Bowu Chen , Yan Xue , Hua Jing , Xiaodong Wang , Peimin Zhu , Weiwei Hao , Man Li , Yueqiu Gao
{"title":"中药复方化十白毒颗粒治疗轻度新冠肺炎患者的疗效：一项前瞻性、非随机对照试验。","authors":"Bowu Chen , Yan Xue , Hua Jing , Xiaodong Wang , Peimin Zhu , Weiwei Hao , Man Li , Yueqiu Gao","doi":"10.1016/j.imr.2023.100950","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The effectiveness and safety of herbal medicine Huashibaidu granule (HSBD) in treating mild Coronavirus Disease 2019 (COVID-19) patients infected with SARS-CoV-2 remain to be identified. We aimed to evaluate the effectiveness of HSBD in mild COVID-19 patients.</p></div><div><h3>Methods</h3><p>A prospective, non-randomized, controlled study in mild COVID-19 patients was conducted in Shanghai, China, from April 8 to May 6, 2022. Finally, 360 mild COVID-19 patients received HSBD (orally 20 g twice daily for 7 days), and 368 patients received herbal medicine placebo (orally 20 g twice daily for 7 days). The primary endpoints were the negative conversion rate of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and the negative conversion time. Secondary endpoints included the hospitalized days and the improvement in the clinical condition.</p></div><div><h3>Results</h3><p>The negative conversion rate of SARS-CoV-2 at 7 days posttreatment in the HSBD group was higher than that in the control group (95.28% vs. 82.61%, <em>P</em> < 0.001). The median negative conversion time in the HSBD group was markedly decreased by 2 days compared with the control group (3 [3–6] vs. 5 [4–7], <em>P</em> < 0.001). In addition, the median hospitalized day was shortened in the HSBD group by 1 day compared with the control group (6 [4–7] vs. 7 [5–9], <em>P</em> < 0.001). The clinical improvement rate (275/360 [76.39%]) in the HSBD group within 7 days was significantly higher than that (203/368 [55.16%]) in the control group (<em>P</em> < 0.001). The improvement of symptom scores in the HSBD group was higher than that in the control group (2 [1–4] vs. 1 [1–2], <em>P</em> < 0.001). No severe adverse events occurred.</p></div><div><h3>Conclusions</h3><p>Our study suggested that HSBD effectively increased the negative conversion rate of SARS-CoV-2 and shortened the negative conversion time and hospitalized days in mild COVID-19 patients.</p></div><div><h3>Clinical trial registration</h3><p>The trial was registered at Chinese Clinical Trial Registry, ChiCTR2200058668.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e9/93/main.PMC10121152.pdf","citationCount":"0","resultStr":"{\"title\":\"Effectiveness of Chinese medicine formula Huashibaidu granule on mild COVID-19 patients: A prospective, non-randomized, controlled trial\",\"authors\":\"Bowu Chen , Yan Xue , Hua Jing , Xiaodong Wang , Peimin Zhu , Weiwei Hao , Man Li , Yueqiu Gao\",\"doi\":\"10.1016/j.imr.2023.100950\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>The effectiveness and safety of herbal medicine Huashibaidu granule (HSBD) in treating mild Coronavirus Disease 2019 (COVID-19) patients infected with SARS-CoV-2 remain to be identified. We aimed to evaluate the effectiveness of HSBD in mild COVID-19 patients.</p></div><div><h3>Methods</h3><p>A prospective, non-randomized, controlled study in mild COVID-19 patients was conducted in Shanghai, China, from April 8 to May 6, 2022. Finally, 360 mild COVID-19 patients received HSBD (orally 20 g twice daily for 7 days), and 368 patients received herbal medicine placebo (orally 20 g twice daily for 7 days). The primary endpoints were the negative conversion rate of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and the negative conversion time. Secondary endpoints included the hospitalized days and the improvement in the clinical condition.</p></div><div><h3>Results</h3><p>The negative conversion rate of SARS-CoV-2 at 7 days posttreatment in the HSBD group was higher than that in the control group (95.28% vs. 82.61%, <em>P</em> < 0.001). The median negative conversion time in the HSBD group was markedly decreased by 2 days compared with the control group (3 [3–6] vs. 5 [4–7], <em>P</em> < 0.001). In addition, the median hospitalized day was shortened in the HSBD group by 1 day compared with the control group (6 [4–7] vs. 7 [5–9], <em>P</em> < 0.001). The clinical improvement rate (275/360 [76.39%]) in the HSBD group within 7 days was significantly higher than that (203/368 [55.16%]) in the control group (<em>P</em> < 0.001). The improvement of symptom scores in the HSBD group was higher than that in the control group (2 [1–4] vs. 1 [1–2], <em>P</em> < 0.001). 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Effectiveness of Chinese medicine formula Huashibaidu granule on mild COVID-19 patients: A prospective, non-randomized, controlled trial
Background
The effectiveness and safety of herbal medicine Huashibaidu granule (HSBD) in treating mild Coronavirus Disease 2019 (COVID-19) patients infected with SARS-CoV-2 remain to be identified. We aimed to evaluate the effectiveness of HSBD in mild COVID-19 patients.
Methods
A prospective, non-randomized, controlled study in mild COVID-19 patients was conducted in Shanghai, China, from April 8 to May 6, 2022. Finally, 360 mild COVID-19 patients received HSBD (orally 20 g twice daily for 7 days), and 368 patients received herbal medicine placebo (orally 20 g twice daily for 7 days). The primary endpoints were the negative conversion rate of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and the negative conversion time. Secondary endpoints included the hospitalized days and the improvement in the clinical condition.
Results
The negative conversion rate of SARS-CoV-2 at 7 days posttreatment in the HSBD group was higher than that in the control group (95.28% vs. 82.61%, P < 0.001). The median negative conversion time in the HSBD group was markedly decreased by 2 days compared with the control group (3 [3–6] vs. 5 [4–7], P < 0.001). In addition, the median hospitalized day was shortened in the HSBD group by 1 day compared with the control group (6 [4–7] vs. 7 [5–9], P < 0.001). The clinical improvement rate (275/360 [76.39%]) in the HSBD group within 7 days was significantly higher than that (203/368 [55.16%]) in the control group (P < 0.001). The improvement of symptom scores in the HSBD group was higher than that in the control group (2 [1–4] vs. 1 [1–2], P < 0.001). No severe adverse events occurred.
Conclusions
Our study suggested that HSBD effectively increased the negative conversion rate of SARS-CoV-2 and shortened the negative conversion time and hospitalized days in mild COVID-19 patients.
Clinical trial registration
The trial was registered at Chinese Clinical Trial Registry, ChiCTR2200058668.
期刊介绍：
Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.
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