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1.
Trials ; 21(1): 827, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008479

RESUMO

OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Kampo , Pneumonia Viral/tratamento farmacológico , Antivirais/efeitos adversos , Betacoronavirus/patogenicidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Interações Hospedeiro-Patógeno , Humanos , Japão , Masculino , Estudos Multicêntricos como Assunto , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
2.
Cochrane Database Syst Rev ; 10: CD013600, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33044747

RESUMO

BACKGROUND: Convalescent plasma and hyperimmune immunoglobulin may reduce mortality in patients with viral respiratory diseases, and are currently being investigated in trials as potential therapy for coronavirus disease 2019 (COVID-19). A thorough understanding of the current body of evidence regarding the benefits and risks is required.  OBJECTIVES: To continually assess, as more evidence becomes available, whether convalescent plasma or hyperimmune immunoglobulin transfusion is effective and safe in treatment of people with COVID-19. SEARCH METHODS: We searched the World Health Organization (WHO) COVID-19 Global Research Database, MEDLINE, Embase, Cochrane COVID-19 Study Register, Centers for Disease Control and Prevention COVID-19 Research Article Database and trial registries to identify completed and ongoing studies on 19 August 2020. SELECTION CRITERIA: We followed standard Cochrane methodology. We included studies evaluating convalescent plasma or hyperimmune immunoglobulin for people with COVID-19, irrespective of study design, disease severity, age, gender or ethnicity. We excluded studies including populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)) and studies evaluating standard immunoglobulin. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. To assess bias in included studies, we used the Cochrane 'Risk of bias' 2.0 tool for randomised controlled trials (RCTs), the Risk of Bias in Non-randomised Studies - of Interventions (ROBINS-I) tool for controlled non-randomised studies of interventions (NRSIs), and the assessment criteria for observational studies, provided by Cochrane Childhood Cancer for non-controlled NRSIs. We rated the certainty of evidence using the GRADE approach for the following outcomes: all-cause mortality at hospital discharge, mortality (time to event), improvement of clinical symptoms (7, 15, and 30 days after transfusion), grade 3 and 4 adverse events (AEs), and serious adverse events (SAEs). MAIN RESULTS: This is the second living update of our review. We included 19 studies (2 RCTs, 8 controlled NRSIs, 9 non-controlled NRSIs) with 38,160 participants, of whom 36,081 received convalescent plasma. Two completed RCTs are awaiting assessment (published after 19 August 2020). We identified a further 138 ongoing studies evaluating convalescent plasma or hyperimmune immunoglobulin, of which 73 are randomised (3 reported in a study registry as already being completed, but without results). We did not identify any completed studies evaluating hyperimmune immunoglobulin. We did not include data from controlled NRSIs in data synthesis because of critical risk of bias. The overall certainty of evidence was low to very low, due to study limitations and results including both potential benefits and harms.  Effectiveness of convalescent plasma for people with COVID-19  We included results from two RCTs (both stopped early) with 189 participants, of whom 95 received convalescent plasma. Control groups received standard care at time of treatment without convalescent plasma. We are uncertain whether convalescent plasma decreases all-cause mortality at hospital discharge (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.22 to 1.34; 1 RCT, 86 participants; low-certainty evidence).  We are uncertain whether convalescent plasma decreases mortality (time to event) (hazard ratio (HR) 0.64, 95% CI 0.33 to 1.25; 2 RCTs, 189 participants; low-certainty evidence). Convalescent plasma may result in little to no difference in improvement of clinical symptoms (i.e. need for respiratory support) at seven days (RR 0.98, 95% CI 0.30 to 3.19; 1 RCT, 103 participants; low-certainty evidence). Convalescent plasma may increase improvement of clinical symptoms at up to 15 days (RR 1.34, 95% CI 0.85 to 2.11; 2 RCTs, 189 participants; low-certainty evidence), and at up to 30 days (RR 1.13, 95% CI 0.88 to 1.43; 2 studies, 188 participants; low-certainty evidence).  No studies reported on quality of life.  Safety of convalescent plasma for people with COVID-19 We included results from two RCTs, eight controlled NRSIs and nine non-controlled NRSIs assessing safety of convalescent plasma. Reporting of safety data and duration of follow-up was variable. The controlled studies reported on AEs and SAEs only in participants receiving convalescent plasma. Some, but not all, studies included death as a SAE.  The studies did not report the grade of AEs. Fourteen studies (566 participants) reported on AEs of possible grade 3 or 4 severity. The majority of these AEs were allergic or respiratory events. We are very uncertain whether convalescent plasma therapy affects the risk of moderate to severe AEs (very low-certainty evidence).  17 studies (35,944 participants) assessed SAEs for 20,622 of its participants. The majority of participants were from one non-controlled NRSI (20,000 participants), which reported on SAEs within the first four hours and within an additional seven days after transfusion. There were 63 deaths, 12 were possibly and one was probably related to transfusion. There were 146 SAEs within four hours and 1136 SAEs within seven days post-transfusion. These were predominantly allergic or respiratory, thrombotic or thromboembolic and cardiac events. We are uncertain whether convalescent plasma therapy results in a clinically relevant increased risk of SAEs (low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain whether convalescent plasma is beneficial for people admitted to hospital with COVID-19. There was limited information regarding grade 3 and 4 AEs to determine the effect of convalescent plasma therapy on clinically relevant SAEs. In the absence of a control group, we are unable to assess the relative safety of convalescent plasma therapy.  While major efforts to conduct research on COVID-19 are being made, recruiting the anticipated number of participants into these studies is problematic. The early termination of the first two RCTs investigating convalescent plasma, and the lack of data from 20 studies that have completed or were due to complete at the time of this update illustrate these challenges. Well-designed studies should be prioritised. Moreover, studies should report outcomes in the same way, and should consider the importance of maintaining comparability in terms of co-interventions administered in all study arms.  There are 138 ongoing studies evaluating convalescent plasma and hyperimmune immunoglobulin, of which 73 are RCTs (three already completed). This is the second living update of the review, and we will continue to update this review periodically. Future updates may show different results to those reported here.


