Abstract:Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication.
A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The resul… Show more
“…The safety and efficacy of AR in the treatment of perimenopausal syndrome have been confirmed [2, 3], but its potential treatment mechanism is still unknown. It is widely recognized that AR activating the neurotransmitter-based effects [24–27], rather than the estrogen activity [28, 29], is an important mechanism for alleviating menopausal symptoms, such as hot flashes and night sweats.…”
Section: Discussionmentioning
confidence: 99%
“…Actaea racemosa (AR) extract has long been used to treat perimenopausal syndrome because it does not contain estrogen but has effects to alleviate menopausal symptoms, particularly hot flushes, night sweats, and correlated sleep disturbances [2, 3]. In addition, its safety and efficacy have already been confirmed [2–11].…”
Section: Introductionmentioning
confidence: 99%
“…In addition, its safety and efficacy have already been confirmed [2–11]. Clinical tests have shown that AR influenced the levels of bone turnover markers in the serum of patients with PMOP, demonstrating its protective effect on the bone [12, 13].…”
Purpose/Objective. To investigate the effect of Actaea racemosa (AR) extract on in vitro osteogenic differentiation of rat bone marrow mesenchymal stem cells (BMSCs) via the ER/NO/cGMP signaling pathway. Methods/Materials. Rat BMSCs were treated with osteogenic differentiation-inducing medium containing AR; estrogen receptor antagonist, ICI 182,780 (10−6 mol/L); and nitric oxide synthase inhibitor, L-nitro arginine methyl ester (L-NAME, 6 × 10−3 mol/L). Markers of osteogenic differentiation (alkaline phosphatase [ALP] activity, osteocalcin secretion, and calcium ion deposit levels) and the levels of key signaling molecules (nitric oxide synthase [NOS], nitric oxide [NO], and cyclic guanosine monophosphate [cGMP]) were assessed. Results. AR (10−1–10−6 g/L) increased ALP activity in a dose-dependent manner, and the highest ALP, osteocalcin, and osteoprotegerin activities were achieved at an AR concentration of 10−4 g/L. Therefore, the concentration of 10−4 g/L was used for promoting osteogenic differentiation of BMSCs in subsequent analyses. At this concentration, AR increased the levels of NO and cGMP, and such effects could be blocked by the estrogen receptor antagonist (ICI 182,780) and nitric oxide synthase inhibitor (L-NAME). Conclusion. AR induced osteogenic differentiation of rat BMSCs through the ER/NO/cGMP signaling pathway. This finding provides the theoretical foundation for the mechanism of AR in the treatment of postmenopausal osteoporosis.
“…The safety and efficacy of AR in the treatment of perimenopausal syndrome have been confirmed [2, 3], but its potential treatment mechanism is still unknown. It is widely recognized that AR activating the neurotransmitter-based effects [24–27], rather than the estrogen activity [28, 29], is an important mechanism for alleviating menopausal symptoms, such as hot flashes and night sweats.…”
Section: Discussionmentioning
confidence: 99%
“…Actaea racemosa (AR) extract has long been used to treat perimenopausal syndrome because it does not contain estrogen but has effects to alleviate menopausal symptoms, particularly hot flushes, night sweats, and correlated sleep disturbances [2, 3]. In addition, its safety and efficacy have already been confirmed [2–11].…”
Section: Introductionmentioning
confidence: 99%
“…In addition, its safety and efficacy have already been confirmed [2–11]. Clinical tests have shown that AR influenced the levels of bone turnover markers in the serum of patients with PMOP, demonstrating its protective effect on the bone [12, 13].…”
Purpose/Objective. To investigate the effect of Actaea racemosa (AR) extract on in vitro osteogenic differentiation of rat bone marrow mesenchymal stem cells (BMSCs) via the ER/NO/cGMP signaling pathway. Methods/Materials. Rat BMSCs were treated with osteogenic differentiation-inducing medium containing AR; estrogen receptor antagonist, ICI 182,780 (10−6 mol/L); and nitric oxide synthase inhibitor, L-nitro arginine methyl ester (L-NAME, 6 × 10−3 mol/L). Markers of osteogenic differentiation (alkaline phosphatase [ALP] activity, osteocalcin secretion, and calcium ion deposit levels) and the levels of key signaling molecules (nitric oxide synthase [NOS], nitric oxide [NO], and cyclic guanosine monophosphate [cGMP]) were assessed. Results. AR (10−1–10−6 g/L) increased ALP activity in a dose-dependent manner, and the highest ALP, osteocalcin, and osteoprotegerin activities were achieved at an AR concentration of 10−4 g/L. Therefore, the concentration of 10−4 g/L was used for promoting osteogenic differentiation of BMSCs in subsequent analyses. At this concentration, AR increased the levels of NO and cGMP, and such effects could be blocked by the estrogen receptor antagonist (ICI 182,780) and nitric oxide synthase inhibitor (L-NAME). Conclusion. AR induced osteogenic differentiation of rat BMSCs through the ER/NO/cGMP signaling pathway. This finding provides the theoretical foundation for the mechanism of AR in the treatment of postmenopausal osteoporosis.
“…In these studies 10,049 patients received a CR-based medicinal product, 93% thereof iCR (Fig. 1; [44–46]).Fig. 1Efficacy data sets from clinical studies on Cimicifuga racemosa ( CR ) from 2000 to 2015. iCR isopropanolic extract of CR rootstock, HP Hypericum perforatum, LOE Oxford Level of Evidence, GR Oxford Grade of Recommendation
…”
Section: Hmpc Monograph and Meta-analysesmentioning
confidence: 99%
“…This principle is fulfilled already by the 6141 patients exposed to iCR for at least 6 months in the study by Briese et al. [36] and several additional hundreds of patients in all the other clinical studies on iCR (for a complete list see [44] and its update [45]).should be at least 100 treated for 12 months. This principle is fulfilled by the 736 patients exposed to iCR for 12 months in the study by Briese et al.…”
Summary
Cimicifuga racemosa (CR) extracts are important worldwide as therapy for menopausal symptoms. The first medicinal product from CR has been available since 1956 (Germany, Remifemin® [Schaper & Brümmer, Salzgitter, Germany], isopropanolic extract iCR). This review describes how CR developed, via clinical studies on safety (breast, breast cancer, endometrium, liver) and efficacy, into a successful and safe medicinal product in Germany, Europe and the world. In line with developing legal frameworks for medicinal products in Germany and Europe, clinical studies on CR were observational during the 50s and 70s, and controlled studies since the 80s. The first placebo-controlled study emerged 1986. From 2000 to 2015, a total of 28 clinical studies in Europe, America and Asia were published on the efficacy of CR. In these studies, 11,073 patients received a CR-based medicinal product, 93% thereof iCR. A meta-analysis of all nine placebo-controlled studies published until 2013 confirmed the reliable efficacy of CR-based medicinal products for menopausal symptoms.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
