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1.
Am J Chin Med ; 50(2): 333-349, 2022.
Article in English | MEDLINE | ID: covidwho-1673506

ABSTRACT

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of traditional Chinese medicine for COVID-19 treatment with a focus on the benefits of symptomatic relief and time-related indexes. Seven electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data, and Chinese Clinical Trial Registry) were systematically searched from their beginning to April 2021. Only randomized controlled trials (RCTs) comparing patients using Western therapy (WT) alone and those using additional Chinese medicine (WT [Formula: see text] CM) were included. Primary outcomes included overall efficacy, lung recovery, and time to viral assay conversion. Secondary outcomes included time and rate of individual symptom recovery, laboratory indicators, and adverse events. Overall, 15 RCTs, including 1469 participants, were included in this review. WT [Formula: see text] CM significantly improved overall efficacy (risk ratio, RR [Formula: see text] 1.21; 95% CI: 1.12 to 1.30; [Formula: see text] [Formula: see text] 0.01) and lung recovery (RR [Formula: see text] 1.30; 95% CI:1.19 to 1.42; [Formula: see text] [Formula: see text] 0.01) and shortened the time to viral assay conversion (weighted mean differences, WMD [Formula: see text]1.38; 95% CI: -1.98 to -0.78; [Formula: see text] [Formula: see text] 0.01) and duration of chest distress (WMD [Formula: see text] 2.41; 95% CI: -2.99 to -1.83; [Formula: see text] [Formula: see text] 0.01) compared to WT alone. There was no difference in safety between the WT [Formula: see text] CM and WT groups (RR [Formula: see text] 0.94; 95% CI: 0.64 to 1.39; [Formula: see text] 0.76). In conclusion, the synthesized evidence from 15 RCTs showed that additional Chinese medication may improve treatment efficacy, relieve symptoms, promote lung recovery, and reduce the inflammatory response against COVID-19, while not increasing the risk of adverse events compared with conventional Western medication alone.


Subject(s)
COVID-19 , Drugs, Chinese Herbal , COVID-19/drug therapy , China , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Treatment Outcome
2.
J Ethnopharmacol ; 284: 114760, 2022 Feb 10.
Article in English | MEDLINE | ID: covidwho-1525847

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese medicines (TCMs) have made great contributions to the prevention and treatment of human diseases in China, and especially in cases of COVID-19. However, due to quality problems, the lack of standards, and the diversity of dosage forms, adverse reactions to TCMs often occur. Moreover, the composition of TCMs makes them extremely challenging to extract and isolate, complicating studies of toxicity mechanisms. AIM OF THE REVIEW: The aim of this paper is therefore to summarize the advanced applications of mass spectrometry imaging (MSI) technology in the quality control, safety evaluations, and determination of toxicity mechanisms of TCMs. MATERIALS AND METHODS: Relevant studies from the literature have been collected from scientific databases, such as "PubMed", "Scifinder", "Elsevier", "Google Scholar" using the keywords "MSI", "traditional Chinese medicines", "quality control", "metabolomics", and "mechanism". RESULTS: MSI is a new analytical imaging technology that can detect and image the metabolic changes of multiple components of TCMs in plants and animals in a high throughput manner. Compared to other chemical analysis methods, such as liquid chromatography-mass spectrometry (LC-MS), this method does not require the complex extraction and separation of TCMs, and is fast, has high sensitivity, is label-free, and can be performed in high-throughput. Combined with chemometrics methods, MSI can be quickly and easily used for quality screening of TCMs. In addition, this technology can be used to further focus on potential biomarkers and explore the therapeutic/toxic mechanisms of TCMs. CONCLUSIONS: As a new type of analysis method, MSI has unique advantages to metabolic analysis, quality control, and mechanisms of action explorations of TCMs, and contributes to the establishment of quality standards to explore the safety and toxicology of TCMs.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/chemistry , Mass Spectrometry/methods , Medicine, Chinese Traditional/standards , SARS-CoV-2 , Biomarkers, Pharmacological , Drugs, Chinese Herbal/adverse effects , Drugs, Chinese Herbal/standards , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional/instrumentation , Quality Control
3.
Medicine (Baltimore) ; 100(28): e26538, 2021 Jul 16.
Article in English | MEDLINE | ID: covidwho-1494086

