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      Cimicifuga racemosa (L.) Nutt. en el tratamiento de los síntomas vasomotores de la menopausia: revisión Translated title: Cimicifuga racemosa (L.) Nutt. in the treatment of vasomotor symptoms of menopause: a review

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          Abstract

          Resumen Introducción: Diversos estudios han puesto de manifiesto que los preparados a base de los rizomas y raíces de cimicífuga (Cimicifuga racemosa (L.) Nutt.) pueden ser útiles para aliviar los síntomas menopáusicos. El objetivo de este trabajo es realizar una revisión de la eficacia y seguridad de estos preparados en el tratamiento de los síntomas vasomotores de la menopausia. Método: Se realizó una búsqueda de los artículos publicados desde enero de 2005 a marzo de 2021 en el buscador de recursos de la Universidad de La Laguna, “el Punto Q”. Se seleccionaron los ensayos clínicos aleatorizados y controlados, que tuvieran las palabras claves en el resumen, texto o título, tanto en inglés como en español. Resultados: Se identificaron 13 ensayos clínicos que incluían los criterios de selección establecidos. Se encontró que los preparados de cimicífuga (principalmente extractos comerciales estandarizados en su contenido en principios activos) produjeron en la mayoría de los estudios una reducción significativa comparada con el placebo de los síntomas vegetativos (sofocos y sudores nocturnos) y psicológicos de la menopausia, así como una mejoría de la calidad de vida. No se observaron efectos adversos serios a las dosis utilizadas. Conclusiones: Los extractos de cimicífuga pueden ser eficaces y seguros para el tratamiento de los síntomas vegetativos y psicológicos de la menopausia, siendo bien tolerados. No obstante, son necesarios más ensayos clínicos con mayor número de pacientes, más extensos, uso de preparaciones estandarizadas, así como con criterios similares de inclusión y valoración de los síntomas, para obtener datos más concluyentes.

          Translated abstract

          Abstract Introduction: Several studies have shown that preparations based on the rhizomes and roots of black cohosh (Cimicifuga racemosa (L.) Nutt.) can be useful in alleviating the menopausal symptoms. The aim of this study is to perform an update bibliographic review of the efficacy and safety of black cohosh in the treatment of the vasomotor symptoms of menopause. Method: A review of published articles from January 2005 to March 2021 in the resource search engine of the University of La Laguna, el punto Q”. Randomized and controlled clinical trials, which had the key words in the abstract, text or title, in both English and Spanish, were selected. Results: We found 13 trials which met the selection criteria. The studies reviewed showed that the black cohosh preparations (mainly commercial extracts standardized in their content of active ingredients) produced in most of the studies a significant reduction compared to placebo in the vegetative (hot flashes and night sweats) and psychological symptoms of menopause, as well as an improvement in the quality of life. No serious adverse effects were reported at the dose administered. Conclusions: Cimicifuga racemosa extracts can be effective and safe for the treatment of vegetative and psychological symptoms of menopause, being well tolerated. However, more clinical trials with a larger number of patients, more extensive, the use of standardized preparations, as well as similar criteria for inclusion and assessment of symptoms, are necessary to obtain more conclusive data.

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          Botanicals and Their Bioactive Phytochemicals for Women’s Health

