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

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.