Black Cohosh

 

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Clinical Studies

References


Black cohosh (Cimicifuga racemosa, Actaea racemosa) rhizome has been used in Chinese medicine, Native American medicine and American medicine for centuries as a remedy for conditions such as headache, non-eruptive measles, gingivitis, arthritic problems and as an antidote for snakebite, as well as for female conditions such as painful menses and difficult childbirth. The active ingredients contained in the roots of black cohosh are its triterpene glycosides, isoflavones and aromatic acids.

Black Cohosh has a powerful action as a relaxant and a normalizer of the female reproductive system. It may be used beneficially in cases of painful or delayed menstruation. Ovarian cramps or cramping pain in the womb may be relieved by Black Cohosh. It is very active in the treatment of rheumatoid arthritis, osteo-arthritis, in muscular and neurological pain. It finds use in sciatica and neuralgia. As a relaxing nervine it may be used in many situations where such an agent is needed. It has been found beneficial in cases of tinnitus.

Black cohosh reportedly has a good safety profile with low toxicity, few and mild side effects and good tolerability. Medical and scientific evidence indicates that constituents contained in the herb have estrogenic activity. Black cohosh should not be used by individuals who are susceptible to hormonally related cancers or who have a history of estrogen-positive cancers. Large doses may cause nausea, vomiting and headache. Black cohosh should not be used in pregnancy as it may activate uterine smooth muscle.

Clinical studies have reported positive effects on menopausal and post-menopausal complaints, with a good safety profile and few side effects when using standardized extracts.

Of recent interest is a report that phytoestrogen compounds found in black cohosh and other herbs such as red clover may inhibit the growth of various breast cancer cell lines. Other studies have used breast cancer cell lines to demonstrate the estrogenic activity of black cohosh.

Black Cohosh may be beneficial in menopause: including hot flashes, heart palpitations, nervousness, irritability, sleep disturbances, tinnitus, vertigo, perspiration and depression; dysmenorrheal (painful menstruation), osteoporosis and premenstrual syndrome.

The dose rates in Total Balance Women's Plus and Female Rejuvenator are the correct amounts for maximum safety and efficacy.

As well as this, a more recent German study suggests that Black cohosh may also be good for bone health (see clinical evidence below).

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Published Clinical Studiesctop

Hot flashes--a review of the literature on alternative and complementary treatment approaches.1

Philp HA.

 

Hot flashes are a common experience for menopausal women, with an 85-percent incidence in the West. With the increased knowledge of side effects attributable to conventional treatment options, more women are exploring natural alternatives. Although more definitive research is necessary, several natural therapies show promise in treating hot flashes without the risks associated with conventional therapies. Soy and other phytoestrogens, black cohosh, evening primrose oil, vitamin E, the bioflavonoid hesperidin with vitamin C, ferulic acid, acupuncture treatment, and regular aerobic exercise have been shown effective in treating hot flashes in menopausal women.

Publication Types:

PMID: 12946239 [PubMed - indexed for MEDLINE]

 

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Nutritional approaches to late toxicities of adjuvant chemotherapy in breast cancer survivors.2

Rock E, DeMichele A.

 

Division of Hematology Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA.

Adjuvant chemotherapy of breast cancer reduces recurrence rates and prolongs survival at the cost of both acute and chronic toxicities. Breast cancer survivors who have received adjuvant chemotherapy may suffer from late effects of chemotherapy including congestive heart failure, neuropathy, premature menopause, and osteoporosis. Nutritional approaches to these problems are distinct in their orientation and success. Study of free radical scavengers for anthracycline-induced cardiomyopathy was born from known pathogenetic mechanisms of cardiotoxicity but has been universally disappointing thus far in clinical trials. Application of agents used for diabetic neuropathy suggests that evening primrose oil, alpha-lipoic acid, and capsaicin may all play a role in the empiric options available to patients with chemotherapy-induced neuropathy. Plant-derived preparations including black cohosh (Actaea racemosa), dong quai (Angelica sinensis), evening primrose (Oenothera biennis), and red clover (Trifolium pretense) are used by patients experiencing hot flashes due to premature menopause despite a paucity of clinical trial data demonstrating either safety or efficacy. Calcium and vitamin D are widely accepted as an effective means to retard bone loss leading to osteoporosis. Nutritional approaches to late effects of breast cancer chemotherapy offer the prospect of preventing or ameliorating these sequelae of treatment. However, except for vitamin D and calcium for prevention of bone loss, current clinical evidence supporting use of nutritional agents remains sparse.

Publication Types:

PMID: 14608115 [PubMed - indexed for MEDLINE]

 

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Morning/evening menopausal formula relieves menopausal symptoms: a pilot study.3

Sun J.

