The reporting quality and risk of bias of randomized controlled trials of acupuncture for migraine: Methodological study based on STRICTA and RoB 2.0

ObjectivesTo investigate the reporting quality and risk of bias of randomized controlled trials (RCTs) of acupuncture for migraine, to facilitate and improve the quality of RCTs of acupuncture for migraine.MethodsThe Cochrane Library, PubMed and EMBASE were searched from inception to June 11, 2019 using a comprehensive search strategy. The reporting quality and risk of bias of included RCTs were independently evaluated by two investigators using STRICTA and RoB 2.0. Any disagreement was resolved by a third investigator.ResultsA total of 28 eligible RCTs were published in 24 academic journals from 1994 to 2018. Based on STRICTA, four sub-items including “details of other interventions’’ (1/28, 4 %), “setting and context of treatment” (9/28, 32 %), “the extent to which treatment was varied” (11/28, 39 %), and “number of needle insertions per subject per session” (13/28, 46 %), showed low reporting quality. A total of 32 different outcomes were reported in 28 RCTs, and based on RoB 2.0, nine (9/28, 32 %) RCTs were judged to be high RoB, three of which were owing to deviations from intended interventions; 11(11/28, 39 %) RCTs elicited some concerns; and eight (8/28, 29 %) RCTs were low RoB for their outcomes.ConclusionsThe reporting quality and risk of bias of RCTs of acupuncture for migraine remain suboptimal. Therefore, all stakeholders should make a contribution to improve the quality of RCTs of acupuncture for migraine using STRICTA and RoB 2.0, while not limiting this approach solely to studies on migraine, using STRICTA and RoB 2.0 tools.     

采用CONSORT和STRICTA评价针刺治疗急性缺血性脑卒中随机对照试验报告质量

目的探讨采用CONSORT和STRICTA标准评价针刺治疗急性缺血性脑卒中随机对照试验的报告质量。方法系统检索Cochrane图书馆临床对照试验数据库(2005年第4期)、PubMed(1980～2005.12)、EMbase(1984～2005.12)、CNKI(1994～2005.12)、CBMdisc(1980～2005.12)和VIP(1989～2005.12)6个数据库。文种限制为中文和英文。手工检索已纳入文献的参考文献。纳入针刺治疗急性缺血性脑卒中的随机对照试验,并采用国际公认的CONSORT声明和报告针刺临床试验中干预措施的国际标准(STRICTA)进行报告质量评价。结果共纳入74篇文献。根据CONSORT条目,在针刺治疗急性缺血性脑卒中的报告中,54篇(72.97%)描述了各组的基线情况和临床特征;26篇(35.14%)提及产生随机分配序列的方法,其中4篇(5.41%)提及用计算机产生随机分配序列;仅有6篇(8.11%)分配方案隐藏充分,其中5篇采用密封不透光的信封,1篇采用中心随机分组;8篇(10.81%)采用盲法的文献中5篇采用双盲;4篇(5.41%)提及样本含量的计算,多数文献样本含量较小;仅5篇(6.76%)文献采用意向治疗(ITT)分析法。根据STRICTA,4篇(5.41%)文献提及用针数目;有35篇(47.30%)提及针具型号,只有26篇(35.14%)提及针刺深度;6篇文献(8.11%)报告了治疗师的资历,其中仅有1篇(1.35%)提及医师的临床实践时间,没有1篇提及治疗师的训练时间。结论目前针刺治疗急性缺血性脑卒中的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。     

Qualitätsstandards randomisierter kontrollierter Akupunkturstudien

To allow scientific evaluation of clinical acupuncture trials, certain internationally approved quality standards should be taken into account. The guidelines of Good Clinical Practice GCP should be the basis of every clinical trial. Consideration of the Consolidated Standards of Reporting Trials (CONSORT) are required for publication by most of the journals. GCP and CONSORT include the most important quality standards for clinical studies. In addition, specific quality standards need to be considered in clinical acupuncture trials as reported in the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).     

Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China

Objective:To evaluate and compare the reports' qualities of acupuncture randomized controlled trials(RCTs) conducted in China before and after the implementation of two guidelines,i.e.,the Consolidated Standards of Reporting Trials(CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture(STRICTA).Methods:Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines.In addition,the total score of each item's reporting were calculated and reported differences during different date ranges were compared.Results:For CONSORT items(maximum score 8),there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined(2.5 + 0.6) and 2004-2005 and2009-2010 combined(3.0 ±0.9;difference 0.4,95%confidence interval,0.3 to 0.6,P0.01).For STRICTA items(maximum score 17),there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined(8.6±2.1) and 2004-2005 and 2009-2010 combined(10.1 ±1.8;difference1.5,95%confidence interval,1.1 to 1.9,P0.01).Conclusion:Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.     

