TY - JOUR AB - OBJECTIVE: To systematically evaluate the therapeutic efficacy and safety of Zishen Yutai Pill (ZYP) as an adjunctive treatment for women with polycystic ovary syndrome (PCOS) through systematic review and meta-analysis of randomized controlled trials. MATERIALS AND METHODS: A systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. Seven major databases, including PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, and Wan Fang Database, were searched from inception through March 1, 2025. Randomized controlled trials comparing ZYP combined with Western medicines vs. Western medicines alone were included. RESULTS: Eighteen randomized controlled trials encompassing 1,751 participants with PCOS met the inclusion criteria. Meta-analysis demonstrated that ZYP, when combined with Western medicines, produced statistically significant improvements compared with Western medicines alone. Combination therapy significantly enhanced pregnancy rates [relative risk [RR]?=?1.52, 95% confidence interval [CI]?=?1.35-1.76, P?