60 years of Cimicifuga racemosa medicinal products : Clinical research milestones, current study findings and current development.
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.
Clinical Research, Schaper & Brümmer GmbH & Co. KG, Bahnhofstraße 35, 38259, Salzgitter, Germany. h.v.zepelin@schaper-bruemmer.de.
Hans-Heinrich
HH
Henneicke-von Zepelin
D016907:Adverse Drug Reaction Reporting Systems; D031885:Cimicifuga; D002979:Climacteric / Q000187:drug effects*; D018849:Controlled Clinical Trials as Topic; D005060:Europe; D005260:Female; D005858:Germany; D006801:Humans; D064887:Observational Studies as Topic; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
C584106:Klimadynon; D010936:Plant Extracts; C073419:Remifemin
Actaea racemosa; Black Cohosh; Cimicifuga racemosa; Climacteric complaints; Cognition; Myoma; Osteoporosis; Survival after breast cancer