The nutraceutical is Belle Dame or Estrosalus as it is known in different markets, contains four medicinal herbs - soy isoflavone, black cohosh, chasteberry and evening primrose oil extract.
It is marketed as a women’s health supplement to relieve menopausal symptoms, menstrual symptoms, improve skin health and general well-being.
In this randomised, double-blind, placebo-controlled clinical trial, which was funded by Max Biocare Pty Ltd (Australia), researchers from Thailand’s Dhurakij Pundit University wanted to evaluate the efficacy of Belle Dame in post-menopausal women.
“Menopause symptoms severely reduce the quality of life of women worldwide, with hot flushes and night sweats, sleep disturbances, and emotional issues. Menopause is further associated with increased risk of osteoporosis, cardiovascular disease, and negative changes to lipid profile,” they wrote in the Journal of Dietary Supplements.
The current treatment method is hormone replacement therapy with estrogen, however it has been suggested that estrogen treatment may increase the risk of uterus and breast cancer.
Hence, nutraceuticals and herbal medicines with estrogenic activity have been touted as a better option.
Study design
The trial recruited 101 post-menopausal women aged 45 to 60 years old from Thailand. These include women who had stopped menstruation for least 12 consecutive months and had reported menopausal symptoms.
The treatment group (n=50) was tasked to take one capsule of Belle Dame/Estrosalus daily after breakfast for 12 weeks.
One capsule of Belle Dame/Estrosalus contains 100 mg of soy isoflavones, 520 mg of black cohosh, 400 mg of chasteberry, and 500 mg evening primrose oil.
The placebo group (n=51) was given soybean oil capsules as the control.
Researchers collected information on menopausal symptoms, endocrine profiles, and blood chemistry at baseline, week six and 12.
Menopause symptoms were assessed using the internationally recognised and validated menopause rating scale (MRS) quality of life questionnaire. It consists of 11 items, including hot flashes/sweating, heart discomfort, sleep problems, joint or muscular discomfort, depressed mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, and dryness of vagina.
Blood samples were used to evaluate kidney, liver function, glucose, lipid levels and serum hormones (FSH, LH, Estradiol, and SHBG).
Reduction in symptoms
Findings showed a significant reduction in hot flushes and sweating (p < 0.0001), sleep problems (p < 0.0005), depressed mood (p = 0.0004) and irritability symptoms (p < 0.0003) in the treatment group compared with the placebo.
There were no differences in heart discomfort, joint or muscular discomfort, anxiety, physical and mental exhaustion, sexual problems or bladder problems.
There were also no significant differences in serum hormone levels and lipid profiles between the treatment and control group.
Although, the treatment group saw significantly lower inflammation marker, hs-CRP levels (p = 0.0002) compared with the placebo group.
The data suggest that supplementation with Belle Dame/Estrosalus could improve menopause symptoms as a combination polyherbal product, in line with previous evidence for the effects of the individual ingredients.
In particular, it contains soy isoflavones (daidzin, glycitin, genistin) which can mediate the effects of insufficient estrogen for the relieve of menopausal symptoms.
Black cohosh, chasteberry and evening primrose oil also provide various support roles, with a combination of central endocrine, antioxidant and anti-inflammatory effects that can assist with managing the severity of both physical and psychological menopausal symptoms, decrease hs-CRP levels, and regulate metabolic changes associated with menopause that may increase cardiovascular risk in this subpopulation of women.
Limitation and future direction
Researchers acknowledged that the polyphenol metabolites derived from the formula were not quantified in plasma after oral intake.
“Future studies to detect these compounds would provide a clearer picture of the timing and individual variations of the observed physiological effects of these herbs.”
In addition, considering that menopausal women are a risk group for cardiovascular disorders, such as hypertension and heart disease, reduction of LDL-C and triglycerides in the treatment group can be further studied.
“Moreover, the only safety biomarkers assessed were of liver and kidney function as well as sex hormone levels. However, there are more adverse events that could affect the safety profile of the treatment, such as neurological and cardiovascular outcomes. Thus, this should be studied in the future study,” they wrote.
This study indicates that supplementation with Belle Dame/Estrosalus could improve menopause symptoms and general well-being in post-menopausal women.
A second part of this study will evaluate dermatology results, and the paper is currently under review.
Source: Journal of Dietary Supplements
https://doi.org/10.1080/19390211.2020.1853648
“Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial”
Authors: Teerapong Rattanatantikul, et al.