          Botanical dietary supplements are increasingly popular for women’s health, particularly for older women. The specific botanicals women take vary as a function of age. Younger women will use botanicals for urinary tract infections, especially Vaccinium macrocarpon (cranberry), where there is evidence for efficacy. Botanical dietary supplements for premenstrual syndrome (PMS) are less commonly used, and rigorous clinical trials have not been done. Some examples include Vitex agnus-castus (chasteberry), Angelica sinensis (dong quai), Viburnum opulus/prunifolium (cramp bark and black haw), and Zingiber officinale (ginger). Pregnant women have also used ginger for relief from nausea. Natural galactagogues for lactating women include Trigonella foenum-graecum (fenugreek) and Silybum marianum (milk thistle); however, rigorous safety and efficacy studies are lacking. Older women suffering menopausal symptoms are increasingly likely to use botanicals, especially since the Women’s Health Initiative showed an increased risk for breast cancer associated with traditional hormone therapy. Serotonergic mechanisms similar to antidepressants have been proposed for Actaea/Cimicifuga racemosa (black cohosh) and Valeriana officinalis (valerian). Plant extracts with estrogenic activities for menopausal symptom relief include Glycine max (soy), Trifolium pratense (red clover), Pueraria lobata (kudzu), Humulus lupulus (hops), Glycyrrhiza species (licorice), Rheum rhaponticum (rhubarb), Vitex agnus-castus (chasteberry), Linum usitatissimum (flaxseed), Epimedium species (herba Epimedii, horny goat weed), and Medicago sativa (alfalfa). Some of the estrogenic botanicals have also been shown to have protective effects against osteoporosis. Several of these botanicals could have additional breast cancer preventive effects linked to hormonal, chemical, inflammatory, and/or epigenetic pathways. Finally, although botanicals are perceived as natural safe remedies, it is important for women and their healthcare providers to realize that they have not been rigorously tested for potential toxic effects and/or drug/botanical interactions. Understanding the mechanism of action of these supplements used for women’s health will ultimately lead to standardized botanical products with higher efficacy, safety, and chemopreventive properties.
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            Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.

            To investigate the efficacy-safety balance of the isopropanolic extract of Actaea (=Cimicifuga) racemosa (iCR, Remifemin) in comparison with tibolone in Chinese women with climacteric complaints. The randomized, double-blind, controlled 3-month study in 5 centers of 3 cities in China enrolled 244 menopausal patients aged 40-60 years and with a Kupperman Menopause Index (KMI)>or=15. The participants were assigned to either iCR corresponding to 40 mg crude drug/day (N=122) or tibolone 2.5mg/day (N=122) orally. The primary endpoint was the combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events (benefit-risk balance) at end of treatment (MWV>0.5 shows superiority; MWV>0.36 shows non-inferiority). KMI decreased from 24.7+/-6.1 to 11.2+/-6.2 and 7.7+/-5.8 (iCR) and to 11.2+/-7.2 and 7.5+/-6.8 (tibolone) at 4 and 12 weeks. This remarkable and clinically relevant improvement was similar in both treatment groups (MWV=0.47; 95% CI=0.39-0.54; p(non-inferiority)=0.002) showing statistical significant non-inferiority of iCR to tibolone. The KMI-responder rate was similar in both groups (84% and 85%). The safety evaluation showed for both groups a good safety and tolerability profile, however, there is a significant lower incidence of adverse events (p<0.0001) in favor of the herbal treatment. None of the postmenopausal iCR patients experienced vaginal bleeding in contrast to tibolone (17 cases). Breast and abdominal pain as well as leukorrhea was mostly observed in the tibolone group (p=0.015, p=0.008, p=0.002). No serious adverse event was observed in the iCR-group, however, two occurred in the tibolone-group. The benefit-risk balance for iCR was significantly (p=0.01) superior to tibolone (MWV=0.56; 95% confidence interval [0.51-0.62]). The efficacy of iCR (medicinal product Remifemin) is as good as tibolone for the treatment of climacteric complaints, even for moderate to severe symptoms, whereby iCR is clearly superior regarding the safety profile. This iCR containing medicinal product is an excellent option for treatment of climacteric complaints which has now for the first time been verified in Asian women.
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              Traditional uses, phytochemistry, pharmacology and toxicology of the genus Cimicifuga : A review

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                Author and article information

                Journal
                ars
                Ars Pharmaceutica (Internet)
                Ars Pharm
                Universidad de Granada (Granada, Granada, Spain )
                2340-9894
                June 2022
                : 63
                : 2
                : 178-188
                Affiliations
                [1] La Laguna Tenerife orgnameUniversidad de La Laguna orgdiv1Facultad de Farmacia orgdiv2Departamento de Medicina Física y Farmacología España
                Article
                S2340-98942022000200178 S2340-9894(22)06300200178
                10.30827/ars.v63i2.21894
                ed7d60a9-bb81-44cc-a4e8-3c2ca01f38f7

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

                History
                : 21 November 2021
                : 28 July 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 19, Pages: 11
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                SciELO Spain

                Categories
                Artículos de Revisión

                Cimicifuga racemosa,review,vasomotor symptoms,hot flushes,menopause,revisión,síntomas vasomotores,sofocos,menopausia

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