Wang Xiao-Yu, Liu Wei, Li Huan, Rong Meng-Ying, Li Jing-Yu, Wang Shao-Kang, Du Yu-Zheng, Zhao Qi
Acupuncture Department, 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. 2023 Nov 2;14:1255999. doi: 10.3389/fneur.2023.1255999. eCollection 2023.
The treatment and rehabilitation of stroke and its complications have become major global health issues. Acupuncture is widely used as a complementary and alternative treatment for stroke. Many clinical studies have evaluated the efficacy and safety of acupuncture, but the research results need to be more consistent. The quality of research based on previously published meta-analyzes is uneven, leading to unstable conclusions. This study aims to provide a comprehensive and systematic analysis of the efficacy of high-quality, randomized controlled trials (RCTs) based on blinded designs for treating stroke and its complications. It also aims to review the characteristics of blinded designs and the current use of sham/placebo acupuncture controls in treating stroke.
This study will be conducted under the reporting guidelines for systematic reviews and meta-analyzes. Randomized controlled trials using acupuncture as the primary measure for stroke will be searched in databases such as China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), Wan-fang, PubMed, Embase, Cochrane Library, and Web of Science. To evaluate high-quality research based on a blind design, if the trial evaluates the efficacy of any acupuncture intervention by including a sham/placebo acupuncture control, it will be included. The primary outcome indicator will be the ability to perform daily activities. Secondary outcome indicators include evaluating quality of life and related functions in stroke-related sequelae. We will assess the quality of evidence, reporting quality, and risk of bias for the acupuncture intervention in the literature included in this study using the GRADE system, the STRICTA 2010 checklist, and ROB2.0, respectively. RevMan 5.4 software will be used to conduct the meta-analysis, and Stata 15.0 software will be used for sensitivity analysis and publication bias testing.
By analyzing high-quality, well-designed, randomized controlled trials of acupuncture, the results of this study may contribute to a more objective and standardized evaluation of acupuncture efficacy in treating stroke and its complications. PROSPERO, Identifier (CRD42023378930).
中风及其并发症的治疗与康复已成为全球主要的健康问题。针灸被广泛用作中风的辅助和替代治疗方法。许多临床研究评估了针灸的疗效和安全性,但研究结果需要更加一致。基于先前发表的荟萃分析的研究质量参差不齐,导致结论不稳定。本研究旨在对基于盲法设计的高质量随机对照试验(RCT)治疗中风及其并发症的疗效进行全面系统的分析。它还旨在回顾盲法设计的特点以及假针刺/安慰剂针刺对照在中风治疗中的当前应用情况。
本研究将按照系统评价和荟萃分析的报告指南进行。将在中国知网(CNKI)、重庆维普(CQVIP)、万方、PubMed、Embase、Cochrane图书馆和Web of Science等数据库中检索以针灸为中风主要治疗措施的随机对照试验。为了评估基于盲法设计的高质量研究,如果试验通过纳入假针刺/安慰剂针刺对照来评估任何针灸干预的疗效,则将其纳入。主要结局指标将是日常活动能力。次要结局指标包括评估中风相关后遗症的生活质量和相关功能。我们将分别使用GRADE系统、2010年STRICTA清单和ROB2.0评估本研究纳入文献中针灸干预的证据质量、报告质量和偏倚风险。将使用RevMan 5.4软件进行荟萃分析,并使用Stata 15.0软件进行敏感性分析和发表偏倚测试。
通过分析高质量、设计良好的针灸随机对照试验,本研究结果可能有助于更客观、标准化地评估针灸治疗中风及其并发症的疗效。国际前瞻性系统评价注册库(PROSPERO),标识符(CRD42023378930)。