Assuntos
Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Viés , Causas de Morte , Infecções por Coronavirus/mortalidade , Humanos , Imunização Passiva/efeitos adversos , Imunização Passiva/métodos , Imunização Passiva/estatística & dados numéricos , Ensaios Clínicos Controlados não Aleatórios como Assunto/estatística & dados numéricos , Pandemias , Pneumonia Viral/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Resultado do Tratamento
3.
Cochrane Database Syst Rev ; 10: CD013686, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33047816

RESUMO

BACKGROUND: Many dental procedures produce aerosols (droplets, droplet nuclei and splatter) that harbour various pathogenic micro-organisms and may pose a risk for the spread of infections between dentist and patient. The COVID-19 pandemic has led to greater concern about this risk. OBJECTIVES: To assess the effectiveness of methods used during dental treatment procedures to minimize aerosol production and reduce or neutralize contamination in aerosols. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases on 17 September 2020: Cochrane Oral Health's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (in the Cochrane Library, 2020, Issue 8), MEDLINE Ovid (from 1946); Embase Ovid (from 1980); the WHO COVID-19 Global literature on coronavirus disease; the US National Institutes of Health Trials Registry (ClinicalTrials.gov); and the Cochrane COVID-19 Study Register. We placed no restrictions on the language or date of publication. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on aerosol-generating procedures (AGPs) performed by dental healthcare providers that evaluated methods to reduce contaminated aerosols in dental clinics (excluding preprocedural mouthrinses). The primary outcomes were incidence of infection in dental staff or patients, and reduction in volume and level of contaminated aerosols in the operative environment. The secondary outcomes were cost, accessibility and feasibility. DATA COLLECTION AND ANALYSIS: Two review authors screened search results, extracted data from the included studies, assessed the risk of bias in the studies, and judged the certainty of the available evidence. We used mean differences (MDs) and 95% confidence intervals (CIs) as the effect estimate for continuous outcomes, and random-effects meta-analysis to combine data. We assessed heterogeneity. MAIN RESULTS: We included 16 studies with 425 participants aged 5 to 69 years. Eight studies had high risk of bias; eight had unclear risk of bias. No studies measured infection. All studies measured bacterial contamination using the surrogate outcome of colony-forming units (CFU). Two studies measured contamination per volume of air sampled at different distances from the patient's mouth, and 14 studies sampled particles on agar plates at specific distances from the patient's mouth. The results presented below should be interpreted with caution as the evidence is very low certainty due to heterogeneity, risk of bias, small sample sizes and wide confidence intervals. Moreover, we do not know the 'minimal clinically important difference' in CFU. High-volume evacuator Use of a high-volume evacuator (HVE) may reduce bacterial contamination in aerosols less than one foot (~ 30 cm) from a patient's mouth (MD -47.41, 95% CI -92.76 to -2.06; 3 RCTs, 122 participants (two studies had split-mouth design); very high heterogeneity I² = 95%), but not at longer distances (MD -1.00, -2.56 to 0.56; 1 RCT, 80 participants). One split-mouth RCT (six participants) found that HVE may not be more effective than conventional dental suction (saliva ejector or low-volume evacuator) at 40 cm (MD CFU -2.30, 95% CI -5.32 to 0.72) or 150 cm (MD -2.20, 95% CI -14.01 to 9.61). Dental isolation combination system One RCT (50 participants) found that there may be no difference in CFU between a combination system (Isolite) and a saliva ejector (low-volume evacuator) during AGPs (MD -0.31, 95% CI -0.82 to 0.20) or after AGPs (MD -0.35, -0.99 to 0.29). However, an 'n of 1' design study showed that the combination system may reduce CFU compared with rubber dam plus HVE (MD -125.20, 95% CI -174.02 to -76.38) or HVE (MD -109.30, 95% CI -153.01 to -65.59). Rubber dam One split-mouth RCT (10 participants) receiving dental treatment, found that there may be a reduction in CFU with rubber dam at one-metre (MD -16.20, 95% CI -19.36 to -13.04) and two-metre distance (MD -11.70, 95% CI -15.82 to -7.58). One RCT of 47 dental students found use of rubber dam may make no difference in CFU at the forehead (MD 0.98, 95% CI -0.73 to 2.70) and occipital region of the operator (MD 0.77, 95% CI -0.46 to 2.00). One split-mouth RCT (21 participants) found that rubber dam plus HVE may reduce CFU more than cotton roll plus HVE on the patient's chest (MD -251.00, 95% CI -267.95 to -234.05) and dental unit light (MD -12.70, 95% CI -12.85 to -12.55). Air cleaning systems One split-mouth CCT (two participants) used a local stand-alone air cleaning system (ACS), which may reduce aerosol contamination during cavity preparation (MD -66.70 CFU, 95% CI -120.15 to -13.25 per cubic metre) or ultrasonic scaling (MD -32.40, 95% CI - 51.55 to -13.25). Another CCT (50 participants) found that laminar flow in the dental clinic combined with a HEPA filter may reduce contamination approximately 76 cm from the floor (MD -483.56 CFU, 95% CI -550.02 to -417.10 per cubic feet per minute per patient) and 20 cm to 30 cm from the patient's mouth (MD -319.14 CFU, 95% CI - 385.60 to -252.68). Disinfectants ‒ antimicrobial coolants Two RCTs evaluated use of antimicrobial coolants during ultrasonic scaling. Compared with distilled water, coolant containing chlorhexidine (CHX), cinnamon extract coolant or povidone iodine may reduce CFU: CHX (MD -124.00, 95% CI -135.78 to -112.22; 20 participants), povidone iodine (MD -656.45, 95% CI -672.74 to -640.16; 40 participants), cinnamon (MD -644.55, 95% CI -668.70 to -620.40; 40 participants). CHX coolant may reduce CFU more than povidone iodine (MD -59.30, 95% CI -64.16 to -54.44; 20 participants), but not more than cinnamon extract (MD -11.90, 95% CI -35.88 to 12.08; 40 participants). AUTHORS' CONCLUSIONS: We found no studies that evaluated disease transmission via aerosols in a dental setting; and no evidence about viral contamination in aerosols. All of the included studies measured bacterial contamination using colony-forming units. There appeared to be some benefit from the interventions evaluated but the available evidence is very low certainty so we are unable to draw reliable conclusions. We did not find any studies on methods such as ventilation, ionization, ozonisation, UV light and fogging. Studies are needed that measure contamination in aerosols, size distribution of aerosols and infection transmission risk for respiratory diseases such as COVID-19 in dental patients and staff.


