摘要
背景中医手法是治疗颈型颈椎病的重要手段。随着研究的不断发展,大量中医手法治疗颈型颈椎病的随机对照试验已经发表,但质量水平参差不齐,限制了中医手法的推广和高质量临床证据的产生。目的评价目前中医手法治疗颈型颈椎病随机对照试验的文献质量。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统、PubMed、Embase和Cochrane Library数据库中手法治疗颈型颈椎病的随机对照试验,检索时限为建库至2021年6月。由2名研究者完成文献筛选和资料提取。采用物理治疗证据数据库(PEDro)量表、Cochrane偏倚风险评估工具、临床试验报告标准(CONSORT)声明2010版及附加指标评价纳入文献的质量。结果共纳入81篇文献,其中2006-2014年共发表文献28篇,年平均发表3.11篇;2015-2021年共发表文献53篇,年平均发表7.57篇。文献质量评价结果显示,PEDro量表总分≥7分的高质量文献仅7篇(8.6%)。Cochrane偏倚风险评估工具显示,高偏倚风险文献所占比例最少,低偏倚风险文献次之,大部分条目因为报告信息不全,评分偏倚风险不确定。CONSORT声明2010版评价结果显示,纳入文献的文题和摘要、方法、结果、讨论、其他信息部分报告率不足。附加指标中采用多中心、伦理审批、干预措施质量控制、志谢报告率低。结论目前中医手法治疗颈型颈椎病随机对照试验的文献质量普遍偏低,建议今后研究者参照PEDro量表、Cochrane偏倚风险评估工具、CONSORT声明对中医手法治疗颈型颈椎病的随机对照试验进行规范性报告。
Background TCM manipulation is an important way for the treatment of cervical spondylosis.A large number of randomized controlled trials(RCTs)about TCM manipulation for cervical spondylosis have been published as relevant research develops.However,various levels of qualities of these RCTs may be non-beneficial to the promotion of TCM manipulation and the generation of high-quality clinical evidence.Objective To evaluate the quality of RCTs of TCM manipulation for cervical spondylosis.Methods We searched RCTs of TCM manipulation for cervical spondylosis in databases of CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase and Cochrane Library from inception to June 2021.RCTs enrollment and data extraction were performed by two researchers,separately.Quality assessment was conducted using the PEDro Rating Scale,The Cochrane Collaboration's tool for assessing risk of bias,and the CONSORT 2010 Statement and other six indicators(whether the RCT is multicenter,with ethical approval,informed consent,quality control for intervention,efficacy assessment criteria,and acknowledgement).Results Finally,81 RCTs were included,of which 28 were published from 2006 to 2014,annually averaged 3.11,other 53 were published from 2015 to 2021,annually averaged 7.57.By the PEDro Rating Scale,the quality of only 7(8.6%)RCTs was rated as high-quality(≥7 points).By the Cochrane Collaboration's tool for assessing risk of bias,the percentage of RCTs with high risk of bias was the least,followed by that of those with low risk of bias.Most of RCTs had unclear risk of bias due to reported incomplete information.By the CONSORT 2010 Statement,the rates of title,abstract,methods,results,discussion and other information reported by the included RCTs were insufficient.By other six indicators,the rate of RCTs with a multicenter design,ethical approval,quality control for intervention,and acknowledgement was low.Conclusion The quality of current RCTs about TCM manipulation for cervical spondylosis is generally low.The improvement recommendation for relevant researchers is writing RCTs about the TCM manipulation for cervical spondylosis standardly in accordance with the PEDro Rating Scale,the Cochrane Collaboration's tool for assessing risk of bias,and the CONSORT 2010 Statement.
作者
冯天笑
李康健
于大伟
何海龙
张君涛
冯敏山
王平
FENG Tianxiao;LI Kangjian;YU Dawei;HE Hailong;ZHANG Juntao;FENG Minshan;WANG Ping(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center of Chinese Medicine Acupuncture and Moxibustion,Tianjin 300193,China;Wang Jing Hospital of CACMS,Beijing 100102,China)
出处
《中国全科医学》
CAS
北大核心
2022年第29期3664-3671,共8页
Chinese General Practice
基金
国家自然科学基金资助项目(82074470)
中医药循证能力建设项目(2019XZZX-GK006)
“十二五”行业重大专项项目(201107004)
王平劳模创新工作室(津教工〔2016〕3号)
中医传承工作室(津卫中〔2017〕193号)。
作者简介
通信作者:王平,主任医师,博士生导师,E-mail:yfywangping@sina.com。
