Herbal Medicine: Expanded Commission E
Black Cohosh root |
Latin Name: Cimicifuga racemosa
Pharmacopeial Name: Cimicifugae racemosae rhizoma
Other Names: black snakeroot, rattleroot
Overview
Black cohosh is a plant native to eastern North America. The plant is found in rich, shady woods ranging from Maine to Ontario, and from Wisconsin south to Georgia and Missouri. Native Americans used the rhizome of black cohosh for general malaise, kidney ailments, malaria, rheumatism, sore throat, and for conditions specific to women, such as menstrual irregularities and childbirth. Black cohosh was adopted and used frequently by early settlers and herbal doctors, and in the 1840s by the Eclectic physicians, who used it for many symptoms, especially those associated with rheumatism and rheumatoid pain. Some of the early patent medicines contained high concentrations of black cohosh, and it was the main ingredient in Lydia Pinkham's famous 'Vegetable Compound,' drunk by women in the early nineteenth century to relieve menstrual stress and nervous tension (Duke, 1985; Felter, 1922; Snow, 1996). Currently, black cohosh has become the largest-selling herbal dietary supplement in the United States for reducing symptoms associated with menopause. Black cohosh influences the endocrine regulatory systems, with effects similar to one of the milder endogenous estrogens, estriol. For a short duration, it binds weakly with estrogen receptors and is thought to exert its effects on the vaginal lining (Murray, 1997). A lack of estrogen-like (hormonal) effect has been demonstrated in animal experiments (Einer-Jensen et al., 1996; Freudenstein and Bodinet, 1999) and human pharmacological studies (Liske and Wüstenberg, 1999; Liske et al., 1998).
Modern clinical studies have investigated the therapeutic efficacy and safety of black cohosh extracts for indications of the neurovegetative symptoms caused by menopause. These studies used several internationally recognized and validated scales as controls, including Kupperman's Menopause Index for the quantitative determination of menopausal symptoms, the Self-evaluation Depression Scale, the Profile of Mood States, the Hamilton Anxiety Scale, and the Clinical Global Impression scale (CGI), for evaluating the success and the risk-to-benefit assessment of the treatment. Somatic symptoms were determined using vaginal-cytological controls, such as vaginal smears, and measures of gonadotropin secretion (Beuscher, 1995).
Clinical studies using hormone replacement therapy (HRT) and black cohosh have been published based on a particular product called Remifemin® (Shaper & Brümmer, Germany), standardized on the basis of triterpene glycosides; each tablet contains 1 mg of triterpenes, calculated as 27-deoxyacteine and totaling 40 mg of black cohosh extract. In 1996, nearly ten million monthly units of Remifemin were sold in Germany, Australia, and the United States (Murray, 1997). At least eight clinical studies have been published on the therapeutic effects of Remifemin in treating menopausal symptoms (Foster, 1999) although the total in the literature, according to the Napralert database, is 19 (Farnsworth, 1999).
Two studies examined the efficacy of Remifemin in 86 women with climacteric complaints who were at risk with HRT, or who wanted a natural alternative. One open study treated 36 women who either showed contraindications to HRT or wished to be treated with a hormone-free preparation (Daiber, 1983). They were given liquid Remifemin (40 drops twice daily) for a period of 12 weeks. The decrease in values of the Kupperman index was highly significant in the treatment group, as was the improvement in the most frequent climacteric symptoms. Also highly significant was the positive change in the Clinical Global Impression scale. No side effects or incompatibility reactions were observed during the three-month trial. In the other open study, 50 women with menopausal complaints were also treated with 40 drops twice daily of liquid Remifemin for 12 weeks (Vorberg, 1984). Thirty-nine patients had shown contraindications to HRT, and 11 had refused hormone treatment. Improvements in the somatic findings, neurovegetative and psychic symptoms and signs, and the Profile of Mood State and Clinical Global Impression scales were all rated significant to highly significant in the treatment group. No serious side effects were observed, with only mild gastrointestinal disturbances in four patients, and in no case did the treatment need to be discontinued.
