DOI
10.1186/s13063-021-05113-y
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
作者地址
Guangzhou Univ Chinese Med, Clin Sch 2, Guangdong Prov Acad Chinese Med Sci, Guangdong Prov Hosp Chinese Med, Guangzhou 510120, Peoples R China
通讯作者
Yaolong Chen; Xiaojia Ni
摘要
ObjectiveTo assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.MethodWe 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.ResultsA 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).ConclusionOverall, 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.
资助信息
This study was supported by the internal funding from Guangdong Provincial Key Laboratory of Research on Emergency in TCM (No. 2017B030314176) and the external funding on Capacity Building for Evidence-based Chinese medicine (No. 2019XZZX-NB002) from the National Administration of Traditional Chinese Medicine, China. The funding body was not involved in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
WOS学科分类
Medicine, Research & Experimental
附件
-
s13063-021-05113-y.pdf
707.3 kB
除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。
