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PubMed2003

Cultivation of Cimicifuga racemosa (L.) nuttal and quality of CR extract BNO 1055.

OBJECTIVES: For Cimicifuga racemosa, well-founded investigations concerning multiplication, germination of seeds and field cultivation have not yet been published. Defined origins or varieties with certain agronomic properties and a specific pattern of active compounds are not commercially available. Special challenges are found with regard to growing of young plantlets from seeds. Comprehensive investigations have been started to find optimal conditions for all steps of the whole process to establish cultivation for Cimicifuga. Aim is to get defined varieties or sources with desirable agronomic characteristics and specific reproducible compound patterns in order to reach homogeneous plant raw material. METHODS: For analytical tests, validated HPLC and TLC methods were used. RESULTS: Results from germination experiments with different temperature regimens show that the time for germination can be shortened from about 20 months to about 6 months. Gibberellic acid had positive influence on the development of the embryo. Content of triterpenglycosides and phenolic compounds was highest in May and June and decreased then from July until September. The quality of the ethanolic extract BNO 1055 (contained in Klimadynon(R) and Menofem(R)) differs from that of an isopropanolic extract. Comparison was carried out by means of TLC pattern of triterpenglycosides and phenolic compounds. CONCLUSION: Extensive systematic research on cultivation parameters with regard to all stages from the seeds to the herbal drug enables commercial field cultivation of Cimicifuga. Controlled cultivation (according to good agricultural practice or GAP) ensures the availability of homogenous standardized raw material. For pharmacological and clinical studies, standardized extracts and finished herbal medicinal products are required. Results of these studies are never transferable to other products and therefore valid only for the tested extracts/products.

Chromatography, High Pressure Liquid↗
PubMed2002

[Pharmacologic and clinical studies using Cimicifuga racemosa in climacteric complaints].

Climacteric complaints are caused by a decrease in estrogen production and are characterized by neurovegetative and psychic complaints. Hot flushes represent the leading symptom, in addition excitability, irritability and sleep disturbances are reported. These complaints are usually treated with estrogens, but extracts of Cimicifuga racemosa are used for this indication, too. Clinical studies gave evidence for the efficacy of Cimicifuga extracts in patients with climacteric symptoms. In pharmacological experiments Cimicifuga extracts exhibited organ specific estrogenic effects and were characterised as selective estrogen-receptor-modulators. In addition pronounced effects on the central nervous system were shown. Taking these relevant therapeutic properties into account further experimental and clinical studies seem to be necessary and promising.

Aged↗
PubMed2006

[Effectiveness and safety of the treatment of menopausal syndrome with Cimicifuga racemosa dry extract].

OBJECTIVES: Phytoestrogens could be an alternative method of the treatment of menopausal syndrome in women with contraindications to hormonal replacement therapy. DESIGN: The aim of the study was to evaluate efficacy and safety of the therapy with Cimicifuga racemosa dry extract. MATERIAL AND METHODS: Twenty women aged mean 52.4 +/- 4.9 years with climacteric syndrome were treated with Cimicifuga racemosa dry extract in a dose of 40 mg a day during 6 months. Kupperman's Index, biochemical parameters and hormonal profile were estimated before and after 3 and 6 months of the therapy. RESULTS: Mean values of Kuppermen's Index were decreased from 30.2 +/- 5.7 points before the therapy to 8.5 +/- 6.3 points after 3 months and to 2.6 +/- 2.1 points after 6 months of the therapy (p < 0.05). No statistical differences in biochemical parameters' concentrations and hormonal profile were observed. CONCLUSIONS: Cimicifuga racemosa dry extract was an effective and safe therapy of climacteric women with contraindications to hormonal replacement therapy.

Cimicifuga↗
PubMed2000

Allozyme Variation and Genetic Relationships among Species of Cimicifuga (Ranunculaceae) from Korea.

Allozyme investigation of the five Cimicifuga taxa in Korea was conducted to assess genetic and clonal diversity within populations and genetic divergence among populations and taxa. Levels of allozyme variation maintained in Korean Cimicifuga taxa were comparable to those for most herbaceous perennials. In general, samples excluding copies of the same multilocus genotype maintained higher levels of genetic diversity than the total samples within populations. Copies of homozygous genotypes at several loci resulting from clonal spread lead to decreased levels of genetic diversity within populations, indicating that clonal reproduction found in Cimicifuga affects population genetic structure. In general, more widely distributed species such as C. dahurica and C. japonica harbored higher levels of allozyme diversity than the other taxa examined. Although two varieties of C. heracleifolia are geographically and reproductively isolated, the genetic and clonal structure of var. bifida seems to resemble var. heracleifolia, indicating that the two varieties may have had a similar evolutionary history. However, the allozyme data strongly indicate that the two morphological types (Groups I and II) of C. simplex should be treated as separate species.