Four studies have compared the efficacy of Remifemin with a placebo, conjugated estrogens, diazepam, estriol, and/or an estrogen-gestagen combination. A 1985 study looked at the efficacy of Remifemin with regard to the symptoms of menopause (neurovegetative, psychological, and somatic disorders) in comparison with hormone treatment or therapy with a psychotropic drug (Warnecke, 1985). In this open, controlled study, 60 patients were given Remifemin liquid (40 drops twice daily), conjugated estrogens (0.625 mg daily), or diazepam (Valium, 2 mg daily) for three months. Standard menopausal symptom indexes showed a clear equivalence of the black cohosh extract to both drugs. The effect of Remifemin liquid on relieving the depressive mood and anxiety associated with menopause was far superior to either the conjugated estrogens or diazepam, as demonstrated by the Kupperman index. The author concluded that the results clearly demonstrated the superiority of Remifemin in treatment of menopausal symptoms, especially when safety and side effects were taken into consideration.
In a study designed to test the effectiveness of black cohosh against an estrogenic drug and placebo, 80 patients were treated for 12 weeks (Stoll, 1987). Thirty were given Remifemin tablets (calculated at 8 mg extract daily: 2 tablets twice daily, each tablet containing 2 mg extract), 30 were given conjugated estrogens (0.625 mg daily), and 20 received placebo. Black cohosh extract produced favorable results in the Kupperman index, Hamilton anxiety test, and improvement in the vaginal lining. The number of hot flashes dropped from an average of 5 daily to less than 1 in the black cohosh group, compared to the estrogen group, which dropped from 5 to 3.5 average daily occurrences. Improvements in the vaginal lining were so significant, the author suggests the extract is suited as the drug of first choice to treat menopausal symptoms, particularly if HRT is contraindicated or not desired by the patient. (While the study refers to 8 mg of the preparation, in actuality, the Remifemin was formerly standardized at 2 mg 27-deoxyacteine; the 8 mg is thus presumably the level of this compound at a dosage of 80 mg of the extract per day.)
In another trial, 60 women under the age of 40 whose hysterectomies had left at least one ovary intact were treated with estriol (1 mg daily), conjugated estrogens (1.25 mg daily), estrogen-gestagen therapy (Trisequens, one tablet daily), or Remifemin (8 mg of black cohosh extract daily). Control was by a modified Kupperman index that assessed the climacteric symptoms associated with menopause, such as hot flashes and nervousness. Serum luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels were also measured. In all groups, the modified Kupperman index became significantly lower, with no significant differences between groups concerning therapy success (Lehmann-Willenbrock and Riedel, 1988).
In one double-blind clinical trial, the efficacy of black cohosh versus placebo in reducing gonadotropin secretion in menopausal women was studied by investigating the effect on the LH and FSH secretions in 110 women (Düker et al., 1991). Half were treated with Remifemin (8 mg of black cohosh extract daily), and half with placebo. The extract was shown to exert improvements in menopausal symptoms and blood hormone measurements. After eight weeks of treatment, levels of LH were reduced in the treatment group compared to placebo. No effect on FSH levels was seen in either group. Analysis of the commercial product suggested the presence of at least three fractions that contribute synergistically to the suppression of LH and bind to estrogen receptors. The authors concluded that Remifemin selectively suppresses LH secretion in menopausal women, pointing to an estrogenic effect, and confirming the estrogenic activity reported in the Stoll study. However, recent experimental and clinical research excludes an estrogen-identical mode of activity (Einer-Jensen et al., 1996; Liske and Wüstenberg, 1999; Liske et al., 1998).
Two further studies examined the efficacy of Remifemin compared to previous treatment with hormones and/or psychoactive drugs, and the practicality of switching from HRT to the black cohosh extract. In a large open study of 629 female patients under the care of 131 doctors, the ability of Remifemin to improve menopausal symptoms was tested, partially in comparison to a preceding therapy with hormones and/or psychoactive drugs (Stolze, 1982). Of the 629 patients, 204 had been previously treated with hormones, 35 with psychotropic agents, 11 with both, 367 had no previous treatment, and in 12 patients premedication could not be evaluated. Remifemin drops (40 drops twice a day) produced clear improvement of menopausal symptoms in over 80% of the patients within six to eight weeks, with relief of both physical and psychological symptoms. In 72% of the cases, physicians observed advantages of the Remifemin therapy in opposition to a preceding hormone treatment, due to a positive response not seen with HRT, or to the safety and tolerability of the extract. The Remifemin was well tolerated, with no discontinuation of therapy, and only 7% of patients reported mild transitory stomach complaints. In 54.3% of the cases, physicians stated advantages of Remifemin compared to previous medication with psychoactive drugs. The author concluded that Remifemin can be an alternative in the treatment of menopausal complaints, especially in those cases where treatment with estrogens or psychotropic agents is not indicated because of the risks and side effects.
