天津中医药2026，Vol.43Issue(5)：595-605,11.DOI:10.11656/j.issn.1672-1519.2026.05.08
基于TidieR-placebo清单和SHARE清单评价针刺治疗偏头痛临床试验中假针刺对照的报告质量
Evaluation of the reporting quality of sham acupuncture controls in clinical trials of acupuncture for migraine based on the TidieR-placebo checklist and SHARE checklist
摘要
Abstract
[Objective]To evaluate the reporting quality of sham acupuncture in randomized controlled trial(RCT)of acupuncture for migraine based on TidieR-placebo checklist and SHARE checklist,and to compare and analyze the applicability of two checklists on sham acupuncture controls,to provide a reference for sham acupuncture controls.[Methods]Randomized controlled trials of acupuncture for migraine were searched in 8 databases,including PubMed,MEDLINE,Embase,Cochrane Library,CNKI,Wanfang,VIP and CBM,from the establishment of the database to June 2024 by computer.The reporting quality of the included literature was evaluated according to the TidieR-placebo checklist and the SHARE checklist.[Results]A total of 46 RCTs were included(24 Chinese literatures and 22 English literatures).Of 19 items in SHARE checklist,11(57.89%)had a reporting rate below 50%.These items include:the rationale or purpose for setting sham acupuncture controls,protocol modifications,practitioner adherence,blinding assessment,patient posture,needle insertion methods,the information informed or explained to patients,the relevant information of practitioners implementing sham acupuncture,training information of sham acupuncture received by the practitioner,communication between practitioner and patient and the method that was applied to enhance the success of blinding.The TidieR-placebo checklist consists of 13 items,of which 8(61.54%)had a reporting rate below 50%.These items are:the rationale or purpose for setting sham acupuncture controls,protocol modifications,practitioner adherence,blinding assessment,description of the qualifications of placebo/sham intervention provider,description of the mode of delivery of the placebo/sham intervention,whether placebo/sham intervention was individually adjusted,and planned assessment of adherence or consistency to the placebo/sham intervention.Among these,3 items(23.08%)had a reporting rate of 0,namely:protocol modifications,description of the mode of delivery of the placebo/sham intervention and whether placebo/sham intervention was individually adjusted.Overall,the reporting rate of English literature(46.2%)was higher than that of Chinese literature(35.8%,P=0.007).The SHARE list has a slightly higher reporting rate for entries than the TidieR-placebo list(P<0.001),the SHARE list has 11%entries unreported and 84%entries partially-reported;the TidieR-placebo list has 5 unreported entries(38%)and 54%entries partially-reported.[Conclusion]The overall reporting quality of sham acupuncture in randomized controlled trials of acupuncture for migraine is low,we advise that researchers should report clinical trials of acupuncture according the SHARE list,to further enhance the reporting quality of acupuncture clinical trials.关键词
针刺/偏头痛/SHARE清单/随机对照试验/报告质量Key words
acupuncture/migraine/the SHARE checklist/randomized controlled trial/reporting quality分类
医药卫生引用本文复制引用
杨芳,李双婧,刘晓玉,张浩然,侯锦璇,田瑞华,张璐瑶,闫世艳..基于TidieR-placebo清单和SHARE清单评价针刺治疗偏头痛临床试验中假针刺对照的报告质量[J].天津中医药,2026,43(5):595-605,11.基金项目
中央高校基本科研业务费专项资金资助(2023-JYB-JBZD-022). （2023-JYB-JBZD-022）
