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

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.