Park Eun-Ji, Baek Seon-Eun, Kim Mikyung, Kim Ae-Ran, Park Hyo-Ju, Kwon Ojin, Lee Jun-Hwan, Yoo Jeong-Eun
Department of Obstetrics and Gynecology, Cheonan Korean Medicine Hospital of Daejeon University, Cheonan, Republic of Korea.
Department of Obstetrics and Gynecology, Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea.
Integr Med Res. 2021 Sep;10(3):100715. doi: 10.1016/j.imr.2021.100715. Epub 2021 Jan 9.
has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of for treating climacteric syndrome with a blood-deficiency-dominant pattern.
This was a randomized, double-blind, placebo-controlled pilot trial. A group of 45-to 60-year-old women with climacteric syndrome were registered for the trial. The participants received treatment over a 4-week period and were then followed for 4 weeks. The primary outcome measure was the mean change in the Menopause Rating Scale (MRS). Secondary outcome measures included the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Blood-Deficiency Scoring System (BDSS), lean body mass, and serum hormone levels, including follicle-stimulating hormone (FSH) and estradiol (E) levels.
The MRS and BDSS scores decreased significantly in both groups, but the differences between two groups were not significant. The WHOQOL-BREF scores increased in the control group. No statistically meaningful differences in serum hormone levels or lean body mass were observed in both groups. There were no serious adverse events, and the laboratory tests were within the normal range. The recruitment rate, completion rate and medication adherence rate were over 90% in both groups, indicating high feasibility.
showed clinical effectiveness in the treatment of climacteric syndrome with a blood-deficiency-dominant pattern. Additionally, was shown to be safe and feasible for a large-scale study to confirm the efficacy of the treatment. Trial registration: Clinical Research Information Service (CRIS, https://cris.nih.go.kr): KCT0002387.
在传统东亚医学中，一直是治疗妇科疾病最常用的草药之一。几项关于[草药名称未给出]的临床研究表明其可改善更年期症状。本试点研究旨在评估[草药名称未给出]治疗以血虚为主型更年期综合征的疗效、安全性和可行性。
这是一项随机、双盲、安慰剂对照的试点试验。一组45至60岁患有更年期综合征的女性登记参加试验。参与者接受为期4周的治疗，然后随访4周。主要结局指标是更年期评定量表（MRS）的平均变化。次要结局指标包括世界卫生组织生活质量简表（WHOQOL - BREF）、血虚评分系统（BDSS）、瘦体重以及血清激素水平，包括促卵泡生成素（FSH）和雌二醇（E）水平。
两组的MRS和BDSS评分均显著下降，但两组之间的差异不显著。对照组的WHOQOL - BREF评分有所增加。两组在血清激素水平或瘦体重方面均未观察到具有统计学意义的差异。未发生严重不良事件，实验室检查均在正常范围内。两组的招募率、完成率和药物依从率均超过90%，表明可行性高。
[草药名称未给出]在治疗以血虚为主型更年期综合征方面显示出临床疗效。此外，[草药名称未给出]被证明对于大规模研究以确认该治疗的疗效是安全可行的。试验注册：临床研究信息服务（CRIS，https://cris.nih.go.kr）：KCT0002387 。
