The International Journal Of Risk & Safety In Medicine[JOURNAL]
Sun
200 papers
Effects on childhood infections of promoting safe and hygienic complementary-food handling practices through a community-based programme: A cluster randomised controlled trial in a rural area of The Gambia.
Manaseki-Holland S, Manjang B, Hemming K … +10 more , Martin JT, Bradley C, Jackson L, Taal M, Gautam OP, Crowe F, Sanneh B, Ensink J, Stokes T, Cairncross S
PLoS Med · 2021 Jan · PMID 33428636 · Full text
BACKGROUND: The Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rat...
BACKGROUND: The Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rates. METHODS AND FINDINGS: A public health intervention using critical control points and motivational drivers, delivered February-April 2015 in The Gambia, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up in September-October 2015 and October-December 2017, respectively. After consent for trial participation and baseline data were collected, 30 villages (clusters) were randomly assigned to intervention or control, stratified by population size and geography. The intervention included a community-wide campaign on days 1, 2, 17, and 25, a reminder visit at 5 months, plus informal community-volunteer home visits. It promoted 5 key complementary-food and 1 key drinking-water safety and hygiene behaviours through performing arts, public meetings, and certifications delivered by a team from local health and village structures to all villagers who attended the activities, to which mothers of 6- to 24-month-old children were specifically invited. Control villages received a 1-day campaign on domestic-garden water use. The background characteristics of mother and clusters (villages) were balanced between the trial arms. Outcomes were measured at 6 and 32 months in a random sample of 21-26 mothers per cluster. There were no intervention or research team visits to villages between 6 and 32 months. The primary outcome was a composite outcome of the number of times key complementary-food behaviours were observed as a proportion of the number of opportunities to perform the behaviours during the observation period at 6 months. Secondary outcomes included the rate of each recommended behaviour; microbiological growth from complementary food and drinking water (6 months only); and reported acute respiratory infections, diarrhoea, and diarrhoea hospitalisation. Analysis was by intention-to-treat analysis adjusted by clustering. (Registration: PACTR201410000859336). We found that 394/571 (69%) of mothers with complementary-feeding children in the intervention villages were actively involved in the campaign. No villages withdrew, and there were no changes in the implementation of the intervention. The intervention improved behaviour adoption significantly. For the primary outcome, the rate was 662/4,351(incidence rate [IR] = 0.15) in control villages versus 2,861/4,378 (IR = 0.65) in intervention villages (adjusted incidence rate ratio [aIRR] = 4.44, 95% CI 3.62-5.44, p < 0.001), and at 32 months the aIRR was 1.17 (95% CI 1.07-1.29, p = 0.001). Secondary health outcomes also improved with the intervention: (1) mother-reported diarrhoea at 6 months, with adjusted relative risk (aRR) = 0.39 (95% CI 0.32-0.48, p < 0.001), and at 32 months, with aRR = 0.68 (95% CI 0.48-0.96, p = 0.027); (2) mother-reported diarrhoea hospitalisation at 6 months, with aRR = 0.35 (95% CI 0.19-0.66, p = 0.001), and at 32 months, with aRR = 0.38 (95% CI 0.18-0.80, p = 0.011); and (3) mother-reported acute respiratory tract infections at 6 months, with aRR = 0.67 (95% CI 0.53-0.86, p = 0.001), though at 32 months improvement was not significant (p = 0.200). No adverse events were reported. The main limitations were that only medium to small rural villages were involved. Obtaining laboratory cultures from food at 32 months was not possible, and no stool microorganisms were investigated. CONCLUSIONS: We found that low-cost and culturally embedded behaviour change interventions were acceptable to communities and led to short- and long-term improvements in complementary-food safety and hygiene practices, and reported diarrhoea and acute respiratory tract infections. TRIAL REGISTRATION: The trial was registered on the 17th October 2014 with the Pan African Clinical Trial Registry in South Africa with number (PACTR201410000859336) and 32-month follow-up as an amendment to the trial.
