Efficacy and Safety of Isopropanolic Black Cohosh Extract for Climacteric Symptoms

Hildesheim General Hospital Department of Obstetrics and Gynecology, Hildesheim, Germany.
Obstetrics and Gynecology (Impact Factor: 5.18). 05/2005; 105(5 Pt 1):1074-83. DOI: 10.1097/01.AOG.0000158865.98070.89
Source: PubMed


Several clinical studies suggest that black cohosh may be effective in climacteric complaints. However, evidence of its efficacy based on current quality standards has been limited.
This randomized, multicenter, double-blind clinical trial compared the efficacy and tolerability of the isopropanolic black cohosh extract in the treatment of climacteric complaints compared with placebo. A total of 304 patients were randomly allocated to receive tablets corresponding to 40 mg drug or matching placebo daily for 12 weeks. The primary efficacy measure was the change from baseline on the Menopause Rating Scale I; secondary measures included changes in its subscores and safety variables.
Patient groups did not differ in baseline characteristics. The isopropanolic black cohosh extract was more effective than placebo (P < .001) depending on time from symptom onset (P = .014) and follicle-stimulating hormone level (P = .011). The effect size was 0.03 to 0.05 Menopause Rating Scale units which is similar to recent hormone replacement therapy study results (0.036 Menopause Rating Scale units) and may therefore be considered clinically relevant. Women in the early climacteric phase benefited more than in the late phase. The hot flush subscore was the most effective measure of the isopropanolic black cohosh extract's efficacy. There were no relevant group differences in adverse events, laboratory findings, or tolerability.
This isopropanolic extract of black cohosh root stock is effective in relieving climacteric symptoms, especially in early climacteric women.