ABSTRACT

ABSTRACT: Corrected QT (QTc) interval prolongation has been associated with poor patient prognosis. In this study, we assessed the effects of different drugs and cardiac injury on QTc interval prolongation in patients with coronavirus disease 2019 (COVID-19).The study cohort consisted of 395 confirmed COVID-19 cases from the Wuhan Union Hospital West Campus. All hospitalized patients were treated with chloroquine/hydroxychloroquine (CQ/HCQ), lopinavir/ritonavir (LPV/r), quinolones, interferon, Arbidol, or Qingfei Paidu decoction (QPD) and received at least 1 electrocardiogram after drug administration.Fifty one (12.9%) patients exhibited QTc prolongation (QTc ≥ 470 ms). QTc interval prolongation was associated with COVID-19 severity and mortality (both P < .001). Administration of CQ/HCQ (odds ratio [OR], 2.759; 95% confidence interval [CI], 1.318-5.775; P = .007), LPV/r (OR, 2.342; 95% CI, 1.152-4.760; P = .019), and quinolones (OR, 2.268; 95% CI, 1.171-4.392; P = .015) increased the risk of QTc prolongation. In contrast, the administration of Arbidol, interferon, or QPD did not increase the risk of QTc prolongation. Notably, patients treated with QPD had a shorter QTc duration than those without QPD treatment (412.10 [384.39-433.77] vs 420.86 [388.19-459.58]; P = .042). The QTc interval was positively correlated with the levels of cardiac biomarkers (creatine kinase-MB fraction [rho = 0.14, P = .016], high-sensitivity troponin I [rho = .22, P < .001], and B-type natriuretic peptide [rho = 0.27, P < .001]).In conclusion, QTc prolongation was associated with COVID-19 severity and mortality. The risk of QTc prolongation was higher in patients receiving CQ/HCQ, LPV/r, and quinolones. QPD had less significant effects on QTc prolongation than other antiviral agents.


Subject(s)
Antiviral Agents/adverse effects , COVID-19/drug therapy , COVID-19/mortality , Long QT Syndrome/mortality , SARS-CoV-2 , Aged , COVID-19/virology , Chloroquine/adverse effects , Drug Therapy, Combination , Drugs, Chinese Herbal/adverse effects , Electrocardiography , Female , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Hydroxychloroquine/adverse effects , Indoles/adverse effects , Interferons/adverse effects , Long QT Syndrome/chemically induced , Lopinavir/adverse effects , Male , Middle Aged , Odds Ratio , Quinolones/adverse effects , Retrospective Studies , Ritonavir/adverse effects , Severity of Illness Index
4.
Pharmacol Res ; 174: 105955, 2021 12.
Article in English | MEDLINE | ID: covidwho-1487920

ABSTRACT

Severe Coronavirus Disease 2019 (COVID-19) is characterized by numerous complications, complex disease, and high mortality, making its treatment a top priority in the treatment of COVID-19. Integrated traditional Chinese medicine (TCM) and western medicine played an important role in the prevention, treatment, and rehabilitation of COVID-19 during the epidemic. However, currently there are no evidence-based guidelines for the integrated treatment of severe COVID-19 with TCM and western medicine. Therefore, it is important to develop an evidence-based guideline on the treatment of severe COVID-19 with integrated TCM and western medicine, in order to provide clinical guidance and decision basis for healthcare professionals, public health personnel, and scientific researchers involved in the diagnosis, treatment, and care of COVID-19 patients. We developed and completed the guideline by referring to the standardization process of the "WHO handbook for guideline development", the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, and the Reporting Items for Practice Guidelines in Healthcare (RIGHT).


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Infectious Disease Medicine/trends , Medicine, Chinese Traditional/trends , SARS-CoV-2/drug effects , Antiviral Agents/adverse effects , COVID-19/diagnosis , COVID-19/virology , Consensus , Delphi Technique , Drugs, Chinese Herbal/adverse effects , Evidence-Based Medicine/trends , Host-Pathogen Interactions , Humans , Patient Acuity , SARS-CoV-2/pathogenicity , Treatment Outcome
5.
Medicine (Baltimore) ; 100(40): e27372, 2021 Oct 08.
Article in English | MEDLINE | ID: covidwho-1462558

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) in many countries is still very serious. At present, there is no specific and effective drug for this disease. Traditional Chinese medicine (TCM) has played a great role in fighting against COVID-19. However, their effectiveness and safety are still obscure and deserve further investigation. The aim of the study was to evaluate the efficacy and safety of TCM assisted in conventional treatment in the treatment of mild and common COVID-19. METHODS: PubMed, EMbase, MEDLINE, China National Knowledge Infrastructure Database, WANFANG DATA, and VIP Chinese Science and Technology Periodical Database were searched for randomized controlled trials (RCTs) and non-randomized controlled trials of TCM assisted in conventional treatment. The RCT research quality was evaluated by Cochrane 5.1.0 bias risk scale and the non-randomized controlled trial research quality was evaluated by Newcastle Ottawa scale, and the statistical analysis was conducted by Revman 5.3 and R software. The bias and sensitivity of the statistical results were analyzed by STATA 14.0. Registration number: CRD42020210619. RESULTS: Fifteen studies were included with 7 RCT studies and 8 retrospective cohort studies, involving a total of 1623 patients. Compared with the control group, TCM can improve the main index clinical effective rate (odds ratio [OR] = 2.64, 95% Confidence interval (CI) [1.94,3.59], P < .00001). The results of Begg test (Pr > z = 0.266) and sensitivity analysis showed that the results were relatively stable. Toujie Quwen (OR = 4.9, 95%CI [1.9,14.0]), Shufeng Jiedu (OR = 2.9, 95%CI [1.5,5.7]), and Lianhua Qingwen (OR = 2.4, 95%CI [1.6,3.6]) were with the best. It can also improve the main clinical symptoms (fever, cough, fatigue, and the regression time of the 3 symptoms), severe conversion rate, and computed tomography improvement rate. Its safety was not significantly compared with conventional treatment. However, in terms of safety of a single TCM, Shufeng Jiedu (OR = -0.86, 95%CI [-1.89,0.09]) and Lianhua Qingwen (OR = -0.49, 95%CI[-0.94,-0.05]) were lower than those of conventional treatment. CONCLUSION: TCM as an adjuvant therapy combined with conventional treatment has good curative effect on mild and common type of COVID-19 patients. Its advantages lie in clinical efficacy and improvement of symptom group, and can prevent patients from transforming to severe disease. In terms of clinical efficacy and safety, Shufeng Jiedu and Lianhua Qingwen have obvious advantages, which are worthy of clinical promotion.


