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. 2023 May 24:1–8. Online ahead of print. doi: 10.1007/s11655-023-3549-8

Efficacy and Safety of Huashi Baidu Granules in Treating Patients with SARS-CoV-2 Omicron Variant: A Single-Center Retrospective Cohort Study

Cai-yu Chen 1, Wen Zhang 1, Xiang-ru Xu 1, Yu-ting Pu 1, Ya-dan Tu 2, Wei Peng 1, Xuan Yao 1, Shuang Zhou 3, Bang-jiang Fang 1,4,✉
PMCID: PMC10206345  PMID: 37222827

Abstract

Objective

To evaluate the efficacy and safety of Huashi Baidu Granules (HSBD) in treating patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant.

Methods

A single-center retrospective cohort study was conducted during COVID-19 Omicron epidemic in the Mobile Cabin Hospital of Shanghai New International Expo Center from April 1st to May 23rd, 2022. All COVID-19 patients with asymptomatic or mild infection were assigned to the treatment group (HSBD users) and the control group (non-HSBD users). After propensity score matching in a 1:1 ratio, 496 HSBD users of treatment group were matched by propensity score to 496 non-HSBD users. Patients in the treatment group were administrated HSBD (5 g/bag) orally for 1 bag twice a day for 7 consecutive days. Patients in the control group received standard care and routine treatment. The primary outcomes were the negative conversion time of nucleic acid and negative conversion rate at day 7. Secondary outcomes included the hospitalized days, the time of the first nucleic acid negative conversion, and new-onset symptoms in asymptomatic patients. Adverse events (AEs) that occurred during the study were recorded. Further subgroup analysis was conducted in vaccinated (378 HSBD users and 390 non-HSBD users) and unvaccinated patients (118 HSBD users and 106 non-HSBD users).

Results

The median negative conversion time of nucleic acid in the treatment group was significantly shortened than the control group [3 days (IQR: 2–5 days) vs. 5 days (IQR: 4–6 days); P<0.01]. The negative conversion rate of nucleic acid in the treatment group were significantly higher than those in the control group at day 7 (91.73% vs. 86.90%, P=0.014). Compared with the control group, the hospitalized days in the treatment group were significantly reduced [10 days (IQR: 8–11 days) vs. 11 days (IQR: 10.25–12 days); P<0.01]. The time of the first nucleic acid negative conversion had significant differences between the treatment and control groups [3 days (IQR: 2–4 days) vs. 5 days (IQR: 4–6 days); P<0.01]. The incidence of new-onset symptoms including cough, pharyngalgia, expectoration and fever in the treatment group were lower than the control group (P<0.05 or P<0.01). In the vaccinated patients, the median negative conversion time and hospitalized days were significantly shorter than the control group after HSDB treatment [3 days (IQR: 2–5 days) vs. 5 days (IQR: 4–6 days), P<0.01; 10 days (IQR: 8–11 days) vs. 11 days (IQR: 10–12 days), P<0.01]. In the unvaccinated patients, HSBD treatment efficiently shorten the median negative conversion time and hospitalized days [4 days (IQR: 2–6 days) vs. 5 days (IQR: 4–7 days), P<0.01; 10.5 days (IQR: 8.75–11 days) vs. 11.0 days (IQR: 10.75–13 days); P<0.01]. No serious AEs were reported during the study.

Conclusion

HSBD treatment significantly shortened the negative conversion time of nuclear acid, the length of hospitalization, and the time of the first nucleic acid negative conversion in patients infected with SARS-COV-2 Omicron variant (Trial registry No. ChiCTR2200060472).

Electronic Supplementary Material

Supplementary material (Appendixes 1 and 2) are available in the online version of this article at 10.1007/s11655-023-3549-8.

KeyWords: Huashi Baidu Granule, severe acute respiratory syndrome Coronavirus 2, Omicron variant, retrospective cohort trial, Chinese medicine

Electronic Supplementary Material

Appendix (64.6KB, pdf)

Acknowledgements

We acknowledge the medical team for their contributions to fight against the epidemic in Shanghai and collect data for this study in the Shanghai New International Expo Center.

Footnotes

Supported by Traditional Chinese Medicine Emergency Project on Novel Coronavirus-Infected Pneumonia of State Administration of Traditional Chinese Medicine (No. 2022ZYLCYJ05-4), Shanghai Key Clinical Specialty Project (No. shslczdzk04401), National Traditional Chinese Medicine Emergency Medical Rescue Base Construction Project [No. ZY(2021-2023)-0101-01], National Traditional Chinese Medicine Multidisciplinary Cross Innovation Team Project (No. ZYYCXTD-D-202203)

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Author Contributions

Chen C and Zhang W: manuscript preparation and editing, data, and statistical analysis; Xu X and Pu Y: data curation and investigation; Tu Y, Peng W and Yao X: data curation and supervision. Fang B and Zhou S: study conception and design. All authors read and approved the final version for publication.

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Supplementary Materials

Appendix (64.6KB, pdf)

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