0% without pallor in the placebo group) and dyspareunia (93% without dyspareunia in the fennel group compared to 0% in the control group). The vaginal pH decreased significantly at the 8 week follow-up in the fennel group compared to the placebo group (100% vs 7.4%). All the women in the fennel group had MVI values of 65-100 at the follow-up but only 40.7% in the placebo group had MVI levels of 50-64.
Practice Implications: The signs and symptoms of vulvovaginal atrophy are very common in postmenopausal women and included pale epithelium, vulvo-vaginal dryness and thinning, inflammation, petechiae and increased friability. This state is also associated with a higher vaginal pH, often 5-5.5. The prevalence of vulvovaginal atrophy ranges from 27% to 55%. Vulvovaginal atrophy can be moderate to severe in symptom presentation; 39% of postmenopausal women and more than 50% report that it significantly affects their quality of life.
According to the North American Menopause Society, vaginal moisturizers, continued vaginal sexual activity and vaginal lubricants are the first line treatments for vulvovaginal atrophy. Many women do need local hormonal therapy. Intravaginal and/or vulvar estrogen are considered safe and effective therapies when used in the common dosages. Options include compounded estriol, estradiol, DHEA, estriol and/or estradiol with progesterone, and big pharma local options include estrogen creams, estrogen vaginal tablets, vaginal estrogen rings and the new FDA approved DHEA suppository.
While the non-hormonal options, including the fennel cream in this study, are not as robust in their results as vulvovaginal estrogens, the results for many, will be adequate. The data not included in this study, which are included in some of the intravaginal estrogen research, are the benefits for stress incontinence.