Hormonal health - Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

A clinical trial, published in the Journal of Dietary Supplements in 2020, describes how supplementation with a multi-herbal formula for 12 weeks may improve the symptoms of menopause.

The nutraceutical is a botanical product comprising of four medicinal herb extracts – soy isoflavones, black cohosh, chaste-berry and evening primrose oil.

In this randomized, double-blind, placebo-controlled clinical trial, researchers in Dhurakij Pundit University evaluated the efficacy of the product in post-menopausal women.

A total of 110 Thai women (45-60 yrs) were recruited, including those who had stopped their menstrual period for at least 12 months and reported menstrual symptoms.

The group was split into two, with the test group given one capsule of the product, and the other given a soybean capsule as a placebo control.

Symptoms were measured using the clinically validated 11-point menopause rating scale (MRS) questionnaire, and blood samples were taken to determine safety and hormone status.

The outcomes showed a significant decrease in hot flushes and sweating (p<0.0001), irritability symptoms (p<0.0003), depressed mood (p<0.0004) and sleep problems (p<0.0005) in the test group, compared to the placebo.

The women reported no significant differences in heart discomfort, joint/muscular discomfort, or physical/mental exhaustion. Vaginal dryness was decreased in severity at 12 weeks, compared to baseline (p=0.05).

Regarding cardiovascular health, women within the test group showed reductions from the start of the trial in their low-density lipoprotein cholesterol (LDL-C) after 6 weeks (p<0.024) and 12 weeks (p<0.0015), as well as a decrease in their blood lipids after 6 weeks and 12 weeks, with no change in total cholesterol.

Additionally, the treatment group showed a marked reduction in their blood levels of high sensitivity C-reactive protein (hsCRP) (p<0.0002), compared to the placebo, which is a globally used marker of inflammation status.

The outcomes suggest that supplementing with the nutraceutical may improve menopause symptoms, cardiovascular health status and general wellbeing in post-menopausal women, in support of previous evidence for the individual herbal ingredients.

Reference: Rattanatantikul et al. Journal of Dietary Supplements 2020, 19(2), 168-183

Full text available at: https://www.tandfonline.com/doi/full/10.1080/19390211.2020.1853648

Financial sponsor of study: Max Biocare Pty Ltd.