Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

Abstract

In December 2019, a number of patients with a new type of pneumonia of unknown etiology were detected in Wuhan, China. (1) It was then soon determined that it was a new severe acute respiratory syndrome (SARS) that was caused by a new coronavirus, the SARS-CoV-2 virus. (2) The new pneumonia was later named the Novel 2019 Coronavirus or COVID-19. (3) In 2002-2003, another SARS-causing coronavirus, the SARS-CoV virus, caused one of the most deadly epidemics in recent history. The outbreak of SARS-CoV caused more than 8,000 reported cases and 774 deaths, with a case-fatality rate (CFR) of 7% in China. (4) Less than a decade later in 2012, another coronavirus, the Middle-East respiratory syndrome (MERS) virus, the MERS-CoV virus, emerged. (5) An outbreak of this virus in 2014 resulted in 662 reported cases and a CFR of 32.97%. (6) Together, these had informed us that coronaviruses represent a new kind of viral pathogens that are characterized by their ability to cause

Chinese Herbal Medicine Used With or Without Conventional Western Therapy for COVID-19: An Evidence Review of Clinical Studies

“…In terms of the random sequence generation methods of the included 10 RCTs, six RCTs (Fu et al, 2020a;Wang et al, 2020c;Duan et al, 2020;Qiu et al, 2020;Sun et al, 2020;Yu et al, 2020) used random number tables, two trials (Ding et al, 2020;Ye, 2020) used a simple random allocation method and the remaining two RCTs (Zhang et al, 2020a;Fu et al, 2020b) only mentioned random without describing the detailed randomization method. Two RCTs (Wang et al, 2020c;Ye, 2020) performed allocation concealment. Therefore, the risk of selection (allocation) bias was unclear for the majority of the included RCTs due to lack of information on allocation concealment.…”

“…Two RCTs (Wang et al, 2020c;Ye, 2020) performed outcome assessor blinding and the remaining eight RCTs (Fu et al, 2020a;Zhang et al, 2020a;Fu et al, 2020b;Ding et al, 2020;Duan et al, 2020;Qiu et al, 2020;Sun et al, 2020;Yu et al, 2020) did not report relevant information, thus the detection bias for the majority of the included RCTs was judged as unclear-risk. In terms of attrition bias, eight RCTs (Fu et al, 2020a;Zhang et al, 2020a;Wang et al, 2020c;Ding et al, 2020;Duan et al, 2020;Qiu et al, 2020;Sun et al, 2020;Ye, 2020) were assessed as low-risk of bias due to complete outcome data or incomplete outcome data being adequately addressed, two RCTs (Fu et al, 2020b;Yu et al, 2020) were assessed as high-risk due to incomplete outcome data that were not adequately addressed. Two RCTs (Wang et al, 2020c;Ye, 2020) registered the study protocol and reported the registration information.…”

“…In terms of attrition bias, eight RCTs (Fu et al, 2020a;Zhang et al, 2020a;Wang et al, 2020c;Ding et al, 2020;Duan et al, 2020;Qiu et al, 2020;Sun et al, 2020;Ye, 2020) were assessed as low-risk of bias due to complete outcome data or incomplete outcome data being adequately addressed, two RCTs (Fu et al, 2020b;Yu et al, 2020) were assessed as high-risk due to incomplete outcome data that were not adequately addressed. Two RCTs (Wang et al, 2020c;Ye, 2020) registered the study protocol and reported the registration information. By comparison, we found that there was no selective reporting of outcomes in these two RCTs, so their reporting bias was evaluated as low-risk.…”

“…We divide them into two categories of non-serious (including mild and common) and serious (including severe and critical). Although the article (Wang et al, 2020c) did not specify the severity of COVID-19, since all participants in this trial were screened from suspected COVID-19 patients, we considered the severity of COVID-19 of these participants as nonserious. Outcomes: ① cure rate; ② aggravation rate; ③ mortality rate; ④ the recovery rate of fever; ⑤ the recovery rate of cough; ⑥ the recovery rate of fatigue;⑦ the duration of fever; ⑧ the duration of cough; ⑨ the duration of fatigue; ⑩ negative conversion rate of nucleic acid test; ⑪ improvement or recovery of chest CT manifestations; ⑫ Length of hospitalization; ⑬ adverse events.…”

“…Although one study (Yu et al, 2020) reported this outcome in their trial, we did not enrolled the data on this outcome in the statistical analysis due to the inconsistency between the data presented in the table and in the text. After analyzing separately according to the study design of the remaining 11 studies, the results of RCTs or retrospective studies with a control group both showed that CHM plus conventional western therapy was better than conventional western therapy alone in reducing aggravation rate (RR 0.43, 95% CI 0.23 to 0.80, 7 RCTs (Fu et al, 2020a;Wang et al, 2020c;Duan et al, 2020;Qiu et al, 2020;Sun et al, 2020;Ye, 2020;Fu et al, 2020b); RR 0.37, 95% CI 0.22 to 0.64, 4 retrospective studies with a control group (Chen et al, 2020;Xia et al, 2020)). Figure 5 illustrates the details of these results.…”