Abstract
Objective: The aim of this study was to evaluate the efficacy and safety of long-term treatment with Cimicifuga foetida extract in menopausal women.
Methods: A prospective, randomized, controlled clinical trial was conducted. A total of 96 early postmenopausal women were randomly assigned to three groups: group A received 1 mg estradiol valerate daily plus 4 mg medroxyprogesterone acetate on days 19–30; group B received 1 mg estradiol valerate daily plus 100 mg micronized progesterone on days 19–30; group C received 100 mg C. foetida extract daily. The efficacy was evaluated. Safety parameters were recorded.
Results: A total of 81 patients completed the treatment and follow-up visit. The modified Kupperman Menopausal Index scores decreased after 3 months in all groups. No significant changes were observed in the liver, renal function and components of metabolic syndrome in group C (p > 0.05). There were no significant differences in the incidences of metabolic syndrome among the three groups (p > 0.05). After 24 months, the endometrial thickness increased significantly in group B (p = 0.014), but not in the C. foetida extract group (p > 0.05).
Conclusions: C. foetida extract is safe and effective for the treatment of menopausal symptoms in postmenopausal women.
Acknowledgements
All authors have fulfilled the conditions required for authorship. Tingping Zheng, Wei Xue, Yanfang Wang, and Yan Deng were primarily responsible for the implementation of the experiment. Lihong Gao and Hongling Zuo performed the statistical analysis. The primary goal of this manuscript was proposed by Aijun Sun. All authors have reviewed the final version of the manuscript.
Conflict of interest
The authors declare that there is no conflict of interest regarding the publication of this paper.