Abstract

Objectives: Lianhua Qingwen capsule/granule (LHQW) is an innovative patented traditional Chinese medicine with potential curative effects on respiratory diseases. However, no consensus has been reached on the security of LHQW to date. The current meta-analysis was performed to evaluate the safety profile of LHQW in relation to conventional drugs (PROSPERO CRD-42020224180). Methods: Comprehensive document retrieval was performed from both English and Chinese databases. Results were reported as risk ratio (RR) with 95% confidence interval (CI). Subgroup, sensitivity and meta-regression analyses were conducted to explore the possible sources of heterogeneity across eligible studies. Results: In total, 217 experimental studies were included. For pooled studies, the incidence of adverse reactions was lower in the LHQW group than the conventional drug group (RR = 0.63, 95% CI = 0.58–0.69, p < 0.001). In the evaluation of treating disease, significant reduced incidence of adverse reactions during treatment of influenza A (H1N1) and influenza were detected in the LHQW group. In the evaluation of security indexes, LHQW group has a reduced incidence of respiratory system damage, skin and its appendages injury, nervous system damage and gastrointestinal system damage, along with other adverse reactions. Subgroup analysis additionally revealed a reduced incidence of some adverse reactions in the LHQW group compared to the conventional drug group (Rash of skin and its appendage damage, dizziness or headache owing to nervous system damage, nausea or vomiting from gastrointestinal system damage and resurgence of disease from other adverse reactions). Conclusion: The current study provides potential a reference for the security of LHQW. Further long-term high-quality studies are essential to validate our conclusions. Systematic Review Registration: https://clinicaltrials.gov/, CRD-42020224180

Highlights

  • Lianhua Qingwen capsule/granule (LHQW) is obtained by combining Ma Xing Shigan Decoction with Yinqiao Powder and widely used in the clinical treatment of respiratory disorders (Liu et al, 2010)

  • The incidence of adverse reactions was lower in the LHQW group than the conventional drug group (RR = 0.63, 95% confidence interval (CI) = 0.58–0.69, p < 0.001)

  • In the evaluation of treating disease, significant reduced incidence of adverse reactions during treatment of influenza A (H1N1) and influenza were detected in the LHQW group

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Summary

Introduction

Lianhua Qingwen capsule/granule (LHQW) is obtained by combining Ma Xing Shigan Decoction with Yinqiao Powder and widely used in the clinical treatment of respiratory disorders (Liu et al, 2010). LHQW was initially approved by the China Food and Drug Administration (CFDA) in 2004 and represents the first traditional Chinese medicine that passed the rapid drug approval channel of CFDA for treatment of severe acute respiratory syndrome (SARS). [Caprifoliaceae; Lonicerae Japonicae Flos] (255 g), Ephedra sinica Stapf [Ephedraceae; Ephedrae Botanical drug] (85 g), Prunus armeniaca L. [Fabaceae; Glycyrrhizae Radix et Rhizoma] (85 g) (Rivera et al, 2014; Royal Botanic Gardens, Kew, 2021; Royal Botanic Gardens, Kew science, 2021; The Plant List, 2021; Yiling Pharmaceutical, 2021). These above ingredients are decocted, distilled, filtered, refrigerated, mixed well with powdered sugar, dextrin or starch, dried and made into LHQW (Chinese Pharmacopoeia, 2020). LHQW has played a significant role in the prevention and control of viral public health events (Yao et al, 2020), and is widely accepted as a representative antiviral Chinese medicine in China

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