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis.
Kim MS, An MH, Kim WJ … +1 more , Hwang TH
PLoS Med · 2020 Dec · PMID 33378357 · Full text
BACKGROUND: Numerous clinical trials and observational studies have investigated various pharmacological agents as potential treatment for Coronavirus Disease 2019 (COVID-19), but the results are heterogeneous and someti...
BACKGROUND: Numerous clinical trials and observational studies have investigated various pharmacological agents as potential treatment for Coronavirus Disease 2019 (COVID-19), but the results are heterogeneous and sometimes even contradictory to one another, making it difficult for clinicians to determine which treatments are truly effective. METHODS AND FINDINGS: We carried out a systematic review and network meta-analysis (NMA) to systematically evaluate the comparative efficacy and safety of pharmacological interventions and the level of evidence behind each treatment regimen in different clinical settings. Both published and unpublished randomized controlled trials (RCTs) and confounding-adjusted observational studies which met our predefined eligibility criteria were collected. We included studies investigating the effect of pharmacological management of patients hospitalized for COVID-19 management. Mild patients who do not require hospitalization or have self-limiting disease courses were not eligible for our NMA. A total of 110 studies (40 RCTs and 70 observational studies) were included. PubMed, Google Scholar, MEDLINE, the Cochrane Library, medRxiv, SSRN, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov were searched from the beginning of 2020 to August 24, 2020. Studies from Asia (41 countries, 37.2%), Europe (28 countries, 25.4%), North America (24 countries, 21.8%), South America (5 countries, 4.5%), and Middle East (6 countries, 5.4%), and additional 6 multinational studies (5.4%) were included in our analyses. The outcomes of interest were mortality, progression to severe disease (severe pneumonia, admission to intensive care unit (ICU), and/or mechanical ventilation), viral clearance rate, QT prolongation, fatal cardiac complications, and noncardiac serious adverse events. Based on RCTs, the risk of progression to severe course and mortality was significantly reduced with corticosteroids (odds ratio (OR) 0.23, 95% confidence interval (CI) 0.06 to 0.86, p = 0.032, and OR 0.78, 95% CI 0.66 to 0.91, p = 0.002, respectively) and remdesivir (OR 0.29, 95% CI 0.17 to 0.50, p < 0.001, and OR 0.62, 95% CI 0.39 to 0.98, p = 0.041, respectively) compared to standard care for moderate to severe COVID-19 patients in non-ICU; corticosteroids were also shown to reduce mortality rate (OR 0.54, 95% CI 0.40 to 0.73, p < 0.001) for critically ill patients in ICU. In analyses including observational studies, interferon-alpha (OR 0.05, 95% CI 0.01 to 0.39, p = 0.004), itolizumab (OR 0.10, 95% CI 0.01 to 0.92, p = 0.042), sofosbuvir plus daclatasvir (OR 0.26, 95% CI 0.07 to 0.88, p = 0.030), anakinra (OR 0.30, 95% CI 0.11 to 0.82, p = 0.019), tocilizumab (OR 0.43, 95% CI 0.30 to 0.60, p < 0.001), and convalescent plasma (OR 0.48, 95% CI 0.24 to 0.96, p = 0.038) were associated with reduced mortality rate in non-ICU setting, while high-dose intravenous immunoglobulin (IVIG) (OR 0.13, 95% CI 0.03 to 0.49, p = 0.003), ivermectin (OR 0.15, 95% CI 0.04 to 0.57, p = 0.005), and tocilizumab (OR 0.62, 95% CI 0.42 to 0.90, p = 0.012) were associated with reduced mortality rate in critically ill patients. Convalescent plasma was the only treatment option that was associated with improved viral clearance rate at 2 weeks compared to standard care (OR 11.39, 95% CI 3.91 to 33.18, p < 0.001). The combination of hydroxychloroquine and azithromycin was shown to be associated with increased QT prolongation incidence (OR 2.01, 95% CI 1.26 to 3.20, p = 0.003) and fatal cardiac complications in cardiac-impaired