Black cohosh

Identification

Summary

Black cohosh is a herbal product indicated in the symptomatic treatment of menopause.

Generic Name

Black cohosh

DrugBank Accession Number

DB13975

Background

Black cohosh (Actaea racemosa or Cimicifuga racemosa), a member of the buttercup family, is a perennial plant which native to North America. Historical names for this plant include snakeroot, black bugbane, rattleweed, macrotys, and rheumatism weed. Black cohosh has a long history of use. Native Americans used it for its purported benefits in treating musculoskeletal pain, fever, cough, pneumonia, sluggish labor, and menstrual irregularities. European settlers were said to use black cohosh as a tonic to support female reproductive health.¹⁰

Hormone replacement therapy (HRT) is the standard treatment for early symptoms in post-menopausal women, however, increases the risk of stroke, heart diseases, as well as breast cancer in older women. Various studies have shown that the number of post-menopausal women using hormone replacement therapy is currently low and that the effects of hormone replacement therapy in reducing menopausal symptoms are not as positive as expected. For these reasons, there has been a trend toward using alternative therapies to relieve menopausal symptoms.⁸

Black cohosh has been associated with serious safety concerns.¹ Results from studies suggest that C. racemosa possesses a central activity instead of a hormonal effect.²

The American College of Obstetrics and Gynecology guidelines on the use of botanicals, such as black cohosh, for the management of menopausal symptoms the use of for up to six months, especially in treating the symptoms of sleep and mood disturbance, and hot flushes.¹²

Type

Biotech

Groups

Experimental

Synonyms

• Black cohosh
• Black snakeroot
• Cimicifuga racemosa
• Cimicifuga racemosa rhizome
• Cimicifuga racemosa root
• Cimicifuga racemosa root with rhizome
• Cimicifugae rhizoma
• Fairy candle root
• Rattleroot

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Pharmacology

Indication

Treatment of menopausal symptoms and menstrual dysfunction ¹².

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Treatment of	Menopausal symptoms		••• •••••• ••• •••			•••••••• ••••••
Symptomatic treatment of	Menopause symptoms		••• •••	••••••••••		••••••• •••• ••••••

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Contraindications & Blackbox Warnings

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Pharmacodynamics

This agent is purported to relieve some of the vasomotor symptoms of menopause, including hot flashes and night sweats.^8,10,11

A 2012 Cochrane review analyzed 16 randomized clinical trials on the effectiveness of black cohosh in reducing menopausal symptoms, including hot flushes, night sweats, vaginal dryness, and numerous combinations of symptoms which were measured by validated rating scales.⁸ There is currently insufficient evidence to support the use of black cohosh for menopausal symptoms.⁸ The studies were quite heterogeneous in design, duration, type and amount of black cohosh used, and main findings.⁸

A 2016 systematic review and meta-analysis of randomized clinical trials analyzed four studies of herbal and plant-based therapies that included black cohosh to treat menopausal symptoms.⁵ It was suggested that composite and specific phytoestrogen supplementations were associated with small reductions in the incidence of hot flashes and vaginal dryness, however, no significant reduction in night sweats.⁵

Mechanism of action

Although the mechanism by which black cohosh relieves menopausal symptoms is unknown, several hypotheses have been made. It is believed to act through the following mechanisms/effects:⁹

1) as a selective estrogen receptor modulator 2) through serotonergic pathways 3) as an antioxidant 4) on inflammatory pathways

The primary active component of the black cohosh root is believed to be the terpene glycoside fraction, including actein and cimifugoside.⁹ The triterpenes are one of the most ubiquitous and diverse groups of plant natural products.¹³ They are classified as complex molecules that are beyond the reach of chemical synthesis in the laboratory. Simple triterpenes are constituents of surface waxes and specialized plant membranes and may possibly serve as signaling molecules. More complex glycosylated triterpenes (also known as saponins) provide protection against pathogens and pests.¹³ The rhizome (stem portion of the plant) also contains other potentially biologically active substances, including alkaloids, flavonoids, and tannins. The therapeutic activity of black cohosh was initially believed to be the activation of estrogen receptors; however, more recent studies show that although some components of the extract bind to at least one subtype of estrogen receptor, the receptor binding produces very little (if any) estrogenic effect, and may selectively block some of the effects.⁹

An early study reported that treatment with black cohosh leads to a decrease in luteinizing hormone (LH) levels consistent with its purported estrogenic effect. Despite this, more recent studies have shown no effect on levels of LH, follicle-stimulating hormone (FSH), or prolactin. To this day it is unclear whether black cohosh exerts its effect via estrogen receptors or through another mechanism.¹²