Assuntos
Microbiologia do Ar , Infecções Bacterianas/prevenção & controle , Controle de Infecções Dentárias/métodos , Doenças Profissionais/prevenção & controle , Viroses/prevenção & controle , Adolescente , Adulto , Aerossóis , Idoso , Filtros de Ar , Criança , Pré-Escolar , Contagem de Colônia Microbiana/métodos , Odontologia , Desinfetantes , Humanos , Controle de Infecções Dentárias/economia , Controle de Infecções Dentárias/instrumentação , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Diques de Borracha , Sucção , Adulto Jovem
4.
Respir Res ; 21(1): 265, 2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33050900

RESUMO

BACKGROUND: Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype, have a great unmet need for new treatments that act on a broad range of inflammatory pathways in the airway. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial cytokine. In the PATHWAY phase 2b study (NCT02054130), tezepelumab reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status. This article reports the design and objectives of the phase 2 CASCADE study. METHODS: CASCADE is an ongoing exploratory, phase 2, randomized, double-blind, placebo-controlled, parallel-group study aiming to assess the anti-inflammatory effects of tezepelumab 210 mg administered subcutaneously every 4 weeks for 28 weeks in adults aged 18-75 years with uncontrolled, moderate-to-severe asthma. The primary endpoint is the change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies. Epithelial molecular phenotyping, comprising the three-gene-mean technique, will be used to assess participants' type 2 (T2) status to enable evaluation of the anti-inflammatory effect of tezepelumab across the continuum of T2 activation. Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity. At the onset of the COVID-19 pandemic, the protocol was amended to address the possibility that site visits would be limited. The amendment allowed for: at-home dosing of study drug by a healthcare professional, extension of the treatment period by up to 6 months so patients are able to attend an onsite visit to undergo the end-of-treatment bronchoscopy, and replacement of final follow-up visits with a virtual or telephone visit. DISCUSSION: CASCADE aims to determine the mechanisms by which tezepelumab improves clinical asthma outcomes by evaluating the effect of tezepelumab on airway inflammatory cells and remodelling in patients with moderate-to-severe, uncontrolled asthma. An important aspect of this study is the evaluation of the anti-inflammatory effect of tezepelumab across patients with differing levels of eosinophilic and T2 inflammation. TRIAL REGISTRATION: NCT03688074 (ClinicalTrials.gov). Registered 28 September 2018.


Assuntos
Antiasmáticos/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/tratamento farmacológico , Adolescente , Adulto , Idoso , Antiasmáticos/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Asma/diagnóstico , Asma/imunologia , Ensaios Clínicos Fase II como Assunto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Adulto Jovem
5.
Trials ; 21(1): 841, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33036662

RESUMO

OBJECTIVES: We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. TRIAL DESIGN: This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. PARTICIPANTS: Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. MAIN OUTCOMES: The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. RANDOMIZATION: An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. BLINDING (MASKING): All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 84 participants will be randomized into two groups of 42 patients. TRIAL STATUS: The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N1 ". Registration date is 23 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in 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.


