Bushen Huatan Formula Combined with Conventional Therapy for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis

Introduction: Clinical research suggests that the Bushen Huatan Formula (BHF) may effectively improve polycystic ovary syndrome (PCOS)-related symptoms and infertility. However, no systematic summary of evidence currently exists. This systematic review was designed to assess the therapeutic efficacy and safety profile of BHF when used as a complementary treatment modality for PCOS. Methods: A systematic search was conducted across multiple databases, including the Cochrane Library, Embase, PubMed, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Database, and the China Science and Technology Journal Database (VIP), up to 20 June 2024. Eligible randomized controlled trials (RCTs) included female patients diagnosed with PCOS and compared BHF treatment with conventional biomedical therapies. Results were pooled using random- or fixed-effects models, with effect sizes reported as odds ratios (ORs) or standardized mean differences (SMDs) and their 95% confidence intervals (CIs). Results: A meta-analysis of 11 RCTs involving 1,006 women with PCOS showed that combining BHF with conventional treatments significantly increased pregnancy rates (OR = 2.58, 95% CI = 1.97 to 3.38, P <0.01) and ovulation rates (OR = 3.55, 95% CI = 2.29 to 5.48, P <0.01). It also improved endometrial thickness (SMD = 0.85, 95% CI = 0.39 to 1.31, P <0.01). Discussion: BHF had no significant effect on serum levels of total testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH), or estradiol (E2). No serious adverse reactions were reported. Conclusion: The combination of BHF and conventional medications significantly improved pregnancy and ovulation rates, as well as endometrial thickness, in PCOS patients compared to conventional treatment alone. This suggests that BHF could serve as a complementary therapy for infertility in PCOS patients. However, these findings should be interpreted with caution due to significant heterogeneity and methodological limitations in the included studies.