NICEVIVA
MONOGRAPH SPEC LATEST 2026

Black Cohosh (Menopause)

WOMEN HEALTH · Evidence Monograph

Black Cohosh (Menopause) is an evidence-graded women health monograph evaluated across 27 peer-reviewed PubMed studies (3 meta-analyses, 4 systematic reviews, and 5 randomized controlled trials, encompassing n = 55,068 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 27 Studies
Meta-Analyses · Reviews 3 Meta · 4 Systematic Reviews
Randomized Trials (RCT) 5 RCTs (6 Double-Blind)
Cumulative Participants n = 55,068
Reported Trial Dosages 40 mg/day · 40 mg · 2.5mg/day
Trial Duration Range 90 days · 4 weeks · 12 weeks
Reading Time ~14 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 27 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (40 mg/day · 40 mg · 2.5mg/day) over a structured 90 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
With Breakfast or Lunch
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
antioxidant (PubMed clinical endpoint)
skin (PubMed clinical endpoint)
01

What Is Black Cohosh (Menopause) & Why Does Form Matter?

Black Cohosh (Menopause) is classified under WOMEN HEALTH and has been investigated across 27 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (40 mg/day, 40 mg, 2.5mg/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Black Cohosh (Menopause) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (5 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Black Cohosh (Menopause) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Black Cohosh (Menopause) an overall evidence rating of GRADE High (4.0 / 4.0) based on 27 PubMed studies: 3 meta-analyses, 4 systematic reviews, and 5 randomized controlled trials (6 double-blind, n = 55,068 total participants).

Representative peer-reviewed findings include: • PMID:40131516 (2025) — "Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial." (CONCLUSION: Black Cohosh, Soy Isoflavones, and SDG Lignans significantly reduced menopausal symptoms with a favorable safety profile.) • PMID:34260808 (2022) — "Effects of a combination of botanical actives on skin health and antioxidant status in post-menopausal women: A randomized, double-blind, placebo-controlled clinical trial." (CONCLUSION: These data indicate the supplementation with the formulated blend of four herbal extracts is supportive of skin health and antioxidant status in women of menopausal age.) • PMID:33331798 (2022) — "Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial." (CONCLUSION: These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 40 mg/day · 40 mg · 2.5mg/day over 90 days · 4 weeks · 12 weeks · 6 weeks. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Black Cohosh (Menopause), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (40 mg/day · 40 mg · 2.5mg/day) and re-evaluate efficacy after 90 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (27 Studies) · 10 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) European journal of nutrition (2025) PMID: 40131516 ↗
Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in European journal of nutrition involving n = 90 participants; statistical significance reported at p = 0.01. Key conclusion: CONCLUSION: Black Cohosh, Soy Isoflavones, and SDG Lignans significantly reduced menopausal symptoms with a favorable safety profile.
View Original PubMed 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. © 2025. Springer-Verlag GmbH Germany, part of Springer Nature.

02
RANDOMIZED TRIAL (RCT) Journal of cosmetic dermatology (2022) PMID: 34260808 ↗
Effects of a combination of botanical actives on skin health and antioxidant status in post-menopausal women: A randomized, double-blind, placebo-controlled clinical trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Journal of cosmetic dermatology involving n = 110 participants. Key conclusion: CONCLUSION: These data indicate the supplementation with the formulated blend of four herbal extracts is supportive of skin health and antioxidant status in women of menopausal age.
View Original PubMed Abstract ↓

