The Methodological Reporting Quality in Strictly Randomized Controlled Trials for COVID-19 and Precise Reporting of Chinese Herbal Medicine Formula Intervention

Min-li Chen ¹ Shi-yan Qian ² Jiang-li Yang ² Jue-yan Zheng ¹ Li-Xiang Wang ² Jing-Ying Wu ² Hai-qin Ye ³ Yan Wang ⁴ Guo-qing Zheng ^2,5*

• ¹ Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China
• ² Department of Neurology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
• ³ Institute of Life Sciences, Key Laboratory of Organ Development and Regeneration of Zhejiang Province, College of Life Sciences, Hangzhou Normal University, Hangzhou, China., Hangzhou, China
• ⁴ Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China, Hangzhou, China
• ⁵ First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China

Background: Chinese herbal medicine(CHM) formulas played an important role during the pandemic of coronavirus disease 2019 . Many randomized controlled trials (RCTs) on CHM for COVID-19 were quickly published. Concerns have been raised about their quality. In addition, inadequate detailed information on CHM formula intervention may arouse suspicion about their effectiveness. We aim to assess the most recent evidence of the methodological reporting quality of these RCTs with strict randomization, and the precise reporting of the CHM formula intervention.Methods: RCTs on CHM formulas for COVID-19 were searched from nine databases. The CONSORT 2010, CONSORT-CHM Formulas 2017, and risk of bias were the guidelines used to assess the included RCTs. The checklist of sub-questions based on CONSORT-CHM Formulas 2017 was used to evaluate the precise reporting of CHM formula intervention. A comparison was made between RCTs that enrolled participants during and after the first wave of the pandemic (defined here as December 2019 to March 2020).The average score for 66 studies evaluated based on three guidelines, the CONSORT 2010, the CONSORT-CHM Formulas 2017, and the checklist of sub-questions based on the CONSORT-CHM Formulas 2017, is 16.4, 15.2, and 17.2, respectively. The reporting rate of sample size calculation, allocation concealment, and blinding is less than 30%. The checklist of sub-questions based on the CONSORT-CHM formulas 2017 can help report and assess CHM formula intervention more precisely. Most studies assessed an "unclear risk of bias" due to insufficient information. RCTs published in English and recruited subjects during the first wave of the pandemic have a higher risk of participant blinding bias than the studies recruited subjects after that (P<0.05).The methodological reporting quality in strictly randomized RCTs on CHM formulas for COVID-19 is inadequate-the reporting of sample size calculation, allocation concealment, and blinding need to improve especially. The checklist of sub-questions based on CONSORT-CHM formulas 2017 can help report and assess CHM formula intervention more precisely. The methodological reporting quality of RCTs published in English and enrolled participants during the first wave of the pandemic is worse than the studies that recruited subjects after the first wave of the pandemic.