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Randomized Controlled Trial
. 2021 May:85:153242.
doi: 10.1016/j.phymed.2020.153242. Epub 2020 May 16.

Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial

Ke Hu  1 , Wei-Jie Guan  2 , Ying Bi  3 , Wei Zhang  4 , Lanjuan Li  5 , Boli Zhang  6 , Qingquan Liu  7 , Yuanlin Song  8 , Xingwang Li  9 , Zhongping Duan  10 , Qingshan Zheng  11 , Zifeng Yang  2 , Jingyi Liang  2 , Mingfeng Han  12 , Lianguo Ruan  13 , Chaomin Wu  8 , Yunting Zhang  1 , Zhen-Hua Jia  14 , Nan-Shan Zhong  15
Affiliations
Randomized Controlled Trial

Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial

Ke Hu et al. Phytomedicine. 2021 May.

Erratum in

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: Coronavirus disease 2019; Lianhuaqingwen Capsule; Symptom recovery; conversion rate.

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Conflict of interest statement

None.

Figures

Fig 1
Fig. 1
Study flow chart. PV: protocol violation; FAS: full analysis set; PPS: per protocol set.
Fig 2
Fig. 2
The rate of and the time to symptom recovery. Fig. 2-A. Comparison of the rate of symptom recovery in treatment and control group in the full analysis set, Fig. 2-B. Comparison of the rate of symptom recovery in treatment and control group in the per protocol set, Fig. 2-C. Comparison of the time to symptom recovery in treatment and control group in the full analysis set, Fig. 2-D. Comparison of the time to symptom recovery in treatment and control group in the per protocol set, Shown in the figure are the median value and 95% confidence intervals (95%CI).
Fig 3
Fig. 3
Dynamic changes in the recovery rate. Fig. 3-A. Dynamic changes in the recovery rate in the full analysis set, Fig. 3-B. Dynamic changes in the recovery rate in the per protocol set, Shown is the Kaplan Meier curve for the rate of recovery of the symptoms (including fever, coughing and fatigue). The percentage of patients who achieved the symptom recovery at individual time points was demonstrated for the control group and treatment group.
Fig 4
Fig. 4
Time to individual symptom recovery in the full analysis set.
Fig 5
Fig. 5
The rate of clinical cure and the improvement of chest computed tomographic imaging. We defined the clinical cure as having met all of the following criteria: recovery of body temperature for more than 3 days, symptom recovery, marked improvement in chest CT images, and two consecutive negative SARS-CoV-2 RNA testing (at least one day apart). An improvement in chest CT images was defined as a decreased area of infiltration, a decreased area of any radiologic abnormality, or decreased density of the ground-glass opacity or nodules.
Fig 6
Fig. 6
Chest computed tomographic manifestations at enrolment and after treatment. Shown are the chest computed tomographic manifestations in a patient of the treatment group and the other in the control group. Panel A: A 71-year-old male who presented with bilateral pulmonary infiltrates at the initiation of treatment with LH capsules; Panel B: Marked absorption of bilateral pulmonary infiltrates at day 12 of the treatment with LH capsules; Panel C: A 66-year-old male who presented with bilateral pulmonary infiltrates (the right lower lobe being more prominent) at the initiation of usual treatment; Panel D: Consolidation of the right lower lobe and absorption of the infiltrations in the left lower lobe at day 10 of the usual treatment. LH: Lianhuaqingwen
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