BACKGROUND: Skin aging is one of the most concerning issues during the post-menopausal period. Despite the promising effects of hormonal therapy, there is still concerned about the long-term outcomes from the treatment. Therefore, nutraceuticals that contain estrogenic and antioxidative effects have gained a lot of attention as an alternative therapy for slowing down skin age-related changes in women after menopause. OBJECTIVE: This study was aimed at evaluating the effects of a combination of nutraceuticals on skin health and antioxidant status in women after menopause. METHODS: Post-menopausal women aged 45-60 years old were enrolled and randomly allocated (n = 110) equally to either treatment or placebo group (n = 55 per group). The test product, a nutraceutical containing a blend of Glycine max, Cimicifuga racemosa, Vitex agnus-castus, and Oenothera biennis extracts, was administered over a 12-week period, with dermatological parameters evaluated at baseline, week 6, and week 12 of the study. Additionally, glutathione (GSH) and malondialdehyde (MDA) levels were detected at baseline and week 12 to evaluate the antioxidant status. RESULTS: At week 6, skin roughness was significantly improved in the treatment group (n = 50 completed), while at week 12, a significant improvement and large effect sizes observed in skin elasticity (Cohen's d = 1.56, [SDpooled = 0.10]), roughness (d = 1.53, [0.67]), smoothness (d = -1.33, [34.65]), scaliness (d = -0.80 [0.095]), and wrinkles (d = -1.02 [13.68]) compared to placebo (n = 51 completed). Moreover, GSH was significantly increased (d = 1.54 [32.52]) whereas MDA was significantly decreased (d = -1.66, [0.66]) in the test group, compared to placebo. Blood biochemistry, along with vital signs, did not differ between groups, and no subjects reported any adverse throughout the trial. CONCLUSION: These data indicate the supplementation with the formulated blend of four herbal extracts is supportive of skin health and antioxidant status in women of menopausal age. © 2021 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

03
RANDOMIZED TRIAL (RCT) Journal of dietary supplements (2022) PMID: 33331798 ↗
Efficacy and Safety of Nutraceutical on Menopausal Symptoms in Post-Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Journal of dietary supplements involving n = 50 participants; statistical significance reported at p = 0.0001. Key conclusion: CONCLUSION: These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.
View Original PubMed Abstract ↓

BACKGROUND: Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women. METHODS: The study was designed as a randomized, double-blinded, placebo-controlled clinical trial. Post-menopausal women aged 45-60 years old were enrolled and randomly assigned to either treatment (n = 50) or placebo group (n = 51). The intervention, a proprietary combination of soy isoflavone, black cohosh, chasteberry and evening primrose oil extracts, and the placebo, were administered to each group for total of 12 weeks. Menopausal symptoms, endocrine profiles, and blood chemistry were evaluated at baseline, 6 weeks, and 12 weeks of the study. RESULTS: Nutraceutical supplementation demonstrated a statistically significant reduction in hot flushes and sweating (p < 0.0001), sleep problems (p < 0.0005), depressed mood (p = 0.0004) and irritability symptoms (p < 0.0003) compared with the placebo group. There were no significant differences in hormonal levels between the test and placebo groups, however levels of C-reactive protein were significantly decreased. Moreover, serum LDL-C and triglyceride levels were significantly lower than baseline levels in the treatment group at 6- and 12-week timepoints. No adverse effects were reported during the treatment. CONCLUSION: These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.

04
CLINICAL STUDY The Journal of emergency medicine (2024) PMID: 38556373 ↗
Black Cohosh Interactions with Prescription Medications Associated with Serotonin Toxicity and Rhabdomyolysis: A Case Report.
Clinical Trial Synthesis 2024 Clinical Study published in The Journal of emergency medicine. Key conclusion: Female patients taking black cohosh to manage hot flashes and menopausal symptoms could be at risk for developing rhabdomyolysis and serotonin toxicity if they are also taking other serotonergic agents.
View Original PubMed Abstract ↓

BACKGROUND: Serotonin toxicity is a well-described phenomenon that is commonly attributed to a variety of drug-drug combinations. Some unregulated herbal supplements have been implicated in the onset of serotonin toxicity, however, there is currently minimal literature available on the potential for black cohosh to contribute to rhabdomyolysis and serotonin toxicity, in spite of its known serotonergic properties. CASE REPORT: A middle-aged woman presented to the emergency department with serotonin toxicity and rhabdomyolysis shortly after taking black cohosh supplements in the setting of long-term dual antidepressant use. The serotonin toxicity and rhabdomyolysis resolved with IV fluids, benzodiazepines, and discontinuation of the offending drugs. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Patients are sometimes not aware of how over-the-counter supplements might interact with their prescription medications. Female patients taking black cohosh to manage hot flashes and menopausal symptoms could be at risk for developing rhabdomyolysis and serotonin toxicity if they are also taking other serotonergic agents.

