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Evidence-Based Complementary and Alternative Medicine
Volume 2012 (2012), Article ID 260301, 10 pages
http://dx.doi.org/10.1155/2012/260301
Research Article

Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study

1Institute for Health Care and Science, 35625 Hüttenberg, Germany
2Institute of Complementary Medicine, University Hospital Zurich (UHZ), 8091 Zurich, Switzerland
3Brunner & Hess, 8038 Zurich, Switzerland
4Clinic for Psychiatry and Psychotherapy, UHZ, 8091 Zurich, Switzerland
5Max Zeller Söhne AG, 8590 Romanshorn, Switzerland

Received 10 August 2012; Accepted 7 October 2012

Academic Editor: Bernhard Uehleke

Copyright © 2012 Ruediger Schellenberg et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients’ self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65–19.35) score points, for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55–11.39) score points, for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.