中国针灸2026，Vol.46Issue(4)：644-654,11.DOI:10.13703/j.0255-2930.20250310-k0006
近十年针刺治疗原发性失眠随机假针刺对照试验的质量评价
Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade
摘要
Abstract
Objective To systematically evaluate the reporting quality of randomized sham-acupuncture controlled trials of acupuncture for primary insomnia(PI).Methods From China Journal Full-text Database(CNKI),China Biomedical Literature Service System(SinoMed),VIP Chinese Science and Technology Journal Database(VIP),and Wanfang Data Knowledge Service Platform(Wanfang),and PubMed,CENTRAL,and EMbase,dated from December 31,2014,to December 31,2024,the articles of randomized sham-acupuncture controlled trials of acupuncture for PI were searched.Using the CONSORT statement,STRICTA guidelines,and SHARE checklist,the multidimensional assessment was performed for the quality of included articles,and the reporting rate of each item and the quality score(QS)were calculated.Results A total of 37 articles were included,of which 31 were in Chinese and 6 in English.There were 8 forms of sham-acupuncture control design,most of which referred to sham-acupuncture without penetrating into points or shallow acupuncture by inserting into non-effective points.Based on CONSORT statement,STRICTA guidelines,and SHARE checklist,the median of QS was 16,11 and 8,respectively.According to CONSORT statement,for the RCTs published in Chinese,62.16%(23/37)of items were below the reporting rate of 50%,the reporting rate of 9 items was 0%,and that of 5 items was 100%;and for those published in English,the reporting rate of 7 items was 0%and that of 13 items was 100%.Regarding STRICTA guidelines,for the RCTs published in Chinese,29.41%(5/17)of items were below the reporting rate of 50%,the reporting rate of 0 item was 0%,and that of 2 items was 100%;and for those published in English,the reporting rate of 0 item was 0%and that of 8 items was 100%.In view of SHARE checklist,for the RCTs published in Chinese,68.42%(13/19)of items were below the reporting rate of 50%,the reporting rate of 3 items was 0%,and that of 0 item was 100%;and for those published in English,36.84%(7/19)of items were below the reporting rate of 50%,the reporting rate of 3 items was 0%and that of 3 items was 100%.Conclusion The reporting quality of randomized sham-acupuncture controlled trials of acupuncture for PI shows overall non-completion,especially in trial design transparency,standardization of the details in sham-acupuncture,and methodological rigor.Future studies should strictly adhere to the CONSORT statement,STRICTA guidelines and SHARE checklist,strengthen the implementation of blinding,calculation of sample size,and trial registration,so as to enhance evidence reliability and promote the global practice of evidence-based acupuncture.关键词
原发性失眠/针刺/假针刺/随机对照试验(RCT)/CONSORT声明/STRICTA标准/SHARE清单/报告质量评价Key words
primary insomnia/acupuncture/sham-acupuncture/randomized controlled trial(RCT)/CONSORT statement/STRICTA guidelines/SHARE checklist/reporting quality evaluation引用本文复制引用
张博宇,高希言,高崚,褚文明,李赟,董莉..近十年针刺治疗原发性失眠随机假针刺对照试验的质量评价[J].中国针灸,2026,46(4):644-654,11.基金项目
国家自然科学基金资助项目:8247655 （）
河南省省级科技研发计划联合基金项目:242301420090 （）
2023 年度河南省"双一流"创建学科中医学科学研究专项项目:HSRP-DFCTCM-2023-3-14 （）
