Abstract
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.
Highlights
60 Jahre Arzneimittel aus Cimicifuga racemosaMeilensteine klinischer Forschung, aktuelle Studienergebnisse und derzeitige Entwicklung den weltweit an Bedeutung gewonnen
The current issue of the Wiener Medizinische Wochenschrift is dedicated to therapy with products containing herbal ingredients
In 2010, the Herbal Medicinal Product Committee (HMPC) of the European Medicinal Agency monograph attested the well-established use of drugs containing Cimicifuga racemosa (CR) extract based on previously published studies on menopausal symptoms
Summary
Meilensteine klinischer Forschung, aktuelle Studienergebnisse und derzeitige Entwicklung den weltweit an Bedeutung gewonnen. The second placebo-controlled clinical study for iCR followed from 2002 to 2005 (MRS, Germany). Controlled studies comparing iCR with other MPS therapies showed no differences in efficacy compared to hormone patches (2005, Italy) and tibolone, but iCR was superior regarding safety (2007, China) Another CR product (Remixin® [Mikro-Gen, Istanbul, Turkey]) was compared to fluoxetine, with inferiority in the psychological component of the MPS and superiority in the KMI (2008, Turkey). In 2010, the Herbal Medicinal Product Committee (HMPC) of the European Medicinal Agency monograph attested the well-established use of drugs containing CR extract based on previously published studies on menopausal symptoms. The latest placebo-controlled clinical study with iCR came from China Second placebo-controlled study on iCR confirms efficacy, identifies confounders influencing the effect size, first Germany subtle hints of supra-hypothalamic CNS influence. Systematic review on efficacy (18 studies) and safety (35 studies); conclusive evidence on efficacy if of licensed Germany product quality
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