The efficacy and safety of combined traditional Chinese and Western medicine treatment for PCOS-related infertility: an umbrella meta-analysis.

BACKGROUND: Polycystic ovary syndrome (PCOS) commonly causes infertility in women of reproductive age. Integrated Chinese-Western medicine is used to improve reproductive outcomes and reduce adverse effects, but its reliability remains uncertain. METHODS: Efficacy and safety meta-analyses of integrated traditional Chinese medicine (TCM) and Western medicine for PCOS-related infertility were synthesized. PubMed, Embase, Web of Science, the Cochrane Library, the China National Knowledge Infrastructure (CNKI), Wanfang, and the Chinese Science and Technology Periodical Database (VIP) were searched from inception to November 2025. A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessed quality and certainty. Outcomes were classified by significance and evidence strength. RESULTS: Twenty meta-analyses included 39 intervention types and 153 outcomes, 135 outcomes (36 interventions) favored integrated treatment, and 18 (13 interventions) were non-significant. Heterogeneity and publication bias affected 33 and 48.4%, respectively. AMSTAR scores were 4-9. Four outcomes from two interventions met Class I-III criteria. Chinese medicine plus Western medicine using the TCM Cycle Method showed Class I evidence for pregnancy rate (OR: 2.76, 95% CI: 2.43, 3.13) and Class II evidence for total clinical efficiency (OR: 3.78, 95% CI: 3.29, 4.34) and ovulation rate (OR: 2.90, 95% CI: 2.39, 3.50). TCM cycle therapy plus ovulation induction showed Class III evidence for ovulation rate (RR: 1.10, 95% CI: 1.06, 1.14). GRADE ratings were high for 45, moderate for 92, and low for 16 outcomes. CONCLUSION: Integrated therapy showed promising associations, but robust evidence remains limited; only four of 153 outcomes met Class I-III criteria. Rigorous randomized trials are required. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251275827, Identifier: CRD420251275827.