针刺临床试验中假针刺对照报告指南ACURATE与SHARE比较分析  

Comparative analysis of ACURATE and SHARE reporting guidelines for sham acupuncture in clinical trials of acupuncture

作　　者：刘川杨 李斌艳 段炎珊 周航[3,4] 王宇 屠建锋 王丽琼 LIU Chuanyang;LI Binyan;DUAN Yanshan;ZHOU Hang;WANG Yu;TU Jianfeng;WANG Liqiong(School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,P.R.China;Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,P.R.China;International Institute of Acupuncture and Moxibustion Innovation,Beijing University of Chinese Medicine,Beijing 100029,P.R.China;School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine,Beijing 100029,P.R.China)

机构地区：[1]北京中医药大学中医学院,北京100029 [2]首都医科大学附属北京中医医院,北京100010 [3]北京中医药大学国际针灸创新研究院,北京100029 [4]北京中医药大学针灸推拿学院,北京100029

出　　处：《中国循证医学杂志》2025年第4期485-490,共6页Chinese Journal of Evidence-based Medicine

摘　　要：为了给研究者未来选用和优化针刺临床试验中假针刺报告指南提供建议,本研究通过定性分析对中韩两国研究人员分别制订的针刺临床试验中假针刺对照报告指南与清单(SHARE)和临床试验与实验针刺对照报告指南(ACURATE)的基本信息及具体内容进行比较,并结合具体案例阐明两者的异同点。本研究发现与既往针刺临床试验干预措施报告规范(STRICTA)和安慰剂和假干预对照的报告指南和清单(TIDieR-Placebo)相比,ACURATE指南与SHARE指南均强调假针刺对照细节与背景因素的报告,但在内容上各有特点与侧重。条目划分方面,ACURATE通过将主题内容拆分以强调单个条目的重要性;SHARE通过将多个条目合并以强调报告内容的全面性。具体内容方面,ACURATE强调合并治疗、向受试者提供的假针刺信息及真/假针刺在治疗设置等方面的任何差异,对于假针刺对照设置具有借鉴价值;SHARE侧重于对假针刺细节、操作者及方案调整等内容的报告。通过案例发现对两项指南均有条目存在未报告或部分报告的情况,建议未来研究者在进行假针刺对照的报告时可以结合使用两项指南,并对以上两项指南的可操作性与实用性进行验证,为两者的持续优化与更新提供建议。This study aimed to provide suggestions for future researchers to select and optimize sham acupuncture reporting guidelines in acupuncture clinical trials.Through qualitative analysis,we compared the basic information and concrete contents between Acupuncture Controls gUideline for Reporting humAn Trials and Experiments(ACURATE)and SHam Acupuncture REporting guidelines in clinical trials(SHARE)developed by researchers from China and Korea.In addition,the similarities and differences of the two guidelines were illustrated through a specific case.We found that the two guidelines had their own characteristics and emphasis in content,but both emphasized the reports of detailed information and background factors of sham acupuncture compared with the previous STRICTA and TIDieR-Placebo checklist.In terms of item division,we found that the ACURATE split the same topic into several items to emphasize the importance of each item content.SHARE emphasized the comprehensive reports of sham acupuncture by combining several items into a single item.In terms of item content,ACURATE also focused on combination therapy,the information regarding sham acupuncture provided to participants,and any differences in treatment settings between versus/sham acupuncture,which had some referential meaning for setting sham acupuncture control.SHARE also focused on sham acupuncture detailed information,practitioner,and modifications,etc.Case analysis showed that there were some"not reported"or"partially reported"items in both guidelines.Therefore,it is suggested that researchers can use the above two guidelines to complement and learn from each other to report sham acupuncture.In addition,it is necessary for researchers to verify the operability and practicability of the above two guidelines,and provide suggestions for optimizing and updating them in the future.

关 键 词：针刺 报告指南 针刺临床试验 ACURATE指南 SHARE指南 

分 类 号：R245[医药卫生—针灸推拿学]