Assuntos
Infecções por Coronavirus , Gengibre , Pandemias , Fitoterapia/métodos , Preparações de Plantas/farmacologia , Pneumonia Viral , Avaliação de Sintomas/métodos , Administração Oral , Adulto , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Método Duplo-Cego , Monitoramento de Medicamentos/métodos , Feminino , Humanos , Irã (Geográfico) , Masculino , Pneumonia Viral/diagnóstico , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Comprimidos
6.
Medicine (Baltimore) ; 99(40): e22266, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019401

RESUMO

INTRODUCTION: Gestational hyperinsulinism is a metabolic disease which is widely concerned at home and abroad. It is a clinical consensus that the embryo implantation ability of patients with hyperinsulinemia is decreased and the abortion rate after implantation is high. The treatment of gestational hyperinsulinism with Multiple dietary fiber diets has been proven. However, due to the lack of evidence, there is no specific method or recommendation, it is necessary to carry out a systematic evaluation of Multiple dietary fiber diet, to provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to August 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and CNKI. Primary outcomes: Fasting glucose, fasting insulin, homeostasis model assessment of insulin resistance, glycosylated hemoglobin. Additional outcomes: Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), triglycerides (TG), total serum cholesterol (TC). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews (SR) of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of Multiple dietary fiber diet interventions in the treatment of gestational hyperinsulinism. CONCLUSION: The SR of this study will summarize the current published evidence of Multiple dietary fiber for the treatment of gestational hyperinsulinism, which can further guide the promotion and application of it. ETHICS AND DISSEMINATION: This study is a SR, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA NETWORK (OSF) REGISTRATION NUMBER: August 19, 2020. osf.io/tbc7z. (https://osf.io/tbc7z).


Assuntos
Fibras na Dieta/uso terapêutico , Hiperinsulinismo/dietoterapia , Complicações na Gravidez/dietoterapia , Glicemia/fisiologia , Fibras na Dieta/administração & dosagem , Fibras na Dieta/efeitos adversos , Feminino , Hemoglobina A Glicada/análise , Humanos , Resistência à Insulina/fisiologia , Lipídeos/sangue , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
7.
Medicine (Baltimore) ; 99(40): e22276, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019402

RESUMO

INTRODUCTION: Thyroid nodules are scattered lesions caused by abnormal local growth of thyroid cells. In recent years, their prevalence rate has been rising gradually, and the probability of cancerations has also been increasing gradually. Therefore, we must pay more attention to them and carry out early intervention. However, at present, most of the intervention measures for patients with thyroid nodules are mainly clinical observation and follow-up, and no clear and effective drug intervention therapy has been proposed. The curative effect of acupuncture on thyroid nodules has been proved clinically. However, as there is no clear mechanism of action, no specific operation methods or Suggestions, it is necessary to make a systematic evaluation of acupuncture therapy, so as to lay a foundation for further research in the future. METHODS AND ANALYSIS: The following databases will be searched from their inception to June 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure (CNKI). Primary outcomes: Color ultrasound of thyroid and cervical lymph nodes, FT3, FT4, TSH, TGAB, TPOAB, insulin resistance index (HOMA-IR). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of acupuncture therapy for patients with thyroid nodule. CONCLUSION: Through the systematic review of this study, the evidence of the treatment of thyroid nodule by acupuncture has been summarized so far, so as to provide guidance for further promoting the application of acupuncture therapy in patients with thyroid nodule. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA NETWORK (OSF) REGISTRATION NUMBER: August 18, 2020. osf.io/uzck4. (https://osf.io/uzck4).


Assuntos
Terapia por Acupuntura/métodos , Nódulo da Glândula Tireoide/terapia , Terapia por Acupuntura/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Testes de Função Tireóidea , Nódulo da Glândula Tireoide/diagnóstico por imagem , Ultrassonografia Doppler
8.
Medicine (Baltimore) ; 99(40): e22315, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019407

RESUMO

INTRODUCTION: chronic obstructive pulmonary disease (COPD) is 1 of the leading causes of morbidity and mortality worldwide; its economic and social burdens are substantial and increasing. Recent years, an increasing number of study has shown the promising advantage of Erchen decoction (ECD) combined with sanziyangqin decoction (SZYQD) in treating COPD. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to provide a protocol for a systematic review on ECD combined with SZYQD for COPD and provide effective evidence for further clinical use. METHODS AND ANALYSIS: We will conduct a Computerized literature searches in the following databases: PubMed, MEDLINE, EMBASE, Cochrane Library, China national information network, China biomedical literature database (CBM), Chinese Scientific Journals Database and wanfang database, from their inception to June 2020, without restrictions of language. Study selection, data collection, and evaluation of the quality of evidence will be performed by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: This study will systematically evaluate the effectiveness and safety of ECD combined with SZYQD for COPD. The results will be published in a peer-reviewed journal. CONCLUSION: This study will provide evidence from the current published RCTs of whether ERD combined with SZYQD is an effective and safe intervention for COPD. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence. In this study, no individual data from participants will be involved, so ethics approval is not required. OPEN SCIENCE FRAMEWORK(OSF)REGISTRATION NUMBER: August 19, 2020; osf.io/zxm24.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Testes de Função Respiratória
9.
Medicine (Baltimore) ; 99(40): e22377, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019413