Subject(s)
COVID-19/therapy , Drugs, Chinese Herbal/therapeutic use , Combined Modality Therapy , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Humans , Randomized Controlled Trials as Topic , SARS-CoV-2 , Severity of Illness Index
6.
Biosci Trends ; 15(4): 201-204, 2021 Sep 22.
Article in English | MEDLINE | ID: covidwho-1436244

ABSTRACT

Traditional Chinese medicine (TCM) is a valuable form of medicine with a long history in China. It has played a significant role in the control and prevention of infectious diseases including SARS and H7N9 flu. After the outbreak of COVID-19, China's National Health Commission included TCM in the Diagnosis and Treatment Protocol for COVID-19. During the COVID-19 pandemic, three traditional Chinese medicines (Jinhua Qinggan granules, Lianhua Qingwen medicine, and a Xuebijing Injection) and three TCM preparations (a Qingfei Paidu decoction, a Huashi Baidu decoction, and a Xuanfei Baidu decoction) have been screened for their efficacy against COVID-19. More than 150 trials involving TCMs are registered in the Chinese Clinical Trial Registry (ChiCTR), and those trials cover prevention, treatment, recovery, and illnesses diagnosed in accordance with TCM principles. TCM can effectively alleviate the symptoms of patients with COVID-19, delay the disease's progression from mild to severe or critical, and reduce severe and critical all-cause mortality. The underlying mechanisms of TCM mainly involve action against SARS-CoV-2, anti-inflammatory and immunomodulatory action, and organ protection. The current work provides a brief description of the current status of and issues with TCM to treat this novel infectious disease. The hope is that TCM can help considerably to control this global epidemic.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Anti-Inflammatory Agents/adverse effects , Anti-Inflammatory Agents/therapeutic use , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , China , Clinical Trials as Topic , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional
7.
PLoS One ; 16(8): e0256429, 2021.
Article in English | MEDLINE | ID: covidwho-1367707

ABSTRACT

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has emerged as a global pandemic since its outbreak in Wuhan, China. It is an urgent task to prevent and treat COVID-19 effectively early. In China's experience combating the COVID-19 pandemic, Chinese herbal medicine (CHM) has played an indispensable role. A large number of epidemiological investigations have shown that mild to moderate COVID-19 accounts for the largest proportion of cases. It is of great importance to treat such COVID-19 cases, which can help control epidemic progression. Many trials have shown that CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 was superior to conventional therapy alone. This review was designed to evaluate the add-on effect of CHM in the treatment of mild to moderate COVID-19. METHODS: Eight electronic databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the Clinical Trials.gov website, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Database and China Biology Medicine (CBM) were searched from December 2019 to March 2021 without language restrictions. Two reviewers searched and selected studies, and extracted data according to inclusion and exclusion criteria independently. Cochrane Risk of Bias (ROB) tool was used to assess the methodological quality of the included RCTs. Review Manager 5.3.0 software was used for statistical analysis. RESULTS: Twelve eligible RCTs including 1393 participants were included in this meta-analysis. Our meta-analyses found that lung CT parameters [RR = 1.26, 95% CI (1.15, 1.38), P<0.00001] and the clinical cure rate [RR = 1.26, 95%CI (1.16, 1.38), P<0.00001] of CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 were better than those of conventional therapy. The rate of conversion to severe cases [RR = 0.48, 95%CI (0.32, 0.73), P = 0.0005], TCM symptom score of fever [MD = -0.62, 95%CI (-0.79, -0.45), P<0.00001], cough cases [RR = 1.43, 95%CI (1.16, 1.75), P = 0.0006], TCM symptom score of cough[MD = -1.07, 95%CI (-1.29, -0.85), P<0.00001], TCM symptom score of fatigue[MD = -0.66, 95%CI (-1.05, -0.28), P = 0.0007], and CRP[MD = -5.46, 95%CI (-8.19, -2.72), P<0.0001] of combination therapy was significantly lower than that of conventional therapy. The WBC count was significantly higher than that of conventional therapy[MD = 0.38, 95%CI (0.31, 0.44), P<0.00001]. Our meta-analysis results were robust through sensitivity analysis. CONCLUSION: Chinese herbal medicine combined with conventional therapy may be effective and safe in the treatment of mild to moderate COVID-19. More high-quality RCTs are needed in the future.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/adverse effects , Drugs, Chinese Herbal/therapeutic use , COVID-19/diagnostic imaging , COVID-19/etiology , Cough/drug therapy , Cough/virology , Diarrhea/chemically induced , Drugs, Chinese Herbal/chemistry , Fever/drug therapy , Fever/virology , Humans , Lung/diagnostic imaging , Lung/virology , Nausea/chemically induced , Tomography, X-Ray Computed , Treatment Outcome , Vomiting/chemically induced
8.
Pharmacol Res ; 160: 105074, 2020 10.
Article in English | MEDLINE | ID: covidwho-1364403

ABSTRACT

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.