In a study to test the practicality of switching from a hormone treatment to black cohosh, 50 patients who had been in hormone treatment because of menopausal complaints were given Remifemin (2 tablets twice a day) for 6 months (Peth, 1987). Twenty-eight patients required no further hormone injections during the trial, 21 patients needed one injection during this time, and one patient needed two injections. The therapeutic result was evaluated by the gynecologist as very good in 21 patients, good in 20 patients, and of minor effect in nine. No side effects were reported. The author concluded that the therapeutic response was maintained in most cases when changing from HRT to black cohosh, and that Remifemin can be regarded as a valuable enrichment to therapy.
From the evidence cited above there exists considerable documentation of the potential benefit of a proprietary black cohosh for premenstrual and menopausal conditions. Additional well-controlled studies performed in the United States are forthcoming to corroborate the European studies. Several recent reviews have been published on black cohosh (Gruenwald, 1992; Liske and Wüstenberg, 1998; Foster, 1999).
Description
Preparations of black cohosh consist of the fresh or dried rhizome with attached roots of Cimicifuga racemosa (L.) Nutt. [Fam. Ranunculaceae] in effective dosage. The preparation contains triterpene glycosides.
Chemistry and Pharmacology
Constituents include oleic, palmitic, and salicylic acids; cimigonite; tannin; and volatile oil (Bruneton, 1995; Leung and Foster, 1996). The tetracyclic triterpenes, which are oxidized and cyclized by ketalization, are derived from cycloartanol (e.g., actein and cimifugoside) (Bruneton, 1995).
Commission E reported estrogen-like action, luteinizing hormone suppression, and binding to estrogen receptors. Recent research on 152 patients suggests no effects of an isopropanolic-aqueous black cohosh extract at two dosages (40 mg and 127 mg) over six months on levels of luteinizing hormone, follicle-stimulating hormone, prolactin and estradiol, demonstrating that this particular black cohosh extract does not have an estrogenic effect (Liske and Wüstenberg, 1998).
Uses
Commission E approved the use of black cohosh root for premenstrual discomfort and dysmenorrhea or climacteric (menopausal) neurovegetative ailments. Acteina, a constituent in black cohosh, has been studied for use in treating peripheral arterial disease (Genazzani and Sorrentino, 1962).
Contraindications
None known.
Side Effects
Occasionally, gastric discomfort.
Use During Pregnancy and Lactation
Not recommended.
Interactions with Other Drugs
None known.
Dosage and Administration
Unless otherwise prescribed: 0.04 g (40 mg) per day of cut rhizome and root or equivalent preparations.
Dried rhizome and root: 40 mg.
Decoction: 0.04 g in 150 ml water.
Fluidextract 1:1 (g/ml), 40-60% alcohol: 0.04 ml.
Tincture 1:10 (g/ml), 40-60% alcohol: 0.4 ml.
Standardized extract (1:1; standardized to 1% 27-deoxyacteine): 8 mg/day.
References
Beuscher, N. 1995. Cimicifuga racemosa L. Black Cohosh. Z Phytotherapie 16:301-310.
Bruneton, J. 1995. Pharmacognosy, Phytochemistry, Medicinal Plants. Paris: Lavoisier Publishing.
Daiber, W. 1983. Climacteric Complaints: success without using hormones. Ärztliche Praxis 35:1946-1947.
Duke, J.A. 1985. Handbook of Medicinal Herbs. Boca Raton: CRC Press. 120-121.
Düker E-M, L. Kopanski, H. Jarry, W. Wuttke. 1991. Effects of extracts from Cimicifuga racemosa on gonadotropin release in menopausal women and ovariectomized rats. Planta Med 57:420-424.
Einer-Jensen, N., J. Zhao, K.P. Andersen, K. Kristoffersen. 1996. Cimicifuga and Melbrosia lack oestrogenic effects in mice and rats. Maturitas 25:149-153.
Farnsworth, N.R. 1999. Personal communication to Mark Blumenthal, May 24.
Felter, H.W. 1922. The Eclectic Materia Medica, Pharmacology and Therapeutics. Cincinnati, OH: Eclectic Medical Publications.
Foster, S. 1999. Black Cohosh, Cimicifuga racemosa—A Literature Review. HerbalGram 46:35-50.
Genazzani, E. and L. Sorrentino. 1962. Vascular action of acteina: active constituent of Actaea racemosa L. Nature 194:544-545.
