Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms
ABSTRACT 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.
SourceAvailable from: Jila Nahaee[Show abstract] [Hide abstract]
ABSTRACT: Introduction: Hot flash is considered to be an early and common symptom of menopause. The present study aimed to determine the impact of black cohosh (Cimicifuga racemosa) on vasomotor symptoms in postmenopausal women. Methods: This was a randomized, double-blind, placebo-controlled clinical trial. This study was performed on 84 postmenopausal women. The participants were randomly divided into control and intervention groups. The participants of the intervention group received one black cohosh tablet per day and the control group received one placebo tablet per day for eight weeks. The severity of vasomotor symptoms and number of hot flashes were recorded during the pre-intervention phase, and 4 and 8 weeks after the intervention. The data were analyzed using repeated measures ANOVA and ANCOVA tests. The level of significance was considered lower than 0.05. Results: There was a significant difference between the two groups in terms of severity and number of hot flashes in weeks 4 and 8 by controlling the intensity of vasomotor symptoms and number of hot flashes before the intervention. Moreover, using repeated measures ANOVA, the intergroup comparison indicated a significant difference in bothgroups (the test and control groups) in terms of severity of vasomotor symptoms and number of hot flashes. Conclusion: According to the findings of the study, it seems that black cohosh can be used as an effective alternative medicine in relieving menopausal vasomotor symptoms.Scandinavian Journal of Caring Sciences 06/2013; 2(2):105-113. DOI:10.5681/jcs.2013.013 · 0.89 Impact Factor
[Show abstract] [Hide abstract]
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. Key pointsSeveral non-hormonal alternatives to hormonal therapy have been established and registered for the treatment of vasomotor climacteric symptoms in peri- and post-menopausal women.There are indications that non-hormonal treatments are useful alternatives in patients with a history of breast and prostate cancer. However, confirmation by larger clinical trials is required.SpringerPlus 12/2015; 4(1). DOI:10.1186/s40064-015-0808-y
[Show abstract] [Hide abstract]
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.Journal of Pharmacology and Experimental Therapeutics 08/2014; 351(2). DOI:10.1124/jpet.114.218024 · 3.86 Impact Factor