Monograph: Black Cohosh

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion.Claims for traditional use must include the term "Herbal Medicine".

Date: 2018-08-28

NHPID name

Actaea racemosa ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Actaea racemosa ( Unavailable )

Common name(s)

Black bugbane ( Unavailable )
Black cohosh ( Unavailable )
Black snakeroot ( Unavailable )

Source material

Route Of administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or purpose(s)

Statement(s) to the effect of:

(Traditionally) used in Herbal Medicine to help relieve the pain associated with menstruation. (Hoffmann 2003, Blumenthal et al. 2000, Bradley 1992, Williamson et al. 1988, Ellingwood 1983[1919], Felter and Lloyd 1983[1898])
Used in Herbal Medicine to help relieve the pain associated with menstruation as well as premenstrual symptoms.
(Traditionally) used in Herbal Medicine to help relieve muscle and joint pain associated with rheumatic conditions (such as rheumatoid arthritis, osteoarthritis and/or fibrositis), and of pain associated with neuralgia (such as sciatica). (Hoffmann 2003, BHP 1983, Ellingwood 1983[1919], Felter and Lloyd 1983[1898])
(Traditionally) used in Herbal Medicine to help ease nervous tension (calmative). (Hoffmann 2003, Williamson 2003, BHP 1983, Ellingwood 1983[1919], Felter and Lloyd 1983[1898])
Used in Herbal Medicine to help relieve premenstrual symptoms. (Blumenthal et al. 2000, Bradley 1992)
(Used in Herbal Medicine to) help(s) relieve symptoms associated with menopause. (Raus et al. 2006, Wuttke et al. 2006, Frei-Kleiner et al. 2005, Blumenthal et al. 2000, Bradley 1992)

Dose(s)

Adults:

Preparation:

Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s):

40 - 2400 Milligrams per day, dried root and rhizome

(Raus et al. 2006, Wuttke et al. 2006, Frei-Kleiner et al. 2005, Hoffmann 2003, Blumenthal et al. 2000, Bradley 1992, Williamson et al. 1988, Ellingwood 1983[1919])

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s):

Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen. (Mills et al. 2006)
Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are breastfeeding, have a liver disorder or develop symptoms of liver trouble. (EMEA 2007, Lynch et al. 2006, Cohen et al. 2004, NIH 2004)

Contraindication(s): Do not use this product if you are pregnant. (Brinker 2010, Hoffmann 2003, Tilgner 1999) Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).
Health Canada is aware of peer-reviewed published cases where products labelled as containing Black Cohosh were found by laboratory analysis to contain different species. In order to prevent misidentification, the identification of authentic Black Cohosh must be completed by an unambiguous validated method such as the HPLC-ELSD, HPLC-MS or HPLC-MS/MS to determine the presence of a specific marker compound and/or the absence of others. For example, Actaea racemosa contains the triterpene glycoside cimiracemoside C (also called cimigenol-3-O-arabinoside), while most other Actaea/Cimicifuga species do not. Conversely, other Actaea/Cimicifuga species contain the phenolic acid derivatives cimifugin and (or) cimifigin-3-O-glucoside (e.g. A. cimicifuga and A. yunnanensis, but not A. dahurica) while Black Cohosh does not. The commonly used markers, 23-epi-26-deoxyactein and actein, are found in more than one species of Actaea and therefore their presence is not sufficient evidence alone of the unambiguous identification of Actaea racemosa (Jiang et al. 2006, He et al. 2000). The NHPD recognizes that there are numerous methods which can be used to unambiguously identify Black Cohosh. These methods include, but are not limited to, those cited in the following references: Avula et al. 2007, He et al. 2006, Jiang et al. 2006, Brigham et al. 2004, Zerega et al. 2002, He et al. 2000. Note: Data relating to the identification of Black Cohosh, using an unambiguous validated method, is not to be submitted with the compendial Product Licence Application, although it may be requested at the NHPD's discretion.
The medicinal ingredient may comply with the specifications outlined in the Black Cohosh, Black Cohosh Fluidextract, Powdered Black Cohosh, Powdered Black Cohosh Extract, or the Black Cohosh Tablets Monographs published in the US Pharmacopeia.

