Chen Lifang, Fang Jianqiao, Ma Ruijie, Froym Ronen, Gu Xudong, Li Jianhua, Chen Lina, Xu Shouyu, Ji Conghua
Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No, 219 Moganshan Road, XiHu District, Hangzhou, Zhejiang Province 310005, China.
Trials. 2014 Jun 8;15:214. doi: 10.1186/1745-6215-15-214.
Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke.
METHODS/DESIGN: In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events.
This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function.
Chinese Clinical Trial Registry ChiCTR-TRC-12001971.
在中国，针灸作为中风治疗手段已广泛应用三千多年。然而，以往研究尚未表明针灸对中风治疗有效。我们报告一项多中心、随机、对照且结果评估者盲法试验的方案，以评估针灸治疗急性缺血性中风的疗效和安全性。
方法/设计：在一项涉及中国浙江省三家医院的前瞻性试验中，将纳入250例近期（发病时间在1周内）发生缺血性中风的患者。患者将被随机分为两组：一组为接受头皮针和电针治疗的针灸组，另一组为不接受针灸治疗的对照组。在三周时间内进行18次治疗。主要结局将通过在第1、3和4周随访时美国国立卫生研究院卒中量表评分的变化来衡量。次要结局指标将包括：1）用于评估运动功能的Fugl-Meyer评估量表；2）用于评估认知功能的简易精神状态检查表和蒙特利尔认知评估；3）用于评估吞咽能力的电视透视吞咽研究；4）不良事件的发生率。
本试验有望阐明针灸对急性中风是否有效。它还将显示针灸是否能改善运动、认知或吞咽功能。
中国临床试验注册中心ChiCTR-TRC-12001971。
