Xiao-Jing Cao1,2, Xuchun Huang2, Jian Liu2, Fei Ma3, Yuyan Zeng1,2, Changqian Chen4, Ji-Ju Wang1, Guangning Nie2, Xiao-Yun Wang2. 1. Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. 2. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. 3. First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 4. Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine, Zhuhai, China.
Abstract
OBJECTIVE: This study was conducted to evaluate the treatment effectiveness of Chinese herbal medicine capsules containing the Yangyin Shugan formula (YYSG) in premature ovarian insufficiency (POI). METHODS:One-hundred forty-six women with POI participated in this stratified, randomized, double-blind, placebo-controlled clinical trial. Participants in two groups (n = 73 in each)-the YYSG group and control group-underwent treatment for 12 weeks. Outcome measures included the Chinese version Menopause-Specific Quality of Life questionnaire (CMS), serum levels of basal follicle-stimulating hormone (bFSH), basal estradiol, and anti-Mullerian hormone (AMH), the antral follicle count (AFC), and ovarian peak systolic velocity (PSV; cm/s). RESULTS: Treatment with YYSG significantly reduced the total scores of the CMS at the end of the 12th week with statistical significance (P < 0.01); the vasomotor, psychosocial, physical, and sexual domains significantly improvement after treatment (P < 0.01). Compared with the baseline hormone levels, YYSG markedly decreased the bFSH level with statistical significance (P < 0.01) and improved the AMH level (P < 0.01). Furthermore, YYSG greatly improved the participants' AFC and ovarian PSV, compared with placebo (P < 0.01). There were no serious adverse events, and the safety indices of whole blood counts, renal function, and liver function were within the normal range, both before and after treatment. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: This study was conducted to evaluate the treatment effectiveness of Chinese herbal medicine capsules containing the Yangyin Shugan formula (YYSG) in premature ovarian insufficiency (POI). METHODS: One-hundred forty-six women with POI participated in this stratified, randomized, double-blind, placebo-controlled clinical trial. Participants in two groups (n = 73 in each)-the YYSG group and control group-underwent treatment for 12 weeks. Outcome measures included the Chinese version Menopause-Specific Quality of Life questionnaire (CMS), serum levels of basal follicle-stimulating hormone (bFSH), basal estradiol, and anti-Mullerian hormone (AMH), the antral follicle count (AFC), and ovarian peak systolic velocity (PSV; cm/s). RESULTS: Treatment with YYSG significantly reduced the total scores of the CMS at the end of the 12th week with statistical significance (P < 0.01); the vasomotor, psychosocial, physical, and sexual domains significantly improvement after treatment (P < 0.01). Compared with the baseline hormone levels, YYSG markedly decreased the bFSH level with statistical significance (P < 0.01) and improved the AMH level (P < 0.01). Furthermore, YYSG greatly improved the participants' AFC and ovarian PSV, compared with placebo (P < 0.01). There were no serious adverse events, and the safety indices of whole blood counts, renal function, and liver function were within the normal range, both before and after treatment. CONCLUSIONS: 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.