RESUMO

INTRODUCTION: Diabetic nephropathy (DN) is one of the most common and serious microvascular complications in patients with diabetes, which seriously affects their life quality and survival time. large dose herb Fuling or compound prescription contain large dose Fuling for treatment of DN has already been confirmed. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on Fuling and provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to June 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WangFang, VIP medicine information, and China National Knowledge Infrastructure (CNKI). Primary outcomes:24-hurinary-albumin, Urinary albumin-to-creatinine ratio. Additional outcomes: Serum creatinine, Blood urea nitrogen, Glomerular filtration rate, Endogenous creatinine clearance rate. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of large dose Fuling intervention for people with DN. CONCLUSION: The systematic review of this study will summarize the current published evidence of large dose Fuling for the treatment of DN, which can further guide the promotion and application of it. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRAMEWORK (OSF) REGISTRATION NUMBER: August 24, 2020. osf.io/ym2c6. (https://osf.io/ym2c6).


Assuntos
Nefropatias Diabéticas/tratamento farmacológico , Wolfiporia , Albuminúria/metabolismo , Creatinina/sangue , Creatinina/urina , Relação Dose-Resposta a Droga , Taxa de Filtração Glomerular , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
10.
Medicine (Baltimore) ; 99(40): e22399, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019414

RESUMO

BACKGROUND: Essential hypertension remains an enormous public health concern, imposing a major burden of morbidity and mortality worldwide. Relevant studies showed that acupuncture therapy might be effective in treating essential hypertension. However, there is no consistent conclusion so far. The aim of this study was to assess the efficacy and safety of acupuncture therapy for patients with essential hypertension. METHODS: We searched the PubMed, Embase, the Cochrane Library, Web of Science, the Chinese National Knowledge Infrastructure (CNKI), and the Wan-fang databases from inception through November 29, 2019. Randomized controlled trials investigating acupuncture therapy for hypertension were included. We will use Endnote software X8 for studies selection, Review Manager software 5.3 for the data analysis. RESULTS: We will synthesize current studies to evaluate the safeties and effectiveness of acupuncture for essential hypertension. CONCLUSIONS: Our study will provide the evidence of acupuncture therapy for essential hypertension.


Assuntos
Terapia por Acupuntura/métodos , Hipertensão Essencial/terapia , Pontos de Acupuntura , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
11.
Medicine (Baltimore) ; 99(40): e22401, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019415

RESUMO

BACKGROUND: A growing body of clinical trials has demonstrated that traditional Chinese medicine Shaoyao Gancao Tang may improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectiveness and safety in the treatment of patients with RLS. METHODS: Eight databases will be searched from the inception to 31 August 2020, including the Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, VIP Information Database, the Cochrane Library, PubMed, EMBASE, and the Web of Science. All published randomized controlled trials that meet the prespecified eligibility criteria will be included. The primary outcomes include the changes in the International Restless Legs Syndrome Rating Scale and the restless sensation assessed by visual analog scales, and the secondary outcomes include effective rate, adverse event rate, quality of life measures, and improvement in the sleep quality index. Study selection, data extraction, and assessment of bias risk will be conducted independently by 2 reviewers. Data synthesis will be carried out with RevMan software (V.5.3.5). Subgroup and sensitivity analysis will be performed when necessary. The strength of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation System. RESULTS: A high-quality synthesis of current evidence of Shaoyao Gancao Tang's effectiveness and safety for patients with RLS will be provided. CONCLUSION: This systematic review will provide evidence of whether Shaoyao Gancao Tang is an effective and safe intervention for RLS.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Síndrome das Pernas Inquietas/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Medicina Tradicional Chinesa , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Sono/fisiologia
12.
Medicine (Baltimore) ; 99(40): e22404, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019416

RESUMO

BACKGROUND: Systemic lupus erythematosus (SLE), known as lupus, is a chronic autoimmune disease and there is no cure for SLE. The western medication can improve syndromes to some extent; however, severe adverse drug reactions appear at the same time. Recently, it is confirmed that Chinese medicine also can have an excellent clinical efficacy on SLE. METHODS AND ANALYSIS: The following databases will be searched for relevant information before July 2020: PubMed, Embase, Cochrane Library, Web of Science, and China National Knowledge Infrastructure. MAJOR RESULTS: levels of total remission rate, SLEDAI. Secondary results: The laboratory index about C3 levels, Hb levels, white blood cell levels, and adverse event. Data will be collected independently by 2 researchers, and the risk of bias in meta analysis will be evaluated according to "Cochrane Handbook for Systematic Reviews of Interventions." All data analysis will be conducted using Review Manager V.5.3. and Stata V.12.0. RESULTS: The curative effect and safety of Chinese herbal compound prescription treatment for SLE patients will be evaluated systematically. CONCLUSION: The systematic review of this study will summarize the currently published evidence of Chinese herbal compound prescription treatment for SLE to further guide its promotion and application. ETHICS AND DISSEMINATION: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OPEN SCIENCE FRAMEWORK (OSF)REGISTRATION NUMBER:: https://osf.io/wvfrx/.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Hemoglobinas/análise , Humanos , Contagem de Leucócitos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Projetos de Pesquisa
13.
Medicine (Baltimore) ; 99(40): e22501, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019447

