Res. Bethesda, MD 20894, Web Policies Traditional Chin. the contents by NLM or the National Institutes of Health. (2020). The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fphar.2022.764774/full#supplementary-material, Ahsan, W., Javed, S., Bratty, M. A., Alhazmi, H. A., and Najmi, A. 12 (12), 753759754755. J. Pharmacovigilance. 343, d5928. Besides, on April 14, 2020, the National Medical Products Administration of China approved modifying the specification of LHQW (Yiling Pharmaceutical Inc.) by adding a new indication for COVID-19 treatment in mild and normal cases. The quantitative analysis of all eligible studies. Li H.R., Chang L.P., Wei C., Jia Z.H. doi:10.14009/j.issn.1672-2124.2013.08.001, Wang, Y. doi:10.3969/j.issn.1672-2809.2020.13.020, Liu, C. Y., Li, X. Q., and Cai, S. Q. Evid. J. Ethnopharmacol. (2021). The quadruple combination therapy including Ribavirin, Lopinavir/ritonavir, Umifenovir, and LHQW, could markedly improve the abnormal coagulation and leukocyte of severe COVID-19 patients with a better prognosis [42]. CONTRAINDICATIONS Uncertainty. The group reported significantly lower incidence of adverse reactions (RR = 0.62, 95% CI = 0.460.82) and lower incidence of gastrointestinal system damage in the LHQW group (RR = 0.65, 95% CI = 0.460.92) relative to the control group. 161, 105126. doi:10.1016/j.phrs.2020.105126, Yang, C., Wang, Y., He, J., Yan, W., Jiang, H., Chen, Q., et al. Traditional Chinese medicine for pulmonary fibrosis therapy: progress and future prospects. doi:10.1016/j.jep.2013.12.022. H. Ohba [Crassulaceae; Rhodiolae Crenulatae Radix et Rhizoma] (85g), Mentha haplocalyx Briq. Meta-analysis and systematic review of efficacy and safety of Lianhua Qingwen in adjuvant treatment of adult pneumonia. Case reports, unrelated studies, those with duplicate data, reviews, commentaries and animal-based studies were excluded from the current meta-analysis. In the COVID-19 pneumonia epidemic of China, traditional Chinese medicine plays a critical role in preventing mild or ordinary COVID-19 patients from developing into serious or critical patients (China Central Television News, 2020). doi:10.13422/j.cnki.syfjx.20201099, Ye, C., Gao, M., Lin, W., Yu, K., Li, P., and Chen, G. (2020). Yiling Pharmaceutical (2021). [Cruciferae; Isatudus Radix], Dryopteris crassirhizoma Nakai [Polypodiaceae; Dryopteris Crassirhizomatis Rhizoma], Houttuynia cordata Thunb. 132 studies documented gastrointestinal system damage. Drafting of the manuscript was done by CH and BH. Hsieh C.F., Lo C.W., Liu C.H., Lin S., Yen H.R., Lin T.Y., Horng J.T. Till August 8, 2020, over 19,000,000 people have been confirmed infected and more than 700,000 people have died during this severe viral prevalence. Reply. Yu P., Li Y.Z., Wan S.B., Wang Y. Efficacy of Lianhua Qingwen granules combined with abidor in the treatment of mild COVID-19. Wang F.C., Shen B.X., He C.Y., Zhao W.C., Nie S.L. After 7 days of treatment, the main TCM syndrome scores (fever, fatigue, cough, dry throat, chest tightness), C-reactive protein and procalcitonin levels in the LHQW group were significantly lower, and the white blood cell and lymphocyte counts were obviously higher than those in abidor group [44]. DerSimonian, R., and Laird, N. (1986). (2020). Study design was done by CH and BH. These data indicate that LHQW prescription protects against the virus attack, and it has been recommended in the treatment of COVID-19 in China [47]. Some composition of LHQW can cause damage to the stomach and intestines, supporting the possibility of injurious effects on the gastrointestinal system: for thia suspensa (Thunb.) The Plant List (2021). Contraindications . [13], A 2020 "randomized controlled trial" of LHQW involving Zhong was also found in April 2022 to have undisclosed funding from Yiling Pharmaceuticals, forcing an erratum. doi:10.13412/j.cnki.zyyl.2010.06.026. Zhong Y., Zhou J., Liang N., Liu B., Lu R., He Y., Liang C., Wu J., Zhou Y., Hu M., Zhou J. ADVERSE REACTION