针灸治疗慢性非特异性腰痛随机对照试验结局指标的现状研究

Outcome Measures Used in Randomized Controlled Trials of Acupuncture for Chronic Nonspecific Low Back Pain

背景针灸是治疗慢性非特异性腰痛(CNSLBP)的重要方法。随着研究的发展,大量针灸治疗CNSLBP的随机对照试验(RCT)已经发表,但由于在结局指标选择方面存在一定的问题,严重限制了高质量临床证据的产生。目的评价针灸治疗CNSLBP RCT选用的结局指标情况,为针灸治疗CNSLBP相关研究提供参考依据。方法系统检索4个中文数据库(中国知网、维普网、万方数据知识服务平台、中国生物医学文献服务系统)、3个英文数据库(PubMed、Embase、Cochrane Library)2017-01-01至2022-03-15发布的针灸治疗CNSLBP的文献,以及自建库以来至2022-03-15发表的非特异性腰痛(NSLBP)的核心结局指标集(COS)。对纳入的针灸治疗CNSLBP的文献基本特征进行分析,对文献的临床结局指标进行归类,对文献中的结局指标及《中医病证诊断疗效标准》的应用现状进行分析。分析NSLBP研究的COS现状,比较其与现有针灸治疗CNSLBP文献结局指标的异同。结果本研究纳入的针灸治疗CNSLBP的49篇文献均为RCT,共包含4篇英文文献和45篇中文文献。共包含4272例患者,其中观察组2049例、对照组2223例,年龄为18~69岁。38篇文献报告了病程。纳入的文献共包含33个结局指标,分为疼痛类指标、功能障碍指标、复合指标、生活质量指标、日常生活能力指标、安全性指标、患者满意度指标、疾病认知指标、心理状态指标、其他指标。单篇文献的结局指标数量为1~8个。42篇文献的结局指标测量时点为治疗前和治疗后2个时点。仅有2篇文献报告了安全性指标。《中医病证诊断疗效标准》中“有效率”指标的使用率为77.55%(38/49)。11篇NSLBP研究的COS的指标域涵盖了疼痛类指标、功能障碍指标、生活质量指标、心理状态指标、社会功能指标和患者满意度指标等,其中3篇文献对指标域重要性进行了分级,4篇文献涵盖了患者满意度指标,5篇文献涵盖了心理状态指标,9篇文献针对不同的指标域选择了不同的测量工具;1篇文献为中医治疗NSLBP研究的COS。结论针灸治疗CNSLBP RCT的结局指标与NSLBP研究的COS均在不同程度上对疼痛、功能障碍、生活质量、心理状态和患者满意度的结局指标有所关注,但在指标域的选择上存在种类、关注方向和测量工具的差异。针灸治疗CNSLBP RCT的结局指标的现状存在主次结局指标、测量时点不明确,指标数量的选择异质性大,指标应用不规范,重视疗效指标、轻视安全性指标等问题,建议今后的针灸研究在设计结局指标时,参照目前已有的NSLBP研究的COS及常用的测量工具,同时结合研究本身的特点扩展相应的公认的结局指标。

Background As an important treatment for chronic nonspecific low back pain(CNSLBP),the effect of acupuncture on CNSLBP has been studied by numerous randomized controlled trials(RCTs)with the development of research on acupuncture.However,there are some problems in the selection of outcome indicators,which severely hinder the generation of high-quality clinical evidence.Objective To describe the outcome measures used in RCTs of acupuncture for CNSLBP,providing a basis for the carrying out of relevant research.Methods Four Chinese databases(CNKI,VIP,Wanfang Data and SinoMed)and three English databases(PubMed,Embase and Cochrane Library)were systematically searched for literature on CNSLBP treated with acupuncture published from January 1,2017 to March 15,2022,and the NSLBP core outcome set(COS)used in studies published from database inception to March 15,2022.According to the enrolment criteria to analyze the following aspects:basic characteristics,classification of clinical outcome indicators,use of composite indicators,and the application of TCM Criteria for Diagnosis and Treatment of Diseases&Syndromes(hereinafter referred to as TCMCDTDS).In addition,11 studies published from database inception to March 15,2022 were enrolled to analyze their basic characteristics and use of COSs of NSLBP.In addition,to analyze the studies’basic characteristics and use of NSLBP COS.The similarities and differences between COSs of NSLBP and outcome measures in the RCTs in recent five years were compared.Results Of the included 49 RCTs,four are in English and the other 45 are in Chinese,involving 4272 cases aged from 18 to 69 years(2049 in the treatment group,and 2223 in the control group).The course of CNSLBP was reported in 38 RCTs.A total of 33 outcome indicators were used in all the RCTs,divided into assessing pain,dysfunction,quality of life,activities of daily living,treatment safety,patient satisfaction,disease recognition,psychological status indicators,and other indicators.The outcome indicator number in one RCT were from 1 to 8.The outcomes were measured twice in 42 RCTs,namely before and after treatment.Safety was reported in only two RCTs.The indicator of"effective rate"in the TCMCDTDS was used in 77.55%(38/49)of the RCTs.The COSs of NSLBP in the aforementioned 11 studies include indicators assessing pain,dysfunction,quality of life,psychological status,social functioning and patient satisfaction.Three of the studies graded the domains of outcome measures in terms of importance,four covered patient satisfaction indicators,five covered psychological assessment indicators,nine used different measurement tools for different outcomes,and one used COSs of NSLBP treated with TCM.Conclusion The COSs of NSLBP used in studies and outcome measures in the included RCTs have similarities in the contents involving pain level,dysfunction,quality of life,psychological status and patient satisfaction,and differences in the selection of the type of outcome domain,direction of attention,and measurement tools.The RCTs used both primary and secondary outcome measures,had unclear measurement time points,great heterogeneity in the number of used outcome measures,and non-standard application of outcome measures,and valued efficacy outcomes but undervalued safety indicators.In view of this,we put forward the recommendation on the use of outcome measures for future relevant studies:according to the research characteristics,choosing the recognized outcome measures with reference to available COSs of NSLBP and common measurement tools.