Subject(s)
Coronavirus Infections/prevention & control , Coronavirus Infections/therapy , Drugs, Chinese Herbal/standards , Drugs, Chinese Herbal/therapeutic use , Materia Medica/standards , Medicine, Chinese Traditional/standards , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/therapy , COVID-19 , Coronavirus Infections/drug therapy , Drug Compounding , Drugs, Chinese Herbal/adverse effects , Humans , Materia Medica/adverse effects , Materia Medica/therapeutic use , Patient Safety , Pharmacopoeias as Topic , Public Health , Quality Control
9.
Pharmacol Res ; 160: 105056, 2020 10.
Article in English | MEDLINE | ID: covidwho-1364402

ABSTRACT

Currently, coronavirus disease 2019 (COVID-19), which can lead to severe respiratory failure and death, is now a global pandemic with no specific anti-viral drugs or vaccines. However, It is worth noting that traditional Chinese medicine (TCM), especially Chinese herbal medicine (CHM), has been widely applied in mainland China since outbreak, bringing new hope for the prevention and control of COVID-19. A comprehensive literature searching was conducted in 7 electronic databases from their inception up to June 21, 2020 to evaluate the efficacy and safety of CHM for COVID-19. Eighteen randomized controlled trials (RCTs) involving 2275 patients were enrolled. Most of CHMs were originated from classical Chinese herbal formulas. Liquoric Root (Gancao, Radix Glycyrrhizae), Baical Skullcap Root (Huangqin, Radix Scutellariae Baicalensis), Pinellia Rhizome (Banxia, Rhizoma Pinelliae Tematae), Forsythia Fruit (Lianqiao, Fructus Forsythiae Suspensae), and Bitter Apricot Seed (Kuxingren, Semen Armeniacae Amarum) were most frequently used Chinese herbs. The most commonly used dosage formulation was decoction. Our meta-analyses found that comparing CHM group and conventional western medicine group, CHM group has improvements in several clinical parameters including lung CT, clinical cure rate, ranging from mild to critical cases, length of hospital stay, total score of clinical symptoms, fever reduction time, symptom score of fever, number of cough reduction cases, symptom score of cough, number of fatigue reduction cases, symptom score of fatigue, disappearing time of fatigue, TCM syndrome, viral nucleic acid testing, and inflammatory biomarkers (C-reactive protein). Besides, no severe adverse effects was identified by CHM. CHM, especially classical Chinese herbal formulas, could be used as potential candidates for COVID-19 in this battle.


Subject(s)
Coronavirus Infections/drug therapy , Drugs, Chinese Herbal/therapeutic use , Pneumonia, Viral/drug therapy , COVID-19 , Coronavirus Infections/complications , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral/complications , Randomized Controlled Trials as Topic
10.
J Ethnopharmacol ; 279: 114367, 2021 Oct 28.
Article in English | MEDLINE | ID: covidwho-1281457

ABSTRACT

BACKGROUND: Although the rapid emergence of coronavirus disease 2019 (COVID-19) poses a considerable threat to global public health, no specific treatment is available for COVID-19. ReDuNing injection (RDN) is a traditional Chinese medicine known to exert antibacterial, antiviral, antipyretic, and anti-inflammatory effects. In addition, RDN has been recommended in the diagnosis and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated pneumonia by the National Health Council and the National Administration of Chinese Medicine. However, there is no information regarding its efficacy against COVID-19. AIM OF STUDY: This study was designed to determine the clinical efficacy of RDN in patients with COVID-19 and characterize its antiviral activity against SARS-CoV-2 in vitro. MATERIALS AND METHODS: A total of 50 adults with COVID-19 were included in this study, and the primary endpoint was recovery from clinical symptoms following 14 days of treatment. General improvements were defined as the disappearance of the major symptoms of infection including fever, fatigue, and cough. The secondary endpoints included the proportion of patients who achieved clinical symptom amelioration on days 7 and 10, time to clinical recovery, time to a negative nucleic acid test result, duration of hospitalization, and time to defervescence. Plaque reduction and cytopathic effect assays were also performed in vitro, and reverse-transcription quantitative PCR was performed to evaluate the expression of inflammatory cytokines (TNF-α, IP-10, MCP-1, IL-6, IFN-α, IFN-γ, IL-2 and CCL-5) during SARS-CoV-2 infection. RESULTS: The RDN group exhibited a shorter median time for the resolution of clinical symptoms (120 vs. 220 h, P < 0.0001), less time to a negative PCR test result (215 vs. 310 h, P = 0.0017), shorter hospitalization (14.8 vs. 18.5 days, P = 0.0002), and lower timeframe for defervescence (24.5 vs. 75 h, P = 0.0001) than the control group. In addition, time to improved imaging was also shorter in the RDN group than in the control group (6 vs.8.9 days, P = 0.0273); symptom resolution rates were higher in the RDN group than in the control group at 7 (96.30% vs. 39.13%, P < 0.0001) and 10 days (96.30% vs. 56.52%, P = 0.0008). No allergic reactions or anaphylactic responses were reported in this trial. RDN markedly inhibited SARS-CoV-2 proliferation and viral plaque formation in vitro. In addition, RDN significantly reduced inflammatory cytokine production in infected cells. CONCLUSIONS: RDN relieves clinical symptoms in patients with COVID-19 and reduces SARS-CoV-2 infection by regulating inflammatory cytokine-related disorders, suggestion that this medication might be a safe and effective treatment for COVID-19.