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    • "); (Saadati et al. 2013) #3447 (Agarwal et al. 2014; Pinkerton et al. 2014); SSRIs: (Simon et al. 2013; Aedo et al. 2011; Suvanto-Luukkonen et al. 2005; Oktem et al. 2007), venlafaxine (Evans et al. 2005; Boekhout et al. 2011; Vitolins et al. 2013), desvenlafaxine (Speroff et al. 2008; Archer et al. 2009a; Archer et al. 2009b; Cheng et al. 2013; Bouchard et al. 2012; Pinkerton et al. 2013), isoflavones (Albertazzi et al. 1998; Han et al. 2002; van de Weijer & Barentsen 2002; Jeri 2002; Sammartino et al. 2003; Nahas et al. 2004; Nahas et al. 2007; Khaodhiar et al. 2008; Cheng et al. 2007; Radhakrishnan et al. 2009; Ye et al. 2012; Aso et al. 2012; Mainini et al. 2013; D&apos;Anna et al. 2007; D&apos;Anna et al. 2009; Ferrari 2009; Evans et al. 2011; Murkies et al. 1995; Crisafulli et al. 2004; Labos et al. 2013; Upmalis et al. 2000; Faure et al. 2002); hops (Heyerick et al. 2006); red clover (Hidalgo et al. 2005; Lipovac et al. 2012), flaxseed (Colli et al. 2012), St. John's wort (Uebelhack et al. 2006; Briese et al. 2007), French maritime pine bark (Yang et al. 2007; Kohama & Negami 2013), Sibiric Rhubarb (Heger et al. 2006; Kaszkin-Bettag et al. 2007; Kaszkin-Bettag et al. 2009; Hasper et al. 2009), and CREs (Drewe et al. 2013; Lopatka et al. 2007; Vermes et al. 2005; Liske et al. 2002; Frei-Kleiner et al. 2005; Schellenberg et al. 2012; Osmers et al. 2005; Ross 2012; Newton et al. 2006; Geller et al. 2009; Stoll 1987; Wuttke et al. 2003; Nappi et al. 2005; Bai et al. 2007; Uebelhack et al. 2006; Briese et al. 2007; Oktem et al. 2007; Hernández Munoz & Pluchino 2003; Rostock et al. 2011). "
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    ABSTRACT: The cardinal climacteric symptoms of hot flushes and night sweats affect 24-93% of all women during the physiological transition from reproductive to post-reproductive life. Though efficacious, hormonal therapy and partial oestrogenic compounds are linked to a significant increase in breast cancer. Non-hormonal treatments are thus greatly appreciated. This systematic review of published hormonal and non-hormonal treatments for climacteric, and breast and prostate cancer-associated hot flushes, examines clinical efficacy and therapy-related cancer risk modulation. A PubMed search included literature up to June 19, 2014 without limits for initial dates or language, with the search terms, (hot flush* OR hot flash*) AND (clinical trial* OR clinical stud*) AND (randomi* OR observational) NOT review). Retrieved references identified further papers. The focus was on hot flushes; other symptoms (night sweats, irritability, etc.) were not specifically screened. Included were some 610 clinical studies where a measured effect of the intervention, intensity and severity were documented, and where patients received treatment of pharmaceutical quality. Only 147 of these references described studies with alternative non-hormonal treatments in post-menopausal women and in breast and prostate cancer survivors; these results are presented in Additional file 1. The most effective hot flush treatment is oestrogenic hormones, or a combination of oestrogen and progestins, though benefits are partially outweighed by a significantly increased risk for breast cancer development. This review illustrates that certain non-hormonal treatments, including selective serotonin reuptake inhibitors, gabapentin/pregabalin, and Cimicifuga racemosa extracts, show a positive risk-benefit ratio.
    Full-text · Article · Dec 2015 · SpringerPlus
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    • "a 4 b 2 g 2S ). Due to the positive GABA A allosteric modulatory effects of Ac-SM (and potentially other cycloartane glycosides; Cicek et al., 2010), it is tempting to speculate that this GABA A receptor modulation leading to sedation and muscle relaxation contributes to the alleviation of mild to moderate symptoms in menopause reported in clinical studies with preparations from A. racemosa L., especially when hot flushes are associated with sleep and mood disturbances (Wuttke et al., 2003; Frei-Kleiner et al., 2005; Osmers et al., 2005; Verhoeven et al., 2005; Newton et al., 2006; Pockaj et al., 2006; Uebelhack et al., 2006; Cheema et al., 2007). A. racemosa L. preparations are currently standardized for their 23-epi-26-deoxyactein content (Pepping, 1999), one of the five main Actaea triterpenoids (actein, 23-epi-26-deoxyactein, cimigenol 3-O-b-D-xylopyranoside, cimiracemoside C, and cimiracemoside F). "
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    ABSTRACT: 23-O-acetylshengmanol-3-O-β-d-xylopyranoside (Ac-SM) isolated from Actaea racemosa L. - an herbal remedy for the treatment of mild menopausal disorders- has been recently identified as a novel efficacious modulator of γ-aminobutyric acid (GABA) type A (GABAA) receptors composed of α1-, β2- and γ2S-subunits. In the present study, we analyzed a potential subunit-selective modulation of GABA-induced chloride currents (IGABA EC3-8) through nine GABAA receptor isoforms expressed in Xenopus laevis oocytes by Ac-SM with 2-microelectrode-voltage-clamp and behavioral effects 30 min after intraperitoneal application in a mouse model. Efficacy of IGABA enhancement by Ac-SM displayed a mild α-subunit-dependence with α2β2γ2S (maximal IGABA potentiation Emax=1454±97%) and α5β2γ2S (Emax=1408±87%) receptors being most efficaciously modulated, followed by slightly weaker IGABA enhancement through α1β2γ2S (Emax=1187±166%), α3β2γ2S (Emax=1174±218%) and α6β2γ2S (Emax=1171±274%) receptors and less pronounced effects on receptors composed of α4β2γ2S (Emax=752±53%) subunits, while potency was not affected by the subunit composition (EC50 values ranging from α1β2γ2S=35.4±12.3µM to α5β2γ2S=50.9±11.8µM). Replacing β2- by β1- or β3-subunits as well as omitting the γ2S-subunit affected neither efficacy nor potency of IGABA enhancement by Ac-SM. Ac-SM shifted the GABA-concentration-response-curve towards higher GABA sensitivity (about 3-fold) and significantly increased the maximal GABA response by 44±13% indicating pharmacological profile distinct from a pure allosteric GABAA receptors modulator. In mice, Ac-SM significantly reduced anxiety-related behavior in the elevated-plus-maze-test at a dose of 0.6mg/kg, total ambulation in the open-field-test at doses ≥6mg/kg, stress-induced hyperthermia at doses ≥0.6mg/kg, and significantly elevated seizure threshold at doses ≥20mg/kg bodyweight. High efficacy and long biological half-life of Ac-SM suggest that potential cumulative sedative side effects upon repetitive intake of Actaea racemosa L. preparations might not be negligible.
    Full-text · Article · Aug 2014 · Journal of Pharmacology and Experimental Therapeutics
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    • "The results of this study are consistent with the results of some previous studies comparing the effects of daily intake of 6.5 mg of dried rhizome extract of Black cohosh [21] or 40 mg of herbal drug Black cohosh with peri- and post-menopausal women [22,23] on reducing climacteric complaints compared with intake of placebo, and the women in the early climacteric phase benefited more than those in the late phase [22]. "
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    ABSTRACT: This study aims to evaluate the efficacy of Black cohosh (Cimicifuga racemosa L.) in treating early menopausal symptoms. This randomized, double-blind, placebo-controlled clinical trial was conducted on 84 early post-menopausal participants with Greene climacteric scale (GCS) scores of 15 to 42, who were referred to two public health care centers in Tehran, Iran, in 2011-2012. The participants were randomly allocated into treatment (6.5 mg of dried extract of Black cohosh roots daily) and control (placebo) groups with a ratio of 1:1. The participants took one tablet per day for 8 weeks. The GCS scores were recorded at baseline, and after 4 and 8 weeks of treatment. Data analysis was carried out using a general linear model with repeated measures with SPSS software. The level of significance was set at P < 0.05. There was no loss to follow-up during the 8 weeks of treatment. The GCS total score (primary outcome) in the treatment group was significantly lower than that in the control group at both week 4 [adjusted mean difference: -7.8 (95% confidence interval: -11.1 to -4.4)] and week 8 [-12.9 (-16.2 to -9.3)]. The treatment group showed significantly more improvement than the control group in all GCS subscale scores (vasomotor, psychiatric, physical, and sexual symptoms; secondary outcomes). The differences between the treatment and control groups at week 8 were significantly higher (P < 0.001) than those at week 4 in terms of the total scores and the vasomotor and psychiatric subscale scores. No side effects were reported. Black cohosh reduced the GCS total score and all GCS subscale scores (vasomotor, psychiatric, physical, and sexual symptoms) during 4 and 8 weeks of treatment. This study was approved (Code 9061) by the Ethics Committee of Tabriz University of Medical Sciences and registered at the Iranian Registry of Clinical Trials with IRCT201107186709N4 on 15 January 2012.
    Full-text · Article · Nov 2013 · Chinese Medicine
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