05
CLINICAL STUDY Journal of the American Pharmacists Association (2010) PMID: 20833608 ↗
Evaluating the evidence for over-the-counter alternatives for relief of hot flashes in menopausal women.
Clinical Trial Synthesis 2010 Clinical Study published in Journal of the American Pharmacists Association. Key conclusion: CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management.
View Original PubMed Abstract ↓

OBJECTIVE: To review the literature on alternative over-the-counter (OTC) therapies for the treatment of hot flashes in menopausal women. DATA SOURCES: A literature search was conducted using PubMed, International Pharmaceutical Abstracts, and Medline from inception to June 2010, combining the term hot flash individually with black cohosh, isoflavones, red clover, soy, vitamin E, ginseng, dong quai, evening primrose oil, wild yam, kava, and melatonin. All publication types including human participants and published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. STUDY SELECTION AND DATA EXTRACTION: Clinical trials comparing the above single-ingredient agents with placebo or active treatment were selected. In addition, only studies assessing the effects of these single-ingredient agents on vasomotor symptoms in menopausal women were included. DATA SYNTHESIS: Since the Women's Health Initiative and Heart and Estrogen/Progestin Replacement Study II, women have sought lifestyle changes and other drug therapies as alternatives to menopausal hormone therapy to relieve hot flashes associated with menopause. The currently available literature is conflicting in regard to efficacy and does not support the use of alternative OTC therapies for hot flash management associated with menopause. In addition, long-term safety data are lacking for any of these therapies. CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management. Based on the current literature, alternative OTC therapies do not have consistent, beneficial data to support their use in hot flash management.

06
CLINICAL STUDY Canadian journal of physiology and pharmacology (2007) PMID: 18066117 ↗
Synergistic cytotoxic effects of tamoxifen and black cohosh on MCF-7 and MDA-MB-231 human breast cancer cells: an in vitro study.
Clinical Trial Synthesis 2007 Clinical Study published in Canadian journal of physiology and pharmacology; statistical significance reported at p = 0.01. Key conclusion: However, black cohosh inhibited MDA-MB-231 cell proliferation at 10(3) microg/mL (p < 0.05), and this inhibitory effect was enhanced by increasing tamoxifen concentrations.
View Original PubMed Abstract ↓

Breast cancer cell cultures were exposed to different concentrations of black cohosh, estradiol (E2), and tamoxifen to examine the effect on cell proliferation; cytotoxicity was assessed by using sulforhodamine B (SRB) dye solution. E2 (10(-10) - 10(-8) mol/L) markedly stimulated the proliferation of MCF-7 cells (p < 0.01). Tamoxifen stimulated MCF-7 cell proliferation at 10(-6) mol/L and 10(-5) mol/L (p < 0.005) but inhibited in a dose-dependent fashion the proliferative effect of E2 (p < 0.001). Black cohosh alone did not show any stimulatory effect, but exhibited a cytotoxic effect, which was significant at 10(3) microg/mL (p < 0.001). Adding black cohosh at 10(0)-10(3) microg/mL to E2 at 10(-9) mol/L also resulted in a dose-dependent inhibition of E2 proliferative effect. Interestingly, the combination of black cohosh (10(0)-10(3) microg/mL) with increasing tamoxifen concentrations further inhibited MCF-7 cell growth. On MDA-MB-231 cells, neither E2 nor tamoxifen displayed any detectable effect. However, black cohosh inhibited MDA-MB-231 cell proliferation at 10(3) microg/mL (p < 0.05), and this inhibitory effect was enhanced by increasing tamoxifen concentrations. This study reveals a cytotoxic effect of black cohosh on both estrogen-sensitive and estrogen-insensitive breast cancer cells and a synergism with tamoxifen for inhibition of cancerous cell growth.

