基于CONSORT与TIDieR-Placebo评价安慰针刺治疗偏头痛随机对照试验的文献报告质量

Evaluation of the Normativeness on Randomized Controlled Trials of Placebo Acupuncture for Migraine Based on CONSORT and TIDieR-Placebo

目的应用试验报告统一标准(Consolidated Standards for Reporting of Trials,CONSORT)与安慰措施描述规范清单(Template for Intervention Description and Replication-Placebo,TIDieR-Placebo)评价安慰针刺治疗偏头痛随机对照试验(Randomized controlled trials,RCT)的文献报告质量。通过评价结果讨论目前安慰针刺的运用现状,并为今后安慰针刺的试验设计提供参考。方法计算机检索中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据资源系统(WF)、中国生物医学文献数据库(SinoMed)、PubMed、Embase、Web of Science(WOS),收集近10年使用单纯针刺与安慰针刺进行对比的针灸治疗偏头痛RCT研究,检索时限为2011年7月20日-2021年7月20日。应用CONSORT与TIDieR-Placebo评价文献报告的规范性,并对结果进行分析讨论。结果共纳入59篇文献。CONSORT评价结果显示报告率低于10%的条目为条目3b、6b、11b、12b、14b、16、17b、18、24。TIDieR-Placebo评价结果显示报告率低于10%的条目为条目6、7、9、10、13。安慰针刺的方式主要为“假穴假刺”、“假穴真刺”、“假穴浅刺”及“非治疗穴真刺”4种。结论目前安慰针刺治疗偏头痛RCT的文献报告质量总体不高,研究者未来应重视使用此两项清单对自身研究进行规范报告。大部分研究的安慰针刺设计方式尚缺合理性,亟需国内外在安慰针刺的设计和选择方面形成共识,以推动针灸临床研究的规范化。

Objective The main objective is to evaluate the normativeness on randomized controlled trials of Placebo acupuncture for migraine by using CONSORT and TIDieR-placebo.The secondary purpose is to discuss the current situation of the use of placebo acupuncture through the evaluation results and provide reference for the design of placebo acupuncture experiments in the future.Methods CNKI,VIP,WF,SinoMed,PubMed,Embase,and WOS were searched by computer.RCTs using simple acupuncture and placebo acupuncture for comparison in the past 10 years were collected from July 20,2011 to July 20,2021.CONSORT and TIDieR-placebo were used to evaluate the normalization of the literature report and the results were analyzed and discussed.Results A total of 59 RCTs were included.The methods of placebo acupuncture were mainly"sham acupuncture at sham acupoints","true acupuncture at sham acupoints","shallow acupuncture at sham acupoints"and"true acupuncture at non-therapeutic acupoints".CONSORT evaluation results showed that items 3b,6b,11b,12b,14b,16,17b,18 and 24 had reporting rates lower than 10%.The TIDieR-placebo evaluation results showed that items 6,7,9,10,and 13 reported less than 10%.Conclusion At present,the normativeness on RCTs of placebo acupuncture for migraine is generally not of high quality.Researchers should attach importance to using these two lists to report their own research in the future.The design of placebo acupuncture in most research lacks rationality,and it is urgent to reach relevant consensus at home and abroad.