populations (OR 2.23, 95% CI 1.24 to 4.00, p = 0.007). No drug was significantly associated with increased noncardiac serious adverse events compared to standard care. The quality of evidence of collective outcomes were estimated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The major limitation of the present study is the overall low level of evidence that reduces the certainty of recommendations. Besides, the risk of bias (RoB) measured by RoB2 and ROBINS-I framework for individual studies was generally low to moderate. The outcomes deducted from observational studies could not infer causality and can only imply associations. The study protocol is publicly available on PROSPERO (CRD42020186527). CONCLUSIONS: In this NMA, we found that anti-inflammatory agents (corticosteroids, tocilizumab, anakinra, and IVIG), convalescent plasma, and remdesivir were associated with improved outcomes of hospitalized COVID-19 patients. Hydroxychloroquine did not provide clinical benefits while posing cardiac safety risks when combined with azithromycin, especially in the vulnerable population. Only 29% of current evidence on pharmacological management of COVID-19 is supported by moderate or high certainty and can be translated to practice and policy; the remaining 71% are of low or very low certainty and warrant further studies to establish firm conclusions.
The efficacy of Tuina for asthma: A protocol for a systematic review and meta-analysis.
Wang C, Jiang Y, Fan Z … +4 more , Zhao M, Jiang Y, Wang Z, Chen Z
Medicine (Baltimore) · 2020 Dec · PMID 33350792 · Full text
BACKGROUND: Asthma is one of the most common chronic diseases in the world, with ∼100 million asthma patients worldwide. China has become one of the countries with the highest asthma death rate in the world. Asthma is a...
BACKGROUND: Asthma is one of the most common chronic diseases in the world, with ∼100 million asthma patients worldwide. China has become one of the countries with the highest asthma death rate in the world. Asthma is a chronic airway inflammatory disease. Patients with this disease may have symptoms such as cough, wheezing, and difficulty breathing. For many years, Western medicine has mainly used anti-inflammatory, anti-bronchial spasm, asthma, cough, and oxygen to treat this disease, but the effect is not good. Tuina is a common treatment for asthma in China. But at present, there is no systematic evaluation report on its therapeutic effectiveness and safety. This protocol aims to reveal the efficacy and safety of Tuina for treating asthma. METHODS: The following databases will be searched by electronic methods: PubMed, EBASE, WHO International Clinical Trials Registry Platform, Embase, the Chinese Biomedical Literature Database (CBM), Wan-fang Data (WANFANG), the China National Knowledge Infrastructure (CNKI), and other sources from inception to November 2020. Bias risk, subgroup analysis, data synthesis, and meta-analyses will be assessed with RevMan V.5.3 software if the data is met inclusion conditions. RESULTS: This study will present a quality evidence of Tuina for the treatment of astma patients. CONCLUSION: The systematic review will present reliable evidence to judge whether or not Tuina is a safe and effective intervention for asthma patients. International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) registration number: INPLASY2020110100.
The efficacy and safety of acupuncture for patients with post-percutaneous coronary intervention depression: A protocol for systematic review and meta analysis.
Liu Y, Dai D, Huang K … +5 more , Zhuang R, Ma L, Liu B, Pan Y, Zhang L
Medicine (Baltimore) · 2020 Dec · PMID 33327293 · Full text
BACKGROUND: Percutaneous coronary intervention (PCI) has been increasingly applied as an effective revascularization strategy in patients with coronary artery disease (CAD). However, recent studies had indicated a higher...