RESUMO

BACKGROUND: Tinnitus is a common disease in otolaryngology. In China, acupuncture has been used as a promising treatment for tinnitus. Yet, the specific effect and safety of acupuncture are still disputable. The ultimate goal of this paper is to formulate a protocol for systematic review and meta-analysis, which can be employed in assessing the benefits and safety of acupuncture on tinnitus. METHODS: Seven databases should be retrieved from their establishment until June 2020, including PubMed, Cochrane Central Register of Controlled Trials, Excerpt Medical Database, Chinese Biomedical Literature Database, Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure and Wan Fang Database. Randomized controlled trials of acupuncture treatment of tinnitus will be included. The experimental group is acupuncture or combined with additional treatment measures, and the control group is a placebo, sham acupuncture, Cognitive Behavioral Therapy, sound therapy, conventional medication, or same additional treatment. The clinical efficacy rate, Tinnitus Handicap Inventory, Tinnitus Questionnaire, visual analogue scale or other indicators are all concerned in the systematic evaluation of the program. Data collection, selection and extraction should be made separately by different researchers. The quality of the literature will be evaluated by the bias analysis table in the Cochrane Handbook, and Review Manager 5.3 software shall be applied to data analysis. RESULTS: This protocol has made a concrete plan to evaluate whether acupuncture is effective and safe in curing tinnitus. CONCLUSION: This protocol is suitable for evaluating the effectiveness and safety of acupuncture in curing tinnitus, and is helpful for subsequent evaluation.Open Science Framework Registration DOI: 10.17605/OSF.IO/85FCS.


Assuntos
Terapia por Acupuntura/métodos , Zumbido/terapia , Terapia por Acupuntura/efeitos adversos , Terapia Cognitivo-Comportamental/métodos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
14.
Medicine (Baltimore) ; 99(40): e22517, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019454

RESUMO

BACKGROUND: Hepatic encephalopathy (HE) is one of the common complications of many serious liver diseases. Western medicine treatment is mainly symptomatic treatment such as neutralizing blood ammonia and protecting liver, which has poor curative effect, easy repetition and high mortality. Retention enema with traditional Chinese medicine (TCM) has been used on treatment of HE in China for many years. And it has been clinically proved that retention enema with TCM is effective and safe. But there is absent convincing evidence-based medicine to confirm the efficacy of retention enema with TCM for HE. Thus, we aimed to conduct this meta-analysis to summarize the efficacy of retention enema with TCM in patients with HE. METHODS: The study only selects clinical randomized controlled trials of retention enema with TCM for HE. We will search each database from the built-in until December 31, 2020. The English literature mainly searches Cochrane Library, Pubmed, EMBASE, and Web of Science. While the Chinese literature comes from CNKI, CBM, VIP, and Wanfang database. Meanwhile, we will retrieve clinical trial registries and gray literature. Two researchers worked independently on literature selection, data extraction and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on the heterogeneity. The total effective rate, blood ammonia and the total bilirubin were evaluated as the main outcomes. While several secondary outcomes were also evaluated in this study. The statistical analysis of this Meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will synthesize and provide high-quality evidence based on the data of the currently published retention enema with TCM for the treatment of HE. CONCLUSION: This meta-analysis aims to evaluate the benefits of retention enema with TCM for the treatment of HE reported in randomized controlled trials, and provide more options for clinicians and patients with HE. REGISTRATION NUMBER: INPLASY202080107.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Encefalopatia Hepática/tratamento farmacológico , Medicina Tradicional Chinesa/métodos , Medicamentos de Ervas Chinesas/efeitos adversos , Enema , Humanos , Medicina Tradicional Chinesa/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
15.
Medicine (Baltimore) ; 99(40): e22524, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019455

RESUMO

TRIAL DESIGN: The current study is a meta-analysis designed to assess the effect of adding magnesium to a combination of intrathecal bupivacaine and fentanyl. METHODS: The protocol was registered in PROSPERO with the number CRD42020177618. PubMed, Cochrane library, Web of Science, and Google Scholar were searched for randomized controlled trials investigating the effect of adding magnesium to a combination of intrathecal bupivacaine and fentanyl. The continuous data were presented as Ratio of means (RoM). Risk ratio (RR) along with 95% confidence interval (CI) was utilized to assess the dichotomous data. RESULTS: Ten trials were involved in the present study with 720 adult patients. Compared with control, intrathecal magnesium prolonged time to the first analgesic requirement by an estimate of 1.23 (RoM: 1.23; 95%CI: 1.13-1.33; P < .00001), prolonged adequate sensory block duration for surgery by an estimate of 1.16 (RoM: 1.16; 95%CI: 1.05-1.27; P = .003), delayed time to maximum sensory level by an estimate of 1.38 (RoM: 1.38; 95%CI: 1.07-1.78; P = .01) and reduced the incidence of shivering following spinal anesthesia (risk ratio: 0.38; 95%CI: 0.18 to 0.81, P = .01) without influence on time to full motor recovery or incidences of hypotention, bradycardia, nausea, and vomiting or pruritis. CONCLUSION: Intrathecal magnesium, when added to a combination of intrathecal bupivacaine and fentany, prolongs the analgesic duration of spinal anesthesia without increased incidences of side effects.


