Abstract
BackgroundTo 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.MethodsWe 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.ResultsOf 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.ConclusionsThese 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.
Highlights
China was the first country to be seriously affected by Corona virus disease (COVID)-19
Specific claims included that the compound significantly improves immunological indicators for both mild and severe COVID-19; that one of the Medicines (LHQW) and the three formulations are effective in improving radiologically-assessed lung infiltrates; that one of the formulations (XFBD) improves lymphocyte count by 17% and cure rate by 22%; and that another of the formulations (HSBD) reduces the time for viral testing to turn negative and shortens hospital stay by 3 days
While the limited studies suggest that three medicines and three formulations (3M3F), when used on top of usual care, may offer some relief for some symptoms and changes in lung lesion on computerized tomography (CT) scan experienced by mostly mild or moderate COVID-19 patients, the results do not support the high-level claims that 3M3F could prevent disease from progressing to a more severe type
Summary
China was the first country to be seriously affected by COVID-19. The first version of the Novel Coronavirus Pneumonia Treatment Plan was published on 16th January 2020,1 and the Plan was soon revised into the seventh edition.[2]. The 3M3F were claimed to have significant efficacy after observation of population data, and the role of 3M3F in COVID-19 treatment was officially announced in a Chinese government press conference on 23 March 2020, with promotion as being able to relieve symptoms, and reduce the number of mild of moderate cases progressing to severe cases.[8] Specific claims included that the compound significantly improves immunological indicators for both mild and severe COVID-19; that one of the Medicines (LHQW) and the three formulations are effective in improving radiologically-assessed lung infiltrates; that one of the formulations (XFBD) improves lymphocyte count by 17% and cure rate by 22%; and that another of the formulations (HSBD) reduces the time for viral testing to turn negative and shortens hospital stay by 3 days. Our review is the first systematic review to evaluate whether 3M3F improves outcome in COVID-19 and test the specific efficacy claims outlined above
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