Journal Article↗
PubMedDate not supplied

Methods of phytochemical standardisation of rhizoma Cimicifugae racemosae.

The methanolic extract of roots of Cimicifuga racemosa and its methanolysis products have been analysed by GC-MS. 2-Hexylcyclopropaneoctanoic acid (9,10-methylenehexadecanoic acid) was found to be the marker most specific for the identification for this herb. For the phytochemical standardisation of Rhizoma Cimicifugae racemosae, validated methods for the quantitative analysis of formononetin (by TLC-fluorometry), of isoferulic acid (by GC-MS of the methyl ester), and of total triterpene glycosides (transformed to coloured complexes and measured photometrically) in roots of C. racemosa have been developed. The contents of formononetin, isoferulic acid and total triterpene glycosides (measured as actein) in the herb ranged from 0.0031 to 0.0035, from 1.22 to 1.35 and from 20.09 to 22.06 mg/g dry weight, respectively.

Chromatography, High Pressure Liquid↗
PubMed2005

No estrogen-like effects of an isopropanolic extract of Rhizoma Cimicifugae racemosae on uterus and vena cava of rats after 17 day treatment.

The effects of black cohosh extracts (Rhizoma Cimicifugae racemosae) on primary estrogen target organs, like mammary gland and endometrium are better described then those on other estrogen-sensitive systems e.g. the vasculature. We therefore treated ovariectomized DA/Han rats for 17 days with an isopropanolic Cimicifuga racemosa rhizoma extract (iCR) alone and in combination with the pure antiestrogen fulvestrant. As control groups vehicle, estradiol, fulvestrant, and estradiol fulvestrant cotreatment were used. Effects of all substances were investigated by vena cava and uterine gene expression analysis using real-time-PCR. Uterus wet weight was increased after estradiol treatment compared to the negative controls but none of the other treatments including the treatment with iCR had a uterotrophic effect. While estradiol-induced changes in uterine gene expression were mainly analogous to those detectable in shorter term experiments, iCR showed no or slightly antiestrogenic effects on gene expression in the uterus. This is mirrored in the vena cava where iCR had a very minor impact on the expression of the genes analyzed. While C. racemosa is effectively used for treatment of peri- and post-menopausal symptoms for a long time its mechanism of action remains unresolved. Contrary to earlier suggestions C. racemosa does not seem to act as an estrogen agonist, but possibly as a weak antiestrogen.

2-Propanol↗
PubMed1991

Effects of extracts from Cimicifuga racemosa on gonadotropin release in menopausal women and ovariectomized rats.

Remifemin is an ethanolic extract of the rhizome of Cimicifuga racemosa (C.r.) and is used to relieve climacteric hot flushes. In the present study the effects of this preparation on LH and FSH secretion of menopausal women were investigated. After an 8 weeks treatment, LH but not FSH levels were significantly reduced in patients receiving the Cimicifuga extract. To further characterize the endocrinologically active principles of this plant extract, a lipophilic extract of C.r. was prepared and subjected to Sephadex chromatography. Fractions obtained were tested for their ability to reduce LH secretion in ovariectomized (ovx) rats and to compete in vitro with 17 beta-estradiol for estrogen receptor binding sites. Three types of endocrinologically active compounds were obtained: (1) Constituents which were not ligands for the estrogen receptor but suppress LH release after chronic treatment, (2) constituents binding to the estrogen receptor and also suppressing LH release, and (3) compounds which are ligands for the estrogen receptor but without an effect of LH release. It is concluded that the LH suppressive effect of C.r. extracts observed in menopausal women and ovx rats is caused by at least three different synergistically acting compounds.

Animals↗
PubMedDate not supplied

First-time proof of endometrial safety of the special black cohosh extract (Actaea or Cimicifuga racemosa extract) CR BNO 1055.