Uncertainty. (2002). Methods: Comprehensive document retrieval was performed from both English and Chinese databases. The documents were filtered and summarized for final evaluation. (2020). Keywords: Lianhua Qingwen, adverse reaction, COVID-19, influenza, traditional Chinese medicine, meta-analysis, Citation: Hu C, He B, Gong F, Liang M, Zhao D and Zhang G (2022) The Adverse Reactions of Lianhua Qingwen Capsule/Granule Compared With Conventional Drug in Clinical Application: A Meta-Analysis. Tradit. The results are expected to enhance its effectiveness against viruses. Meanwhile, the median effective concentrations (EC50) in above-mentioned effects were 0.042, 0.031, 0.051 and 0.050mg/mL, respectively, while the prevention effect on virus adsorption was the strongest [25]. Lianhua Qingwen can be a complementary strategy for treating COVID-19. There was no statistically significant difference in the incidence of adverse reactions during treatment of chronic obstructive pulmonary disease between the LHQW group and the conventional drug group (RR = 1.27, 95% CI = 0.513.17, p = 0.608). Besides, in view of the definite effects of LHQW in preventing severe viral infections such as SARS and COVID-19 [17,44,45,49,52,53], LHQW may represent a considerable and effective strategy against unknown viral epidemics. 152 (3), 393402. Zhang, R. X., and Liu, W. W. (2014). World Health Organization Adverse Drug Reaction Terminology (2009). Lianhua Qingwen Prescription is approved for the treatment of fever, cough, and fatigue caused by light and common type of COVID-19 . Dang Y., Xu J., Yang Y., Li C., Zhang Q., Zhou W., Zhang L., Ji G. Ling-gui-zhu-gan decoction alleviates hepatic steatosis through SOCS2 modification by N6-methyladenosine. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. Upon full text filtering of the remaining 715 citations, 498 were excluded due to a number of reasons (shown in Figure 1). In conclusion, this review has summarized the benefits of LHQW for treating virus infection, especially its anti-SARS-CoV-2 role as an alternative candidate and complementary strategy. Ther. As a library, NLM provides access to scientific literature. First, the quality of qualified studies was generally medium, randomization procedures and blinding information were lacking in most studies. LQ15H280003), the Clinical Research Projects of Zhejiang Medical Association (No. In vitro, LHQW capsules could inhibit the proliferation of influenza viruses of various strain with the 50 % inhibitory concentration ranging from 0.35 to 2mg/mL [24]. N. Engl. No adverse treatment-related effects were reported in all the included publications (from 2009 to 2011). Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: a multicenter, prospective, randomized controlled trial. Further clinical trial showed that LHQW was superior to oseltamivir in improving the symptoms of influenza A virus infection by a meta-analysis of randomized, controlled trials [37]. Lianhua-qingwen Displays Antiviral and Anti-inflammatory Activity and Synergistic Effects with Oseltamivir against Influenza B Virus Infection in the Mouse Model. Duan Z.P., Jia Z.H., Zhang J., Liu S., Chen Y., Liang L.C., Zhang C.Q., Zhang Z., Sun Y., Zhang S.Q., Wang Y.Y., Wu Y.L. As the Financial Times report showed, these appeared to be serious conflicts of interest as the investments benefited from the PRC and HK governments' rapid approval and then widespread national & international promotion of Lianhua Qingwen and other suspect treatments for purportedly helping COVID-19 sufferers. 