Wong Eliza L Y, Cheung Annie W L, Haines C J, Wang C C, Wong Chun-Kwok, Tsim Karl W K, Cheng William K F, Leung Ping-Chung
The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.
Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong Kong.
J Menopausal Med. 2022 Apr;28(1):33-39. doi: 10.6118/jmm.21024.
This study aimed to further explore the efficacy and safety of (DBT), a simple herbal formula, for improving the quality of life of women suffering from menopausal symptoms.
A third clinical trial to determine the clinical efficacy of high-dose DBT for a period of 12 weeks was carried out. The standard Menopause-Specific Quality of Life (MENQOL) assessment chart was used for the evaluation. Safety was defined as an absence of direct estrogenic effects, serum inflammatory cytokines. Notably, interleukin IL-6, IL-8 and tumor necrosis factor TNF-α, known to be directly related to estrogenic reactions in menopause studies, were monitored.
The third clinical trial indicated an overall improvement in the four domains of MENQOL, offering further proof of the efficacy of DBT demonstrated in the two previous trials. The serial checks of the three cytokines related to estrogen activities did not show either upward or downward trends. The haphazard behavior reactions of the three cytokines offered indirect indications that DBT improved the MENQOL independently from estrogen activities.
The three clinical trials using DBT to relieve menopausal syndrome have offered solid evidence for its efficacy. The uncertainty regarding whether the "phytoestrogen" contained in DBT had bioactivities similar to estrogen was alleviated through the confirmation that no strict estrogenic bioactivities were observed. The issue of safety was further clarified via laboratory platform studies on DBT, which not only showed the lack of similarity with estrogen actions but also confirmed the value of combining the two herbs in the classic formula.
本研究旨在进一步探讨一种简单的草药配方——DBT改善绝经症状女性生活质量的疗效和安全性。
开展了一项为期12周的确定高剂量DBT临床疗效的第三次临床试验。采用标准的更年期特异性生活质量（MENQOL）评估表进行评估。安全性定义为无直接雌激素效应、血清炎性细胞因子。值得注意的是，监测了已知在绝经研究中与雌激素反应直接相关的白细胞介素IL-6、IL-8和肿瘤坏死因子TNF-α。
第三次临床试验表明MENQOL的四个领域总体有所改善，为前两次试验中证明的DBT疗效提供了进一步证据。与雌激素活性相关的三种细胞因子的系列检查未显示上升或下降趋势。三种细胞因子的随机行为反应间接表明DBT独立于雌激素活性改善了MENQOL。
使用DBT缓解绝经综合征的三项临床试验为其疗效提供了确凿证据。通过确认未观察到严格的雌激素生物活性，减轻了DBT中所含“植物雌激素”是否具有与雌激素相似生物活性的不确定性。通过对DBT的实验室平台研究进一步阐明了安全性问题，该研究不仅表明与雌激素作用缺乏相似性，还证实了经典配方中两种草药组合的价值。
