Abstract
Background: In January, national guidelines were developed and recommended for use throughout China to fight coronavirus disease 2019 (COVID-19). Chinese herbal medicine (CHM) was also included as part of the treatment plans at various stages of COVID-19.Methods: We conducted a pilot randomized, controlled trial in patients with severe COVID-19 in Wuhan, China. Eligible adult patients were randomly assigned in a 2:1 ratio to receive either CHM plus standard care or standard care alone for 7 days. The primary outcome was the change in the disease severity category of COVID-19 after treatment.Results: Between Jan 31, 2020, and Feb 19, 2020, 42 out of 100 screened patients were included in the trial: 28 in the CHM plus standard care group and 14 in the standard care alone group. Among 42 participants who were randomized (mean [SD] age 60.43 years [12.69 years]), 21 (21/42, 50%) were aged ≥65 years, 35 (35/42, 83%) were women, and 42 (42/42, 100%) had data available for the primary outcome. For the primary outcome, one patient from each group died during treatment; the odds of a shift toward death was lower in the CHM plus group than in the standard care alone group (common OR 0.59, 95% CI 0.148–2.352, P = 0.454). Three (two from the CHM plus group and one from the standard care alone group) patients progressed from severe to critical illness. After treatment, mild, moderate, and severe COVID-19 disease accounted for 17.86% (5/28) vs. 14.29% (2/28), 71.43% (20/28) vs. 64.29% (9/28), and 0% (0) vs. 7.14% (1/28) of the patients treated with CHM plus standard care vs. standard care alone.Conclusions: For the first time, the G-CHAMPS trial provided valuable information for the national guideline-based CHM treatment of hospitalized patients with severe COVID-19. The effects of CHM in COVID-19 may be clinically important and warrant further consideration and studies.Clinical Trial Registration: http://www.chictr.org.cn/index.aspx. Uniqueidentifier: ChiCTR2000029418.
Highlights
14–16% patients with Coronavirus disease 2019 (COVID-19) suffer from severe diseases like pneumonia, and 5% become critically ill [1, 2]
One patient from each group died during treatment; the odds of a shift toward death was lower in the Chinese herbal medicine (CHM) plus group than in the standard care alone group
Mild, moderate, and severe COVID-19 disease accounted for 17.86% (5/28) vs. 14.29% (2/28), 71.43% (20/28) vs. 64.29% (9/28), and 0% (0) vs. 7.14% (1/28) of the patients treated with CHM plus standard care vs. standard care alone
Summary
14–16% patients with Coronavirus disease 2019 (COVID-19) suffer from severe diseases like pneumonia, and 5% become critically ill [1, 2]. The mortality rate of COVID19 among those suffering critical illness was reported to be over 50% [2]. The use of Chinese herbal medicine (CHM), such as the classic formula maxingshigantang, yinqiaosan, dayuanyin, xiaochaihutang, et al, in epidemics has a history of thousands of years in China. Showing no mortality benefits, CHM in combination with conventional care might have facilitated pulmonary infiltrate resolution and improved symptoms and quality of life in patients with severe acute respiratory syndrome in the 2002 SARS epidemic [5]. Chinese herbal medicine (CHM) was included as part of the treatment plans at various stages of COVID-19
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