References cited

Avula B, Ali Z, Khan IA. 2007. Chemical Fingerprinting of Actaea racemosa (Black Cohosh) and its comparison study with closely related Actaea species (A. pachypoda, A. podocarpa, A. rubra) by HPLC. Chromatographia 66(9/10):757-762
BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
Brigham T, Schröder M, Cocksedge M. 2004. Good Practices for Plant Identification for the Herbal Industry. Prepared for the Saskatchewan Herb and Spice Association/National Herb and Spice Coalition. Ottawa (ON): Agriculture and Agri-food Canada. Available from: http://www.saskherbspice.org/Good%20Practices%20for%20plant%20identification.pdf [Accessed: 11 September 2008]
Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
Cohen SM, O'Connor AM, Hart J, Merel NH, Te HS. 2004. Autoimmune hepatitis associated with the use of black cohosh: a case study. Menopause: the Journal of the North American Menopause Society 11(5):575-577
Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
EMEA 2007: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC) Annex 1. Assessment of case reports connected to herbal medicinal products containing Cimicifugae racemosae rhizoma (Black cohosh, root) [online]. London (UK): European Medicines Agency; May 8, 2007. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/26925806en.pdf [Accessed 19 September 2008]
Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
Frei-Kleiner S, Schaffner W, Rahlfs VW, Bodmer C, Birkhäuser M. 2005. Cimicifuga racemosa dried ethanolic extract in menopausal disorders. Maturitas 51(4):397-404
He K, Pauli GF, Zheng B, Wang H, Bai N, Peng T, Roller M, and Zheng Q. 2006. Cimicifuga species identification by high performance liquid chromatography-photodiode array/mass spectrometric/evaporative light scattering detection for quality control of Black Cohosh products. Journal of Chromatographic Science 1112(1-2):241-254
He K, Zhen B, Kim CH, Rogers L, and Zheng Q. 2000. Direct analysis and identification of triterpene glycosides by LC/MS in Black Cohosh, Cimicifuga racemosa, and in several commercially available Black Cohosh products. Planta Medica 66(7):635-640
Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
Jiang B, Kronenberg F, Nuntanakorn P, Qiu M-H, and Kennelly EJ. 2006. Evaluation of the botanical authenticity and phytochemical profile of Black Cohosh products by high-performance liquid chromatography with selected ion monitoring liquid chromatography-mass spectrometry. Journal of Agricultural and Food Chemistry 54(9):3242-3253
Lynch CR, Folkers ME, Hutson WR. 2006. Fulminant hepatic failure associated with the use of black cohosh: a case report. Liver Transplantation 12(6):989-992
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
NIH 2004: National Institutes of Health. Workshop on the Safety of Black Cohosh in Clinical Studies. [online]. Bethesda (MD): National Institutes of Health, Department of Health and Human Services; November 22, 2004. Available from: http://nccam.nih.gov/news/pastmeetings/blackcohosh_mtngsumm.pdf [Accessed 19 September 2008]
Raus K, Brucker C, Gorkow C, Wuttke W. 2006. First-time proof of endometrial safety of the special black cohosh extract (Actaea or Cimicifuga racemosa extract) CR BNO 1055. Menopause: the Journal of the North American Menopause Society 13(4):678-691
Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.
Wuttke W, Raus K, Gorkow C. 2006. Efficacy and tolerability of the Black cohosh (Actea racemosa) ethanolic extract BNO 1055 on climacteric complaints. Maturitas 55(Supplement 1):S583-S591
Zerega NJC, Mori S, Lindqvist C, Zheng Q, Motley TJ. 2002. Using Amplified Fragment Length Polymorphisms (AFLP) to identify Black Cohosh (Actaea racemosa). Economic Botany 56(2): 154-164