66 (6), 771777. Medicine (Baltimore). Chakraborty C., Sharma A.R., Sharma G., Bhattacharya M., Lee S.S. SARS-CoV-2 causing pneumonia-associated respiratory disorder (COVID-19): diagnostic and proposed therapeutic options. The sensitivity results are shown in Table 2. Alternat Med. showed that the usual treatment in combination with LHQW capsules (4 capsules thrice daily for 14 days) had significantly higher recovery rate, and shorter median time to symptom recovery, as compared with control group [43]. Li L.C., Kan L.D. Subgroup, sensitivity and meta-regression analyses were conducted to determine the potential sources of heterogeneity. This study was supported by the COVID-19 Pneumonia of Traditional Chinese Medicine Emergency Project, State Administration of Traditional Chinese Medicine of the Peoples Republic of China (2020ZYLCYJ02-1). Therefore, further attention should be paid to the occurrence of adverse reaction with LHQW among different age groups in the future. In addition to western medicine, the potential adverse drug reactions (ADRs) can not be ignored. A multicenter retrospective study showed similar results, which revealed that combined application of LHQW granules (6g, tid) could notably improve the clinical symptoms of fever, fatigue, cough, expectoration, chest tightness, and anorexia, and reduce the proportion of common to severe cases in COVID-19 patients with common type [20]. Runfeng L., Yunlong H., Jicheng H., Weiqi P., Qinhai M., Yongxia S., Chufang L., Jin Z., Zhenhua J., Haiming J. Lianhuaqingwen exerts anti-viral and anti-inflammatory activity against novel coronavirus (SARS-CoV-2). Analysis of the molecular mechanism of Pudilan (PDL) treatment for COVID-19 by network pharmacology tools. [Caprifoliaceae; Lonicerae Japonicae Flos] (255g), Ephedra sinica Stapf [Ephedraceae; Ephedrae Botanical drug] (85g), Prunus armeniaca L. [Rosaceae; Armeniacae Semen Amarum] (85g), Gypsum Fibrosum (255g), Isatis indigotica Fort. [8] A January 2022 meta-analysis from China reports that it may cause GI discomfort, rashes and itches, dry mouth, and dizziness, but emphasizes that the effects are more common with "conventional treatment". Are there any known contraindications? No use, distribution or reproduction is permitted which does not comply with these terms. COVID-19 pandemic has caused a serious threat to public health and become the greatest challenge facing the world. High-quality randomized controlled trials conducted over the long-term from multiple countries are warranted to further validate the efficacy and safety of LHQW. Future related studies will provide accumulated evidence to clarify it. Accordingly, other biases were defined as low risk of bias. The risk of bias data is presented as a percentage, as shown in Figure 2. 43 studies on treatment of respiratory tract infection were examined, with 29 reporting adverse reactions. The most common adverse reactions in our analysis were gastrointestinal system damage, skin and its appendage damage. Natural herbal medicine Lianhuaqingwen capsule anti-influenza A (H1N1) trial: a randomized, double blind, positive controlled clinical trial. Received 2020 Jul 3; Revised 2020 Aug 9; Accepted 2020 Aug 16. Academician Yiling Wu systematically constructs the theory of collateral disease, provides theoretical guidance for the formulation of Lianhua Qingwen, and gives . Kunming: Kunming University of technology. Among the 13 included studies on treatment of hand-foot-mouth disease, eight reported adverse reactions. doi:10.26434/chemrxiv.12016236.v1. The trim and fill method was employed in cases where publication bias existed (Duval and Tweedie, 2000). Our findings support the adverse reactions recorded by Yiling Pharmaceutical, and compare the incidence risk of gastrointestinal system damage and rash with the control group. [5], Sources of its formulation reportedly consist of:[6], The medicine is both in capsule and granular form. Chin. LHQW has been recommended by the China International Exchange and Promotive Association for Medical and Health Care and the Chinese Research Hospital Association as comprehensive treatment for moderate or chronic COVID-19 pneumonia in conjunction with routine therapy (Jin et al., 2020). The documents were filtered and summarized for final evaluation. The discovery of potential effective drugs on the market becomes one of the principal means to develop antiviral drugs for COVID-19. 