 

Enzymatic Therapy, Inc., Green Bay, WI 54311, USA. jidong@enzy.com

OBJECTIVE: The purpose of the study was to determine the efficacy of a morning/evening menopause formula (morning capsule contains panax ginseng, black cohosh, soy, and green tea extracts; evening capsule contains black cohosh, soy, kava, hops, and valerian extracts) for relieving menopausal symptoms such as hot flashes and sleep disturbance. METHODS: Healthy postmenopausal women, between 45 and 65 years of age, were asked to take the menopause formula orally, one capsule of the morning formula every morning and one capsule of the evening formula every evening for 2 months. The Greene Climacteric Scale (GCS) and the Pittsburgh Sleep Quality Index (PSQI) were used to determine the efficacy. RESULTS: Morning/evening menopause formula significantly reduced the number of hot flashes. The reduction in the number of hot flashes was observed as early as at the end of the second week. At the end of the second week, the number of hot flashes was reduced by 47%. The morning/evening menopause formula also significantly reduced the GCS total and subscale scores. At the end of the eighth week, the vasomotor, anxiety, and depression scores of GCS were reduced by 50%, 56%, and 32%, respectively. Furthermore, the morning/evening menopause formula significantly reduced global PSQI score and scores in five components (sleep quality, sleep latency, sleep duration, sleep disturbance, and daytime dysfunction) by 18%-46%. CONCLUSIONS: This study suggests that the morning/evening menopausal formula is safe and effective for relieving menopausal symptoms including hot flashes and sleep disturbance.

PMID: 12816628 [PubMed - indexed]

 

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Black cohosh.4

Kligler B.

 

Department of Family Medicine, Albert Einstein College of Medicine, New York, New York, USA. bkligler@bethisraelny.org

The herb black cohosh, or Actaea racemosa (formerly named Cimicifuga racemosa), is native to North America. The roots and rhizomes of this herb are widely used in the treatment of menopausal symptoms and menstrual dysfunction. Studies have demonstrated that this botanic medicine, when standardized properly to the terpene glycoside fraction, appears to be effective in alleviating menopausal symptoms. Adverse effects are extremely uncommon, and there are no known significant adverse drug interactions.

Publication Types:

PMID: 12887117 [PubMed - indexed for MEDLINE]

 

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Black cohosh, a menopausal remedy, does not have estrogenic activity and does not promote breast cancer cell growth.

Lupu R, Mehmi I, Atlas E, Tsai MS, Pisha E, Oketch-Rabah HA, Nuntanakorn P, Kennelly EJ, Kronenberg F.

 

Evanston Northwestern Healthcare Research Institute, Northwestern Medical School, Department of Medicine, Evanston, IL 60201, USA. r-lupu@northwestern.edu

Black cohosh is an increasingly popular alternative to estrogen replacement therapy for the relief of menopausal symptoms, primarily hot flushes. However, an important consideration for long-term therapy is potential toxicity and carcinogenicity. Therefore, we undertook a study to assess the estrogenic activity of black cohosh to examine its safety for those with, or at high risk of developing, breast cancer. Several assays were utilized as listed: RNAse protection assays, which ascertain the regulation of the expression of E2-responsive genes; estrogen-responsive-element (ERE)-luciferase, which determines modulation of the ER function by transactivation of the ERE; the Ishikawa cell system, which has an E2-regulated endogenous alkaline phosphatase; and colony formation of ER-expressing breast cancer cells, which indicates possible progression of early stage breast cancer into a more aggressive state. Black cohosh extracts did not demonstrate estrogenic activity in any of these assay systems. This is an encouraging step in the assessment of the safety of black cohosh for treatment of menopausal hot flushes.

PMID: 14532983 [PubMed - in process]

 

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Cimicifuga extract BNO 1055: reduction of hot flushes and hints on antidepressant activity.6

Winterhoff H, Spengler B, Christoffel V, Butterweck V, Lohning A.

 

Institute for Pharmacology and Toxicology, Central Clinic, University of Munster, Domagkstrasse 12, 48149 Munster, Germany. winterh@uni-muenster.de

Ethanolic- and isopropanolic-aqueous extracts of Cimicifuga racemosa are used for the treatment of climacteric complaints. As hot flushes and psychic complaints seem to be special targets for Cimicifuga extracts in clinical studies, these parameters were studied in experimental animals. Hot flush equivalents were measured in castrated rats as a quick increase in peripheral temperature with the aid of a transmitter implanted subcutaneously on the ventral side. The hot flush equivalents proved to respond to estrogen and the antidopaminergic drug veralipride but they were also reduced very effectively by Cimicifuga extract BNO 1055 (which is contained in Klimadynon/Menofem). In addition, an ethanolic-aqueous extract of C. racemosa was studied in the tail suspension test (TST), a behavioural test indicative for antidepressant activity. A significant decrease of the period of immobility was observed after treatment with 30 mg/kg body weight (bw) imipramine or with 50 or 100 mg/kg bw Cimicifuga extract. These findings in pharmacological tests-a reduction of the frequency of hot flush equivalents and hints on antidepressant activity of Cimicifuga extracts-are in good agreement with the therapeutical responses in climacteric women.

PMID: 12609559 [PubMed - indexed for MEDLINE]

 

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Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief.7

Dog TL, Powell KL, Weisman SM.

