Chinese Medicine Formula Huashibaidu Granule Early Treatment for Mild COVID-19 Patients: An Unblinded, Cluster-Randomized Clinical Trial

Abstract

Background: Previous research suggested that Chinese Medicine (CM) Formula Huashibaidu granule might shorten the disease course in coronavirus disease 2019 (COVID-19) patients. This research aimed to investigate the early treatment effect of Huashibaidu granule in well-managed patients with mild COVID-19.Methods: An unblinded cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. Two cabins were randomly allocated to a CM or control group, with 204 mild COVID-19 participants in each cabin. All participants received conventional treatment over a 7 day period, while the ones in CM group were additionally given Huashibaidu granule 10 g twice daily. Participants were followed up to their clinical endpoint. The primary outcome was worsening symptoms before the clinical endpoint. The secondary outcomes were cure and discharge before the clinical endpoint and alleviation of composite symptoms after the 7 days of treatment.Results: All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (P > 0.05). The number of worsening patients in the CM group was 5 (2.5%), and that in the control group was 16 (7.8%) with a significant difference between groups (P = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (P = 0.151).Conclusion: Seven days of early treatment with Huashibaidu granule reduced the likelihood of worsening symptoms in patients with mild COVID-19. Our study supports Huashibaidu granule as an active option for early treatment of mild COVID-19 in similar well-managed medical environments.Clinical Trial Registration:www.chictr.org.cn/showproj.aspx?proj=49408, identifier: ChiCTR2000029763.

Efficacy and Safety of “Three Chinese Patent Medicines and Three TCM Prescriptions” for COVID-19: A Systematic Review and Network Meta-Analysis

“…After reviewing the titles and abstracts, 604 articles were excluded because they did not comply with the inclusion criteria, and 28 trials initially met the predetermined requirements for detailed evaluation by reading the full text. Finally, 18 trials were included for meta-analysis [ 13 – 30 ]. The PRISMA flow diagram of the literature retrieval process was shown in Figure 1 .…”

“…In these 18 trials, 10 were randomized controlled trials [ 13 , 15 , 18 , 19 , 21 , 23 , 24 , 27 , 29 , 30 ] and 8 were retrospective studies [ 14 , 16 , 17 , 20 , 22 , 25 , 26 , 28 ]. 7 trials used LHQW vs. CD [ 14 , 16 , 18 , 22 , 25 – 27 ], 5 trials used XBJ vs. CD [ 13 , 17 , 21 , 23 , 29 ], 3 used QFPD vs. CD [ 19 , 20 , 28 ], 1 used JHQG vs. CD [ 15 ], 1 used XFBD vs. CD [ 24 ], and 1 used HSBD vs. CD [ 30 ]. Figure 2 provided the network plot of all the included trials.…”

“…The methodological quality of 10 randomized controlled trials was summarized in Table A.3 , and the criteria in the Cochrane Handbook for Systematic Reviews of Interventions were used to assess the risk of bias in the study. Although randomization was announced in all 10 trials, 5 trials used random number table [ 15 , 18 , 21 , 23 , 27 ], 1 used the R 3.6.2 software [ 30 ], 1 used the method of flip a coin [ 24 ], and 3 did not report the method [ 13 , 19 , 29 ]. Moreover, only 1 trial reported allocation concealment [ 21 ], and all the trials did not report the blind method.…”

“…Exacerbation after treatment was reported in 9 trials, in which 4 used LHQW vs. CD [ 14 , 18 , 22 , 27 ], 2 used XBJ vs. CD [ 21 , 23 ], 1 used JHQG vs. CD [ 15 ], 1 used QFPD vs. CD [ 20 ], and 1 used HSBD vs. CD [ 30 ]. Figure 6 provided the forest plots for the network meta-analysis of each relevant drug.…”

Advances in the development of therapeutic strategies against COVID-19 and perspectives in the drug design for emerging SARS-CoV-2 variants

“…A retrospective analysis of JHQG treatment promotes the absorption of pneumonia permeate with a higher 7-day viral clearance rate compared with the control group [159] . HSBD is suitable for early COVID-19 treatment [160] , while XBJ is mainly used for patients in critical conditions [161] . The XBJ may relieve systemic inflammation by inhibiting the secretion of pro-inflammatory cytokines mediated by the HMGB1/RAGE axis to reduce mortality [162] , [163] .…”