Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.
The Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
J Eval Clin Pract. 2022 Feb;28(1):13-32. doi: 10.1111/jep.13614. Epub 2021 Sep 16.
To evaluate the evidence behind claims that Chinese Herbal Medicine, specifically "three medicines and three formulations" (3M3F, comprising Jinhua Qinggan, Lianhua Qingwen, Xuebijing, Qingfei Paidu, Huashi Baidu, and Xuanfei Baidu), is an effective treatment for COVID-19.
We searched PubMed, MEDLINE and CNKI databases, preprint servers, clinical trial registries and supplementary sources for Chinese- or English-language randomized trials or non-randomized studies with comparator groups, which tested the constituents of 3M3F in the treatment of COVID-19 up to September 2020. Primary outcome was change in disease severity. Secondary outcomes included various symptoms. Meta-analysis (using generic inverse variance random effects model) was performed when there were two or more studies reporting on the same symptom.
Of 607 articles identified, 13 primary studies (6 RCTs and 7 retrospective non-randomized comparative studies) with 1467 participants met our final inclusion criteria. Studies were small and had significant methodological limitations, most notably potential bias in assessment of outcomes. No study convincingly demonstrated a statistically significant impact on change in disease severity. Eight studies reported sufficiently similar secondary outcomes to be included in a meta-analysis. Some statistically significant impacts on symptoms, chest CT manifestations, laboratory variables and length of stay were demonstrated, but such findings were sparse and many remain unreplicated.
These findings neither support nor refute the claim that 3M3F alters the severity of COVID-19 or alleviates symptoms. More rigorous studies are required to properly ascertain the potential role of Chinese Herbal Medicine in COVID-19.
评估声称中药,特别是“三药三方”(3M3F,包括金花清感、连花清瘟、血必净、清肺排毒、化湿败毒、宣肺败毒)对 COVID-19 有效的证据。
我们检索了 PubMed、MEDLINE 和中国知网(CNKI)数据库、预印本服务器、临床试验注册库以及补充来源中,截至 2020 年 9 月,以中文或英文发表的、比较 3M3F 组成成分治疗 COVID-19 的随机试验或非随机研究。主要结局是疾病严重程度的变化。次要结局包括各种症状。当有两项或两项以上研究报告相同症状时,采用通用倒数方差随机效应模型进行荟萃分析。
在 607 篇文章中,有 13 项初级研究(6 项 RCT 和 7 项回顾性非随机对照研究)和 1467 名参与者符合我们的最终纳入标准。这些研究规模较小,存在严重的方法学局限性,最显著的是结局评估的潜在偏倚。没有研究能令人信服地证明对疾病严重程度的改变有统计学显著影响。有 8 项研究报告了足够相似的次要结局,可进行荟萃分析。一些症状、胸部 CT 表现、实验室变量和住院时间的统计学显著影响得到了证明,但此类发现很少且许多仍未被重复。
这些发现既不支持也不反驳 3M3F 改变 COVID-19 严重程度或缓解症状的说法。需要更严格的研究来正确确定中药在 COVID-19 中的潜在作用。