Twelve weeks of supplementation with a combination of soy isoflavone, black cohosh, chasteberry and evening primrose oil extracts also led to significant improvements in LDL cholesterol and triglyceride levels in the women, according to findings published in the Journal of Dietary Supplements.
Scientists from Dhurakij Pundit University used the commercial product Belle Dame, sometimes marketed as Estosalus, manufactured by Australian firm Max Biocare. The Australian company funded the new study.
“In the present clinical study, a combination of soy isoflavones, black cohosh, chasteberry, and evening primrose oil extracts supplemented orally for a period of 12 weeks was found to improve menopause symptoms, inflammatory and cardiovascular status in post-menopausal women,” wrote the scientists.
The researchers noted that the individual ingredients themselves are reported to exert benefits for menopause but noted that the combination may act synergistically to improve menopausal symptoms.
“[The combination] contains the proprietary soy isoflavone, which provide estrogen analogs that can mediate the effects of insufficient estrogen for the relief of menopausal symptoms,” they stated, and added: “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.”
The new randomized, double-blinded, placebo-controlled clinical trial include 101 post-menopausal women aged between 45 and 60 randomly assigned to receive either the Belle Dame product (100 mg isoflavones, 520 mg black cohosh, 400 mg chasteberry, and 500 mg evening primrose oil per day) or placebo for 12 weeks.
The data indicated that the herbal combination led to statistically significant reductions in a number of menopause symptom, as measured by physicians using the validated menopause rating scale (MRS) quality of life questionnaire.
Specifically, the number of women in the test product group with severe hot flashes and sweating at the start of the study was 23, compared to 24 in the placebo group. After 12 weeks, the number of women in the test product group with severe hot flashes had fallen to only 3 (the other 20 had transitioned to non-severe symptoms), while the number in the placebo group stayed high at 22 at the end of the study.
Sever sleep problems also improved in the Belle Dame group, with the number of women with severe sleep problems declining from 22 at the start of the study to six after 12 weeks, compared with 23 at Day 0 in the placebo group and 19 at the end of the study.
On the other hand, no significant changes between the groups were observed for hormonal levels.
LDL cholesterol levels also decreased significantly in the test product group, dropping an average of 21.4 mg/dL over 12 weeks, compared to an average decline of only 0.4 mg/dL in the placebo group. Similarly, triglyceride levels fell by about 12 mg/dL in the test group over the course of the study, compared to less than 2 mg/dL in the placebo group.
“These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women,” concluded the researchers.
Source: Journal of Dietary Supplements
2022, Volume 19, Issue 2, Pages 168-183, doi: 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: T. Rattanatantikul, et al.