Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial
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Published:2023-11-28
Issue:1
Volume:20
Page:
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ISSN:1743-422X
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Container-title:Virology Journal
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language:en
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Short-container-title:Virol J
Author:
Zheng Jin-ping,Ling Yun,Jiang Liang-shuang,Mootsikapun Piroon,Lu Hong-zhou,Chayakulkeeree Methee,Zhang Li-xiu,Arttawejkul Pureepat,Hu Feng-yu,Truong Thi Ngoc Lan,Perez Roxan A.,Gu Xing,Sun Hui-min,Jiang Jian-jie,Liu Ren-jie,Ding Zhen,Zhan Yang-qing,Yang Zi-feng,Guan Wei-jie,Zhong Nan-shan
Abstract
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 registrationChiCTR2200056727.
Funder
Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine the Science and Technology Program of Hebei
Publisher
Springer Science and Business Media LLC
Subject
Infectious Diseases,Virology
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