Black Cohosh (Actaea racemosa) and Hot flashes: evidence and sources

Importance Black cohosh (BC) is a herbal medicine being prescribed for the management of climacteric complaints. This is the first review to assess the quality of evidence for BC as measured by adherence to Consolidated Standards of Reporting Trials (CONSORT) extensions for herbal interventions and harms. Objective Herbal medicines such as Actaea racemosa ( A. racemosa ; synonym Cimicifuga racemosa , BC) are commonly being used by women seeking relief from menopausal (climacteric) complaints. Our objective is to evaluate the quality of reporting of clinical trials investigating A. racemosa for climacteric complaints, by grading their adherence to both the CONSORT extensions for herbal interventions, and for reporting adverse events (harms). Evidence review A systematic search of the databases: AMED, CINAHL, EBSCO, Academic Search Ultimate, Google Scholar, PubMed and Science Direct, was conducted in April 2023 and another search done March 2024. The search phrase employed included relevant herbal or herbal product keywords ["black cohosh," "actaea racemosa," "cimicifuga racemosa," "BNO 1055," "remifemin," "Ze 450"] combined using the Boolean operator term AND with keywords regarding climacteric complaints ["menopausal symptoms," "menopause," "climacteric complaints"]. Additional citation searching was conducted to identify any other published studies. Articles were included if they were clinical trials of oral use of A. racemosa in humans. Quality assessment of included articles was undertaken to review adherence to the CONSORT Statement Extensions for reporting on herbal interventions, and harms (adverse events). Findings Fourteen records were included in the final analysis. Adherence to the herbal extension for the CONSORT ranged between 39% and 87%, with four of them receiving an adherence rating of 50% or less. Adherence to the Harms Extension for the CONSORT ranged between 6% and 90%, with three of the articles receiving an adherence rating of 50% or less. Conclusions and relevance This is the first time a systematic review of the quality of clinical trial reports of BC, using the CONSORT herbal extension and harms checklists, has been conducted. The wide range of ratings found in our quality assessment suggests the need for further high-quality investigation of this widely used herbal preparation.

Black cohosh ( Cimicifuga racemosa ) is a perennial plant used to treat menopause. This plant is known to have a serotonergic rather than estrogenic impact. It has been recommended to treat vasomotor symptoms associated with breast cancer patients. It also relieves symptoms such as night sweats and hot flashes, commonly called vasorelaxation. The variability in the study's results, doses, and assessment methods requires more rigorous research to establish its efficacy and safety. Standardized trials are needed to provide more precise information on the benefits and limitations of menopause treatment, informing women seeking alternatives to hormone therapy. Black cohosh has shown the potential to reduce the frequency and intensity of vasomotor symptoms in breast cancer patients undergoing tamoxifen treatment. In addition to its effectiveness in alleviating night sweats and hot flashes, the vasorelaxation properties contribute to its overall positive impact on menopausal symptoms. Due to discrepancies, varying dosages, and assessment techniques, further comprehensive studies are essential to determine the optimal dosage, long-term safety, and overall efficacy. Only through standardized trials can women make informed decisions about black cohosh as a viable alternative to hormone therapy during menopause.

Background Cimicifuga racemosa extracts (CRE) have obtained a "well-established use status" in the treatment of postmenopausal (i.e., climacteric) complaints, which predominantly include vasomotor symptoms such as hot flushes and sweating, as well as nervousness, irritability, and metabolic changes. Although characteristic postmenopausal complaints are known for a very long time and the beneficial effects of CRE on climacteric symptoms are well accepted, both the pathophysiology of postmenopausal symptoms and the mechanism of action of CREs are not yet fully understood. In particular, current hypotheses suggest that changes in the α-adrenergic and serotonergic signaling pathways secondary to estrogen depletion are responsible for the development of hot flushes. Purpose Some of the symptoms associated with menopause cannot be explained by these hypotheses. Therefore, we attempted to extend our classic understanding of menopause by integrating of partly age-related metabolic impairments. Methods A comprehensive literature survey was performed using the PubMed database for articles published through September 2021. The following search terms were used: (cimicifuga OR AMPK) AND (hot flush* OR hot flash* OR menopaus* OR osteoporos* OR cancer OR antioxida* OR cardiovasc*). No limits were set with respect to language, and the references cited in the articles retrieved were used to identify additional publications. Results We found that menopause is a manifestation of the general aging process, with specific metabolic changes that aggravate menopausal symptoms, which are accelerated by estrogen depletion and associated neurotransmitter dysregulation. Cimicifuga extracts with their metabolic effects mitigate climacteric symptoms but may also modulate the aging process itself. Central to these effects are effects of CRE on the metabolic key regulator, the AMP-activated protein kinase (AMPK). Conclusions As an extension of this effect dimension, other off-label indications may appear attractive in the sense of repurposing of this herbal treatment.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR ( p Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR ( p Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Since conventional hormone replacement therapy has fallen out of favour, alternatives are being sought by many women. These therapies include herbal preparations such as black cohosh (Cimicifuga racemosa). The purpose of this update of a previous systematic review is to evaluate the clinical evidence for or against the efficacy of black cohosh in alleviating menopausal symptoms. Five computerized databases (Medline, Embase, Amed, Phytobase and Cochrane Library) were searched to identify all clinical data that provided evidence on the efficacy of C. racemosa. Bibliographies of the articles thus located were scanned for further relevant publications. Only double blind, randomized, clinical trials (RCTs) were included in the evaluation of efficacy. No language restrictions were imposed. Trials were excluded if they did not focus on menopausal problems, they included women suffering medically induced menopause, they did not use black cohosh monopreparations, or they did not use placebo or a standard drug treatment for the control group. Six studies with a total of 1112 peri- and post-menopausal women met our inclusion criteria. The evidence from these RCTs does not consistently demonstrate an effect of black cohosh on menopausal symptoms; a beneficial effect of black cohosh on peri-menopausal women cannot be excluded. The efficacy of black cohosh as a treatment for menopausal symptoms is uncertain and further rigorous trials seem warranted.

