Abstract
IntroductionPremature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI.Methods and designWe plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization.Ethics and disseminationThis study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals.Trial registrationChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx.
Highlights
Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age
The results showed that Bushen Huoxue (BSHX) appears to be a safe and effective drug to treat patients with POI, and herbal may be superior to western medicines [17]
A standardized preparation of traditional Chinese medicine particles, record screening, randomization process, verification of biomarkers, and objective measurement were formulated by this study
Summary
Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. POI is a clinical syndrome in which ovarian activity declines in women before the age of 40 It is characterized by menstrual disorders (such as menopause, rare menstruation) and accompanied by high gonadotropin and low estrogen, which seriously affects the reproductive health and quality of life of women of childbearing age [1]. The most commonly used treatment is hormone supplementation until the average age of natural menopause in people with no contraindications Some women need this therapy for decades. If women have a history of breast or ovarian cancer, hormone therapy should be replaced [10, 11]
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