Nutritional Fundamentals for Health

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Three Non-Hormonal Options for Vulvovaginal Atrophy

Fennel Cream for Vaginal Atrophy in Postmenopausal Women
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 of the placebo cream (5 g/day) was given for 8 weeks.

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 was 49-49.5 years. 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.

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 fs 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 f/u 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 a the f/u but only 40.7% in the placebo group had MVI levels of 50-64.

Commentary: The signs and symptoms of vulvovaginal atrophy are very common in postmenopausal women and include pale epithelium, vulvo-vaginal dryness and thinning, inflammation, petechiae, increased friability and vulvovaginal pain with touch. This state is also associated with a higher vaginal pH, often 5-5.5. The prevalence vulvovaginal atrophy ranges from 27% to 55%. Vulvovaginal atrophy can be moderate to severe in symptom presentation in 39% of postmenopausal women and more than 50% report that it significantly effects 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 than is vulvovaginal estrogens, the results for many women, will be adequate. The data not included in this study, which is included in some of the intravaginal estrogen research are the benefits for stress incontinence.

Reference: Yaralizadeh M, Abedi P, Najar S, at al. 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

Pueraria Mirifica Vaginal Gel for Vulvovaginal Atrophy in Menopausal Women

This was a prospective, single blind, randomized, controlled study conducted in Bangkok, Maryland over a 12 week period. Eighty-two women were divided into two groups. The first group (n=41) received a 6% Pueraria mirifica extract gel intravaginally each day for the first 2 weeks and then three times per week for the remainder of the study period. The second group (n=41), received 0.5 gm vaginal conjugated estrogen cream intravaginally and daily for 2 weeks then 3 times per week for the remainder of the study period. Both groups received baseline exams, then follow-up exams at 6 weeks and 12 weeks. A phone appointment was done after week 1 and study participants were told to not use any substances or herbs with an estrogenic effect other than the study products.

All women were postmenopausal women with at least one vaginal symptom of estrogen deprivation such as vulvovaginal dryness, soreness, irritation, dyspareunia or abnormal discharge. Women were between 45 to 70 years, with an intact uterus and the last menstrual period at least 1 year prior to recruitment. The mean age was 56.41 in the Pueraria group and 55.71 in the estrogen group. Women also were chosen who had not received hormonal therapy in the previous 3 months and had no contraindications for the use of hormonal therapy. There were no significant differences in the two groups in height, weight, BMI, and the initial assessment of endometrial thickness, vaginal symptom score, vaginal assessment score and lactobacillus grading. The primary objective was to compare the effects of Pueraria mirifica gel or conjugated estrogen cream on the vaginal maturation index, vaginal symptom score, vaginal health assessment score and vaginal flora in postmenopausal women.

Results: Vaginal dryness, soreness, irritation, abnormal discharge and dyspareunia scores decreased significantly after the 12 week treatment period in both groups and no statistically significant difference for the mean scores was seen between the Pueraria gel group and the conjugated estrogen group (4.37 to 0.95 in the Pueraria gel group and from 4.15 to 0.68 in the estrogen group). The vaginal maturation index increased significantly in both treatment groups at 12 weeks in both groups, ( 22.4 to 47.56 in the Pueraria gel group and 27.0 to 66.90 in the estrogen group) with a significantly higher effect observed in the estrogen group.

Commentary: Many women prefer not to use vulvovaginal estrogen cream or other vaginal estrogen deliveries for the treatment and maintenance of their vulvovaginal atrophic symptoms. The use of vulvovaginal estrogen estrogen products in breast cancer patients are the primary group of patients for whom there is some specific conversation to be had about the benefits and risks of each of the product choices. In brief, the vaginal estrogen tablet, the local estrogen ring and estriol products are considered safe, based on studies done on serum estrogen changes or not, with these products. While safety of vulvovaginal estrogen with knowledgeable prescribing is possible, some women and practitioners will still choose to use non estrogen products for the breast cancer patients. Other non breast cancer patients may also choose to use non estrogen products for personal reasons. Options include over the counter pharmaceutical vaginal lubricants or moisturizers, and lubricants and moisturizers with more natural ingredients.

