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1.广州中医药大学第七临床医学院,广东深圳 518133
2.深圳市宝安区中医院针灸科,广东深圳 518133
3.广东省中医院针灸科
☒周鹏,主任中医师、教授。E-mail:zhoupeng80@gzucm.edu.cn
收稿:2024-01-10,
网络首发:2024-05-20,
纸质出版:2024-08-12
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李仲贤, 徐海燕, 阎路达, 等. 基于CONSORT声明、STRICTA标准、SHARE清单的针刺治疗抑郁症随机对照试验报告质量评价[J]. 中国针灸, 2024,44(8):966-974.
LI Zhongxian, XU Haiyan, YAN Luda, et al. Evaluation of the reporting quality of randomized controlled trials of acupuncture for depression based on CONSORT statement, STRICTA criteria and SHARE checklist[J]. Chinese Acupuncture & Moxibustion, 2024, 44(8): 966-974.
李仲贤, 徐海燕, 阎路达, 等. 基于CONSORT声明、STRICTA标准、SHARE清单的针刺治疗抑郁症随机对照试验报告质量评价[J]. 中国针灸, 2024,44(8):966-974. DOI: 10.13703/j.0255-2930.20240110-k0003.
LI Zhongxian, XU Haiyan, YAN Luda, et al. Evaluation of the reporting quality of randomized controlled trials of acupuncture for depression based on CONSORT statement, STRICTA criteria and SHARE checklist[J]. Chinese Acupuncture & Moxibustion, 2024, 44(8): 966-974. DOI: 10.13703/j.0255-2930.20240110-k0003.
目的:
2
评价针刺治疗抑郁症随机对照试验(RCT)的报告质量。
方法:
2
系统检索PubMed、Cochrane图书馆(Cochrane Library)、EMbase、中国期刊全文数据库(CNKI)、万方学术期刊全文数据库(Wanfang)、中国生物医学文献数据库(SinoMed)和维普中文科技期刊数据库(VIP)中针刺治疗抑郁症的RCT,检索时限为建库至2023年12月1日,文种限制为中英文。采用国际公认的临床试验报告统一标准(CONSORT声明)、针刺临床试验干预措施的国际标准(STRICTA标准)以及假针刺对照报告指南(SHARE清单)评价针刺治疗抑郁症RCT的报告质量。
结果:
2
根据CONSORT声明条目,中文RCT报告率小于50%的条目占所有条目的54.05%,报告率为0%和100%的条目分别有8个和1个;英文RCT报告率小于50%的条目占所有条目的35.14%,报告率为0%和100%的条目分别有3个和7个。中英文RCT在结构式摘要、背景和目的等15个条目的报告率均大于50%。中英文RCT的STRICTA标准报告率都相对较高,中文RCT报告率小于50%的条目占所有条目的23.53%,报告率为0%和100%的条目分别有1个和4个;英文RCT报告率小于50%的条目占所有条目的11.76%,报告率为0%和100%的条目各有1个。中英文RCT的SHARE清单报告率都相对较低,中文RCT报告率小于50%的条目占所有条目的57.89%,报告率为0%和100%的条目分别有2个和0个;英文RCT报告率小于50%的条目占所有条目的52.63%,报告率为0%和100%的条目各有1个。
结论:
2
目前针刺治疗抑郁症RCT的报告质量整体偏低,尤其是假针刺对照细节信息的报告亟需加强,建议今后开展相关RCT研究时应严格遵照CONSORT声明、STRICTA标准以及SHARE清单对RCT进行规范报告。
Objective
2
To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression.
Methods
2
Systematic searches were performed in PubMed
the Cochrane Library
EMbase
CNKI
Wanfang
SinoMed and VIP Database for RCTs of acupuncture in treatment of depression.The search time was from the establishment of database to December 1
2023
and the language restriction was Chinese and English.The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement
the international standardization for trial reporting
STRICTA
the international standard for clinical trial interventions of acupuncture
and SHARE
the guideline and checklist for reporting sham acupuncture controls.
Results
2
According to the CONSORT statement items
the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles
and there were 8 and 1 items with a reporting rate of 0% and 100%
respectively.For the English articles
the items with the reporting rate less than 50% was accounted for 35.14% of all of the items
and there were 3 and 7 items with a reporting rate of 0% and 100%
respectively.The reporting rate of 15 items in Chinese and English articles was greater than 50%
e.g.structured abstract
background and purpose.Based on STRICTA criteria
the reporting rate of either Chinese or English articles was relatively high.The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items
and there were 1 and 4 items with a reporting rate of 0% and 100%
respectively.For English articles
the items with the reporting rate less than 50% was accounted for 11.76% of all of the items
and there was 1 item with a reporting rate of either 0% or 100%.In compliance with SHARE checklist
the reporting rate was low for either Chinese or English articles.The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles
and there were 2 and 0 items with a reporting rate of 0% and 100%
respectively.For English articles
the items with the reporting rate less than 50% was accounted for 52.63% of all of the items
and there was 1 item with a reporting rate of 0% and 100%
respectively.
Conclusion
2
The overall reporting quality of RCTs of acupuncture for depression is low currently.It is urgent to enhance the reporting of the details on sham acupuncture control especially.It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement
STRICTA criteria
and SHARE checklist in the future.
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