Therapeutic efficacy of Yangyin Shugan capsules against premature ovarian insufficiency: results from a multicenter, placebo-controlled trial.

Objectives: This multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of Yangyin Shugan (YYSG) capsules in women with premature ovarian insufficiency (POI).

Methods: This study enrolled 548 Chinese women with POI (August 2016-June 2021) from 13 Guangdong hospitals. After screening, 333 participants were randomized (2:1) to receive YYSG capsules or placebo for 12 weeks. Primary outcomes included the modified Kupperman Index (KI) and serum basal follicle-stimulating hormone, basal E2, and anti-Müllerian hormone levels. Secondary outcomes included psychological status scores (Self-Rating Depression Scale, Self-Rating Anxiety Scale) and ovarian markers (antral follicle count, peak systolic velocity).

Results: YYSG demonstrated superior efficacy versus placebo across all endpoints (P < 0.01), including greater reductions in KI scores (-22.2 vs -6.0) and basal follicle-stimulating hormone levels (-23.7 vs -10.4 IU/L) and greater increases in anti-Müllerian hormone levels (2.5 vs 0.8 ng/mL). The YYSG group exhibited larger antral follicle count gains (4.3 vs 1.1 follicles) and bilateral peak systolic velocity improvements (left: 10.8 vs 4.9 cm/s; right: 10.0 vs 4.4 cm/s) and greater reductions in psychological scores (Self-Rating Depression Scale: -12.9 vs -1.3; Self-Rating Anxiety Scale: -15.7 vs -3.7).

Conclusions: YYSG capsules significantly improved ovarian reserve function and emotional disorders in women with POI, demonstrating good efficacy and safety. These findings support the potential application of YYSG capsules in clinical practice.