A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine capsules for the treatment of premature ovarian insufficiency

Cao, Xiaojing; Huang, Xichang; Liu, Jian; Ma, Fei; Zeng, Yuyan; Chen, Changqian; Ji-ju, Wang; Nie, Guangning; Wang, Xiaoyun

doi:10.1097/gme.0000000000001099

Cited by 13 publications

(8 citation statements)

References 36 publications

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“…Chinese medicine has been clinically proven to have an effect on treating female ovarian hypofunction [ 23 ]. DBT is a well-known Chinese medicine prescription that is widely recognized for improving blood deficiency diseases.…”

Section: Discussionmentioning

confidence: 99%

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Danggui Buxue Tang Rescues Folliculogenesis and Ovarian Cell Apoptosis in Rats with Premature Ovarian Insufficiency

Wang

Liu

Nie

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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Premature ovarian insufficiency (POI) is a common female endocrine disease that is closely linked to ovarian function. Danggui Buxue Tang (DBT) is a classic prescription of traditional Chinese medicine that is helpful for rescuing ovarian function. However, the mechanism by which DBT rescues ovarian function remains unclear. This study explored the molecular mechanism of DBT with respect to apoptosis and related signals in ovarian cells. The quality control of DBT was performed by HPLC. After DBT intervention in the POI rat model, serum AMH/FSH/LH/E2 levels were detected by ELISA, follicles at various developmental stages were observed by HE staining, apoptosis was detected by TUNEL, and the expression profiles of Bcl-2 family proteins and key proteins in the Jak2/Foxo3a signaling pathway were evaluated by western blot. The results demonstrated that DBT could encourage the development of primary/secondary/antral follicles and increase the secretion of AMH. Moreover, DBT might inhibit Foxo3a by upregulating Jak2, thereby mediating Bcl-2 family activities and inhibiting apoptosis in ovarian cells. In conclusion, DBT promotes follicular development and rescues ovarian function by regulating Bcl-2 family proteins to inhibit cell apoptosis, which could be related to the Jak2/Foxo3a signaling pathway.

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Section: Discussionmentioning

confidence: 99%

“…DBT is a well-known Chinese medicine prescription that is widely recognized for improving blood deficiency diseases. DBT has been reported to promote erythropoietin, platelets, and angiogenesis [ 23 ]. The effects of stimulating the immune response [ 24 ] and alleviating myocardial damage [ 25 ] have also been reported [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Danggui Buxue Tang Rescues Folliculogenesis and Ovarian Cell Apoptosis in Rats with Premature Ovarian Insufficiency

Wang

Liu

Nie

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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“…Thus, the parameters are not suitable to estimate the sample size of the trial. We referred to other clinical trials of traditional Chinese medicine in the treatment of POI patients [ 22 ]. We assumed that BSHX administration would reduce CMS score by 2.9 points and the SD is 7.42 in the study [ 23 ].…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial

Cao

Peijuan-Wang

Lü

et al. 2021

Trials

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Introduction Premature 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 design We 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 dissemination This 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 registration ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx.

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“…Thus, the parameters are not suitable to estimate the sample size of the trial. We referred to other clinical trials of traditional Chinese medicine in the treatment of POI patients 23 . We assumed that BSHX administration would reduce CMS score by 2.9 points and the SD is 7.42 in the study.…”

Section: Sample Size Calculationmentioning

confidence: 99%

Effectiveness and Safety of Bushen Huoxue in Treatment of Premature Ovarian Insufficiency: study protocol for a randomised, double-blinded, placebo-controlled and multicentre clinical trial

Cao

Wang

Lü

et al. 2021

Preprint

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Introduction Premature 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, randomised, double-blind, and multicentre clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI.Methods and Design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomised in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3-month 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)1. The other measurements include serum sex hormone levels, anti-mullerian 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 was evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). Ethics and dissemination This 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 registration number ChiCTR1900028451.Registered 22 December 2019, www.chictr.org.

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A randomized, double-blind, placebo-controlled trial of Chinese herbal medicine capsules for the treatment of premature ovarian insufficiency

Abstract: Treatment with YYSG was more effective than placebo for improving menopausal symptoms, basal hormone levels, and ovarian function in women with POI in Guangdong, China.

Cited by 13 publications

References 36 publications

Danggui Buxue Tang Rescues Folliculogenesis and Ovarian Cell Apoptosis in Rats with Premature Ovarian Insufficiency

Danggui Buxue Tang Rescues Folliculogenesis and Ovarian Cell Apoptosis in Rats with Premature Ovarian Insufficiency

Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial

Effectiveness and Safety of Bushen Huoxue in Treatment of Premature Ovarian Insufficiency: study protocol for a randomised, double-blinded, placebo-controlled and multicentre clinical trial

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