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Guideline-Based Chinese Herbal Medicine Treatment Plus Standard Care for Severe Coronavirus Disease 2019 (G-CHAMPS):
1Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Insights
This pilot study explored Chinese herbal medicine (CHM) for severe COVID-19 patients. CHM combined with standard care showed potential benefits, warranting further investigation for coronavirus disease 2019 treatment.
Area of Science:
- Integrative Medicine
- Infectious Diseases
- Clinical Trials
Background:
- National guidelines for COVID-19 treatment in China included Chinese herbal medicine (CHM).
- CHM was integrated into treatment plans for various stages of coronavirus disease 2019.
- A pilot randomized controlled trial was conducted in Wuhan to evaluate CHM's efficacy.
Purpose of the Study:
- To assess the impact of Chinese herbal medicine (CHM) plus standard care on severe COVID-19 patient outcomes.
- To provide data for national guideline refinement regarding CHM in coronavirus disease 2019 treatment.
- To evaluate the change in disease severity category in patients receiving CHM.
Main Methods:
- Pilot randomized controlled trial with a 2:1 allocation ratio.
- Adult patients with severe COVID-19 received either CHM plus standard care or standard care alone for 7 days.
- Primary outcome: change in COVID-19 disease severity category.
Main Results:
- 42 patients with severe COVID-19 were randomized; 28 received CHM plus standard care, 14 received standard care alone.
- One death occurred in each group; odds of shifting towards death were lower in the CHM group (OR 0.59).
- CHM group showed a trend towards improved severity categories, with 17.86% mild vs. 14.29% in the control group post-treatment.
Conclusions:
- The G-CHAMPS trial offers initial insights into CHM for severe COVID-19 patients.
- CHM's effects on coronavirus disease 2019 warrant further clinical consideration and study.
- Findings support the inclusion of CHM in national guidelines for severe COVID-19 management.
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.
