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Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

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机构: [1]Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical School of Guangzhou University of Chinese Medicine, Guangzhou 510120, China. [2]Evidence-based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China. [3]Chinese GRADE Centre, Lanzhou University, Lanzhou 730000, China. [4]WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou 730000, China. [5]Guangzhou University of Chinese Medicine, Guangzhou 510720, China. [6]Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou 510120, China.
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关键词: Traditional Chinese medicine Clinical trial registration WHO Trial Registration Data Set COVID-19 H1N1 SARS

摘要:
Objective: To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method: We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results: A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion: Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data. © 2021, The Author(s).

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出版当年[2020]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2019]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者机构: [1]Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical School of Guangzhou University of Chinese Medicine, Guangzhou 510120, China.
通讯作者:
通讯机构: [1]Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical School of Guangzhou University of Chinese Medicine, Guangzhou 510120, China. [2]Evidence-based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China. [3]Chinese GRADE Centre, Lanzhou University, Lanzhou 730000, China. [4]WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou 730000, China. [6]Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou 510120, China.
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