INTRODUCTION: Post-stroke dysphagia (PSD) is a highly prevalent dysfunction after stroke, characterized by high mortality and seriously affecting the quality of life of patients. Previous studies have shown that acupuncture improves symptoms of PSD. However, repeated tests of significance may exaggerate Type I errors. To update the evidence on the effectiveness and safety of acupuncture for PSD using a meta-analysis and trial sequential analysis (TSA). METHODS: A comprehensive search of PubMed, Embase, Cochrane Library, and Web of Science was conducted to identify randomized controlled trials evaluating the effects of acupuncture on PSD. Trials published up to September 15, 2024, meeting the predetermined inclusion criteria, were included. RESULTS: Twenty studies involving 1,718 participants were included. Combined acupuncture with rehabilitation therapies significantly improved the Standard Swallowing Assessment (mean difference [MD] = -3.64, 95% confidence interval (CI): -4.72 to -2.56, p <
0.0001), Videofluoroscopic Swallowing Study scale (MD = 1.49, 95% CI: 0.89 to 2.09, p <
0.0001), Water Swallow Test (MD = -0.72, 95% CI: -0.96 to -0.47, p <
0.0001), and Swallowing Quality of Life Questionnaire (MD = 16.56, 95% CI: 9.94 to 23.18, p <
0.0001). TSA indicated that the sample size exceeded the required information size. In addition, acupuncture showed safety for PSD treatment (relative ratio [RR] = 1.23, 95% CI: 0.70 to 2.17, p = 0.48)
however, the sample size was insufficient. CONCLUSIONS: TSA demonstrated the positive effects of acupuncture on swallowing function in patients with PSD. Nonetheless, high-quality trials are needed to validate the safety of acupuncture.