DataSheet1_Role of Traditional Chinese Medicine in Treating Severe or Critical COVID-19: A Systematic Review of Randomized Controlled Trials and Observational Studies.docx

Background: The coronavirus disease 2019 (COVID-19) continues to spread globally. Due to the higher risk of mortality, the treatment of severe or critical patients is a top priority. Traditional Chinese medicine (TCM) treatment has played an extremely important role in the fight against COVID-19 in China; a timely evidence summary on TCM in managing COVID-19 is crucial to update the knowledge of healthcare for better clinical management of COVID-19. This study aimed to assess the effects and safety of TCM treatments for severe/critical COVID-19 patients by systematically collecting and synthesizing evidence from randomized controlled trials (RCTs) and observational studies (e.g., cohort).
Methods: We searched nine databases up to 19th March 2022 and the reference lists of relevant publications. Pairs of reviewers independently screened studies, extracted data of interest, and assessed risk of bias. We performed qualitative systematic analysis with visual presentation of results and compared the direction and distribution of effect estimates for each patient’s important outcome. We performed sensitivity analyses to observe the robustness of results by restricting analysis to studies with low risk of bias.
Results: The search yielded 217,761 records, and 21 studies (6 RCTs and 15 observational studies) proved eligible. A total of 21 studies enrolled 12,981 severe/critical COVID-19 patients with a mean age of 57.21 years and a mean proportion of men of 47.91%. Compared with usual supportive treatments, the effect estimates of TCM treatments were consistent in direction, illustrating that TCM treatments could reduce the risk of mortality, rate of conversion to critical cases, and mechanical ventilation, and showed significant advantages in shortening the length of hospital stay, time to viral clearance, and symptom resolution. The results were similar when we restricted analyses to low-risk-bias studies. No serious adverse events were reported with TCM treatments, and no significant differences were observed between groups.
Conclusion: Encouraging evidence suggests that TCM presents substantial advantages in treating severe/critical COVID-19 patients. TCM has a safety profile that is comparable to that of conventional treatment alone. TCMs have played an important role in China’s prevention and treatment of COVID-19, which sets an example of using traditional medicine in preventing and treating COVID-19 worldwide.

Background: 2019冠状病毒病（coronavirus disease 2019, COVID-19）仍在全球持续蔓延。鉴于重症/危重症患者的死亡风险更高，其救治工作已成为重中之重。中医药（Traditional Chinese Medicine, TCM）在我国抗击新冠疫情中发挥了极为重要的作用；及时总结中医药治疗新冠的相关证据，对于更新医护人员的专业知识、优化新冠临床救治方案至关重要。本研究旨在通过系统收集并整合随机对照试验（randomized controlled trial, RCT）及观察性研究（如队列研究）的证据，评估中医药治疗重症/危重症新冠患者的疗效与安全性。
Methods: 我们检索了截至2022年3月19日的9个数据库及相关文献的参考文献列表。由两名评审员独立完成文献筛选、目标数据提取及偏倚风险评估。本研究采用定性系统分析方法对结果进行可视化呈现，并对比分析各重要患者结局的效应量方向与分布特征。此外，通过将分析限定在低偏倚风险的研究中开展敏感性分析，以验证结果的稳健性。
Results: 本次检索共获取217761条记录，最终纳入21项符合标准的研究，其中随机对照试验6项、观察性研究15项。21项研究共纳入12981例重症/危重症新冠患者，患者平均年龄为57.21岁，男性占比平均为47.91%。与常规支持治疗相比，中医药治疗的效应量方向一致，提示中医药可降低患者死亡风险、病情转重率及机械通气使用率，并在缩短住院时长、病毒转阴时间及症状缓解时间方面展现出显著优势。当仅纳入低偏倚风险的研究进行分析时，上述结果仍保持一致。中医药治疗未报告严重不良事件，两组间不良事件发生率无显著差异。
Conclusion: 令人振奋的研究证据表明，中医药在治疗重症/危重症新冠患者方面具有显著优势。中医药的安全性与单纯常规治疗相当。中医药在我国新冠疫情防控与救治中发挥了重要作用，为全球范围内利用传统医学防治新冠树立了典范。