I suppose one could have the same considerations for vaginal phytoestrogen that one has for vaginal estrogen cream in terms of breast cancer patients. I would consider this a non issue based on discussions in many other settings on the safety of phytoestrogens in breast cancer patients.

The major components of Pueraria mirifica extract include the phytoestrogen compounds deoxymiroestrol and miroestrol . Oral Pueraria mirifica products have been used to be quite effective for common symptoms of menopause including vasomotor symptoms. There was a previous study on Pueraria mirifica oral capsules for vaginal health. After 12 weeks, there were significant improvements in most measures of vaginal health. (J NAMS 2007; 12(5): 919-924).

While the vaginal estrogen cream used in this study was superior to vaginal Pueraria mirifica gel, the herbal gel had significant enough benefits to be a worthy choice, as long as vulvovaginal symptoms do actually improve adequately with treatment by 6-12 weeks.

Reference: Suwanvesh N, Manonai J, Sophonsritsuk A, Cherdshewasart W. Comparison of Pueraria mirifical gel and conjugated equine estrogen cream effects on vaginal health in postmenopausal women. Menopause 2017;24(2): 210-215.

Vitamin E/A/Hyaluronic Acid Suppository for Vulvovaginal Atrophy
This open, non-controlled design study, included 150 women aged 44-64, all in surgical or physiological menopause, presented with vaginal dryness and correlated symptoms. The treatment was a combination of hyaluronic acid/vitamin E and A=( Övuli from Santes in Italy). A daily vaginal suppository, was inserted in the vagina for 14 days continuously. Then every other day for 14 days. A total of 20 patients did not complete the study( 4 d/c, 7 non compliant, 9 had insufficient follow-up). Vaginal dryness was the primary endpoint using the VAS (visual analogue scale).

Results: The suppositories decreased vaginal dryness from 7.92 at baseline to 4.22 at visit #1 (7 days after beginning the treatment), to 0.84 at visit #2 (14 days) to 0.0 at visit 3 (28 days, the end of the treatment). At the beginning, symptoms were severe in 106 of the women and moderate in 24 women. Only 4 women still reported the symptom at the end of the treatment. Burning was present as a severe symptom in 93 women, moderate in 26 and mild in 11. this symptom progressively disappeared during the treatment and at the end, only 4 women complained about a mild burning symptom. Dyspareunia was a severe symptom in 18 women, moderate in 78 and mild in 34. This symptom decreased progressively and only 5 women had mild dyspareunia at the end of the treatment. Inflammation and edema was severe in 30 women, moderate in 52 and mild in 28 and absent in 20. it disappeared progressively during the treatment and only 5 women still had the mild symptom at the end. Vaginal mucosa irritation was severe in 25 women, moderate in 32, mild in 50 and absent in 23, disappeared progressively during the treatment in all patients.

Overall response:
Optimal in 108, good in 20, moderate in 2.

Commentary: Hyaluronic acid sodium salt belongs to the class of glycosaminoglycans and consists of repeated disaccharides units (glycuronic acid and N-acetylglucosamine). It is able to retain very high amount of water molecules, forming a moisturizing, not greasy film. On the external skin, it helps to maintain water balance and makes the skin smooth and elastic. Vitamin E, a fat-soluble vitamin prevents the degradation of the tissue due to oxidant agents. Even though only a few studies have been performed on the effects of vitamin E, used alone, as a vaginal suppository, it has improved quality of life measurements in at least one study (Emamverdikhan A. et al. JMRH 2014;2(4): 253-261). Vitamin A is also a fat-soluble vitamin that has shown to have properties to increase the function of the immune local cells as well as ensure the integrity of morphological and functional vaginal epithelium.

I have not used this product yet, but I’m encouraged by the results. I am not aware of the problems one might have procuring this commercial product from Italy and the internet. It is conceivable that one could compound something similar from a compounding pharmacist if those three ingredients are within the licensing realm of compounding pharmacies. The specifics of the formula as I understand it from a search: A 2 gr. vaginal suppository contains : Hyaluronic acid sodium salt mg 5,00, Tocopheryl acetate mg 100, Retinyl palmitate 100mg, semisynthetic glicerides q.b.

Reference: Costantino D, Guaraldi C.  Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial European Review for Medical and Pharmacological Sciences 2008; 12: 411-416.