Efficacy and safety of acupuncture for erectile dysfunction: a systematic review and meta-analysis of randomized controlled trials

INTRODUCTION: Acupuncture, a key component of traditional Chinese medicine, has emerged as a potential non-pharmacological option for erectile dysfunction (ED) management, yet high-level evidence regarding its efficacy and safety remains limited. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the clinical effectiveness and safety of acupuncture for the treatment of ED. METHODS: A comprehensive search of 8 Chinese and English databases was conducted from inception to May 20, 2025, eligible randomized controlled trials (RCTs). Risk of bias was assessed using the Cochrane Risk of Bias tool (RoB 2.0). Meta-analyses were performed using RevMan 5.4, while sensitivity and publication bias analyses were conducted with STATA 17.0. Trial Sequential Analysis (TSA) was applied to evaluate cumulative evidence reliability, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence certainty. RESULTS: A total of 21 RCTs were included. Meta-analysis showed that acupuncture significantly improved International Erectile Function Index-5 (IIEF-5) scores (MD = 3.28, 95% CI, 2.47-4.09), Erectile Hardness Score (EHS) (MD = 0.75, 95% CI, 0.59-0.91), serum testosterone levels (MD = 0.79, 95% CI, 0.14-1.44), and reduced TCM symptom scores (MD = -4.82, 95% CI -6.49 to -3.15), anxiety state assessment (SMD = -0.86, 95% CI, -1.50 to -0.22), and depression state assessment (SMD = -0.85, 95% CI, -1.52 to -0.17). The clinical efficacy rate (CEr) was also significantly higher in the acupuncture group (RR = 1.24, 95% CI, 1.17-1.32). According to GRADE, evidence quality ranged from very low to moderate. TSA confirmed the robustness of findings for IIEF-5 and CEr. No significant differences in adverse events were found. CONCLUSIONS: The certainty of evidence for acupuncture in ED is very low to moderate. Although improvements were observed, the weak evidence precludes definitive conclusions and underscores the need for high-quality trials.