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Randomized Controlled Trial
. 2023 Nov 28;20(1):277.
doi: 10.1186/s12985-023-02144-6.

Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial

Jin-Ping Zheng #  1 , Yun Ling #  2 , Liang-Shuang Jiang #  3 , Piroon Mootsikapun #  4 , Hong-Zhou Lu #  5 , Methee Chayakulkeeree #  6 , Li-Xiu Zhang #  7 , Pureepat Arttawejkul #  8 , Feng-Yu Hu  9 , Thi Ngoc Lan Truong  10 , Roxan A Perez  11 , Xing Gu  12 , Hui-Min Sun  13 , Jian-Jie Jiang  14 , Ren-Jie Liu  15 , Zhen Ding  16 , Yang-Qing Zhan  17 , Zi-Feng Yang  17 , Wei-Jie Guan  17 , Nan-Shan Zhong  18
Affiliations
Randomized Controlled Trial

Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial

Jin-Ping Zheng et al. Virol J. .

Abstract

Background: In a randomized trial, Lianhuaqingwen (LHQW) capsule was effective for accelerating symptom recovery among patients with coronavirus disease 2019 (COVID-19). However, the lack of blinding and limited sample sizes decreased the level of clinical evidence.

Objectives: To evaluate the efficacy and safety of LHQW capsule in adults with mild-to-moderate COVID-19.

Methods: We conducted a double-blind randomized controlled trial in adults with mild-to-moderate COVID-19 (17 sites from China, Thailand, Philippine and Vietnam). Patients received standard-of-care alone or plus LHQW capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the median time to sustained clinical improvement or resolution of nine major symptoms.

Results: The full-analysis set consisted of 410 patients in LHQW capsules and 405 in placebo group. LHQW significantly shortened the primary endpoint in the full-analysis set (4.0 vs. 6.7 days, hazards ratio: 1.63, 95% confidence interval: 1.39-1.90). LHQW capsules shortened the median time to sustained clinical improvement or resolution of stuffy or runny nose (2.8 vs. 3.7 days), sore throat (2.0 vs. 2.6 days), cough (3.2 vs. 4.9 days), feeling hot or feverish (1.0 vs. 1.3 days), low energy or tiredness (1.3 vs. 1.9 days), and myalgia (1.5 vs. 2.0 days). The duration to sustained clinical improvement or resolution of shortness of breath, headache, and chills or shivering did not differ significantly between the two groups. Safety was comparable between the two groups. No serious adverse events were reported.

Interpretation: LHQW capsules promote recovery of mild-to-moderate COVID-19 via accelerating symptom resolution and were well tolerated. Trial registration ChiCTR2200056727 .

Keywords: Coronavirus disease 2019; Inflammation; Lianhuaqingwen Capsule; Omicron; Symptom resolution.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Study flow chart. FAS: full analysis set; PPS: per protocol set
Fig. 2
Fig. 2
The time to the resolution of the four major symptoms in the treatment group (red curve) and placebo group (blue curve) according to the full-analysis set. A Time to resolution of the nine major symptoms; B Time to resolution of cough; C Time to resolution of stuffy or runny nose; D Time to resolution of sore throat; E Time to resolution of feeling hot or feverish; Shown in the figures are the median value and 95% confidence intervals (95%CI)
Fig. 3
Fig. 3
The time to the resolution of the other major symptoms in the treatment group (red curve) and placebo group (blue curve) according to the full-analysis set. A Time to resolution of shortness of breath; B Time to resolution of low energy or tiredness symptoms; C Time to resolution of myalgia; D Time to resolution of headache; E Time to resolution of chills or shivering
Fig. 4
Fig. 4
Cumulative negative conversion rate of SARS-CoV-2 NAAT findings in the treatment group (red curve) and placebo group (blue curve) according to the full-analysis set. No significant difference was shown between the two curves for each individual time points
Fig. 5
Fig. 5
Subgroup analysis of the therapeutic effect of the primary endpoint (the median time to sustained clinical improvement or resolution of the nine above-mentioned major symptoms as of day 14)
See this image and copyright information in PMC

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