The effect of a Cimicifuga racemosa extracts Ze 450 in the treatment of climacteric complaints – an observational study.

Abstract: Background: Root extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints. Method: In this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions. Physicians were suggested to treat patients for the first 3 months with 13mg/d CR (high dose, HD) and to continue over additional 6 months either with this treatment or to switch to 6.5mg/d CR (low dose, LD). The choice of treatment and its dose, however, was fully at the discretion of the physician. Results: After 3-months treatment with HD, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p <0.001) from baseline values. Continuation of treatment with HD or LD decreased total KMI and its sub-item scores further (HD, LD: p <0.001). However, more patients (84.9%) responded to HD than to LD (78.4%) and showed an improvement of symptoms (p =0.011). Conclusion: This observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial. [Copyright &y& Elsevier]