Cao Jiang-Peng, Du Xin-Yue, Liu Xiao-Xi, Li Meng-Han, Zhang Man, Guo Sheng-Xuan, Cai Qiu-Han, Zhang Jia-Xin, Sun Shan-Shan, Han Jia-Wei, Chen Lin-Ling, Zheng Na, Jia Lan-Yu, Li Gui-Ping, Du Yuan-Hao
Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
Front Neurol. 2025 Apr 11;16:1509204. doi: 10.3389/fneur.2025.1509204. eCollection 2025.
Acute cerebral infarction (ACI) is the second leading cause of death and the major cause of disability worldwide, and there is an increasing interest in non-pharmacological treatments. Acupuncture has promising effects on ACI, but its efficacy and safety need to be verified through well-designed randomized clinical trials. We aimed to investigate the efficacy and safety of acupuncture as adjunctive therapy to improve neurological function in patients with ACI.
The multicenter, sham-controlled, patient- and assessor-blinded randomized controlled trial was conducted in 4 tertiary hospitals in China from January to September 2024. All participants received standard care as recommended by the guidelines and were randomly assigned (1:1:1) to manual acupuncture (MA), sham acupuncture (SA), or standard care (SC) only. Participants in the MA and SA groups received acupuncture treatment 6 times weekly for 2 weeks for a total of 12 sessions. The primary outcome was the change in the National Institutes of Health Stroke Scale score from baseline to 14 days. Safety outcomes included adverse events and serious adverse events.
A total of 132 patients (median [IQR] age, 65 [58-69] years; 96 men [72.73%]), with a median (IQR) baseline National Institutes of Health Stroke Scale score of 11 (9-12) points, were included in the intention-to-treat analysis. Ten patients withdrew during the 14-day intervention, and another 7 patients withdrew during the 90-day follow-up. During the 14-day intervention, the median neurological impairment was significantly improved in the MA group compared to the SA group (4 [3, 5] vs. 3 [1.25, 4] points; Cohen's , 0.76; 95% CI, 0.33 to 1.19; = 0.001). Adverse events occurred relatively equally between the MA and SA groups (19 [43.2%] vs. 13 [29.5%]; relative risk, 1.46; 95% CI, 0.83 to 2.58; = 0.184).
Twelve sessions of MA were safe and effective in improving the neurological function of patients with ACI. The results of this trial indicate that MA can be recommended as a routine, supplemental therapy for improving neurological function in patients with ACI.
ChiCTR2300079204 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 27/12/2023).
急性脑梗死（ACI）是全球第二大致死原因和主要致残原因，对非药物治疗的关注日益增加。针灸对ACI有显著疗效，但其有效性和安全性需要通过精心设计的随机临床试验来验证。我们旨在研究针灸作为辅助治疗改善ACI患者神经功能的有效性和安全性。
2024年1月至9月在中国4家三级医院进行了多中心、假针刺对照、患者和评估者双盲的随机对照试验。所有参与者均接受指南推荐的标准治疗，并随机分配（1:1:1）至手针组（MA）、假针刺组（SA）或仅接受标准治疗组（SC）。MA组和SA组的参与者每周接受6次针灸治疗，共2周，总计12次。主要结局是从基线到14天的美国国立卫生研究院卒中量表评分变化。安全性结局包括不良事件和严重不良事件。
共有132例患者（年龄中位数[四分位间距]为65[58 - 69]岁；男性96例[72.73%]）纳入意向性分析，基线美国国立卫生研究院卒中量表评分中位数（四分位间距）为11（9 - 12）分。10例患者在14天干预期间退出，另外7例患者在90天随访期间退出。在14天干预期间，与SA组相比，MA组的神经功能缺损中位数显著改善（4[3, 5]分对3[1.25, 4]分；Cohen's d，0.76；95%CI，0.33至1.19；P = 0.001）。MA组和SA组不良事件发生情况相对均等（19例[43.2%]对13例[29.5%]；相对风险，1.46；95%CI，0.83至2.58；P = 0.184）。
12次手针治疗对改善ACI患者神经功能安全有效。本试验结果表明，手针可推荐作为改善ACI患者神经功能的常规辅助治疗方法。
ChiCTR2300079204（中国临床试验注册中心，http://www.chictr.org.cn，于2023年12月27日注册）
