Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study

Abstract

This study aimed to evaluate the clinical efficacy of Longyizhengqi granule, a traditional Chinese medicine, in patients with mild COVID-19. Patients and Methods: We conducted a prospective study including mild COVID-19 participants conducted at Mobile Cabin Hospital in Shanghai, China. Participants were assigned to receive Longyizhengqi granule or conventional treatment. The primary outcome was the time for nucleic acid to turn negative and the secondary outcomes are hospital stay and changes in cycle threshold (Ct) values for N gene and Orf gene. Multilevel random-intercept model was performed to analyze the effects of treatment. Results: A total of 3243 patients were included in this study (Longyizhengqi granule 667 patients; conventional treatment 2576 patients). Age (43.5 vs 42.1, p<0.01) and vaccination doses (not vaccinated: 15.8% vs 21.7%, 1 dose: 3.5% vs 2.9%, 2 doses: 27.9% vs 25.6%, 3 doses: 52.8% vs 49.8%. p<0.01) show statistical difference between Conventional treatment group and LYZQ granules group. The use of Longyizhengqi granule could significantly reduce the time for nucleic acid to turn negative (14.2 days vs 10.7 days, p<0.01), shorten hospital stay (12.5 days vs 9.9 days, p<0.01), and increase the changes in Ct value for N gene (8.44 vs 10.33, p<0.01) and Orf gene (7.31 vs 8.44, p<0.01) to approximately 1.5. Moreover, the difference in the changes of Ct values on the 4th, 6th, 8th, and 10th days seem to increase between two groups. No serious adverse events were reported. Conclusion: Longyizhengqi granule might be a promising drug for the treatment of mild COVID-19, and it might be beneficial to effectively shorten the negative transition time of nucleic acid, the total days of hospitalization, and increase the changes of Ct values. Long-term randomized controlled trials with follow-up evaluations are required to confirm its long-term efficacy.

Combination of Chinese herbal medicine and conventional western medicine for coronavirus disease 2019: a systematic review and meta-analysis

“…As 29 studies failed to mention their allocation concealment implementation, 144 outcomes were determined to be “some concerns” in this domain. Additionally, three studies ( 43 – 45 ) grouped the participants using inappropriate randomization methods, as a result, 9 outcomes were assessed as “high risk” in the three studies.…”

“…Five of them were assessed as “low risk” ( 59 , 65 , 82 – 84 ), 8 as “some concerns” ( 41 , 42 , 46 , 48 , 60 , 61 , 63 , 85 ), and 4 as “high risk” ( 43 , 45 , 56 , 65 ). Among them, 16 studies enrolled symptomatic cases ( 41 , 43 , 45 , 46 , 48 , 56 , 59 – 61 , 63 , 65 , 82 – 85 ) and the rest one ( 42 ) evaluated nucleic acid conversion time in asymptomatic patients with COVID-19. A total of 2,856 participants involved in CHM plus CWM groups, and 4,657 involved in CWM groups.…”

“…Of the 36 studies reporting adverse reactions, 5 were assessed as “low risk” ( 50 , 53 , 67 , 83 , 84 ), 22 as “some concerns” ( 46 – 48 , 61 , 62 , 64 , 66 , 68 , 69 , 71 – 73 , 82 , 85 , 88 , 90 – 92 ), and 9 as “high risk” ( 43 , 45 , 49 , 51 , 52 , 54 , 56 , 59 , 65 ). The main adverse reactions contained diarrhea ( 45 – 48 , 50 , 51 , 56 , 59 , 62 , 64 , 65 , 67 , 72 , 75 , 78 , 82 , 84 , 89 , 91 ), vomiting ( 46 , 48 , 50 , 51 , 56 , 64 , 67 , 72 , 75 , 82 , 89 , 91 ), nausea ( 46 , 48 , 50 , 51 , 56 , 64 , 67 , 72 , 75 , 89 , 90 ), loss of appetite ( …”

“…A total of 17 studies evaluated SARS-CoV-2 nucleic acid conversion time. Five of them were assessed as "low risk" (59, 65, 82-84), 8 as "some concerns" (41, 42,46,48,60,61,63,85), and 4 as "high risk" (43,45,56,65). Among them, 16 studies enrolled symptomatic cases (41, 43, 45, 46, 48, 56, 59-61, 63, 65, 82-85) and the rest one (42) evaluated nucleic acid conversion time in asymptomatic patients with COVID-19.…”