OBJECTIVE: To investigate endometrial safety by assessment of endometrial biopsy samples and the tolerability and efficacy of the special Actaea or Cimicifuga racemosa extract (CR BNO 1055). DESIGN: Four hundred postmenopausal women with symptoms related to estrogen deficiency were enrolled into a prospective, open-label, multinational, multicenter study. Treatment duration (daily dose corresponds to 40 mg of herbal drug) was 52 weeks. To determine the probability of endometrial hyperplasia and more serious adverse endometrial outcome, the point estimator and upper limit of 95% CI were calculated. Descriptive statistics was used to assess the secondary endpoints. RESULTS: Endometrial safety has been proven because no case of hyperplasia or more serious adverse endometrial outcome occurred (point estimate: 0.0; upper limit of 95% CI: 0.011). Endometrial thickness, which was measured by endovaginal ultrasonography, did not show an increase. The number and intensity of hot flushes were markedly decreased. The dropout rate was less than 10%. The overall tolerability was good. CONCLUSIONS: The lack of endometrial proliferation and improvement of climacteric complaints as well as only few gynecologic organ-related adverse events are reported for the first time after a treatment period of 1 year. Due to the improved benefit:risk ratio, it must be assumed that the Cimicifuga racemosa special extract BNO 1055 is a safe alternative for treatment of climacteric complaints.

Administration, Oral↗
PubMed2001

Analysis of terpene compounds in Cimicifuga foetida L. by reversed-phase high-performance liquid chromatography with evaporative light scattering detection.

An RP-HPLC method with evaporative light scattering detection (ELSD) was developed for the analysis of terpene compounds in traditional Chinese medicine. Actein, 27-deoxyactein and cimicifugoside in a typical Chinese medicine of Cimicifuga foetida L. were quantitatively analyzed. Comparing ELSD with UV detection under the same eluent conditions, the former showed better sensitivity and a more stable baseline. The ELSD responses versus sample size of three terpenes and those in double logarithmic were investigated. The good calibration curves in double logarithmic coordinator for actein, 27-deoxyactein and cimicifugoside were obtained. Three solutions for the extraction of the terpene compounds were also compared, the results indicated that methanol-water (80:20) is the best among them. The method was applied to quantify actein, 27-deoxyactein and cimicifugoside in Cimicifuga foetida L. from Hunan, China. It was shown that ELSD is an effective detection method for the analysis of the non-volatile terpenes in traditional Chinese medicine.

Calibration↗
PubMed2006

Anticomplement activity of cycloartane glycosides from the rhizome of Cimicifuga foetida.

A tetranor-cycloartane glycoside and two 9,19-cycloartane glycosides were isolated from the EtOAc-soluble fraction of the rhizome of Cimicifuga foetida. The structures of the compounds were determined to be cimilactone A (1), 25-O-acetylcimigenol 3-O-beta-d-xylopyranoside (2) and cimigenol 3-O-alpha-l-arabinopyranoside (3), respectively, using spectroscopic analysis. The three compounds were examined for their anticomplement activity against the classical pathway of the complement system. Compound 1 showed significant anticomplement activity with an IC(50) value of 28.6 microm, whereas compounds 2 and 3 were inactive.

Animals↗
PubMed2003

Identification of caffeic acid derivatives in Actea racemosa (Cimicifuga racemosa, black cohosh) by liquid chromatography/tandem mass spectrometry.

Caffeic acid derivatives occurring in black cohosh [Cimicifuga racemosa (L.) Nutt., Actaea racemosa (Ranunculaceae)], some of which may have pharmacological activity, were analyzed using high-performance liquid chromatography (HPLC) electrospray ionization tandem mass spectrometry (ESI-MS/MS) with the aim of developing a methodology for their rapid identification in a complex plant matrix. Based on these studies, structurally characteristic product ions and neutral molecule losses were identified, which were then used during LC/MS/MS with product ion scanning, precursor scanning and constant neutral loss scanning to detect caffeic acid derivatives in a crude extract of black cohosh. Several caffeic acid derivatives were detected, and the identification of six of them were confirmed by comparison with authentic standards including caffeic acid, ferulic acid, isoferulic acid, fukinolic acid, cimicifugic acid A, and cimicifugic acid B. Four other compounds were detected that appeared to be caffeic acid derivatives based on LC/MS/MS retention times, molecular weights, and fragmentation patterns during MS/MS. Since standards were unavailable for these four compounds, they were tentatively identified using LC/MS/MS as cimicifugic acid E, cimicifugic acid F, dehydrocimicifugic acid A, and dehydrocimicifugic acid B. Dehydrocimicifugic acid A and dehydrocimicifugic acid B have not been reported previously to be constituents of black cohosh.