17 (13), 6264. Qualitative and Quantitative Analysis of the Major Constituents in Chinese Medical Preparation Lianhua-Qingwen Capsule by UPLC-DAD-QTOF-MS. ScientificWorldJournal. Pharmacological Action, Clinical Application and Adverse Reactions of Houttuynia Cordata. Similar results were obtained in subgroup analysis of hepatic function abnormal and transaminase increased. "This medicine has a cooling effect so if you take this, lalo kang magchi -chill," he cautions. The LHQW group has a reduced incidence of gastrointestinal system damage than the conventional drug group (RR = 0.83, 95% CI = 0.740.93, p = 0.002). Our meta-analysis was conducted in accordance with the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement (Moher et al., 2009), and registered with PROSPERO (CRD42020224180). Efficacy of Lianhuaqingwen capsule compared with oseltamivir for influenza A virus infection: a meta-analysis of randomized, controlled trials. Adv. While the results from our study showed that LHQW has a potentially reduced incidence of adverse reactions in certain diseases and symptoms to a greater extent than conventional treatment, efficacy is an important consideration that should not be overlooked. [Saururaceae; Houttuyniae Botanical drug] (255g), Pogostemon cablin (Blanco) Benth. 56 (2), 455463. (Bohe), Glycyrrhiza uralensis Fisch. Other Symptoms Sputum.Four studies reported the effects of Lianhua Qingwen and those of conventional drugs on the duration of sputum. Literature searching and extraction of data were done by CH, BH, FG, and ML. Wang L., Yang Z.H., Zhang H.R., Yu H.X., Yang K., Fu B.H., Yang H.T. Previous studies reported that Lianhua Qingwen might have positive effects, including broad-spectrum antiviral, cough and expectorant, antipyretic and anti-inflammatory, immune-regulating, effective antibacterial and other systemic intervention functions (Liu et al., 2010; Liu 2015; Wang, et al., 2015). A recent meta-analysis came from Zhang and Liu, (2014), focused on treatment for influenza A (H1N1) with LHQW in conjunction with oseltamivir. There was no statistically significant difference in the incidence of adverse reactions during treatment of COVID-19 pneumonia between the LHQW group and the conventional drug group (RR = 0.51, 95% CI = 0.141.82, p = 0.297). Language links are at the top of the page across from the title. Further investigation confirmed that the combination treatment of LHQW capsules (200mg/kg/day) with oseltamivir (2mg/kg/day) markedly reduced IBV infection over the individual administration of either alone in vivo, proving that LHQW capsules could be used as an assistant drug to enhance the effect of oseltamivir against IBV infection [26]. Nervous system damage was described as an adverse event in 34 studies. Impressively, LHQW in conjunction with conventional treatment could significantly improve COVID-19 patients as a synergetic strategy. (japanese honeysuckle) flower 27.41 mg, gypsu . There was no statistically significant difference in the incidence of hepatobiliary system damage between the LHQW group and the conventional drug group (RR = 0.86, 95% CI = 0.581.28, p = 0.461). For pooled studies, the incidence of adverse reactions was lower in the LHQW group than the conventional drug group (RR = 0.63, 95% CI = 0.580.69, p < 0.001). Heterogeneity was evaluated using I2 statistic. Furthermore, they identified two important metabolites, prostaglandin F2 and arachidonic acid, and their arachidonic acid metabolism pathway, as vital indicators of LHQW in treating influenza by using serum metabolomics analysis [19]. COVID-19 has led to a great case fatality. Available at: http://www.plantsoftheworldonline.org (Accessed December 18, 2021). Experimental study on prevention and treatment of influenza virus FM1 infection in mice by Lianhua Qingwen capsule. (2020). J. Med. Lianhua Qingwen (LHQW) is a commonly used Chinese medical preparation to treat viral influenza, including in the