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Randomized Controlled Trial
. 2025 Mar 25;64(3):138.
doi: 10.1007/s00394-025-03588-y.

Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial

Evgeny Pokushalov  1   2 , A Ponomarenko  3 , C Garcia  4 , L Kasimova  3 , I Pak  3 , E Shrainer  3 , A Romanova  3 , D Kudlay  3 , M Johnson  4 , R Miller  4
Affiliations
Randomized Controlled Trial

Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial

Evgeny Pokushalov et al. Eur J Nutr. .

Abstract

Objective: This randomized, double-blind, parallel-group clinical trial aimed to evaluate the efficacy of Black Cohosh, Soy Isoflavones, and SDG Lignans in alleviating menopausal symptoms compared to a placebo.

Methods: Ninety-six postmenopausal women aged 45-60 years were enrolled. Participants were randomized to receive either the study supplements or a placebo for 90 days, with Menopause Rating Scale (MRS) scores collected at baseline and every 4 weeks to monitor symptom changes. Secondary outcomes assessed included hormonal variations and the incidence of adverse symptoms.

Results: Of the initial cohort, 90 participants completed the study with high adherence. Significant improvements were observed in the treatment group across all MRS domains: somatic (- 54.3% difference, p < 0.01), psychological (- 54.3% difference, p < 0.01), urogenital (-37.3% difference, p < 0.01), and total score (- 48.0% difference, p < 0.01). Hormonal changes were modest yet statistically significant for FSH (- 6.7% difference, p < 0.01) and estradiol (12.6% difference, p < 0.01). Adverse events were minimal, transient, and did not require cessation of supplementation.

Conclusion: Black Cohosh, Soy Isoflavones, and SDG Lignans significantly reduced menopausal symptoms with a favorable safety profile. These findings support the potential of this supplement combination as a therapeutic option for menopausal symptom management.

Trial registration: ClinicalTrials.gov NCT06328348.

Keywords: Black Cohosh; Menopause; Menopause Rating Scale; SDG Lignans; Soy Isoflavones.

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Conflict of interest statement

Declarations. Conflict of interest: Authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Institutional review board statement: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Center for New Medical Technologies Ethics Committee (approval number 0162CS_2023, 1 Aug 2023). Informed consent statement: Informed consent was obtained from all subjects involved in the study.

References

    1. Gold EB (2011) The timing of the age at which natural menopause occurs. Obstetr Gynecol Clin 38:425–440 - DOI
    1. Kumari M, Stafford M, Marmot M (2005) The menopausal transition was associated in a prospective study with decreased health functioning in women who report menopausal symptoms. J Clin Epidemiol 58:719–727 - DOI - PubMed
    1. Thurston RC, Joffe H (2011) Vasomotor symptoms and menopause: findings from the study of women’s health across the nation. Obstetr Gynecol Clin 38:489–501 - DOI
    1. Panay N (2007) Menopause and the postmenopausal women. In: Edmonds DK (ed) Dewhurst’s Textbook of Obstetrics and Gynaecology, 7th edn. Blackwell Publishing, Oxford, pp 479–492
    1. Bansal R, Aggarwal N (2019) Menopausal hot flashes: a concise review. J Mid Life Health 10:6–13 - DOI

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