Objective This randomized, double-blind, parallel-group clinical trial aimed to evaluate the efficacy of Black Cohosh, Soy Isoflavones, and SDG Lignans in alleviating menopausal symptoms compared to a placebo. Methods Ninety-six postmenopausal women aged 45-60 years were enrolled. Participants were randomized to receive either the study supplements or a placebo for 90 days, with Menopause Rating Scale (MRS) scores collected at baseline and every 4 weeks to monitor symptom changes. Secondary outcomes assessed included hormonal variations and the incidence of adverse symptoms. Results Of the initial cohort, 90 participants completed the study with high adherence. Significant improvements were observed in the treatment group across all MRS domains: somatic (- 54.3% difference, p Conclusion Black Cohosh, Soy Isoflavones, and SDG Lignans significantly reduced menopausal symptoms with a favorable safety profile. These findings support the potential of this supplement combination as a therapeutic option for menopausal symptom management. Trial registration ClinicalTrials.gov NCT06328348.

Objectives To evaluate the effectiveness of black cohosh extract 40 mg/day for relieving moderate to severe menopausal symptoms and improving quality of life in Thai women. Methods A randomized, double-blind, placebo-controlled clinical trial was conducted in a menopause clinic of a tertiary-care university hospital during 2011-2013. Participants were peri- or postmenopausal Thai women aged at least 40 years, who have moderate to severe menopausal symptoms evaluated using the Kupperman index (KI). Outcome measures included KI, frequency of hot flushes, Menopause-Specific Quality of Life (MENQOL) score, participants' global satisfaction and safety outcomes. Results There were 54 participants assigned to treatment (black cohosh extract 40 mg/day, n = 27) or placebo group (n = 27). Both the treatment and placebo groups had comparable baseline KI scores (33.9 ± 7.9 vs. 31.3 ± 6.8), frequency of hot flushes (3.1 ± 2.0 vs. 2.8 ± 2.1), and MENQOL scores, all of which improved with time. Neither the improvements nor the global satisfaction were significantly different between the two groups; but the proportion of participants with moderate to severe symptoms seemed to be lower in the treatment group than in the placebo group (40% vs. 60%, p = 0.174). There was no serious adverse event or significant change in liver function tests. Conclusions A black cohosh extract of 40 mg/day is not superior to a placebo for relieving moderate to severe menopausal symptoms or improving quality-of-life scores in Thai women.

Purpose Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (P = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (P = .36). Patient treatment preferences were measured after completion of both treatment periods by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Conclusion This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Women's health is an imminent concern worldwide, but it remains an ignored segment of research in most developing countries, and is yet to take the center stage in even developed nations. Some exclusive female health concerns revolve around both pathological and physiological aspects. These gender-specific maladies include breast, cervical, and ovarian cancers, and physiological concerns such as menopause and osteoporosis, which are often coexistent. Recently, women's health issues, including postmenopausal syndrome, have attracted the attention of researchers and practitioners alike, opening newer pharmaceutical research and clinical avenues. Although not counted as a disease, postmenopausal syndrome (PMS) is a female health phenomenon underpinned by hormonal depletion. Enhanced life expectancy in women has added to their suffering, and pharmacological interventions are needed. Amongst the available treatment modalities, the use of numerous botanicals has emerged as an efficient health management tool for women. Cimicifuga racemosa (CR or Black Cohosh) is a plant/herb which has been traditionally exploited and extensively used by women. This review is an attempt to compile and provide a summary of the importance of CR in complementary and alternative therapies for the improvement of various disorders related to women, such as menopausal syndrome, mammary cancer, and osteoporosis. It aims to systematically highlight the bioactive constituents, pharmacology, pharmacokinetics, therapeutic potentials, quality control processes, chromatographic techniques, and possible mechanisms of action of clinically effective phytomedicine for women's health. Various clinical trials and patents relating to CR and women's health have been collated. Furthermore, the plant and its related products have been considered from a regulatory perspective to reveal its commercial feasibility. The present review summarizes the existing data on CR focusing on women's health, which can help to introduce this traditional phytomedicine to the world and provide some reference for future drug development.