Assuntos
Raquianestesia/métodos , Anestésicos/uso terapêutico , Sulfato de Magnésio/uso terapêutico , Analgésicos Opioides/uso terapêutico , Período de Recuperação da Anestesia , Raquianestesia/efeitos adversos , Anestésicos/administração & dosagem , Anestésicos/efeitos adversos , Bupivacaína/uso terapêutico , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Fentanila/uso terapêutico , Humanos , Sulfato de Magnésio/administração & dosagem , Sulfato de Magnésio/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tremor por Sensação de Frio/efeitos dos fármacos , Fatores de Tempo
16.
JAMA ; 324(14): 1439-1450, 2020 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-33048152

RESUMO

Importance: The evidence for palliative care exists predominantly for patients with cancer. The effect of palliative care on important end-of-life outcomes in patients with noncancer illness is unclear. Objective: To measure the association between palliative care and acute health care use, quality of life (QOL), and symptom burden in adults with chronic noncancer illnesses. Data Sources: MEDLINE, Embase, CINAHL, PsycINFO, and PubMed from inception to April 18, 2020. Study Selection: Randomized clinical trials of palliative care interventions in adults with chronic noncancer illness. Studies involving at least 50% of patients with cancer were excluded. Data Extraction and Synthesis: Two reviewers independently screened, selected, and extracted data from studies. Narrative synthesis was conducted for all trials. All outcomes were analyzed using random-effects meta-analysis. Main Outcomes and Measures: Acute health care use (hospitalizations and emergency department use), disease-generic and disease-specific quality of life (QOL), and symptoms, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (range, 0 [worst] to 184 [best]; minimal clinically important difference, 9 points) and symptoms translated to units of the Edmonton Symptom Assessment Scale global distress score (range, 0 [best] to 90 [worst]; minimal clinically important difference, 5.7 points). Results: Twenty-eight trials provided data on 13 664 patients (mean age, 74 years; 46% were women). Ten trials were of heart failure (n = 4068 patients), 11 of mixed disease (n = 8119), 4 of dementia (n = 1036), and 3 of chronic obstructive pulmonary disease (n = 441). Palliative care, compared with usual care, was statistically significantly associated with less emergency department use (9 trials [n = 2712]; 20% vs 24%; odds ratio, 0.82 [95% CI, 0.68-1.00]; I2 = 3%), less hospitalization (14 trials [n = 3706]; 38% vs 42%; odds ratio, 0.80 [95% CI, 0.65-0.99]; I2 = 41%), and modestly lower symptom burden (11 trials [n = 2598]; pooled standardized mean difference (SMD), -0.12; [95% CI, -0.20 to -0.03]; I2 = 0%; Edmonton Symptom Assessment Scale score mean difference, -1.6 [95% CI, -2.6 to -0.4]). Palliative care was not significantly associated with disease-generic QOL (6 trials [n = 1334]; SMD, 0.18 [95% CI, -0.24 to 0.61]; I2 = 87%; Functional Assessment of Chronic Illness Therapy-Palliative Care score mean difference, 4.7 [95% CI, -6.3 to 15.9]) or disease-specific measures of QOL (11 trials [n = 2204]; SMD, 0.07 [95% CI, -0.09 to 0.23]; I2 = 68%). Conclusions and Relevance: In this systematic review and meta-analysis of randomized clinical trials of patients with primarily noncancer illness, palliative care, compared with usual care, was statistically significantly associated with less acute health care use and modestly lower symptom burden, but there was no significant difference in quality of life. Analyses for some outcomes were based predominantly on studies of patients with heart failure, which may limit generalizability to other chronic illnesses.


Assuntos
Demência/terapia , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Insuficiência Cardíaca/terapia , Cuidados Paliativos/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/terapia , Qualidade de Vida , Idoso , Viés , Doença Crônica , Demência/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Insuficiência Cardíaca/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Razão de Chances , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Avaliação de Sintomas/estatística & dados numéricos
17.
Medicine (Baltimore) ; 99(40): e22231, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019397

RESUMO

BACKGROUND: There is a worldwide outbreak of coronavirus disease 2019 (COVID-19), at present, accumulative attention has been paid to COVID-19 due to its global prevalence. Acupuncture may play a beneficial role in patients who suffer from COVID-19. In China and East Asia, acupuncture has been widely used to treat diverse diseases for thousands of years, as an important method of treatment now, it plays an indispensable role in the treatment of respiratory diseases in China. This study is designed to determine the efficacy and safety of acupuncture in COVID-19. METHODS: We will search the following sources for the Randomized controlled trials (RCT): The Cochrane Library, PubMed, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science, and the Wanfang Database. All the above databases will be searched from the available date of inception until the latest issue. No language or publication restriction will be used. Primary outcomes will include chest CT and nucleic acid detection of respiratory samples. RESULTS: The results will provide a high-quality synthesis of current evidence for researchers in this subject area. CONCLUSION: The conclusion of our study will provide evidence to evaluate whether acupuncture is an effective treatments for patients suffering from COVID-19. PROSPERO REGISTRATION NUMBER: CRD42020180875.


