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European journal of nutrition
Mar 25, 2025;64 (3): 138.

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
Author Information
  1. Evgeny Pokushalov: Center for New Medical Technologies, Novosibirsk, Russia. E.pokushalov@gmail.com. ORCID
  2. A Ponomarenko: Center for New Medical Technologies, Novosibirsk, Russia.
  3. C Garcia: Scientific Research Laboratory, Triangel Scientific, San Francisco, USA.
  4. L Kasimova: Center for New Medical Technologies, Novosibirsk, Russia.
  5. I Pak: Center for New Medical Technologies, Novosibirsk, Russia.
  6. E Shrainer: Center for New Medical Technologies, Novosibirsk, Russia.
  7. A Romanova: Center for New Medical Technologies, Novosibirsk, Russia.
  8. D Kudlay: Center for New Medical Technologies, Novosibirsk, Russia.
  9. M Johnson: Scientific Research Laboratory, Triangel Scientific, San Francisco, USA.
  10. R Miller: Scientific Research Laboratory, Triangel Scientific, San Francisco, USA.
PMID: 40131516 DOI: 10.1007/s00394-025-03588-y

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

Associated Data

ClinicalTrials.gov | NCT06328348

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MeSH Term

Humans
Female
Isoflavones
Double-Blind Method
Middle Aged
Glycine max
Lignans
Cimicifuga
Menopause
Dietary Supplements
Hot Flashes
Estradiol
Plant Extracts
Postmenopause

Chemicals

Isoflavones
Lignans
Estradiol
Plant Extracts
Journal Article Randomized Controlled Trial

Word Cloud

Created with Highcharts 10.0.0differencep���<���001BlackCohoshSoyIsoflavonesSDGLignansmenopausalrandomizedsymptomsMenopause3%double-blindclinicaltrialplacebostudyRatingScaleMRSsymptomchanges- 54OBJECTIVE:parallel-groupaimedevaluateefficacyalleviatingcomparedMETHODS:Ninety-sixpostmenopausalwomenaged45-60 yearsenrolledParticipantsreceiveeithersupplements90 daysscorescollectedbaselineevery4 weeksmonitorSecondaryoutcomesassessedincludedhormonalvariationsincidenceadverseRESULTS:initialcohort90participantscompletedhighadherenceSignificantimprovementsobservedtreatmentgroupacrossdomains:somaticpsychologicalurogenital-37totalscore- 480%HormonalmodestyetstatisticallysignificantFSH- 67%estradiol126%AdverseeventsminimaltransientrequirecessationsupplementationCONCLUSION:significantlyreducedfavorablesafetyprofilefindingssupportpotentialsupplementcombinationtherapeuticoptionmanagementTRIALREGISTRATION:ClinicalTrialsgovNCT06328348Assessingcombinedeffectssymptoms:placebo-controlled

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