Gruenwald, J. 1998. Standardized black cohosh (Cimicifuga) extract clinical monograph. Quarterly Rev Nat Med Summer:117-125.
Lehmann-Willenbrock, E. and H.H. Riedel. 1988. Clinical and endocrinologic examinations concerning therapy of climacteric symptoms following hysterectomy with remaining ovaries. Zentralbl Gynakol 110:611-618.
Leung, A.Y. and S. Foster. 1996. Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics, 2nd ed. New York: John Wiley & Sons, Inc.
Liske, E. and P. Wüstenberg. 1999. Efficacy and safety of phytomedicines for gynecologic disorders with particular reference to Cimicifuga racemosa and Hypericum perforatum. 1st Asian-European Congress on Menopause. Bangkok, Thailand, Jan. 26-31.
Liske, E. and P. Wüstenberg. 1998. Therapy of climacteric complaints with Cimicifuga racemosa: herbal medicine with clinically proven evidence. Menopause 5(4):250.
Liske, E., P. Wüstenberg, N. Boblitz. 1998. Human-pharmacological investigations during treatment of climacteric complaints with Cimicifuga racemosa (Remifemin): No estrogen-like effects. 5th International ESCOP Symposium, London, Oct. 15-16.
Murray, M. 1997. Remifemin: Answers to some common questions. Am J Nat Med 4(3):35.
Pethö, A. 1987. Menopausal complaints: Change-over of a hormone treatment to a herbal gynecological remedy practicable? Ärztl Praxis 47:1551-1553.
Snow, J.M. 1996. Cimicifuga racemosa (L.) Nutt. (Ranunculaceae). Protocol J Botanical Med 1(4):17-19.
Stoll, W. 1987. Phytopharmacon influences atrophic vaginal epithelium: Double blind-study—cimicifuga vs. estrogenic substances. Therapeuticum 1:23-31.
Stolze, H. 1982. An alternative to treat menopausal complaints. Gyne 1:14-16.
Vorberg, G. 1984. Treatment of menopause symptomsSuccessful hormone-free therapy with Remifemin. ZFA 60:626-629.
Warnecke, G. 1985. Influencing Menopausal Symptoms with a Phytotherapeutic Agent: Successful therapy with Cimicifuga mono-extract. Med Welt 36:871-874.
Additional Resources
Baillie, N. and P. Rasmussen. 1997. Black and blue cohosh in labour. N Z Med J 110(1036):20-21.
British Herbal Pharmacopoeia (BHP). 1983. Keighley: British Herbal Medicine Association.
____. 1990. Exeter, U.K.: British Herbal Medicine Association.
Foster, S. and J.A. Duke. 1990. A Field Guide to Medicinal Plants: Eastern and Central North America. Boston: Houghton Mifflin Co.
Jarry, H., G. Harnischfeger, E. Duker. 1985. Untersuchungen zur endokrinen wirksamkeit von inhaltsstoffen aus Cimicifuga racemosa 2. In-vitro-bindung von inhaltsstoffen an östrogenrezeptoren [The endocrine effects of constituents of Cimicifuga racemosa. 2. In vitro binding of constituents to estrogen receptors]. Planta Med (4):316-319.
Lieberman, S. 1998. A review of the effectiveness of Cimicifuga racemosa (black cohosh) for the symptoms of monopause. J Womens Health 7(5):525-529.
Liske, E. Therapeutic efficacy and safety of Cimicifuga racemosa for gynecological disorders. Adv Ther 15(1):45-53.
McGuffin, M., C. Hobbs, R. Upton, A. Goldberg. 1997. American Herbal Product Association's Botanical Safety Handbook. Boca Raton: CRC Press.
Resing, K. and A. Fitzgerald. 1978. Crystal data for 15-o-acetylacerinol and two related triterpenes isolated from Japanese Cimicifuga plants. J Appl Cryst (11):58.
Wren, R.C. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Essex: The C.W. Daniel Company Ltd.
This material was adapted from The Complete German Commission E Monographs—Therapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.
1) The Overview section is new information.
2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references.
3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example:
- Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
- Infusion: 2 g in 150 ml of water
- Fluidextract 1:1 (g/ml): 2 ml
- Tincture 1:5 (g/ml): 10 ml
4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes.
This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.
Excerpt from Herbal Medicine: Expanded Commission E Monographs
Copyright 2000 American Botanical Council
Published by Integrative Medicine Communications
Available from the American Botanical Council.
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