Subject(s)
COVID-19 , Cytokines/analysis , Drugs, Chinese Herbal , SARS-CoV-2 , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , COVID-19/drug therapy , COVID-19/epidemiology , COVID-19/immunology , COVID-19 Nucleic Acid Testing/methods , Cell Line , China/epidemiology , Cytotoxicity Tests, Immunologic/methods , Drug Monitoring/methods , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Female , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , SARS-CoV-2/drug effects , SARS-CoV-2/isolation & purification , Symptom Assessment/methods , Treatment Outcome
11.
Medicine (Baltimore) ; 100(24): e26370, 2021 Jun 18.
Article in English | MEDLINE | ID: covidwho-1269624

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an epidemic infectious disease resulted from 2019 novel coronavirus (2019-nCoV). Up till now, COVID-19 has swept globally. Currently, due to many high-profiled benefits, clinical studies on Toujie Quwen granule (TJQW) have been increasing. The aim of the study is to assess the efficacy and safety of TJQW used with conventional western therapy for COVID-19. METHODS: Relevant randomized controlled trials (RCTs) were searched in Chinese and English databases, and the search time is January 2020 to May 2021. English databases include PubMed, Embase, Web of Science, and the Cochrane Library. Chinese databases include CNKI, WF, VIP, and CBM. The international clinical trial registration platform and the Chinese clinical trial registration platform of controlled trials will be searched by us from January 2020 to May 2021. According to the inclusion and exclusion criteria, screening literature, extraction data will be conducted by 2 researchers independently. Statistical analysis will be conducted using the RevMan 5.3.5 software. After screening the literature based on the inclusion and exclusion criteria, The Recommendation, Assessment, Development, and Evaluation (GRADE) system will be used to evaluate the quality of each result. RESULTS: This study will provide the evidence for TJQW to be used with conventional western therapy for COVID-19. CONCLUSION: The efficacy and safety of TJQW used with conventional western therapy for COVID-19 will be assessed. INPLASY REGISTRATION NUMBER: INPLASY202150038.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Meta-Analysis as Topic , Nutritional Support , Phytotherapy , Respiratory Therapy , Systematic Reviews as Topic , Antiviral Agents/adverse effects , Combined Modality Therapy , Drugs, Chinese Herbal/adverse effects , Humans , Pandemics , SARS-CoV-2
12.
Medicine (Baltimore) ; 100(21): e26059, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1242122

ABSTRACT

BACKGROUND: : Coronavirus disease 2019 (COVID-19) is an emerging and rapidly evolving disease, with no recommended effective anti-coronavirus treatments. Traditional Chinese Medicine (TCM) has been widely used to treat COVID-19 in China, and the most used one is Lianhuaqingwen (LH). This study aimed to assess the efficacy and safety of LH combined with usual treatment vs usual treatment alone in treating mild or moderate COVID-19 by a meta-analysis of randomized controlled trials (RCTs). METHODS AND ANALYSIS: : We systematically searched the Medline (OVID), Embase, the Cochrane Library, and 4 Chinese databases from inception to July 2020 to include the RCTs that evaluated the efficacy and safety of LH in combination with usual treatment vs usual treatment for mild or moderate COVID-19. A meta-analysis was performed to calculate the risk ratio (RR) and 95% confidence interval (CI) for binary outcomes and mean difference (MD) for continuous outcomes. RESULTS: : A total of 5 RCTs with 824 individuals with mild or moderate COVID 19 were included. Compared with the usual treatment alone, LH in combination with usual treatment significantly improved the overall clinical efficacy (RR = 2.39, 95% CI 1.61-3.55), increased the rate of recovery of chest computed tomographic manifestations (RR = 1.80, 95% CI 1.08-3.01), reduced the rate of conversion to severe cases (RR = 0.47, 95% CI 0.29-0.74), shorten the duration of fever (MD = -1.00, 95% CI -1.17 to -0.84). Moreover, LH in combination with usual treatment did not increase the occurrence of the adverse event compared to usual treatment alone. CONCLUSION: : Our meta-analysis of RCTs indicated that LH in combination with usual treatment may improve the clinical efficacy in patients with mild or moderate COVID-19 without increasing adverse events. However, given the limitations and poor quality of included trials in this study, further large-sample RCTs or high-quality real-world studies are needed to confirm our conclusions.


