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

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...

“Three medicines and three formulas” in COVID-19: From bench to bedside

“…In a single-center, open-label, randomized controlled trial of 204 patients with COVID-19, HSBD substantially improved symptoms such as fever, cough, fatigue, and lung CT findings, and did not cause observed serious adverse events [45] . Furthermore, the findings of a retrospective cohort study conducted at a single center have revealed that HSBD treatment notably reduced the duration until negative nucleic acid conversion and the length of hospitalization in patients infected with the SARS-CoV-2 Omicron variant [46][47] . In addition, HSBD can enhance the therapeutic effect of lopinavir-ritonavir on COVID-19, and it can also show advantages when used in combination with TCM injections to treat COVID-19, especially by shortening the clinical remission time [48][49] .…”