OBJECTIVE: To evaluate the efficacy and safety of acupuncture in the treatment of poststroke insomnia. METHODS: PubMed, the Cochrane Library, Embase, Web of Science, China Biology Medicine (CBM), CNKI, VIP, and Wanfang databases were searched by computer from their inception to April 29, 2021, for collecting all randomized controlled trials of acupuncture in the treatment of poststroke insomnia. After two reviewers independently screened the literature, extracted the data, and evaluated the risk of bias in the included studies, the data were analyzed by RevMan 5.3 and STATA 16.0. The quality of outcomes was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: A total of 26 studies with 1,874 cases were included, which had 942 cases in the treatment group and 932 cases in the control group. Meta-analysis results showed that, compared with oral medications alone, acupuncture alone or acupuncture combined with oral medications could improve the clinical effective rate and the sleep quality of patients, and the combined effects were RR 1.21; 95% CI 1.15 to 1.27; p < 0.00001 and MD 3.41; 95% CI 2.40 to 4.41; p < 0.00001, respectively. As for adverse reactions, the incidence of acupuncture alone or acupuncture combined with oral drugs was lower than that of oral drugs alone, which was safer and the combined effect was RR 0.21; 95% CI 0.09 to 0.48; p = 0.0002. Sensitivity analysis showed that the results were stable. We evaluated the quality of evidence with the GRADE system; the clinical effective rate was rated as "LOW," the evidence grade of PSQI score was "LOW," and the evidence grade of adverse reactions was "Very LOW." CONCLUSION: Acupuncture alone or acupuncture combined with oral drugs is more effective and safer than oral drugs alone in the treatment of poststroke insomnia, which is suitable to promote in clinical practice.

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