Journal
TRIALS
Volume 22, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s13063-021-05113-y
Keywords
Traditional Chinese medicine; Clinical trial registration; WHO Trial Registration Data Set; COVID-19; H1N1; SARS
Categories
Funding
- Guangdong Provincial Key Laboratory of Research on Emergency in TCM [2017B030314176, 2019XZZX-NB002]
- National Administration of Traditional Chinese Medicine, China
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The study assessed the registration quality of traditional Chinese medicine clinical trials for COVID-19, H1N1, and SARS by examining records in the WHO ICTRP and Chinese Clinical Trial Registry. The findings indicate deficiencies in reporting detailed intervention and outcome information in the registered clinical trials of TCM.
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.
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