Assuntos
Terapia por Acupuntura/métodos , Betacoronavirus , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Feminino , Humanos , Masculino , Metanálise como Assunto , Pandemias , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Resultado do Tratamento
18.
Medicine (Baltimore) ; 99(40): e22448, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019431

RESUMO

BACKGROUND: Cancer patients are associated with a series of long lasting and stressful treatments and experiencing, and case management (CM) has been widely used and developed with the aim to increase the quality of treatments and improve the patient care services. The purpose of this review is to identify and synthesize the evidence of randomized controlled trial studies to prove that case management could be one way to address the quality of life of cancer patients. METHODS: We performed a literature search in 4 electronic bibliographic databases and snowball searches were performed to ensure a complete collection. Two review authors independently extracted and analyzed data. A data extraction form was used to collect the characteristics of case management intervention, report outcomes, and quality assessment. RESULTS: Our searches identified 3080 articles, of which 7 randomized controlled trials met the inclusion criteria. The intervention was varied from the target population, measurement tools, duration of intervention, and so on, and 5 studies consistently showed improvement in the intervention group compared with control groups, no significant difference was found between health care costs of case management care services and the routine care services. CONCLUSION: There is some evidence that case management can be effective in cancer patients quality of life. However, due to the heterogeneity in the target population, measurement tools, and results applied, no conclusion can be made from a meta-analysis on the present bias. More rigorously multi-centered randomized controlled studies should be provided with detailed information about intervention in future research.


Assuntos
Administração de Caso , Neoplasias/terapia , Qualidade de Vida , Feminino , Humanos , Masculino , Neoplasias/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Medicine (Baltimore) ; 99(40): e22457, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019433

RESUMO

INTRODUCTION: Ulcerative Colitis is a chronic nonspecific inflammatory disease of the colon and rectum, which is of global concern. It has the characteristics of a long course of disease and repeated attacks, which seriously affects the quality of life and economic and social development of the affected population. The treatment of UC by herb Huanglian and compound prescription contain Huanglian have been proved. However, due to the lack of evidence, there is no specific method or suggestion, it is necessary to systematically evaluate coptidis so as to provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to June 2020: Electronic databases included PubMed, Embase, Cochrane Library, Web of Science, Nature, Science Online, WanFang China Biomedical Database, VIP Medical Information, CNKI (Knowledge Infrastructure of China). MAIN OUTCOMES: Colonoscopy, improved condition (tenesmus), stool routine. Additional outcomes: Electrocardiogram (ECG), erythrocyte (RBC), leukocyte (WBC), platelet (PLT). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of rhizoma coptidis intervention in patients with Ulcerative Colitis. CONCLUSION: Through the systematic review of this study, the published evidence of rhizoma coptidis on the treatment of UC is summarized so as to further guide its promotion and application. ETHICS AND COMMUNICATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: August 27, 2020. osf.io/7nh3k (https://osf.io/7nh3k).


Assuntos
Colite Ulcerativa/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
20.
Medicine (Baltimore) ; 99(40): e22542, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019463

RESUMO

BACKGROUND: The goal of this study was to review relevant randomized controlled trials or case-control studies to determine the clinical efficacy of minodronate in the treatment of osteoporosis. METHOD: The relevant studies were identified on PubMed, Cochrane, and Embase databases using appropriate keywords. Pertinent sources in the literature were also reviewed, and all articles published through October 2019 were considered for inclusion. For each study, we assessed odds ratios, mean difference, and 95% confidence interval (95% CI) to evaluate and synthesize outcomes. RESULT: Thirteen studies comprising 3740 patients were included in this study. Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD]: -13.669, 95% confidence interval [CI]: -23.108 to -4.229), bone alkaline phosphatase (BAP) (WMD: -1.26, 95% CI: -2.04 to -0.47) and tartrate-resistant acid phosphatase 5b (WMD: -154.11, 95% CI: -277.85 to -30.37). Minodronate combined with other drugs would significantly decrease BAP (WMD: -3.10, 95% CI: -5.20 to -1.00) than minodronate. Minodronate-naïve would significantly decrease BAP (WMD: -3.00, 95% CI: -5.47 to 0.53) and tartrate-resistant acid phosphatase 5b (WMD: -128.20, 95% CI: -198.11 to -58.29) than minodronate-switch. The incidence of vertebral fracture was significantly decreased in the minodronate group than the other drugs (relative risk: 0.520, 95% CI: 0.363-0.744). CONCLUSION: Minodronate has better clinical efficacy in the treatment of osteoporosis than other drugs (alendronate, risedronate, raloxifene, or eldecalcitol).


Assuntos
Difosfonatos/uso terapêutico , Imidazóis/uso terapêutico , Osteoporose/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Alendronato/uso terapêutico , Fosfatase Alcalina/efeitos dos fármacos , Conservadores da Densidade Óssea/uso terapêutico , Estudos de Casos e Controles , Colágeno Tipo I/efeitos dos fármacos , Creatinina , Quimioterapia Combinada/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cloridrato de Raloxifeno/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Risedrônico/uso terapêutico , Fraturas da Coluna Vertebral/epidemiologia , Fosfatase Ácida Resistente a Tartarato/efeitos dos fármacos , Resultado do Tratamento , Vitamina D/análogos & derivados , Vitamina D/uso terapêutico
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