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

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

摘要:

[目的] 基于TidieR-placebo清单和SHARE清单评价针刺治疗偏头痛的随机对照试验中假针刺的报告质量，并分析比较两清单对于假针刺对照的适用情况，为假针刺对照提供参考。[方法] 计算机检索PubMed、MEDLINE、Embase、Cochrane Library、中国知网（CNKI）、万方数据库（Wanfang Database）、维普数据库（VIP）和中国生物医学文献数据系统（SinoMed）中针刺治疗偏头痛的随机对照试验，检索时间为建库至2024年6月，依照TidieR-placebo清单和SHARE清单评价纳入文献的报告质量。[结果] 共纳入46篇文献（中文24篇，英文22篇）。基于SHARE清单的评价结果中，19个条目中有11个条目（57.89%）的报告率低于50%，分别是设置假针刺对照的理由或目的、方案调整、操作者依从性、盲法评价、受试者的体位、进针法、研究期间向受试者传递或解释的与假针刺相关的信息、假针刺操作者资质、操作者的培训信息、是否对医患交流进行规范、是否采取了维持或提高盲法效果的辅助措施。TidieR-placebo共有13个条目，其中报告率低于50%的条目有8条（61.54%），分别是设置假针刺对照的理由或目的、方案调整、操作者依从性、盲法评价、描述不同类型假干预提供者的资质、描述安慰剂假干预的实施方式、安慰剂/假干预是否进行个体化调整、预期效果，是否评估了安慰剂/假干预的依从性或一致性。有3个条目（23.08%）报告率为0，分别为方案调整、描述安慰剂假干预的实施方式、安慰剂/假干预是否进行个体化调整。整体上，英文文献的报告率（46.2%）高于中文文献（35.8%，P=0.007）。SHARE清单的条目报告率略高于TidieR-placebo清单（P<0.001），SHARE清单中，未报告的条目占比11%，部分报告的条目占清单条目的84%；TidieR-placebo清单中，未报告的条目有5条（38%），部分报告的条目占清单条目的54%。[结论] 针刺治疗偏头痛的随机对照试验中假针刺对照整体报告质量较低，建议研究人员依照SHARE清单进行针刺临床试验的报告，进一步提高针刺临床试验的报告质量。

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.