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Traditional Chinese medicine shenhuang granule in patients with severe/critical COVID-19: A randomized controlled
Shuang Zhou1, Jun Feng2, Qin Xie3
1LongHua Hospital, Shanghai University of Traditional Chinese Medicine, 725 Wanping South Road, Xuhui District, Shanghai 200032, China; Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai China, 201203.
Insights
Shenhuang Granule significantly reduced mortality in severe/critical COVID-19 patients compared to standard care. This traditional Chinese medicine shows promise as an integrative therapy for severe coronavirus disease 2019.
Area of Science:
- Integrative Medicine
- Infectious Diseases
- Critical Care Medicine
Background:
- Coronavirus disease 2019 (COVID-19) remains a global pandemic with high mortality in severe and critical cases.
- Traditional Chinese Medicine, specifically Shenghuang Granule (SHG), has shown efficacy in treating viral infections and septic shock.
- Investigating novel therapeutic strategies is crucial for managing severe COVID-19 outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of Shenhuang Granule (SHG) as an adjunct therapy for hospitalized patients with severe/critical COVID-19.
- To compare outcomes between patients receiving SHG plus standard care and those receiving standard care alone.
- To assess the impact of SHG on mortality and clinical improvement in severe COVID-19.
Main Methods:
- An open-label, multicenter, randomized controlled clinical trial was conducted.
- 111 patients with severe/critical COVID-19 were randomized into two groups: SHG plus standard care or standard care alone.
- Patients received SHG twice daily for 14 days, with a maximum follow-up of 75 days to assess clinical endpoints, including mortality.
Main Results:
- Overall mortality was significantly lower in the SHG group (38.6%) compared to the control group (75.9%) (p < 0.01).
- In severe COVID-19 cases, SHG reduced mortality from 58.8% to 5.3% (p < 0.01), and in critical cases, from 83.8% to 55.3% (p < 0.05).
- SHG administration was linked to increased lymphocytes and fewer adverse events, notably zero mortality among severe patients requiring invasive ventilation in the SHG group.
Conclusions:
- Shenhuang Granule demonstrates significant potential as an integrative therapy for severe and critical COVID-19.
- SHG offers a promising treatment option that improves survival rates and clinical outcomes in high-risk COVID-19 patients.
- Further research into traditional Chinese medicine for infectious diseases is warranted.
Background:
Coronavirus disease 2019 (COVID-19) is still a pandemic, with a high mortality rate in severe/critical cases. Therapies based on the Shenghuang Granule have proved helpful in viral infection and septic shock.
Hypothesis/Purpose:
The objective of the current study was to compare the efficacy and safety of the traditional Chinese medicine, Shenhuang Granule, with standard care in hospitalized patients with severe/critical COVID-19.
Study Design And Methods:
This was an open-label, multicenter, randomized, controlled clinical trial. At 4 medical centers, a total of 111 severe/critical patients were randomly assigned to receive Shenhuang Granule (SHG group) twice a day for 14 days, in addition to standard care, or to receive standard care alone (Control group). The maximal follow up time was 75 days. The clinical endpoint was clinical improvement and mortality.
Results:
54 patients were assigned to the control group and 57 to the SHG group. The overall mortality was 75.9% (41/54) in the control group, and 38.6% (22/57) in the SHG group (p < 0.01 vs. control). The post hoc analysis showed that in the severe category, the mortality of the control group vs. the SHG group was 58.8% (10/17) vs. 5.3% (1/19) (p < 0.01); while in the critical category, it was 83.8% (31/37) vs. 55.3% (21/38) (p < 0.05). In the severe category, the mortality of patients who eventually received an invasive ventilator in the control vs. the SHG group was 58.8% (10/17) vs. 0 (0/19) (p < 0.01). Administration of SHG was associated with increased lymphocytes and decreased adverse events.
Conclusion:
Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