Caffeic Acids↗
PubMed2002

Cimicifuga racemosa: a systematic review of its clinical efficacy.

BACKGROUND: Cimicifuga racemosa has long been advocated as an alternative to hormone-replacement therapy. However, recent experimental studies and a clinical trial have raised some questions on its utility. The aim of this systematic review is principally to summarise the trial evidence regarding the efficacy of C. racemosa in the treatment of menopausal symptoms. In addition, we also explore the evidence relating to the mechanism of action of this herbal medicine. METHODS: Searches of seven computerised databases were performed to identify all randomised clinical trials (RCTs) on C. racemosa as well as animal and in vitro experiments. No language restrictions were imposed. Data were extracted by both authors according to predefined criteria and are summarised in narrative form. RESULTS: Four RCTs of C. racemosa as a treatment of menopausal symptoms were included. They yielded no compelling evidence for the efficacy of C. racemosa on menopausal symptoms. The small beneficial effects observed in some studies could be explained by a central activity, and an oestrogenic activity cannot be completely excluded. CONCLUSIONS: In spite of plausible mechanisms of action of C. racemosa, its clinical efficacy for the treatment of menopausal symptoms has not been convincingly demonstrated through rigorous clinical trials. Additional rigorous RCTs and biochemical and chemical investigations are warranted.

Animals↗
PubMed2003

Effects of an isopropanolic extract of Cimicifuga racemosa on urinary crosslinks and other parameters of bone quality in an ovariectomized rat model of osteoporosis.

A potential bone-sparing effect of Rhizoma actaeae (= cimicifugae) racemosae (black cohosh) was evaluated in ovariectomized Sprague-Dawley rats. The rats were ovariectomized at 12 weeks of age (body weight, 219-226 g) and placed on a soy-free diet 6 days after surgery. Animals were randomly assigned the following groups: control (n = 10), soy-free diet only; RAL (n = 10), soy-free diet plus raloxifene 3 mg/kg intragastrically; and REM (n = 10), soy-free diet supplemented with an isopropanolic black cohosh extract (Remifemin) with a daily intake of 4500 micro g triterpeneglycosides. Urinary levels of pyridinoline (PYR) and deoxypyridinoline (DPY), specific markers for bone loss, were measured at baseline and at weekly intervals. At the end of the study, the animals were killed and bone loss was determined by volumetric bone mineral density (BMD) measurements and peripheral quantitative computed tomography (pQCT). Mechanical resistance to fracture was also determined. Results demonstrated that an isopropanolic extract of black cohosh significantly diminished the urinary content of PYR and DPY and the morphometric correlates of bone loss associated with ovariectomy in rats. Reversal of the effects of ovariectomy on bone loss began 2-5 weeks after the start of treatment and continued through at least 7 weeks. Results similar in quality and magnitude were obtained in the group treated with raloxifene, a known selective estrogen receptor modulator (SERM). Because extracts of black cohosh are already recognized as safe and effective in the treatment of certain gynecological disorders, a longer-term clinical trial of this herbal remedy for the treatment of osteoporosis is warranted.

2-Propanol↗
PubMed2004

Anti-AIDS agents. Part 57: Actein, an anti-HIV principle from the rhizome of Cimicifuga racemosa (black cohosh), and the anti-HIV activity of related saponins.

Actein (1), a tetracyclic triterpenoid from the rhizome of Cimicifuga racemosa (black cohosh), and 82 related triterpenoid and steroidal saponins isolated from higher plants were evaluated for anti-HIV activity as a continuing study to discover potential anti-AIDS agents from natural products. Actein showed potent activity and another twelve saponins showed moderate activity. The active compounds included two steroidal, seven tetracyclic triterpenoid, and four pentacyclic triterpenoid compounds.

Anti-HIV Agents↗
PubMed2005

Cytotoxicity of cycloartane triterpenoids from aerial part of Cimicifuga foetida.

Our previous study had demonstrated cytotoxicity of EtOAc fraction from aerial part of Cimicifuga foetida on various cancer cell lines. In the present study, we investigated the cytotoxicity of five cycloartane triterpenoids isolated from the EtOAc fraction. Compounds (1,2,3) showed moderate cytotoxic activity on R-HepG2 cells and drug resistant sub line R-HepG2 but exhibited less toxicity against primary cultured normal mouse hepatocytes. Compounds (4) and (5) were inactive on all tested cell lines.