BACKGROUND: Percutaneous coronary intervention (PCI) has been increasingly applied as an effective revascularization strategy in patients with coronary artery disease (CAD). However, recent studies had indicated a higher incidence of depression on post-PCI patients. Acupuncture therapy is effective for depression. However, the treatment effect of depression on post-PCI patients is still not clear. Therefore, this systematic review and meta-analysis protocol is planned to evaluate the efficacy and safety of acupuncture for depression in post-PCI patients. METHODS: Six English databases (PubMed, Web of science, Medline, EMBASE, Springer Cochrane Library and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wan fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database (CNKI) and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to August 1, 2020. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on the Hamilton depression scale (HAMD) and the Self-rating depression scale (SDS) will be used as the main outcome measure. All-cause mortality, cardiac mortality, Major Adverse Cardiovascular Events (MACEs), rehospitalisation rate and Quality of Life Scale (SF-36) as the secondary outcome. Treatment Emergent Symptom Scale (TESS), General physical examination (temperature, pulse, respiration, blood pressure), Routine examination of blood, urine and stool, Electrocardiogram, Liver and kidney function examination as the security indexs. RevMan5.3.5 will be used for meta-analysis. RESULTS: This study will provide high-quality evidence to assess the efficacy and safety of acupuncture for depression in post-PCI patients. CONCLUSION: This systematic review will explore whether acupuncture is an effective and safe intervention for depression in post-PCI patients.
Efficacy and safety of different doses of tenecteplase for the treatment of acute ischemic stroke: A protocol for a systematic review and network meta-analysis.
Shen T, Zhou J, Zhao Y
Medicine (Baltimore) · 2020 Dec · PMID 33285721 · Full text
BACKGROUND: Acute ischemic stroke (AIS) has become the major reason of causing death around the world. As a newer generation fibrinolytic agent, the potential of tenecteplase in treating AIS has been determined in clinic...
BACKGROUND: Acute ischemic stroke (AIS) has become the major reason of causing death around the world. As a newer generation fibrinolytic agent, the potential of tenecteplase in treating AIS has been determined in clinical studies and meta-analysis. However, various doses have been prescribed for tenecteplase in clinical practice, and the optimal dose is not yet clear. METHODS: We will perform a systematic search to capture all potential randomized controlled trials (RCTs) of persons with confirmed AIS who were instructed to administer tenecteplase that report at least one outcome in PubMed, Embase, and the Cochrane Library. Two reviewers will independently check the titles, abstracts, and full-texts, extracting data, assessing the risk of bias and evaluating the certainty of evidence. We will use a random-effect model based on the Bayesian framework to completely direct and network meta-analyses. We will also test the robustness of all pooled results through conducting subgroup analyses according to the following criteria: DISCUSSION:: Our systematic review and network meta-analysis will generate several valuable findings and have several strengths including:We therefore believe that findings from this network meta-analysis will benefit future study design and improve evidence-based treatment of AIS. ETHICS AND DISSEMINATION: We will disseminate the results from the present study through submitting it to conferences or peer-reviewed journal. PROTOCOL REGISTRY: The protocol of our systematic review and network meta-analysis was registered in International Plateform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) platform with an approval number of INPLASY2020100086 (https://inplasy.com/inplasy-2020-10-0086/). Moreover, this protocol was funded through a protocol registry.
Gegen huangqin huanglian decoction for children rotavirus enteritis: A protocol for systematic review and meta-analysis.
Wu Y, Tu X, Liang X … +5 more , Chen J, Wan X, Zhang T, Jiang J, Zhong S
Medicine (Baltimore) · 2020 Dec · PMID 33285720 · Full text
BACKGROUND: Rotavirus infection is the main cause of severe dehydration enteritis in children under 5 years old. It gives rise to malnutrition and even death in children even though there were rotavirus vaccines. However...