Subject(s)
Antiviral Agents/administration & dosage , COVID-19/therapy , Drugs, Chinese Herbal/administration & dosage , Oxygen/administration & dosage , Antiviral Agents/adverse effects , COVID-19/diagnosis , COVID-19/virology , China , Combined Modality Therapy/adverse effects , Combined Modality Therapy/methods , Drugs, Chinese Herbal/adverse effects , Humans , Lung/diagnostic imaging , Nutritional Support , Oxygen/adverse effects , Randomized Controlled Trials as Topic , SARS-CoV-2/isolation & purification , Severity of Illness Index , Tomography, X-Ray Computed , Treatment Outcome
13.
Acta Pharmacol Sin ; 42(12): 2155-2172, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1209738

ABSTRACT

LianhuaQingwen capsule, prepared from an herbal combination, is officially recommended as treatment for COVID-19 in China. Of the serial pharmacokinetic investigations we designed to facilitate identifying LianhuaQingwen compounds that are likely to be therapeutically important, the current investigation focused on the component Glycyrrhiza uralensis roots (Gancao). Besides its function in COVID-19 treatment, Gancao is able to induce pseudoaldosteronism by inhibiting renal 11ß-HSD2. Systemic and colon-luminal exposure to Gancao compounds were characterized in volunteers receiving LianhuaQingwen and by in vitro metabolism studies. Access of Gancao compounds to 11ß-HSD2 was characterized using human/rat, in vitro transport, and plasma protein binding studies, while 11ß-HSD2 inhibition was assessed using human kidney microsomes. LianhuaQingwen contained a total of 41 Gancao constituents (0.01-8.56 µmol/day). Although glycyrrhizin (1), licorice saponin G2 (2), and liquiritin/liquiritin apioside (21/22) were the major Gancao constituents in LianhuaQingwen, their poor intestinal absorption and access to colonic microbiota resulted in significant levels of their respective deglycosylated metabolites glycyrrhetic acid (8), 24-hydroxyglycyrrhetic acid (M2D; a new Gancao metabolite), and liquiritigenin (27) in human plasma and feces after dosing. These circulating metabolites were glucuronized/sulfated in the liver and then excreted into bile. Hepatic oxidation of 8 also yielded M2D. Circulating 8 and M2D, having good membrane permeability, could access (via passive tubular reabsorption) and inhibit renal 11ß-HSD2. Collectively, 1 and 2 were metabolically activated to the pseudoaldosterogenic compounds 8 and M2D. This investigation, together with such investigations of other components, has implications for precisely defining therapeutic benefit of LianhuaQingwen and conditions for its safe use.


Subject(s)
Antiviral Agents/pharmacokinetics , COVID-19/drug therapy , Drugs, Chinese Herbal/pharmacokinetics , Phytochemicals/pharmacokinetics , 11-beta-Hydroxysteroid Dehydrogenase Type 2/antagonists & inhibitors , 11-beta-Hydroxysteroid Dehydrogenase Type 2/metabolism , Administration, Oral , Animals , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Biological Availability , Biotransformation , Capsules , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Female , Glycyrrhiza/adverse effects , HEK293 Cells , Humans , Liddle Syndrome/chemically induced , Liddle Syndrome/enzymology , Male , Patient Safety , Phytochemicals/administration & dosage , Phytochemicals/adverse effects , Rats, Sprague-Dawley , Risk Assessment
14.
Ann Palliat Med ; 10(5): 5146-5155, 2021 May.
Article in English | MEDLINE | ID: covidwho-1200420

ABSTRACT

BACKGROUND: Reduning injection is a traditional Chinese medicine (TCM) with known efficacy against a variety of viral infections, but there is no data about its efficacy against coronavirus disease 2019 (COVID-19). METHODS: To explore the efficacy and safety of Reduning injection in the treatment of COVID-19, a randomized, open-labeled, multicenter, controlled trial was conducted from 12 general hospitals between 2020.02.06 and 2020.03.23. Patients with COVID-19 who met the diagnostic criteria of the "Diagnosis and Treatment Program for Novel Coronavirus Infection Pneumonia (Trial Fifth Edition)". Patients were randomized to routine treatment with or without Reduning injection (20 mL/day for 14 days) (ChiCTR2000029589). The primary endpoint was the rate of achieving clinical symptom recovery on day 14 of treatment. RESULTS: There were 77 and 80 participants in the Reduning and control groups. The symptom resolution rate at 14 days was higher in the Reduning injection than in controls [full-analysis set (FAS): 84.4% vs. 60.0%, P=0.0004]. Compared with controls, the Reduning group showed shorter median time to resolution of the clinical symptoms (143 vs. 313.5 h, P<0.001), shorter to nucleic acid test turning negative (146.5 vs. 255.5 h, P<0.001), shorter hospital stay (14.1 vs. 18.1 days, P<0.001), and shorter time to defervescence (29 vs. 71 h, P<0.001). There was no difference in AEs (3.9% vs. 8.8%, P=0.383). CONCLUSIONS: This preliminary trial suggests that Reduning injection might be effective and safe in patients with symptomatic COVID-19.