One study observed that while the most prominent triterpene in black cohosh, known as 23-epi-26-deoxyactein, inhibits cytokine-induced nitric oxide production in brain microglial cells, the complete black cohosh extract demonstrated to enhance this pathway.⁹ A variety of activities have been reported for black cohosh and its compounds, however, the absorption and tissue distribution of these compounds is not known.⁹

Cimicifuga racemosa (black cohosh) is used most often to treat symptoms occurring during menopause. However, in recent years, several concerns regarding its safety have been voiced.¹

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Not Available

Half-life

Approximately 2h.⁷

Clearance

Not Available

Adverse Effects

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Toxicity

The oral LD50 for rats is 17,000 to 27,211 mg/kg.^MSDS

Clinical trials using a variety of black cohosh formulas to manage menopausal symptoms have shown that its use is associated with a low incidence of adverse effects. The most commonly reported side effects are gastrointestinal discomfort and rashes, both of which have shown to be mild and transient. Some other adverse effects in clinical trials have included breast pain or enlargement, infection, vaginal bleeding or spotting, and musculoskeletal discomfort. The incidence of these symptoms, however, was similar in women taking black cohosh and those taking a placebo.¹⁰

Reports have been made globally of at least 83 cases of liver damage—including hepatitis, liver failure, elevated liver enzymes, and various other liver injuries—associated with black cohosh use. However, no evidence of a causal relationship exists. It is possible that a subset of reported cases of hepatotoxicity were due to impurities, adulterants, or incorrect Acteae species in the black cohosh products used. However, no independent analysis of these drugs has been done to confirm the existence of these problems.¹⁰

The American Herbal Products Association recommends that pregnant women not ingest black cohosh, except under the supervision of their healthcare provider because studies have not thoroughly evaluated its use during pregnancy. The U.S. Pharmacopeia advises that individuals with liver disorders should also avoid the use of black cohosh. In addition, users who develop symptoms of liver disease, such as abdominal pain, dark urine, or jaundice, while taking the supplement should discontinue use and contact their healthcare provider.¹⁰

As with other drugs believed to have potential estrogenic effects, there has been concern about the safety of black cohosh in women with a personal history or family history of breast cancer. Though further research is warranted, at least one tissue-culture study showed no stimulation of estrogen receptor-positive breast cancer cell lines by black cohosh extract.⁶ This study found that black cohosh extract amplified the inhibitory action of tamoxifen (Nolvadex) on breast cancer cell lines. Because this question has not yet been fully answered, physicians should discuss this issue with their patients who are at risk of breast cancer while considering taking black cohosh.¹²

Black cohosh is contraindicated during pregnancy due to its potential ability to promote uterine contraction. The safety of black cohosh in breastfeeding mothers and the level of transmission of black cohosh in breast milk are both unknown.¹²

Pathways

Not Available

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Not Available

Interactions

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This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
Integrate drug-drug interactions in your software
Acebutolol	The metabolism of Acebutolol can be decreased when combined with Black cohosh.
Acenocoumarol	The serum concentration of Acenocoumarol can be increased when it is combined with Black cohosh.
Acetaminophen	The metabolism of Acetaminophen can be decreased when combined with Black cohosh.
Alfuzosin	The metabolism of Alfuzosin can be decreased when combined with Black cohosh.
Almotriptan	The metabolism of Almotriptan can be decreased when combined with Black cohosh.

Food Interactions

Not Available

Products

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Over the Counter Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Black Cohosh Root Powder	Capsule	100 mg	Oral	Swiss Herbal Remedies Ltd.	1998-10-23	2006-07-25
Black Cohosh Tablet	Tablet	40 mg	Oral	Purity Life Health Products A Division Of Sunopta Inc.	2002-06-01	2006-08-28
Ethical Herbals Menstrual/menopause Symptom Relief	Tablet	75 mg / tab	Oral	Ashbury Research Corporation	Not applicable	Not applicable
Women's Formula	Capsule	75.00 mg	Oral	Natures Sunshine Products, Inc.	1999-12-15	2009-08-07

Categories

ATC Codes

G02CX04 — Cimicifugae rhizoma

• G02CX — Other gynecologicals
• G02C — OTHER GYNECOLOGICALS
• G02 — OTHER GYNECOLOGICALS
• G — GENITO URINARY SYSTEM AND SEX HORMONES