BACKGROUND: Rotavirus infection is the main cause of severe dehydration enteritis in children under 5 years old. It gives rise to malnutrition and even death in children even though there were rotavirus vaccines. However, there is no effective anti-virus drugs for rotavirus, supporting treatments are used in the clinics. Traditional Chinese medicine (TCM) has been treating diarrhea for many years. Gegen Huangqin Huanglian Decoction (GHHD)is a classic prescription for diarrhea in TCM. With the development of clinical trials and basic studies, GHHD has been proved that a good curative effect on diarrhea. Therefore, a systematic review is necessary to improve available evidence for GHHD in therapy of children under 5 years old with rotavirus enteritis. METHODS: Different studies from various databases will be involved in this study. Only randomized controlled trials of rotavirus enteritis patients diagnosed with Guidelines for the Treatment of Acute Gastroenteritis in Outpatient Pediatrics, which released by the Washington International Children's Medical Center, Zhu Futang's Practical Pediatrics (7 th Edition), and the 2016 clinical practice guidelines for children with acute infectious diarrhea in China. We will search the literature in the databases from China Conference Paper Database, manual searching. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, CNKI (China National Knowledge Internet), WanFang, VIP (Chongqing VIP), and CBM (China Biomedical Literature CDROM Database). The primary outcomes include the total effective rate, the time of stopping diarrhea, the level of IL-6 serum concentration, fecal microflora ratio, the conversion of fecal rotavirus antigen. The secondary outcomes include clinical efficacy and the quantitative integral of TCM symptom, recovery time of stool character, treatment period. Besides, incidence of adverse events (such as irritation and toxicity) and costs will be also considered. 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: This study will synthesize and provide high-quality evidence based on the data of the currently published GHHD for the treatment of children rotavirus enteritis, in terms of the total effective rate, the time of stopping diarrhea, the level of IL-6 serum concentration, fecal microflora ratio, stool rotavirus antigen, clinical efficacy and the quantitative integral of TCM symptom, recovery time of stool character, treatment period, and safety. CONCLUSION: This systematic review aims to evaluated the benefits and harms of GHHD for the treatment of children rotavirus enteritis reported in randomized controlled trials, and provide more options for clinicians and patients to treat children rotavirus enteritis. REGISTRATION NUMBER: INPLASY2020100023.
The efficacy and safety of health qigong for anti-aging: Protocol for a systematic review and meta-analysis.
Yu P, Li W, Li H … +5 more , Ouyang S, Cai H, Wu J, Tang C, Huang Q
Medicine (Baltimore) · 2020 Dec · PMID 33285677 · Full text
BACKGROUND: Aging is a phenomenon that human's physiology and psychology is progressive decline for natural environment. Health Qigong, as a convenient and effective exercise therapy,is widely used for anti-aging. Howeve...
BACKGROUND: Aging is a phenomenon that human's physiology and psychology is progressive decline for natural environment. Health Qigong, as a convenient and effective exercise therapy,is widely used for anti-aging. However, there are no systematic reviews or meta-analysises to evaluate the efficacy and safety of Health Qigong on anti-aging. METHODS: We will systematically search for 7 English databases(PubMed, Excerpta Medica Database, MEDLINE, Web of Science, Cochrane Library, SpringerLink, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases(namely the China National Knowledge Infrastructure Database, the Wanfang Database, the Chinese Scientific Journal Database, and the Chinese BioMedical Literature Database) from their inceptions to August 2020. Randomized controlled trials (RCTs) using Health Qigong to anti-aging will be included. After the selection and extraction of eligible studies, a meta-analysis will be undertaken to assess the efficacy and safety of Health Qigong on anti-aging. Moreover, study selection, data extraction, and the evaluation of the methodological quality of trials will each be independently completed by at least 2 researchers. The Review Manager Software V.5.3 will be employed for meta-analysis to assess the risk of bias, data synthesis, and subgroup analysis. RESULTS: This review will provide the latest knowledge and evidence on the efficacy and safety of Health Qigong for anti-aging through the analysis of various evaluation scales. CONCLUSION: The conclusion of this review will help clinicians provide effective exercise therapy for anti-aging. REGISTRATION NUMBER: INPLASY202090017.
Serological evidence of human infections with highly pathogenic avian influenza A(H5N1) virus: a systematic review and meta-analysis.
