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

doi:10.1007/s11684-021-0853-6

Randomized Controlled Trial

. 2021 Oct;15(5):704-717.

doi: 10.1007/s11684-021-0853-6. Epub 2021 Apr 28.

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

Li Ni^#¹, Zheng Wen^#¹, Xiaowen Hu^#², Wei Tang^#³, Haisheng Wang^#⁴, Ling Zhou¹, Lujin Wu¹, Hong Wang¹, Chang Xu¹, Xizhen Xu¹, Zhichao Xiao¹, Zongzhe Li¹, Chene Li¹, Yujian Liu¹, Jialin Duan¹, Chen Chen¹, Dan Li¹, Runhua Zhang¹, Jinliang Li⁵, Yongxiang Yi⁶, Wei Huang^{1

7}, Yanyan Chen⁸, Jianping Zhao⁹, Jianping Zuo¹⁰, Jianping Weng¹¹, Hualiang Jiang^{12

13}, Dao Wen Wang¹⁴

Affiliations

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 Cardiology, Chinese People's Liberation Army Central War Command General Hospital, Wuhan, 430010, China.
⁸ Department of Information Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
⁹ Division of Respiratory, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
¹⁰ State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. jpzuo@simm.ac.cn.
¹¹ The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China. wengjp@ustc.edu.cn.
¹² State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. hljiang@simm.ac.cn.
¹³ Shanghai Institute for Advanced Immunochemical Studies and School of Life Science and Technology, ShanghaiTech University, Shanghai, 201210, China. hljiang@simm.ac.cn.
¹⁴ 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.

^# Contributed equally.

PMID: 33909260
PMCID: PMC8079840
DOI: 10.1007/s11684-021-0853-6

Randomized Controlled Trial

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

Li Ni et al. Front Med. 2021 Oct.

. 2021 Oct;15(5):704-717.

doi: 10.1007/s11684-021-0853-6. Epub 2021 Apr 28.

Authors

Affiliations

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 Cardiology, Chinese People's Liberation Army Central War Command General Hospital, Wuhan, 430010, China.
⁸ Department of Information Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
⁹ Division of Respiratory, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
¹⁰ State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. jpzuo@simm.ac.cn.
¹¹ The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230026, China. wengjp@ustc.edu.cn.
¹² State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. hljiang@simm.ac.cn.
¹³ Shanghai Institute for Advanced Immunochemical Studies and School of Life Science and Technology, ShanghaiTech University, Shanghai, 201210, China. hljiang@simm.ac.cn.
¹⁴ 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.

^# Contributed equally.

PMID: 33909260
PMCID: PMC8079840
DOI: 10.1007/s11684-021-0853-6

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.

Keywords: COVID-19; SARS-CoV-2; Shuanghuanglian oral liquid; clinical trial.

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Answer for questions of repeated measurements of variance analysis and distribution test of data - Authors' reply.
Wang DW, Ni L, Jiang H. Wang DW, et al. Front Med. 2022 Aug;16(4):661-665. doi: 10.1007/s11684-021-0907-9. Epub 2022 Jul 1. Front Med. 2022. PMID: 35776404 Free PMC article. No abstract available.
The adoption of repeated measurement of variance analysis and Shapiro-Wilk test.
Wei J. Wei J. Front Med. 2022 Aug;16(4):659-660. doi: 10.1007/s11684-021-0908-8. Epub 2022 Jul 1. Front Med. 2022. PMID: 35776406 Free PMC article. No abstract available.

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[1] Coronaviridae Study Group of the International Committee on Taxonomy of Viruses The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020;5(4):536–544. doi: 10.1038/s41564-020-0695-z. - DOI - PMC - PubMed

[2] Coronaviridae Study Group of the International Committee on Taxonomy of Viruses The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020;5(4):536–544. doi: 10.1038/s41564-020-0695-z. - DOI - PMC - PubMed

[3] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. doi: 10.1016/S0140-6736(20)30183-5. - DOI - PMC - PubMed

[4] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. doi: 10.1016/S0140-6736(20)30183-5. - DOI - PMC - PubMed

[5] Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507–513. doi: 10.1016/S0140-6736(20)30211-7. - DOI - PMC - PubMed

[6] Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507–513. doi: 10.1016/S0140-6736(20)30211-7. - DOI - PMC - PubMed

[7] Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061–1069. doi: 10.1001/jama.2020.1585. - DOI - PMC - PubMed

[8] Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061–1069. doi: 10.1001/jama.2020.1585. - DOI - PMC - PubMed

[9] Yu B, Li C, Chen P, Zhou N, Wang L, Li J, Jiang H, Wang DW. Low dose of hydroxychloroquine reduces fatality of critically ill patients with COVID-19. Sci China Life Sci. 2020;63(10):1515–1521. doi: 10.1007/s11427-020-1732-2. - DOI - PMC - PubMed

[10] Yu B, Li C, Chen P, Zhou N, Wang L, Li J, Jiang H, Wang DW. Low dose of hydroxychloroquine reduces fatality of critically ill patients with COVID-19. Sci China Life Sci. 2020;63(10):1515–1521. doi: 10.1007/s11427-020-1732-2. - DOI - PMC - PubMed

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

Affiliations

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

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