Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial.

Li NI; Zheng Wen; Xiaowen HU; Wei Tang; Haisheng Wang; Ling Zhou; Lujin WU; Hong Wang; Chang XU; Xizhen XU; Zhichao Xiao; Zongzhe LI; Chene LI; Yujian Liu; Jialin Duan; Chen Chen; Dan LI; Runhua Zhang; Jinliang LI; Yongxiang YI; Wei Huang; Yanyan Chen; Jianping Zhao; Jianping Zuo; Jianping Weng; Hualiang Jiang; Dao Wen Wang

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Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial.

Author: Li NI ¹ ; Zheng WEN ¹ ; Xiaowen HU ² ; Wei TANG ³ ; Haisheng WANG ⁴ ; Ling ZHOU ¹ ; Lujin WU ¹ ; Hong WANG ¹ ; Chang XU ¹ ; Xizhen XU ¹ ; Zhichao XIAO ¹ ; Zongzhe LI ¹ ; Chene LI ¹ ; Yujian LIU ¹ ; Jialin DUAN ¹ ; Chen CHEN ¹ ; Dan LI ¹ ; Runhua ZHANG ¹ ; Jinliang LI ⁵ ; Yongxiang YI ⁶ ; Wei HUANG ¹ ; Yanyan CHEN ⁷ ; Jianping ZHAO ⁸ ; Jianping ZUO ⁹ ; Jianping WENG ¹⁰ ; Hualiang JIANG ¹¹ ; Dao Wen WANG ¹²
Author Information

1. Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
2. The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China.
3. State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
4. Harbin Pharmaceutical Group Co., Ltd., Harbin, 150070, China.
5. The Sixth Hospital of Harbin, Harbin, 150036, China.
6. The Second Hospital of Nanjing and the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210003, China.
7. Department of Information Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
8. Division of Respiratory, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
9. State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. jpzuo@simm.ac.cn.
10. The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China. wengjp@ustc.edu.cn.
11. State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. hljiang@simm.ac.cn.
12. Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. dwwang@tjh.tjmu.edu.cn.
Publication Type:Randomized Controlled Trial
Keywords: COVID-19; SARS-CoV-2; Shuanghuanglian oral liquid; clinical trial
MeSH: COVID-19; Humans; Medicine, Chinese Traditional; Research; SARS-CoV-2; Treatment Outcome
From: Frontiers of Medicine 2021;15(5):704-717
CountryChina
Language:English
Abstract: We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.