Subject(s)
COVID-19 , Drugs, Chinese Herbal , Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , SARS-CoV-2 , Treatment Outcome
16.
Complement Ther Clin Pract ; 42: 101297, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-977991

ABSTRACT

OBJECTIVE: This review aimed at systematically evaluating the efficacy and safety of Yinqiao powder combined with western medicine in the treatment of pneumonia. METHODS: A systematic search for randomized controlled trials (RCTs) focusing on pneumonia treatment using a combination of Yinqiao powder and western medicine was performed in PubMed, the Cochrane Library, EMBASE, Web of Science, CNKI, Wanfang, Weipu (VIP) and CBM. The retrieval time limit was from the establishment of the database to June 2020. Two researchers independently screened the literature, extracted the data and evaluated the bias risk of the included studies. A meta-analysis was performed using RevMan5.3 software. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULT: Fifteen RCTs involving 1705 patients were included in the analysis. The meta-analysis results revealed the total effective rate of the treatment group [RR = 1.21, 95% CI (1.15, 1.27), P < 0.00001], bacterial clearance rate [RR = 1.13, 95% CI (1.05, 1.22), P = 0.001], adverse reactions [RR = 0.54, 95% CI (0.38, 0.76), P = 0.0005]. There were statistically significant differences in the cooling time, T cell number, procalcitonin (PCT) and C-reactive protein (CRP) value decline rate (P < 0.05). There was no statistically significant difference in the decline rate of neutrophils and leukocytes (P > 0.05). CONCLUSION: The current evidence indicated that the Yinqiao powder combined with western medicine can improve total efficiency in the treatment of pneumonia patients. The combination therapy performed better when compared to western medicine alone in the cooling time, bacterial clearance rate, T cell count, decline rates of CRP and PCT as well as in the incidences of adverse reactions. However, there was no significant difference in the decline rates of neutrophils and leucocytes between the two groups. The funnel plot, Egger's test and Begg's test indicated publication bias, which may be associated with unpublished negative study results. Due to the limitation of the quality and quantity of the included studies, more high-quality studies should be performed to verify our conclusions.


Subject(s)
Drugs, Chinese Herbal , Medicine , Pneumonia , Child , Drugs, Chinese Herbal/adverse effects , Humans , Pneumonia/drug therapy , Powders
17.
Biomed Pharmacother ; 133: 111037, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1059801

ABSTRACT

COVID-19 is a global pandemic, with over 50 million confirmed cases and 1.2 million deaths as of November 11, 2020. No therapies or vaccines so far are recommended to treat or prevent the new coronavirus. A novel traditional Chinese medicine formula, Taiwan Chingguan Yihau (NRICM101), has been administered to patients with COVID-19 in Taiwan since April 2020. Its clinical outcomes and pharmacology have been evaluated. Among 33 patients with confirmed COVID-19 admitted in two medical centers, those (n = 12) who were older, sicker, with more co-existing conditions and showing no improvement after 21 days of hospitalization were given NRICM101. They achieved 3 consecutive negative results within a median of 9 days and reported no adverse events. Pharmacological assays demonstrated the effects of the formula in inhibiting the spike protein/ACE2 interaction, 3CL protease activity, viral plaque formation, and production of cytokines interleukin (IL)-6 and tumor necrosis factor (TNF)-α. This bedside-to-bench study suggests that NRICM101 may disrupt disease progression through its antiviral and anti-inflammatory properties, offering promise as a multi-target agent for the prevention and treatment of COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , Drugs, Chinese Herbal/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Angiotensin-Converting Enzyme 2/drug effects , Coronavirus 3C Proteases/drug effects , Drug Compounding , Drugs, Chinese Herbal/adverse effects , Drugs, Chinese Herbal/pharmacology , Female , Humans , Interleukin-6/antagonists & inhibitors , Male , Medicine, Chinese Traditional , Middle Aged , Negative Results , Spike Glycoprotein, Coronavirus/drug effects , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Viral Plaque Assay , Young Adult
18.
Trials ; 22(1): 23, 2021 Jan 06.
Article in English | MEDLINE | ID: covidwho-1011236