References reviewed

AHPA 2006. United States District Court for Nebraska: Court documents filed on June 2, 2006 for the case of Grant and Beck versus Pharmavite, LLC and Nutraceutical Corporation. Testimony 1 [online]. Silver Spring (MD): American Herbal Products Association. Available from:http://ahpa.org/Portals/0/pdfs/06_0602_BlackCohosh_NebraskaCt_Testimony1.pdf [Accessed 19 September 2008]
AHPA 2006. United States District Court for Nebraska: Decision of September 8th, 2006 on the case of Grant and Beck versus Pharmavite, LLC and Nutraceutical Corporation [online]. Silver Spring (MD): American Herbal Products Association. Available from: http://ahpa.org/Portals/0/pdfs/06_0908_BlackCohosh_NebraskaDistrictCt.pdf [Accessed 19 September 2008]
Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
Cohen SM. 2004. Black Cohosh and Hepatotoxicity: Case Reports. Hepatitis Associated with Black Cohosh, Case 2. In: Workshop on the Safety of Black Cohosh in Clinical Studies. [online]. Bethesda (MD): National Institutes of Health, Department of Health and Human Services. Available from: http://nccam.nih.gov/news/pastmeetings/blackcohosh_mtngsumm.pdf [Accessed 19 September 2008]
DerMarderosian A, Beutler JA, editors. The Review of Natural Products, 3rd edition. St. Louis (MO): Facts and Comparisons, A Wolters Kluwer Company; 2002.
EMEA 2006: European Medicines Agency. EMEA public statement on herbal medicine products containing Cimicifugae racemosae rhizome (Black cohosh, root) - serious hepatic reactions [online]. London (UK). Available from: http://www.emea.europa.eu/pdfs/human/hmpc/26925906en.pdf. [Accessed 19 September 2008]
Geller SE, Studee L. 2006. Contemporary alternatives to plant estrogens for menopause. Maturitas 55(Supplement 1):S3-S13
Gurley B, Gardner SF, Hubbard MA, Williams DK, Gentry B, Khan IA, Shah A. 2005. In vivo effects of goldenseal, kava kava, black cohosh, and valerian on human cytochrome P450 1A2, 2D6, 2E1, and 3A4/5 phenotypes. Clinical Pharmacology and Therapeutics 77(5):415-426
Gurley B, Hubbard MA, Williams DK, Thaden J, Tong Y, Gentry B, Breen P, Carrier D, Cheboyina S. 2006. Assessing the clinical significance of botanical supplementation on human cytochrome P4503A activity: comparison of a milk thistle and black cohosh product to rifampin and clarithromycin. Journal of Clinical Pharmacology 46:211-213
HC 2006: Health Canada. Advisories, Warnings and Recalls [online]. Ottawa (ON): Health Canada. Available from: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2006/2006_72_e.html [Accessed 19 September 2008]
Hernández Muñoz G, Pluchine S. 2003. Cimicifuga racemosa for the treatment of hot flashes in women surviving breast cancer. Maturitas 44(Supplement 1):S59-S65
Hirschberg AL, Edlund M, Svane G, Azavedo E, Skoog L, von Schoultz B. 2007. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause: the Journal of the North American Menopause Society 14(1):89-96
Jacobson JS, Troxel AB, Evans J, Klaus L, Vahdat L, Kinne D, Lo KM, Moore A, Rosenman PJ, Kaufman EL, Neugut AI, Grann VR. 2001. Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology 19(10):2739-2745
Kronenberg F and Fugh-Berman A. 2002. Complementary and alternative medicine for menopausal symptoms: A review of randomized, controlled trials. [online]. Annals of Internal Medicine 137:805-813. Available from: http://www.annals.org/cgi/reprint/137/10/805.pdf [Accessed 19 September 2008]
Levitsky J, Alli TA, Wisecarver J, Sorrell MF. 2005. Fulminant liver failure associated with the use of black cohosh. Digestive Diseases and Sciences 50(3):538-539
Liske E, Hänggi W, Henneike-von Zepelin H-H, Boblitz N, Wüstenberg P, Rahlfs VW. 2002. Physiological investigation of a unique extract of Black cohosh (Cimicifuga racemosa rhizome): a 6-month clinical study demonstrates no systemic estrogenic effect. Journal of Women's Health and Gender-based Medicine 11(2):163-174
Lontos S, Jones RM, Angus PW, Gow PJ. Acute liver failure associated with the use of herbal preparations containing black cohosh. The Medical journal of Australia 2003;179(7):390-1.
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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Dried root and rhizome:

40 mg per day (Blumenthal et al. 2000)
40 to 200 mg per day (Bradley 1992)

Decoction:

40 to 200 mg dried root and rhizome per day (Bradley 1992)

Fluid extract:

40 mg dried equivalent per day (1:1, 40-60% alcohol, 0.04ml) (Blumenthal et al. 2000)
300 to 2000 mg dried equivalent per day (1:1, alcohol, 0.3-2 ml) (Williamson et al. 1988)
300 to 1800 mg dried equivalent per day (1:1, 0.3-1.8 ml (5 to 30 minims)) (Ellingwood 1983[1919])

Tincture:

400-800 mg dried equivalent, 3 times per day (1:5, 60% alcohol, 2-4 ml) (Hoffman 2003)
40 mg dried equivalent per day (1:10, 40-60% alcohol, 0.4 ml)(Blumenthal et al. 2000)
40 to 200 mg dried equivalent per day (1:10, 60% alcohol, 0.4 to 2 ml)(Bradley 1992)
200 to 400 mg dried equivalent per day (1:10, 2-4 ml) (Williamson et al. 1988)
185 to 370 mg dried equivalent per day (1:10, 1.85 to 3.7 ml (0.5-1 dram)) (Ellingwood 1983[1919])

Dried aqueous or ethanolic extract:

40 mg dried equivalent per day (Frei-Kleiner et al. 2006)
40 mg dried equivalent per day (Raus et al. 2006)
20 mg dried equivalent, 2 times per day (Wuttke et al. 2006)