fight against SARS in 20022003 in China. In treating fine particulates PM2.5 (7.5mg/kg)-exposed model rats, LHQW significantly relieved the pathological changes of thickened alveolar septum, congestion of capillary, interstitial edema and infiltration of lymphocyte and neutrophil surrounding bronchiole [34]. National Library of Medicine Li X., Yang Y., Liu L., Yang X., Zhao X., Li Y., Ge Y., Shi Y., Lv P., Zhang J., Bai T., Zhou H., Luo P., Huang S. Effect of combination antiviral therapy on hematological profiles in 151 adults hospitalized with severe coronavirus disease 2019. Lianhua Qingwen capsules have been proven to speed up symptoms recovery but no effect in preventing infections from worsening. We would like to express our appreciation to all authors of eligible studies which were included in the current meta-analysis. The different incidence of these adverse reactions may be related to the metabolic level, which varies greatly among the different age groups. Skin rashes, allergic dermatitis and other skin allergic reactions are also reported to be associated with LHQW treatment, and may be related to Houttuynia cordata Thunb. aDepartment of Pharmacy, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, PR China, bShanghai TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, PR China, cShanghai TCM-Integrated Institute of Vascular Anomalies, Shanghai, 200082, PR China, dDepartment of Pharmacy, The First Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou, 310018, PR China, eDepartment of Pharmacy, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, 310018, PR China, fState Key Laboratory of Pharmaceutical Biotechnology, Department of Biotechnology and Pharmaceutical Sciences, School of Life Science, Nanjing University, Nanjing, 210023, PR China. Ren Y., Yao M.C., Huo X.Q., Gu Y., Zhu W.X., Qiao Y.J., Zhang Y.L. Literature analysis of clinical application and adverse drug reaction/event of Lianhua Qingwen capsule. Among the eight included studies on rheum therapy, six reported adverse reactions. Management of adverse reactions was clearly documented in 38 studies, which reported improvement or resolution through discontinuation of medication, changes to post-meal administration, symptomatic or no treatment. Based Complement. Traditional Chinese medicine, such as Lianhua Qingwen, has achieved some curative effect in many countries, but its effect is not clear. J. Chin. The epidemic of 2019-novel-coronavirus (2019-nCoV) pneumonia and insights for emerging infectious diseases in the future. Recently, Yu et al. Lianhua Qingwen Capsules/granules Product Details. The serious attack of Coronavirus Disease 2019 (COVID-19), infected by Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (SARS-CoV-2), has quickly spread around the globe [[1], [2], [3]]. MANILA, Philippines The Makati Medical Center's therapeutics and medication safety committee (TMSC) has said that the Chinese drug, Lianhua Qingwen (LQ), should not be taken without a doctor's prescription to ease new coronavirus disease (COVID-19) symptoms, warning that it may do more harm than good. 38 studies reported dispose or outcomes of adverse reactions. This review has introduced the advances of LHQW in anti-viral treatment, intending to provide ideas for the timely treatment of COVID-19 patients. [8], Lianhua Qingwen has also been promoted and distributed by the government in Hong Kong (HK). Traditional Chinese medicine Lianhua Qingwen capsule has been proven effective for the treatment of COVID-19, China's top respiratory expert Zhong Nanshan said in a webinar with overseas Chinese students on Monday. The following terms were searched using the title, abstract or keywords in the English databases: Lianhuaqinwen granule, Lianhuaqinwen capsule, Lianhua Qingwen capsule/granule. For the Chinese databases, the search terms used were: , , /.. Seven studies reported the adverse reactions of hepatobiliary system damage.
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