Abstract / Summary
Introduction 5-alpha-reductase inhibitors (5-ARIs), such as finasteride and dutasteride, are effective in reducing prostate volume and urinary symptoms; however, these drugs are associated with specific adverse events, including suicidal ideation, anxiety, and self-harm. Methods A systematic review and meta-analysis of observational studies was conducted in PubMed, Embase and Web of Science on July 16, 2025, with no time restrictions. Studies involved individuals diagnosed with benign prostatic hyperplasia (BPH) or androgenetic alopecia (AGA), and experiencing suicide and neuropsychiatric events, including anxiety, depression and intentional self-harm (ISH) during the treatment with 5-ARIs. This study followed the PRISMA statement. Results Eleven studies were included in the systematic review, of which nine were eligible for meta-analysis. Comparisons included 5-ARI users versus non-users or alpha-blocker users. Overall, no statistically significant differences were observed between groups (HR 1.07, 95% CI: 0.76–1.51), with substantial heterogeneity across studies (I² = 59%). Conclusion This meta-analysis found no significant association between 5-ARIs and the risk of suicide or neuropsychiatric events in patients with benign prostatic hyperplasia or androgenetic alopecia. Nevertheless, given regulatory concerns regarding suicidal ideation, continued real-world monitoring through active surveillance and prospective observational studies remain warranted. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420251106035 , identifier CRD420251106035.