Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

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

  • 2025-03-25
  • European journal of nutrition 64(3)
    • Evgeny Pokushalov
    • A Ponomarenko
    • C Garcia
    • L Kasimova
    • I Pak
    • E Shrainer
    • A Romanova
    • D Kudlay
    • M Johnson
    • R Miller

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 90
Population
ninety-six postmenopausal women aged 45-60 years
Methods
randomized, double-blind, parallel-group clinical trial; participants received either study supplements (Black Cohosh, Soy Isoflavones, SDG Lignans) or placebo for 90 days
Blinding
Double-blind
Duration
90 days
Funding
Unclear
  • Rigorous Journal

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.

Research Insights

  • Black Cohosh→Increased Estradiol Level

    Hormonal changes were modest yet statistically significant for estradiol (12.6% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Small
  • Black Cohosh→Reduced Depression Severity

    Significant improvements were observed in the treatment group across all MRS domains: total score (- 48.0% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Black Cohosh→Reduced Follicle-Stimulating Hormone Level

    Hormonal changes were modest yet statistically significant for FSH (- 6.7% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Small
  • Black Cohosh→Reduced Psychological Score

    Significant improvements were observed in the treatment group across all MRS domains: psychological (- 54.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Black Cohosh→Reduced Somatic Symptom Score

    Significant improvements were observed in the treatment group across all MRS domains: somatic (- 54.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Black Cohosh→Reduced Urogenital Symptom Score

    Significant improvements were observed in the treatment group across all MRS domains: urogenital (-37.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Moderate
  • Soy→Increased Estradiol Level

    Hormonal changes were modest yet statistically significant for estradiol (12.6% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Small
  • Soy→Reduced Depression Severity

    Significant improvements were observed in the treatment group across all MRS domains: total score (- 48.0% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Soy→Reduced Follicle-Stimulating Hormone Level

    Hormonal changes were modest yet statistically significant for FSH (- 6.7% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Small
  • Soy→Reduced Psychological Score

    Significant improvements were observed in the treatment group across all MRS domains: psychological (- 54.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Soy→Reduced Somatic Symptom Score

    Significant improvements were observed in the treatment group across all MRS domains: somatic (- 54.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Large
  • Soy→Reduced Urogenital Symptom Score

    Significant improvements were observed in the treatment group across all MRS domains: urogenital (-37.3% difference, p < 0.01)

    Effect
    Beneficial
    Effect size
    Moderate

Adverse Events Reported

  • Black Cohosh→Overall tolerability

    Adverse events were minimal, transient, and did not require cessation of supplementation.

    Finding
    Reported
  • Soy→Overall tolerability

    Adverse events were minimal, transient, and did not require cessation of supplementation.

    Finding
    Reported
Back to top