针灸治疗心律失常质量评价

目的:采用STRICTA标准和CONSORT声明评价国内临床随机对照试验质量关于心律失常使用的针灸疗法。方法:使用计算机检索与手工检索,检索中国知网(CNKI),中国生物医学文献数据库(CBM),万方,维普(VIP)等数据库,另外采用手工检索,筛选出符合标准的文献,使用STRICTA标准和CONSORT声明进行质量评价。结果:纳入合格文献共计16篇,这些文献存在一定问题,例如:随机方法描述不具体;很少使用盲法;样本量计算少;针刺细节报道不充分;无意向治疗分析或针刺治疗医生的资历无报道等。结论:目前针灸治疗心律失常的临床试验质量偏低,文章的同质可比性以及可靠性受到影响,将CONSORT声明与STRICTA标准在临床执行,可以提高针灸临床随机试验的质量。     

针刺治疗原发性高血压RCT报告质量的研究*

目的评价针刺治疗原发性高血压的临床随机对照试验(RCT)报告质量。方法 计算机检索Web of Science、PubMed、Embase、Cochrane Library、中国知网、万方、维普七大数据库建库以来至2019年12月关于针刺治疗原发性高血压的RCT报告,由2名研究者按照纳排标准筛选出符合的文献,并采用Cochrane风险偏倚评估工具、CONSORT声明以及STRICTA标准评估报告质量。结果 最终纳入87篇RCT报告。Cochrane偏倚风险评估工具统计结果表明,大多数文献各类偏倚风险较高或不清楚。CONSORT声明及STRICTA标准条目统计结果表明,纳入文献中仅部分条目的完整报告率较高,受试者合格标准、资料收集的场所和地点、干预措施、结局指标的统计学方法分析、针刺治疗的类型、针刺刺激方式、留针时间、治疗单元数、治疗单元的频数和持续时间的完整报告率分别为63.2%、59.8%、50.5%、88.5%、100%、92%、81.6%、86.2%及75.9%,其余条目完整报告率均偏低甚至无报告。结论 纳入的针刺治疗原发性高血压RCT报告质量不佳,未来的研究中需注重研究设计、严格实施过程、规范试验报告,与国际前沿接轨,以利于针刺疗法的发展和传播。     

针刺作为辅助手段治疗精神分裂症的探索性病例研究

目的：探索个体针刺疗法作为常规治疗的辅助手段在精神分裂症患者中的效果;采用探索性病例研究的方法,使用定量和定性评价工具,以便能够对针刺治疗此类患者的确切疗效作出科学评价,并对未来采用针刺治疗此类患者的试验设计提供方法学建议。方法：共纳入11例精神分裂症患者,在予以10周的针刺治疗前,治疗过程中及治疗后分别采用多种有效的定量和定性评价工具对患者进行多方面的评价。这些评价手段包括对针刺治疗、全科医生及精神科医生病历的整理回顾。分析定性资料以评价受试者向研究者及其临床医生和护理人员报告的内容的可靠性。结果：11名受试者中共有8名完成了1个疗程的针刺治疗,全部11名受试者都报告了针刺治疗的积极作用,包括精神分裂症症状的改善,缓解药物的副作用,对精力、内在动机、睡眠、成瘾症状及其他身体机能的促进作用。但是,受试者向研究者和针刺医生报告的信息在不同治疗阶段有一定差别,且往往不一致;在研究结束后,受试者向研究者报告了更多的信息。结论：本研究表明,在常规疗法之外辅以针刺治疗能够给精神分裂症病人带来一定益处。对数据的三角测量表明了受试者报告内容的某些不一致性,而这些可以通过多种研究方法的混合使用得以克服。通过对数据的比较,推荐在将来的研究设计中使用阳性与阴性症状量表、针刺临床试验干预措施报告标准以及在问卷中增加对药物副作用、运动、睡眠以及日常作息的调查。在将来的研究中还应充分考虑到,恢复期患者容易复发,应该让他们可以方便地获得帮助。     

采用CONSORT和STRICTA评价针刺治疗糖尿病胃轻瘫随机对照试验报告质量

[目的] 采用试验报告统一标准(CONSORT)和报告针刺临床试验中干预措施(STRICTA)标准评价针刺治疗糖尿病胃轻瘫随机对照试验的报告质量。 [方法] 计算机检索Cochrane 图书馆临床对照试验数据库、PubMed、中国知识基础设施工程、维普等数据库。文种限制为中英文。纳入针刺治疗糖尿病胃轻瘫的随机对照试验, 并采用CONSORT声明和STRICTA标准进行报告质量评价。[结果] 共纳入针刺治疗糖尿病胃轻瘫随机对照研究28篇文献。根据CONSORT声明和STRICTA标准对纳入文献进行分析, 无文献提及随机分配方案的隐藏、样本量的计算方法和治疗师资历。大部分研究对随机方法描述不清、盲法使用率低、未使用流程图、不良反应报道少、针刺细节报道不充分等问题。[结论] 目前针刺治疗糖尿病胃轻瘫的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。