Introduction

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 [1], 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.

Study Design

The study, published by Rattanatantikul and colleagues (2020) [2] 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.

Outcomes  

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 [3].

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 [4], Cimicifuga racemosa [5] and Oenothera biennis [6]. Additionally, Glycine max has been reported to reduce menopause symptoms by a similar degree (44%), as well as improving LDL-cholesterol [7]. 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.

Conclusion

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.

References

1. Johnson, A., L. Roberts, and G. Elkins, Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med., 2019. 24:2515690X19829380.(doi): p. 10.1177/2515690X19829380.
2. Rattanatantikul, T., et al., Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Diet Suppl, 2022. 19(2): p. 168-183. doi: 10.1080/19390211.2020.1853648. Epub 2020 Dec 17.
3. El Khoudary, S.R., Age at menopause onset and risk of cardiovascular disease around the world. Maturitas., 2020. 141:33-38.(doi): p. 10.1016/j.maturitas.2020.06.007. Epub 2020 Jun 20.
4. Taku, K., et al., Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause., 2012. 19(7): p. 776-90. doi: 10.1097/gme.0b013e3182410159.
5. Bai, W., et al., Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone. Maturitas., 2007. 58(1): p. 31-41. doi: 10.1016/j.maturitas.2007.04.009. Epub 2007 Jun 22.
6. Sharif, S.N. and F. Darsareh, Impact of evening primrose oil consumption on psychological symptoms of postmenopausal women: a randomized double-blinded placebo-controlled clinical trial. Menopause., 2020. 27(2): p. 194-198. doi: 10.1097/GME.0000000000001434.
7. Petri Nahas, E., et al., Benefits of soy germ isoflavones in postmenopausal women with contraindication for conventional hormone replacement therapy. Maturitas., 2004. 48(4): p. 372-80. doi: 10.1016/j.maturitas.2003.09.026.

from an Expert Author

George Thouas

BSc, MRepSc, PhD – Biomedical Scientist

George has worked as a medical researcher for 17 years in the university sector, at both Monash University health institutes, and The University of Melbourne. He spent 12 of those years in reproductive health and fertility research, in roles such as Clinical Research Associate, Clinical Embryologist, Post-graduate Demonstrator, Lecturer, and later as a Senior Research Fellow and Lab Manager. His doctoral thesis investigated the effects of mitochondrial damage in the oocyte. He also worked on improving the nutrient and growth requirements for in vitro fertilization and embryo development.

George has authored and coauthored more than 50 publications, including 1 book, 5 book chapters, 30 peer-reviewed journal reports and reviews, 6 patents, international scientific conference proceedings and health practitioner journal articles.

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