tetano
Editor, Senior Moderator
Phytomedicine
. 2020 May 16;153242.
doi: 10.1016/j.phymed.2020.153242. Online ahead of print.
Efficacy and Safety of Lianhuaqingwen Capsules, a Repurposed Chinese Herb, in Patients With Coronavirus Disease 2019: A Multicenter, Prospective, Randomized Controlled Trial
Ke Hu[SUP] 1 [/SUP], Wei-Jie Guan[SUP] 2 [/SUP], Ying Bi[SUP] 3 [/SUP], Wei Zhang[SUP] 4 [/SUP], Lanjuan Li[SUP] 5 [/SUP], Boli Zhang[SUP] 6 [/SUP], Qingquan Liu[SUP] 7 [/SUP], Yuanlin Song[SUP] 8 [/SUP], Xingwang Li[SUP] 9 [/SUP], Zhongping Duan[SUP] 10 [/SUP], Qingshan Zheng[SUP] 11 [/SUP], Zifeng Yang[SUP] 2 [/SUP], Jingyi Liang[SUP] 2 [/SUP], Mingfeng Han[SUP] 12 [/SUP], Lianguo Ruan[SUP] 13 [/SUP], Chaomin Wu[SUP] 8 [/SUP], Yunting Zhang[SUP] 1 [/SUP], Zhen-Hua Jia[SUP] 14 [/SUP], Nan-Shan Zhong[SUP] 2 [/SUP]
Affiliations
Abstract
Background: Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
Purpose: To determine the safety and efficacy of LH capsule in patients with Covid-19.
Methods: We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
Results: We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, P=0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, P<0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all P<0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P<0.001) and clinical cure (78.9% vs. 66.2%, P=0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both P>0.05). No serious adverse events were reported.
Conclusion: In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
Keywords: 95%CI, 95% confidence interval; CT, computed tomography; Coronavirus disease 2019; Covid-19, coronavirus disease 2019; FAS, full-analysis set; HR, hazards ratio; LH, Lianhuaqingwen; Lianhuaqingwen Capsule; MERS, Middle East Respiratory Syndrome coronavirus; PPS, per protocol set; PV, protocol deviation; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; conversion rate; symptom recovery.
. 2020 May 16;153242.
doi: 10.1016/j.phymed.2020.153242. Online ahead of print.
Efficacy and Safety of Lianhuaqingwen Capsules, a Repurposed Chinese Herb, in Patients With Coronavirus Disease 2019: A Multicenter, Prospective, Randomized Controlled Trial
Ke Hu[SUP] 1 [/SUP], Wei-Jie Guan[SUP] 2 [/SUP], Ying Bi[SUP] 3 [/SUP], Wei Zhang[SUP] 4 [/SUP], Lanjuan Li[SUP] 5 [/SUP], Boli Zhang[SUP] 6 [/SUP], Qingquan Liu[SUP] 7 [/SUP], Yuanlin Song[SUP] 8 [/SUP], Xingwang Li[SUP] 9 [/SUP], Zhongping Duan[SUP] 10 [/SUP], Qingshan Zheng[SUP] 11 [/SUP], Zifeng Yang[SUP] 2 [/SUP], Jingyi Liang[SUP] 2 [/SUP], Mingfeng Han[SUP] 12 [/SUP], Lianguo Ruan[SUP] 13 [/SUP], Chaomin Wu[SUP] 8 [/SUP], Yunting Zhang[SUP] 1 [/SUP], Zhen-Hua Jia[SUP] 14 [/SUP], Nan-Shan Zhong[SUP] 2 [/SUP]
Affiliations
- PMID: 32425361
- PMCID: PMC7229744
- DOI: 10.1016/j.phymed.2020.153242
Abstract
Background: Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
Purpose: To determine the safety and efficacy of LH capsule in patients with Covid-19.
Methods: We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
Results: We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, P=0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, P<0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all P<0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P<0.001) and clinical cure (78.9% vs. 66.2%, P=0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both P>0.05). No serious adverse events were reported.
Conclusion: In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
Keywords: 95%CI, 95% confidence interval; CT, computed tomography; Coronavirus disease 2019; Covid-19, coronavirus disease 2019; FAS, full-analysis set; HR, hazards ratio; LH, Lianhuaqingwen; Lianhuaqingwen Capsule; MERS, Middle East Respiratory Syndrome coronavirus; PPS, per protocol set; PV, protocol deviation; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; conversion rate; symptom recovery.