Effectiveness of Chinese medicine formula Huashibaidu granule on mild COVID-19 patients: A prospective, non-randomized, controlled trial

IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
Bowu Chen , Yan Xue , Hua Jing , Xiaodong Wang , Peimin Zhu , Weiwei Hao , Man Li , Yueqiu Gao
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引用次数: 0

Abstract

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.

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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。
背景:华事白毒颗粒(HSBD)治疗2019年新冠肺炎轻度冠状病毒病(SARS-CoV-2)患者的有效性和安全性尚待确定。我们旨在评估HSBD在轻度新冠肺炎患者中的有效性。方法:于2022年4月8日至5月6日在上海对新冠肺炎轻症患者进行前瞻性、非随机、对照研究。入选患者被诊断为轻度新冠肺炎。最后,360名患者接受HSBD治疗,368名患者接受中药安慰剂治疗(口服20克,每天两次,持续7天)。主要终点是严重急性呼吸系统综合征冠状病毒2型(SARS-CoV-2)的阴性转化率和阴性转化时间。次要终点包括住院天数和临床状况的改善。结果:HSBD组治疗后7天的严重急性呼吸系统综合征冠状病毒2型阴转率高于对照组(95.28%对82.61%,P<0.001)。HSBD组的中位阴转时间与对照组相比显著缩短了2天(3[3-6]对5[4-7],P<001)。此外,与对照组相比,HSBD组的中位住院天数缩短了1天(6[4-7]vs.7[5-9],P<0.001)。HSBD组在7天内的临床改善率(275/360[76.39%])显著高于对照组(203/368[55.16%])(P<0.001);HSBD组症状评分的改善高于对照组(2[1-4]vs.1[1-2],P<0.001)。未发生严重不良事件。结论:我们的研究表明,HSBD有效提高了轻度新冠肺炎患者的SARS-CoV-2阴性转化率,缩短了阴性转化时间和住院天数。临床试验注册:中国临床试验注册中心,ChiCTR220058668。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Integrative Medicine Research
Integrative Medicine Research Medicine-Complementary and Alternative Medicine
CiteScore
6.50
自引率
2.90%
发文量
65
审稿时长
12 weeks
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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