Objective <p>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.</p> Methods <p>Ninety-six postmenopausal women aged 45–60&#xa0;years were enrolled. Participants were randomized to receive either the study supplements or a placebo for 90&#xa0;days, with Menopause Rating Scale (MRS) scores collected at baseline and every 4&#xa0;weeks to monitor symptom changes. Secondary outcomes assessed included hormonal variations and the incidence of adverse symptoms.</p> Results <p>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 (−&#xa0;54.3% difference, p &lt; 0.01), psychological (−&#xa0;54.3% difference, p &lt; 0.01), urogenital (-37.3% difference, p &lt; 0.01), and total score (−&#xa0;48.0% difference, p &lt; 0.01). Hormonal changes were modest yet statistically significant for FSH (−&#xa0;6.7% difference, p &lt; 0.01) and estradiol (12.6% difference, p &lt; 0.01). Adverse events were minimal, transient, and did not require cessation of supplementation.</p> Conclusion <p>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.</p> Trial registration <p>ClinicalTrials.gov NCT06328348.</p>

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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,
  • A. Ponomarenko,
  • C. Garcia,
  • L. Kasimova,
  • I. Pak,
  • E. Shrainer,
  • A. Romanova,
  • D. Kudlay,
  • M. Johnson,
  • R. Miller

摘要

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.