Clinical evaluation of an herbal formula for menopause symptoms
Menopause occurs naturally in aging women form their early 50’s and is defined by a stoppage of menstrual cycles for at least 12 months. Many women experience a range of physical and psychological symptoms during this time, to different degrees of severity, due to declines in reproductive hormone production, including estradiol and progesterone. Herbal medicines have provided a valuable alternative to conventional treatments for these symptoms , whilst also providing additional benefits such as antioxidant effects. This article highlights the outcomes of a recent clinical trial of a combination herbal extract in a group of Thai post-menopausal women.
The study, published by Rattanatantikul and colleagues (2020)  in the Journal of Dietary Supplements presents the outcomes of a randomized, placebo-controlled trial of a commercial combination of dry extracts of Glycine max isoflavones, Cimicifuga racemosa, Vitex agnus castus and Oenothera biennis. The study was conducted in a group of 110 women (45-60 yrs) with menopause symptoms. The subjects were randomly allocated to take either the intervention or a placebo once daily for a period of 12 weeks. Menopause symptoms were recorded before and after the trial using the standardized menopausal rating scale (MRS) metric, and safety assessments were monitored throughout the trial period based on vital signs and blood test results for liver, kidney, cardiovascular, endocrine, and inflammatory status.
A compliance rate of 98% suggested the test product was very well tolerated. Blood levels of estradiol were consistently low (5-7pg/ml), with elevated LH (~20 mIU/ml) and FSH (~60mIU/ml) in all groups, indicating the women were post-menopausal as per their screening status. Significant decreases were observed within the treatment group for LDL-cholesterol, triglycerides and C-reactive protein (CRP), a marker of inflammatory status (Fig. 1), which combine to indicate a beneficial response in cardiovascular health status. This result was promising, considering menopausal women are a well-known risk group for ageing related cardiovascular problems .
Design team, use graphs from belle dame trial ppt or catalogue, change design to be consistent with website.
Amongst the assessed menopausal symptoms, the most significant improvements were observed as declines in the occurrence of severe hot flushes or sweating (~40%); sleep disturbances (~30%); depressed mood (~30%); irritability (~30%) and vaginal dryness (~20%) compared to placebo (Figure 2). There were no statistically significant changes in heart discomfort, joint or muscular discomfort, anxiety, exhaustion, sexual problems, or bladder problems. Overall, there were no significant changes across the trial period in vital signs (blood pressure, pulse, BMI), liver or kidney function, suggesting the product was safe during the time of administration.
Implications of the study
These results agree with previously reported improvements in menopause symptoms, following intake of the individual herbal ingredients, Glycine max isoflavones , Cimicifuga racemosa  and Oenothera biennis . Additionally, Glycine max has been reported to reduce menopause symptoms by a similar degree (44%), as well as improving LDL-cholesterol . The isoflavones are sometimes referred to as phytoestrogens, because they have a mild receptor binding effect that mimic the effects of estradiol even when circulating levels are diminished. Overall, the results of this trial reinforce the known actions of herbal medicines for controlling menopause symptoms, and extend to other related mechanisms, such as cardiovascular indicators.
The present study highlights that controlled and defined extracts of medicinal herbs have measurable effectiveness, with favorable safety profiles in ageing women. The findings also suggests that herbal medicines may be present an alternatives to standard hormone replacement strategies in non-responders.
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