Abstract
BACKGROUND: Auricular therapy (AT) has attracted significant interest as a potential treatment for polycystic ovary syndrome (PCOS). A systematic review and a meta-analysis were conducted to evaluate the effectiveness and safety of AT in managing PCOS by analyzing evidence from randomized controlled trials (RCTs). METHODS: Eight electronic databases were searched from their inception until December 22, 2024. Two independent reviewers performed study screening, data extraction, and quality assessment using the Cochrane Collaboration's Risk of Bias tool. A random-effects meta-analysis was conducted to synthesize data from included studies using mean differences (MDs). This study was registered with the Open Science Framework (OSF) (DOI: 10.17605/OSF.IO/VBPSM). RESULTS: This systematic review and meta-analysis, which included 18 RCTs involving 1,231 patients with PCOS, found insufficient evidence to support the efficacy of AT as a stand-alone intervention for PCOS. However, AT used as an adjunct therapy exerted beneficial effects on PCOS outcomes. For AT combined with traditional Chinese medicine (TCM) formula versus TCM formula alone, a reduction in body mass index (BMI) (MD: -0.82, 95% confidence interval (CI): -1.60 to -0.03, P = 0.04) was observed. Moreover, the reductions were associated with scores on the Self-rating Anxiety Scale (SAS) (MD: -3.81, 95% CI: -6.26 to -1.36, P = 0.002) and Self-rating Depression Scale (SDS) (MD: -4.22, 95% CI: -7.74 to -0.69, P = 0.02). No significant effect was identified for hormonal profiles (luteinizing hormone (LH) levels, LH/follicle-stimulating hormone (FSH) ratio, testosterone (T) levels), metabolic parameters (fasting blood glucose (FBG) levels, fasting insulin (FINS) levels, or Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)), or waist-hip ratio (WHR). For AT combined with metformin versus metformin alone, a reduction was observed in BMI (MD: -0.77, 95% CI: -1.23 to -0.31, P = 0.0009), WHR (MD: -0.03, 95% CI: -0.05 to -0.02, P < 0.0001), and LH levels (MD: -0.81, 95% CI: -1.05 to -0.57, P < 0.0001). For AT combined with acupuncture versus acupuncture alone, a reduction was observed in BMI (MD: -3.21, 95% CI: -5.09 to -1.33, P = 0.0008), LH levels (MD: -0.80, 95% CI: -1.16 to -0.43, P < 0.0001), and HOMA-IR (MD: -0.10, 95% CI: -0.16 to -0.05, P < 0.0001). A reduction was also associated with the LH/FSH ratio (MD: -1.39, 95% CI: -1.76 to -1.02, P < 0.0001). However, no significant effect was identified for WHR, and the evidence was insufficient for the effect on FINS levels. CONCLUSION: Our findings suggest that adjunctive AT may be associated with improvements in key clinical outcomes, including anthropometric measures (BMI, WHR), hormonal parameters (T levels, LH levels, LH/FSH ratio), and psychological health. However, the specific benefits may vary depending on the co-intervention. Although the included studies did not report any serious adverse events, this should be interpreted with caution due to the potential for underreporting. Methodological limitations warrant careful interpretation of our findings, including a high risk of bias, high heterogeneity, and small sample sizes. These limitations highlight the need for further high-quality, well-designed, and adequately powered RCTs to confirm the efficacy and safety of AT in PCOS management. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/vbpsm/, identifier DOI: 10.17605/OSF.IO/VBPSM.