Title: Traditional Chinese medicine Shenhuang granule in patients with severe/critical COVID-19: A randomized controlled multicenter trial
• One of the very first clinical trials to be conducted in real time during the actual start of the future world-wide pandemic at the very center of the outbreak
• The first randomized, controlled and multicenter trial involved critically ill COVID-19 patients and with meaningful clinical significance
• The one with the longest follow up time of all COVID-19 trials
• The first RCT report of Traditional Chinese Medicine in management of severe/critical COVID-19 cases.
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.
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.
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.
Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
Graphic abstract: Trial profile and Severity Status at Baseline and after Treatment. For each severity category, percentages were calculated with the number of patients at baseline as the denominator. Improvement (light blue cells), no change (beige) and worsening (gray) in severity status are shown.
I am the co-correspondence author.
Shuang Zhou, Jun Feng, Qin Xie, Tingrong Huang, Xiaoming Xu, Daixing Zhou, Wen Zhang, Shuting Sun, Xudong Liu, Xinxin Wu, Jinhua Che, Tian Fan, Dengxiu Zou, Junshuai Wang, Daqian Zhan, Dan Peng, Yikuan Feng, Gang Yu, Zuobiao Yuan, Bangjiang Fang. Traditional Chinese medicine Shenhuang granule in patients with severe/critical COVID-19: A randomized controlled multicenter trial. Phytomedicine. 2021;89:153612.