Animals↗
PubMed2004

Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial.

OBJECTIVES: To compare the efficacy and safety of the black cohosh root extract Cr 99 with placebo in women with climacteric complaints. METHODS: A multicenter, randomized, placebo-controlled, double-blind, parallel group study was conducted in 122 menopausal women (intention-to-treat population) with > or =3 hot flashes a day, treated over 12 weeks. Two main efficacy measures - weekly weighted score of hot flashes and Kupperman Index - and secondary efficacy variables, e.g. Menopause Rating Scale, were defined. Routine safety laboratory parameters and adverse events were documented. RESULTS: The primary efficacy analysis showed no superiority of the tested black cohosh extract compared to placebo. However, in the subgroup of patients with a Kupperman Index> or =20 a significant superiority regarding this index could be demonstrated (P<0.018). A decrease of 47% and 21% was observed in the black cohosh and placebo group, respectively. The weekly weighted scores of hot flashes (P<0.052) and the Menopause Rating Scale (P<0.009) showed similar results. Prevalence and intensity of the adverse events did not differ in the two treatment groups. CONCLUSIONS: The results indicate a superiority of the tested Cimicifuga racemosa extract compared to placebo in patients with menopausal disorders of at least moderate intensity according to a Kupperman Index > or =20, but not in the intention-to-treat population as a whole.

Cimicifuga↗
PubMed2005

Cimicifuga racemosa extract BNO 1055 inhibits proliferation of the human prostate cancer cell line LNCaP.

Extracts from black cohosh (Cimicifuga racemosa, CR) exert an anti-proliferative action in human breast cancer cell cultures, which has been attributed to an anti-estrogenic effect. However, CR constituents do not bind to either of the known estrogen receptors. Thus, the anti-tumor effect of CR me be mediated by mechanisms not involving these receptors. Polycyclic aromatic hydrocarbons are toxic environmental pollutants, which indirectly act as anti-estrogens by activating the aryl hydrocarbon receptor (AhR). The AhR is widely expressed in mammalian tissues and tumors. A recent screening study demonstrated activation of the AhR by a variety of herbal extracts, among others, CR. Since activation of the AhR causes inhibition of growth of prostate cancer cells, we addressed the question, whether CR may not only inhibit growth of breast cancer--but also of prostate cancer cells. In the AhR ligand assay, the CR extract BNO 1055 reduced tracer binding to 71% of the control demonstrating interaction of constituents of this extract with the receptor. Under basal as well as under estradiol- and dihydrotestosterone stimulated conditions, the CR extract dose dependently inhibited proliferation of LNCaP cells. A significant reduction of cell growth was observed at a concentration as low as 50 ng/ml. Thus, it is demonstrated for the first time that CR compounds potently inhibit the growth of human prostate cancer cells in vitro. This anti-proliferative effect may be mediated via the AhR.

Antineoplastic Agents, Phytogenic↗
PubMed2005

Muscle damage induced by black cohosh (Cimicifuga racemosa).

Extracts of black cohosh (Cimicifuga racemosa) are commonly used for the treatment of symptoms associated with menopause. Adverse events with black cohosh are rare, mild and reversible. A few number of serious adverse events, including hepatic and circulatory conditions, have been also reported, but without a clear causality relationship. We report the case of a woman with severe asthenia and very high blood levels of creatine phosphokinase and lactate dehydrogenase. The patient referred to take a dietary supplement derived from black cohosh for ameliorating menopause vasomotor symptoms. To exclude a possible involvement of this product, the patient was suggested to discontinue this therapy. After suspicion the patient showed a progressive normalization of biochemical parameters and improvement of clinical symptoms. We can hypothesise a causative role for black cohosh in the muscle damage observed in this patient. Factors suggesting an association between black cohosh and the observed myopathy included the temporal relationship between use of herbal product and asthenia and the absence of other identified causative factors. Rechallenge with the suspected agent was inadvisable for ethic reasons because of the risk of a serious relapse. This is the first time that asthenia associated with high muscle enzymes serum levels by black cohosh has been reported. In our opinion, this report is of interest because of the widespread diffusion of use of black cohosh as an alternative medicine for relief from menopausal symptoms.

Asthenia↗