Cimicifuga racemosa bei klimakterischen Beschwerden

 

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Zusammenfassung

Seit Jahrzehnten wird Extrakten aus Cimicifuga racemosa (CR) zur Behandlung klima­k­terischer Beschwerden ein positives Nutzen-Risiko-Profil bescheinigt. Ein kürzlich erschienener systematischer Review stellte unter Differenzierung der eingesetzten CR-Extrakte in von 2000 bis 2012 publizierten klinischen Studien fest, dass nur zugelassene Arzneimittel einen signifikanten Therapieerfolg zeigten. Level-1-Evidenz und Empfehlungsgrad A erbrachte nur ein isopropanolischer CR-Spezialextrakt (iCR), der an über 11 000 Patientinnen untersucht wurde. In dem vorliegenden Update wurden weitere klinische Studien für den Zeitraum von 2012 bis 2014 recherchiert. Identifiziert wurden 8 neue Studien mit ca. 1000 Frauen mit menopausalen Beschwerden: 5 Studien plus 1 Subgruppenanalyse (China) mit iCR, 1 Studie (Schweiz) mit dem ethanolischen Extrakt Ze 450 und 2 Studien (Iran und Thailand) jeweils mit ethanolischem Extrakt. Es bestätigte sich, dass nur die Studien erfolgreich waren, die ein zugelassenes CR-Arzneimittel einsetzten (7/8). Übereinstimmend zeigten die CR-Extrakte ein gutes/sehr gutes Sicherheitsprofil, keine östrogenartigen Effekte und keine Auffälligkeiten in den durchgeführten Leberfunktionstests.

Die Ergebnisse dieser Literaturrecherche legen nahe, dass aufgrund der pharmazeutischen Qualität nur zugelassene Arzneimittel aus Cimicifugawurzelstock zuverlässig wirksam sind. Insgesamt liegen für den iCR-Extrakt (Remifemin®) weltweit die meisten klinischen Studien vor.

Summary

Treating menopause symptoms with black cohosh: Recent data confirm efficacy and safety

Cimicifuga racemosa is an outstanding example for evidence-based phytomedicine and for many decades internationally accepted for menopause symptoms treatment with a positive benefit-risk-ratio. A recent systematic review on clinical trials from 2000 to 2012 with respect to differentiation of the used extracts proved that only officially authorized medicinal products show significant therapeutic success. Only a special isopropanolic CR-extract (iCR) studied in about 11,000 patients furnished proof for evidence level 1 and grade A of recommendation. The current update includes studies from 2012 to 2014. Worldwide 8 new studies could be identified involving about 1,000 women complaining about menopausal symptoms: 5 studies plus 1 subgroup-analysis (China) with the iCR, 1 study (Switzerland) with the ethanolic extract Ze 450 and 2 studies (Iran and Thailand) each using an ethanolic extract. The results confirmed that only those clinical trials conducted with officially approved extracts showed beneficial results (7/8). All studies concurred that CR-extracts showed good to very good safety profile, no estrogenic effects and no abnormalities with respect to liver function tests.

Results of this literature search on clinical trials suggest that due to the pharmaceutical quality control and review by the authorities, it is only those officially approved Cimicifuga racemosa products that are effective and reliable. The majority of clinical trials worldwide were performed with the iCR (Remifemin®).

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