Drug Categories

• Angiosperms
• Biological Products
• Complex Mixtures
• Cytochrome P-450 CYP1A2 Inhibitors
• Cytochrome P-450 CYP1A2 Inhibitors (strength unknown)
• Cytochrome P-450 CYP2C9 Inhibitors
• Cytochrome P-450 CYP2C9 Inhibitors (strength unknown)
• Cytochrome P-450 CYP2D6 Inhibitors
• Cytochrome P-450 CYP2D6 Inhibitors (strength unknown)
• Cytochrome P-450 CYP3A Inhibitors
• Cytochrome P-450 CYP3A4 Inhibitors
• Cytochrome P-450 CYP3A4 Inhibitors (strength unknown)
• Cytochrome P-450 Enzyme Inhibitors
• Embryophyta
• Eukaryota
• Genito Urinary System and Sex Hormones
• Herbs and Natural Products
• Pharmaceutical Preparations
• Plant Preparations
• Ranunculaceae
• Ranunculales
• Streptophyta
• Tracheophyta
• Viridiplantae

Classification

Not classified

Affected organisms

• Humans and other mammals

Chemical Identifiers

UNII

K73E24S6X9

CAS number

Not Available

References

General References

1. Borrelli F, Ernst E: Black cohosh (Cimicifuga racemosa): a systematic review of adverse events. Am J Obstet Gynecol. 2008 Nov;199(5):455-66. doi: 10.1016/j.ajog.2008.05.007. [Article]
2. Borrelli F, Izzo AA, Ernst E: Pharmacological effects of Cimicifuga racemosa. Life Sci. 2003 Jul 25;73(10):1215-29. [Article]
3. Mohammad-Alizadeh-Charandabi S, Shahnazi M, Nahaee J, Bayatipayan S: Efficacy of black cohosh (Cimicifuga racemosa L.) in treating early symptoms of menopause: a randomized clinical trial. Chin Med. 2013 Nov 1;8(1):20. doi: 10.1186/1749-8546-8-20. [Article]
4. Fritz H, Seely D, McGowan J, Skidmore B, Fernandes R, Kennedy DA, Cooley K, Wong R, Sagar S, Balneaves LG, Fergusson D: Black cohosh and breast cancer: a systematic review. Integr Cancer Ther. 2014 Jan;13(1):12-29. doi: 10.1177/1534735413477191. Epub 2013 Feb 25. [Article]
5. Franco OH, Chowdhury R, Troup J, Voortman T, Kunutsor S, Kavousi M, Oliver-Williams C, Muka T: Use of Plant-Based Therapies and Menopausal Symptoms: A Systematic Review and Meta-analysis. JAMA. 2016 Jun 21;315(23):2554-63. doi: 10.1001/jama.2016.8012. [Article]
6. McKenna DJ, Jones K, Humphrey S, Hughes K: Black cohosh: efficacy, safety, and use in clinical and preclinical applications. Altern Ther Health Med. 2001 May-Jun;7(3):93-100. [Article]
7. van Breemen RB, Liang W, Banuvar S, Shulman LP, Pang Y, Tao Y, Nikolic D, Krock KM, Fabricant DS, Chen SN, Hedayat S, Bolton JL, Pauli GF, Piersen CE, Krause EC, Geller SE, Farnsworth NR: Pharmacokinetics of 23-epi-26-deoxyactein in women after oral administration of a standardized extract of black cohosh. Clin Pharmacol Ther. 2010 Feb;87(2):219-25. doi: 10.1038/clpt.2009.251. Epub 2009 Dec 23. [Article]
8. Efficacy of black cohosh (Cimicifuga racemosa L.) in treating early symptoms of menopause: a randomized clinical trial [Link]
9. Black Cohosh: Insights into its Mechanism(s) of Action [Link]
10. Black Cohosh [Link]
11. Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo [Link]
12. Black Cohosh [Link]
13. Triterpene Biosynthesis in Plants [Link]
14. Isolation of CYP3A4 Inhibitors from the Black Cohosh (Cimicifuga racemosa) [Link]
15. Cytochrome P450 enzyme mediated herbal drug interactions (Part 2) [Link]
16. BASG: Mensifem (Black Cohosh) Oral Tablet [Link]

External Links

RxNav

236665

Wikipedia

Actaea_racemosa

MSDS

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Clinical Trials

Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Unknown Status	Treatment	Sexuality	1
4	Unknown Status	Treatment	Vasomotor Symptoms Associated With Menopause	1
3	Completed	Treatment	Menopause	1
3	Unknown Status	Treatment	Hot Flashes	1
3	Unknown Status	Treatment	Menopause / Quality of Life (QOL)	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Capsule	Oral	100 mg
Tablet	Oral	40 mg
Capsule	Oral	12.3 mg
Tablet	Oral
Tablet, film coated	Oral	2.8 mg
Tablet	Oral	75 mg / tab
Capsule	Oral	75.00 mg

Prices

Not Available

Patents

Not Available

Properties

State

Liquid

Experimental Properties

Property	Value	Source
boiling point (°C)	290	MSDS

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Drug created at January 17, 2018 23:01 / Updated at February 20, 2024 23:55