07
CLINICAL STUDY Forschende Komplementarmedizin (2006) (2007) PMID: 17464162 ↗
Is black cohosh a hepatotoxic medicinal herb?
Clinical Trial Synthesis 2007 Clinical Study published in Forschende Komplementarmedizin (2006). Key conclusion: DOI: 10.1159/000101352 PMID: 17464162 [Indexed for MEDLINE]
View Original PubMed Abstract ↓

114. Forsch Komplementmed. 2007 Apr;14(2):109-10. doi: 10.1159/000101352. Epub 2007 Apr 23. Is black cohosh a hepatotoxic medicinal herb? Gori L(1), Firenzuoli F. Author information: (1)Center of Natural Medicine, S. Giuseppe Hospital, Empoli, Italy. DOI: 10.1159/000101352 PMID: 17464162 [Indexed for MEDLINE]

08
CLINICAL STUDY Clinical journal of oncology nursing (2005) PMID: 16235591 ↗
Complementary and alternative medicine patients are talking about: black cohosh.
Clinical Trial Synthesis 2005 Clinical Study published in Clinical journal of oncology nursing. Key conclusion: [email protected] DOI: 10.1188/05.CJON.628-629 PMID: 16235591 [Indexed for MEDLINE]
View Original PubMed Abstract ↓

115. Clin J Oncol Nurs. 2005 Oct;9(5):628-9. doi: 10.1188/05.CJON.628-629. Complementary and alternative medicine patients are talking about: black cohosh. Lee CO(1). Author information: (1)Office of Cancer Complementary and Alternative Medicine at the National Cancer Institute in Bethesda, MD, USA. [email protected] DOI: 10.1188/05.CJON.628-629 PMID: 16235591 [Indexed for MEDLINE]

09
CLINICAL STUDY The journal of the British Menopause Society (2004) PMID: 15667753 ↗
Drug-herb interactions with herbal medicines for menopause.
Clinical Trial Synthesis 2004 Clinical Study published in The journal of the British Menopause Society. Key conclusion: For others, there are many and significant drug-herb interactions.
View Original PubMed Abstract ↓

Herbal medicine is one of most popular choices of complementary therapies for women, particularly as an alternative treatment for menopausal symptoms. The most commonly used herbal medicines for the menopause is probably black cohosh (Actaea/Cimcifuga racemosa); other preparations used include red clover (Trifolium pratense), dong quai (Angelica sinesis) and evening primrose (Oenothera biennis). Some of these herbal medicines have a very good safety profile with little or no suggestion of interaction with conventional drugs. For others, there are many and significant drug-herb interactions. This article outlines the major known and theoretical drug-herb interactions of herbal medicines thought to be of benefit for menopausal symptoms, as well as discussing the implications for the medical profession.

10
CLINICAL STUDY Expert opinion on drug safety (2004) PMID: 15500420 ↗
The safety of black cohosh (Actaea racemosa, Cimicifuga racemosa).
Clinical Trial Synthesis 2004 Clinical Study published in Expert opinion on drug safety. Key conclusion: More research is needed to evaluate the safety of this herb over longer periods of time, and also to further investigate its mechanism of action.
View Original PubMed Abstract ↓

Black cohosh (Actaea racemosa/Cimicifuga racemosa) is a North American perennial plant that has been used for traditional medicinal purposes by the native Indian population. Its modern day application is the treatment of menopausal symptoms. Unlike conventional non-herbal medications, herbal preparations have not been systematically evaluated for their safety. However, the evidence from in vitro, animal and clinical studies all suggest that black cohosh is a safe herbal therapy for menopausal women if taken for a limited period. More research is needed to evaluate the safety of this herb over longer periods of time, and also to further investigate its mechanism of action.

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