Black cohosh (Actaea racemosa)

Australian Herbal Pharmacopoeia (working title), Monograph AIP-HP 003
Status: version 1.0, live at https://www.australian-pharmacognosy.org/pharmacopoeia/actaea-racemosa/, all reviews and the pre-publication final test on record. Published at first draft under the CEO’s order of 23/09/2026. Botanical technical review done 22/09/2026; full-text source revision by the compiler 22/09/2026; QA review done 22/09/2026; Medicine review done 22/09/2026; Education and Research evidence and citation audit done 22/09/2026; Community Outreach layout and figure review done 22/09/2026; not reviewed by Legal (internal draft).
Date: 22/09/2026 (AEST). Next review: on sign-off, then three-yearly or sooner if a major trial, safety signal or new pharmacopoeial text appears.
Prepared by: Dr Thomas Ridley, Head of Education and Research, Australian Institute of Pharmacognosy, Cardwell QLD.
Contributors: Dr Thomas Ridley (library and literature search, registry search, regulatory instrument search, synthesis, drafting, figure placement, reference verification, evidence and citation audit). Technical review: Dr Fiona MacAllister (Botanical, sections 1-5 and 10), Dr Hana Suzuki (QA, sections 6-10) and Dr Eleanor Whitcombe (Medicine, sections 12, 13 and 15), each on 22/09/2026. Jesse Kirby (Community Outreach) reviewed figure placement, captions and credit lines and set the page layout on 22/09/2026. Librarian and History and Philosophy checks are still to come and will be credited once done. Dr Luke Iggulden set the scope of the series in the CEO directive of 22/09/2026; he did not write this monograph.

Access marker for IT and Community Outreach: everything from here to the line "END OF FREE TEASER" is the free portion (section 0). Everything after it is paid.

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0. Free teaser

0.1 Identity card

Monograph	AIP-HP 003, Black cohosh root. Version 1.0, 22/09/2026. Next review: on sign-off
Accepted name	Actaea racemosa L., Ranunculaceae (APG IV). Accepted in POWO/WCVP (release of 16/09/2026, read 22/09/2026 through ChecklistBank dataset 2000; IPNI 316204-2) [1]
Basionym and synonyms	Homotypic synonyms: Cimicifuga racemosa (L.) Nutt. (the name used by the EMA, WHO and most trials), Cimicifuga serpentaria Pursh, Macrotrys racemosa (L.) Sweet, Botrophis serpentaria Raf., Megotrys serpentaria Raf., Thalictrodes racemosa (L.) Kuntze [1]. Cimicifuga was merged into Actaea in a 1998 revision [2]
Drug name	Cimicifugae rhizoma (Ph. Eur. 2069: dried rhizome and root) [3]; WHO title Rhizoma Cimicifugae Racemosae [4]
Common names	Black cohosh, black snakeroot, bugbane, rattle root, squaw root, macrotys (English); Traubensilberkerze, Cimicifugawurzelstock (German); actée à grappes (French) [2,4,5]
Pharmacopoeial status	Ph. Eur.: monograph 2069 Black cohosh (text 07/2012, read in the Ph. Eur. 8.0 library copy) [3]. WHO monographs vol. 2 (2002): yes [4]. EMA/HMPC: EU herbal monograph, well-established use, 2018 [5,6]. USP-NF: black cohosh extracts are listed in USP 39-NF 34 (dietary supplement monographs, as recorded by the HMPC) [6]. BHP 1983 and BHP 1996: monographs exist; the WHO monograph takes its macroscopy and most of its purity limits from BHP 1996 (its loss-on-drying limit comes from Hagers Handbuch) [4,7]. Chinese and Japanese pharmacopoeias use the name Rhizoma Cimicifugae for other Actaea species [4]
Australian status	Permitted in listed medicines: Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026, Schedule 1 item 386 (ACTAEA RACEMOSA, herbal ingredient); oral medicines must carry the BCOHOSH liver warning [8]. No entry in the Poisons Standard June 2026 [9] or the Medicines Advisory Statements Specification 2021 [10]. Not native; no wild or cultivated records in the Atlas of Living Australia; not on the Queensland prohibited or restricted invasive plant lists [11,12]
Assay marker	Triterpene glycosides, expressed as monoammonium glycyrrhizate (CID 62074): not less than 1.0% on the dried drug (Ph. Eur. 2069, HPLC-ELSD) [3]
Identity markers	Actein (CID 10032468) and 23-epi-26-deoxyactein (CID 21668683) on the Ph. Eur. TLC. Adulteration marker: cimifugin (CID 441960, Asian species) on the Ph. Eur. TLC; cimifugin, cimifugin-3-O-glucoside and cimigenol-3-O-arabinoside separate A. racemosa from other Actaea species by HPLC [3,13]
Evidence snapshot	Menopausal symptoms, isopropanolic extract 40 mg herb/day: Tier B, 5 RCTs (2 placebo-controlled), low certainty. Menopausal vasomotor symptoms, all mono-preparations pooled: Tier B/C, 16 RCTs in one Cochrane review with no pooled benefit over placebo, and a 2026 review rating benefit as moderate certainty; results conflict. Hot flushes after breast cancer: Tier C, 2 RCTs, no benefit over placebo. Anxiety in menopause: Tier C, 1 RCT, no benefit. Fertility with clomiphene: grade withheld (both trials under 2026 Expressions of Concern). Menstrual and rheumatic uses: Tier T. Bone: Tier P
Main safety point	Rare idiosyncratic liver injury, including liver failure, transplantation and one death during transplantation; causality is disputed and some cases involved wrong species. Australian label warning is mandatory. Avoid in pregnancy and lactation and in liver disease
Suggested citation	Ridley T. Black cohosh root (Actaea racemosa L.). Australian Herbal Pharmacopoeia monograph AIP-HP 003 (v1.0). Cardwell (QLD): Australian Institute of Pharmacognosy; 2026. DOI to be assigned
Compiler and review	Compiled by Dr Thomas Ridley (Education and Research). Technical review: Dr Fiona MacAllister (Botanical, sections 1-5, 10), reviewed 22/09/2026; Dr Hana Suzuki (QA, sections 6-10), reviewed 22/09/2026; Dr Eleanor Whitcombe (Medicine, sections 12, 13, 15), reviewed 22/09/2026; Dr Thomas Ridley (Education and Research, evidence and citation audit of all sections and figure sources), reviewed 22/09/2026 (the compiler’s own audit, not an independent check); Jesse Kirby (Community Outreach, teaser and whole-document layout, figure placement and credit lines), reviewed 22/09/2026. Published: 23/09/2026. Last modified: 22/09/2026. Version 1.0
Provenance	Original AIP data: none. Every limit, method, measurement and trial result comes from the cited pharmacopoeias, regulators, reference works and papers; sections 4, 5, 8, 9 and 10 are marked "AIP bench data pending"
Canonical URL	/pharmacopoeia/actaea-racemosa/