 

1Integrative Medicine Education Associates, Corrales, NM, and 2Innovative Science Solutions, LLC, Morristown, NJ 87048, USA. lowdogmd@aol.com

OBJECTIVE: This comprehensive review examines the safety of Cimicifuga racemosa for the treatment of menopause symptoms, particularly in populations in which conventional menopause treatment regimens, including estrogen replacement, are contraindicated. DESIGN: An extensive database of information on Cimicifuga, which included all published literature pertaining to preclinical and clinical safety of various forms of Cimicifuga, the FDA and World Health Organization adverse-event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical anecdotal reports, was reviewed, and findings pertaining to the safety of Cimicifuga use for menopause treatment were reported. RESULTS: Uncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%). Of the reported adverse events, 97% were minor and did not result in discontinuation of therapy, and the only severe events were not attributed to Cimicifuga treatment. CONCLUSIONS: Although the effects of Cimicifuga may be dependent on the specific extract preparation, this review clearly supports the safety of specific Cimicifuga extracts, particularly isopropanolic preparations, for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated.

Publication Types:

PMID: 12851513 [PubMed - indexed for MEDLINE]

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German studies suggests that Black cohosh may be good for bone health.g

The studies compared Black cohosh extracts with estrogen and a placebo in 62 postmenopausal women whose ages ranged from 40 to 60. Every day for 12 weeks, each of the women took a capsule that contained one of the three substances. The daily dose of Black cohosh corresponded to 40 mg of the herbal preparation.  When results were analyzed, both the estrogen and Black cohosh had similar effects on bones - an increase in activity of an enzyme associated with bone formation. 

 

The positive effect on bone formation seen in this study is the first indication that a plant product can benefit bones, and researchers called for larger studies to further explore the effects of Black cohosh on bone density. However, they said that since the specific active compounds in Black cohosh haven't been identified, other extracts may not deliver the same results.

(This study was published in the March-April 2006, issue of ‘Menopause’.)
  

 

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Referencesr

  1. Liske E. Therapeutic efficacy and safety of Cimicifuga racemosa for gynecologic disorders. Adv Ther 1998;15:45-53.
  2. Pepping J. Black cohosh: Cimicifuga racemosa. Am J Health Syst Pharm 1999;56:1400-2.
  3. Lieberman S. A Review of the effectiveness of cimicifuga racemosa (Black Cohosh) for the symptoms of menopause. J Womens Health 1998;7:525-9.
  4. McFarlin BL, Gibson MH, O'Rear J, Harman P. A national survey of herbal preparation use by nurse-midwives for labor stimulation. Review of the literature and recommendations for practice. J Nurse Midwifery 1999;44:205-16.
  5. Duker EM, Kopanski L, Jarry H, Wuttke W. Effects of extracts from Cimicifuga racemosa on gonadotropin release in menopausal women and ovariectomized rats. Planta Med 1991;57:420-4.
  6. Anon. Black cohosh: was Lydia E. Pinkham on to something? The Wellness Letter 2001;17:5.
  7. Liske E, Wustenberg P. Therapy of climacteric complaints with Cimicifuga racemosa: herbal medicine with clinically proven evidence. Menopause 1998;5:250.
  8. Kruse SO, Lohning A, Pauli GF, et al. Fukiic and piscidic acid esters from the rhizome of Cimicifuga racemosa and the in vitro estrogenic activity of fukinolic acid. Planta Med 1999;65:763-4.
  9. Jacobson JS, Troxel AB, Evans J, et al. Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. J Clin Oncol 2001;19:2739-45.
  10. Whiting PW, Clouston A, Kerlin P. Black cohosh and other herbal remedies associated with acute hepatitis. Med J Aust 2002;177:440-3.
  11. Loser B, Kruse SO, Melzig MF, Nahrstedt A. Inhibition of neutrophil elastase activity by cinnamic acid derivatives from Cimicifuga racemosa. Planta Med 2000;66:751-3.
  12. Einer-Jensen N, Zhao J, Andersen KP, Kristoffersen K. Cimicifuga and Melbrosia lack oestrogenic effects in mice and rats. Maturitas 1996;25:149-53.
  13. Bodinet C, Freudenstein J. Influence of Cimicifuga racemosa on the proliferation of estrogen receptor-positive human breast cancer cells. Breast Cancer Res Treat 2002;76:1-10.
  14. Kennelly EJ, Baggett S, Nuntanakorn P, et al. Analysis of thirteen populations of black cohosh for formononetin. Phytomedicine 2002;9:461-7.
  15. Liske E, Hanggi W, Henneicke-von Zepelin HH, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med 2002;11:163-74.
  16. Gunn TR, Wright IM. The use of black and blue cohosh in labour. N Z Med J 1996;109:410-1.
  17. Amato P, Christophe S, Mellon PL. Estrogenic activity of herbs commonly used as remedies for menopausal symptoms. Menopause 2002;9:145-50.
  18. Baillie N, Rasmussen P. Black and blue cohosh in labour. N Z Med J 1997;110:20-1.
  19. Lehmann-Willenbrock E, Riedel HH. [Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa]. [Article in German]. Zentralbl Gynakol 1988;110:611-8.
  20. Freudenstein J, Dasenbrock C, Nisslein T. Lack of promotion of estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract. Cancer Res 2002;62:3448-52.