The effect of a Cimicifuga racemosa extracts Ze 450 (simidona) in the treatment of climacteric complaints – an observational study
Keywords:menopausal symptoms, Cimicifuga racemosa, observational study, Kupperman Menopause Index, phytotherapy, Ze 450
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 13 mg/d CR (high dose) and to continue over additional 6 months either with this treatment or to switch to 6.5 mg/d CR (low dose). The choice of treatment and its dose, however, was fully at the discretion of the physician.
Results: After 3-months treatment with high dose, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p < 0.001) from baseline values. Continuation of treatment with high dose or low dose decreased total KMI and its sub-item scores further (high dose, low dose: p < 0.001). However, more patients (84.9%) responded to high dose than to low dose (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. Treatment with both doses Ze 450 (low and high dose) is well tolerated by patients and has an additional positive effect in extending the treatment for more than 3 months, with a further decrease in the total KMI. However, prolonged treatment with a high dose is more efficient, since it, in contrast to the low dose therapy, can significantly reduce each of menopausal symptoms.
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