Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.

C Castelo-Branco, M Gambacciani, A Cano, M J Minkin, D Rachoń, X Ruan, A-M Beer, J Schnitker, H-H Henneicke-von Zepelin, S Pickartz

Journal: Climacteric : the journal of the International Menopause Society 2021;24(2):109-119

PMID: 33021111

Abstract

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic 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 ( < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort ( [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.

Address: Clinic Institute of Gnyecology, Obstetrics and Neonatology, Faculty of Medicine, University of Barcelona, Hospital Clinic-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.; Menopause Center, Department of Obstetrics and Gynecology, University of Pisa, Pisa, Italy.; Department of Obstetrics and Gynecology, University of Valencia, Valencia, Spain.; Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, USA.; Department of Clinical and Experimental Endocrinology, Medical University of Gdańsk, Gdańsk, Poland.; Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.; Hospital for True Naturopathy, Katholisches Klinikum Bochum, Blankenstein Hospital, Hattingen, Germany.; Institut für Angewandte Statistik (IAS) GmbH, Bielefeld, Germany.; Clinical Research, Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany.; Medical Service, Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany.
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