ABSTRACT

OBJECTIVE: We aimed to test our hypothesis that traditional Japanese (Kampo) medicine, hochuekkito (Hochu-ekki-to: HET) has a preventive effect for the symptoms on COVID-19. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator sponsored, two-arm study. PARTICIPANTS: Six thousand participants will be recruited from healthy hospital workers in 7 Japanese University Hospitals. INCLUSION CRITERIA: 1. Age from 20 to 75 years old at the time of registration 2. Asymptomatic and body temperature below 37°C at the time of registration 3. Capable of eating orally Exclusion criteria: 1. Previous upper respiratory inflammation due to viral infection (including suspected COVID-19) 2. Taking immunosuppressants 3. Allergic to the Kampo medicines used in this study 4. History of hypokalaemia, severe hypertension, severe liver dysfunction, and interstitial pneumonia 5. Regularly taking other Kampo medicines 6. Pregnant or possibly pregnant 7. Participating in other research 8. Judged to be unsuitable for this study by the doctor in charge INTERVENTION AND COMPARATOR: Kampo group: participants receive HET in 9 tablets 2 times per day for 8 weeks. CONTROL GROUP: participants receive placebo in the same dosage as the Intervention group - 9 tablets 2 times per day for 8 weeks. Placebo tablets are identical in appearance and package to HET. Taste of placebo is different from that of HET. The Ohsugi Pharmaceutical Co. Ltd, Osaka, Japan manufactured the placebo and HET. MAIN OUTCOMES: Primary outcome: Number of patients with a SARS-CoV-2 RNA by ploymerase chain reaction (PCR) positive result with at least one symptom (fever, cough, sputum, malaise, shortness of breath) during the 12-week study period (including the 4-week observation period after oral administration). SECONDARY OUTCOMES: 1. Period from infection to onset 2. Period from the appearance of symptoms to the disappearance of PCR positive 3. Number of days until the appearance or improvement of symptoms 4. Severe stage: presence of hospitalization 5. Shock stage: ICU management required for mechanical ventilation, shock vitals or failure of organ(s) other than lungs Safety endpoints include numbness in the hands and/or feet, edema, skin rash or other allergic symptoms, and gastric discomfort. RANDOMISATION: Patients are randomized (1:1 ratio) to each group using minimization implemented with the Electric data capture system (DATATRAK Enterprise Cloud), with balancing of the arms with age range (under 50 years of age or not) and having a history of risk factors for COVID-19 (cardiovascular disease, hypertension, diabetes, respiratory diseases). BLINDING (MASKING): Only participants will be randomized. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The main research hypothesis of this study is that Kampo medicines significantly prevent the onset of COVID-19. It is assumed that the infection rate before the administration of the drug under consideration will be 0% and that the incidence of COVID-19 thereafter will be 2- 3%, of which 70%-80% will show symptoms of COVID-19. Assuming that the pharmaceutical effect of the drug will be effective in 50% of patients and that the incidence rates in the placebo and drug groups will be 1.4%-2.4% and 0.7%-1.2%, respectively, the placebo is calculated at 2%, and the study drug at 1%. Since the frequency of verification is low and the number of cases will be large, we set a total of 10 analyses (9 interim analyses and a final analysis). Since the number of cases at the time of the final analysis will be 4,986 under the conditions of α = 0.05 and a power of 80% by the Peto method. We set at 600 cases in each interim analysis with an estimated dropout rate of 16.9%. Finally, the total number of cases is set to 6,000 with 3,000 in the placebo group and 3,000 in the HET group. TRIAL STATUS: Protocol version 1.3 of October 23rd , 2020. Recruitment start (expected): December 1st, 2020. Recruitment finish (expected): December 31st, 2022. TRIAL REGISTRATION: This trial is registered in the Japan Registry of Clinical Trials (jRCT) ( jRCTs031200150 ) on 14 October 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
COVID-19/prevention & control , Drugs, Chinese Herbal/administration & dosage , Medicine, Kampo/methods , Pandemics/prevention & control , SARS-CoV-2/isolation & purification , Administration, Oral , Adult , Aged , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , COVID-19 Nucleic Acid Testing , Drug Administration Schedule , Drugs, Chinese Herbal/adverse effects , Female , Humans , Japan/epidemiology , Male , Medicine, Kampo/adverse effects , Middle Aged , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Risk Factors , Severity of Illness Index , Treatment Outcome , Young Adult
19.
Medicine (Baltimore) ; 99(50): e23293, 2020 Dec 11.
Article in English | MEDLINE | ID: covidwho-983597

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) epidemic is spreading worldwide. Shufeng Jiedu capsule (SFJDC) is a commonly used drug in the treatment of COVID-19. However, there is insufficient evidence for clinical efficacy and safety. METHODS: Two authors will independently search the Chinese National Knowledge Infrastructure (CNKI), VIP database, Wanfang database, the Cochrane Library, EMBASE, PubMed and Web of Science, in English and Chinese. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. Review Manager 5.3 and Stata 16.0 software will be used to analyze the eligible data. RESULTS: This protocol will conduct a systematic review and meta-analysis of literature listed above, and reliable outcomes about the clinical efficacy and safety of SFJDC in the treatment of COVID-19 will be obtained. CONCLUSIONS: These findings will provide guidance for clinicians and patients using SFJDC for COVID-19 treatment. PROSPERO REGISTRATION NUMBER: CRD42020185764.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Humans , Randomized Controlled Trials as Topic , Research Design
20.
Medicine (Baltimore) ; 99(49): e23093, 2020 Dec 04.
Article in English | MEDLINE | ID: covidwho-963626

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a global pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). There is no specific cure for this disease, and the clinical management mainly depends on supportive treatment. This disease may affect SARS-CoV-2 conjunctivitis. Yuxingcao eye drops is used in treating COVID-19 conjunctivitis in China. METHODS: A comprehensive literature search will be conducted. Two methodological trained researchers will read the title, abstract, and full texts and independently select the qualified literature according to inclusion and exclusion criteria. After assessment of the risk of bias and data extraction, we will conduct meta-analyses for outcomes related to COVID-19 conjunctivitis. The heterogeneity of data will be investigated by Cochrane X and I tests. Then publication bias assessment will be conducted by funnel plot analysis and Egger test. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: Our study aims to systematically present the clinical evidence of Yuxingcao eye drops in treating COVID-19 conjunctivitis, which will be of significant meaning for further research and clinical practice. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020209059.


Subject(s)
COVID-19/complications , Conjunctivitis/drug therapy , Conjunctivitis/etiology , Drugs, Chinese Herbal/therapeutic use , Clinical Trials as Topic , Conjunctivitis/virology , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Humans , Ophthalmic Solutions , Pandemics , Research Design , SARS-CoV-2
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