0.2 Summary

Black cohosh is the dried rhizome and root of Actaea racemosa, a tall woodland perennial of eastern North America, still traded under its older name Cimicifuga racemosa. The drug is a dark, knotted, horny rhizome with thin brittle roots; under the microscope it shows starch, lignified vessels and fibres and brown cork, with no crystals. The European Pharmacopoeia identifies it by thin-layer chromatography of its cycloartane triterpene glycosides (actein, 23-epi-26-deoxyactein) and assays at least 1.0 per cent triterpene glycosides by HPLC. Substitution with Asian Actaea species is a documented trade problem and is the main quality risk. The herb is used for menopausal hot flushes and sweating. Trials of standardised European extracts at about 40 mg of herb a day show modest benefit in some studies and none in others, and pooled analyses disagree. The main safety concern is rare liver injury, which carries a mandatory Australian label warning. Anyone considering it should consult a degree-qualified herbalist with competencies and adequate training in pharmacognosy.

0.3 Contents and extent (draft)

Section	Approx. pages
1-3 Nomenclature, definition, source and Australian supply	2
4-5 Macroscopy and microscopy (7 figures and 1 placeholder)	2.5
6-7 Chemistry, markers and limits (9 structures)	2.5
8-9 TLC and HPLC	2
10 Identity, purity, adulterants, contaminants	1
11 Traditional use	0.5
12 Current practice and doses	0.5
13 Clinical evidence (search, graded trials, registries)	5
14 Pharmacology	1.5
15 Safety, liver injury, interactions, pregnancy	2.5
16-18 Discussion, conclusions, research needed	1
19-20 References and document control	4
Totals (draft)	25 A4 pages in the draft PDF as laid out by Community Outreach on 22/09/2026 (section page counts above are measured from that PDF to the nearest half page; the teaser takes 2 pages); 19 tables; 22 embedded figures plus 1 captioned placeholder (3 licensed photographs, 2 public-domain plates, 9 PubChem structures, 3 AIP schematics each labelled as redrawn from Ph. Eur. and WHO text, 1 AIP range map drawn from Catalogue of Life data, 3 AIP data charts, 1 published CC BY chromatogram); 0 photomicrographs; 1 chromatogram (published, ref 57). Gaps: F4 photomicrographs are AIP bench data pending, no licensed alternative found; the AIP TLC plate and AIP HPLC chromatogram are bench data pending (F7 is a schematic, F8 a published licensed chromatogram); F5 was redrawn at Botanical review (labels separated, bundle orientation corrected). Trials: 17 in 16 table rows plus 9 systematic reviews and meta-analyses, each with a provisional risk-of-bias call (full RoB 2 pending). 59 references, every one read in full (ref 57 read in full text on Europe PMC by QA)

0.4 Contributors and access

Prepared by Dr Thomas Ridley, Head of Education and Research. Botanical, QA and Medicine reviews and the Education and Research evidence audit done 22/09/2026; Librarian reference audit pending; A Legal read is advisory only and does not gate publication (CEO order 22/09/2026). The Australian Herbal Pharmacopoeia is AIP’s own series and carries no statutory, TGA or government standing. The full monograph, from section 1 onward, is for subscribers (paywall wording to come from Legal and Community Outreach).