Chen X, Wang W, Wang Y … +6 more , Lai S, Yang J, Cowling BJ, Horby PW, Uyeki TM, Yu H
BMC Med · 2020 Dec · PMID 33261599 · Full text
BACKGROUND: Highly pathogenic avian influenza A(H5N1) virus poses a global public health threat given severe and fatal zoonotic infections since 1997 and ongoing A(H5N1) virus circulation among poultry in several countri...
BACKGROUND: Highly pathogenic avian influenza A(H5N1) virus poses a global public health threat given severe and fatal zoonotic infections since 1997 and ongoing A(H5N1) virus circulation among poultry in several countries. A comprehensive assessment of the seroprevalence of A(H5N1) virus antibodies remains a gap and limits understanding of the true risk of A(H5N1) virus infection. METHODS: We conducted a systematic review and meta-analysis of published serosurveys to assess the risk of subclinical and clinically mild A(H5N1) virus infections. We assessed A(H5N1) virus antibody titers and changes in titers among populations with variable exposures to different A(H5N1) viruses. RESULTS: Across studies using the World Health Organization-recommended seropositive definition, the point estimates of the seroprevalence of A(H5N1) virus-specific antibodies were higher in poultry-exposed populations (range 0-0.6%) and persons exposed to both human A(H5N1) cases and infected birds (range 0.4-1.8%) than in close contacts of A(H5N1) cases or the general population (none to very low frequencies). Seroprevalence was higher in persons exposed to A(H5N1) clade 0 virus (1.9%, range 0.7-3.2%) than in participants exposed to other clades of A(H5N1) virus (range 0-0.5%) (p < 0.05). Seroprevalence was higher in poultry-exposed populations (range 0-1.9%) if such studies utilized antigenically similar A(H5N1) virus antigens in assays to A(H5N1) viruses circulating among poultry. CONCLUSIONS: These low seroprevalences suggest that subclinical and clinically mild human A(H5N1) virus infections are uncommon. Standardized serological survey and laboratory methods are needed to fully understand the extent and risk of human A(H5N1) virus infections.
Acupuncture combined with Tongxieyaofang for diarrhea-type irritable bowel syndrome: A protocol for meta-analysis.
Li YL, Yao CJ, Lei R … +4 more , Xie F, Xiong Q, Luo LH, Feng PM
Medicine (Baltimore) · 2020 Nov · PMID 33235133 · Full text
BACKGROUND: As a traditional Chinese medicine external treatment method, acupuncture is characterized by simple operation, significant treatment effect and few side effects. Tong-Xie-Yao-Fang (TXYF), a Chinese patent med...
BACKGROUND: As a traditional Chinese medicine external treatment method, acupuncture is characterized by simple operation, significant treatment effect and few side effects. Tong-Xie-Yao-Fang (TXYF), a Chinese patent medicine, combined with acupuncture has been widely used on treating Diarrhea Predominant Irritable Bowel Syndrome (IBS-D). However, the efficacy and safety of TXYF combined with acupuncture for the treatment of IBS-D are unclear. This study aims to investigate verify the efficacy and safety of TXYF combined with acupuncture for IBS-D. METHODS AND ANALYSIS: Randomized controlled trials of TXYF combined with acupuncture for all IBS-D will be searched in PubMed, the Cochrane Library, Embase, Web of Science, the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, and Chinese Biomedical Literature Database from inception to October 20, 2020. And Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain more relevant studies comprehensively. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: Based on the current evidence, the potential rank of the efficacy and safety of TXYF plus acupuncture for IBS-D will be assessed. CONCLUSION: The findings of the study will provide helpful evidence for the efficacy and safety of TXYF combined with acupuncture in the treatment of IBS-D, facilitating clinical practice and further scientific studies.
Maxingshigan decoction for treating COVID-19: A protocol for systematic review and meta analysis.
Shao G, Huang S, Cui Y … +1 more , Yang D
Medicine (Baltimore) · 2020 Nov · PMID 33235080 · Full text
BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has been in a public health emergency of international concern since its outbreak in 2020. Due to the complex pathogenesis and susceptib...
BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has been in a public health emergency of international concern since its outbreak in 2020. Due to the complex pathogenesis and susceptibility of COVID-19, many commonly used drugs for the treatment of COVID-19 have not shown excellent clinical effects. Traditional Chinese medicine has a long clinical history of preventing and treating this respiratory infectious disease. Maxingshigan Decoction (MXSG) is widely used in China to treat COVID-19. However, there is no comprehensive and systematic evidence on the effectiveness and safety of Maxingshigan Decoction. METHODS: PubMed, EMBASE, Clinical Trials, the Cochrane Library, Sino Med, and China National Knowledge Infrastructure up to September 2020. This study only screens clinical randomized controlled trials on MXSG for COVID-19 to evaluate its efficacy and safety. Data were extracted by 1 investigator and checked by an independent investigator. Review Manager 5.3 software was used for the data analysis. The dichotomous data is represented by relative risk, and the continuous is expressed by mean difference or standard mean difference, eventually the data is synthesized using a fixed effect model or a random effect model depending on whether or not heterogeneity exists. RESULTS: The time from a positive diagnosis to a negative result of 2 consecutive nucleic acid tests (not on the same day), cure rate. The results of our research will be published in a peer-reviewed journal. CONCLUSION: The purpose of this systematic review is to provide new evidence for the effectiveness and safety of Maxingshigan decoction in the treatment of COVID-19. PROSPERO REGISTRATION NUMBER: CRD42020211962.
Parental income as a marker for socioeconomic position during childhood and later risk of developing a secondary care-diagnosed mental disorder examined across the full diagnostic spectrum: a national cohort study.
Hakulinen C, Mok PLH, Horsdal HT … +4 more , Pedersen CB, Mortensen PB, Agerbo E, Webb RT
BMC Med · 2020 Nov · PMID 33190641 · Full text
BACKGROUND: Links between parental socioeconomic position during childhood and subsequent risks of developing mental disorders have rarely been examined across the diagnostic spectrum. We conducted a comprehensive analys...
BACKGROUND: Links between parental socioeconomic position during childhood and subsequent risks of developing mental disorders have rarely been examined across the diagnostic spectrum. We conducted a comprehensive analysis of parental income level, including income mobility, during childhood and risks for developing mental disorders diagnosed in secondary care in young adulthood. METHODS: National cohort study of persons born in Denmark 1980-2000 (N = 1,051,265). Parental income was measured during birth year and at ages 5, 10 and 15. Follow-up began from 15th birthday until mental disorder diagnosis or 31 December 2016, whichever occurred first. Hazard ratios and cumulative incidence were estimated. RESULTS: A quarter (25.2%; 95% CI 24.8-25.6%) of children born in the lowest income quintile families will have a secondary care-diagnosed mental disorder by age 37, versus 13.5% (13.2-13.9%) of those born in the highest income quintile. Longer time spent living in low-income families was associated with higher risks of developing mental disorders. Associations were strongest for substance misuse and personality disorders and weaker for mood disorders and anxiety/somatoform disorders. An exception was eating disorders, with low parental income being associated with attenuated risk. For all diagnostic categories examined except for eating disorders, downward socioeconomic mobility was linked with higher subsequent risk and upward socioeconomic mobility with lower subsequent risk of developing mental disorders. CONCLUSIONS: Except for eating disorders, low parental income during childhood is associated with subsequent increased risk of mental disorders diagnosed in secondary care across the diagnostic spectrum. Early interventions to mitigate the disadvantages linked with low income, and better opportunities for upward socioeconomic mobility could reduce social and mental health inequalities.
Effects of probiotics on glycemic control and intestinal dominant flora in patients with type 2 diabetes mellitus: A protocol for systematic review and meta-analysis.
Sun Y, Huang Y, Ye F … +6 more , Liu W, Jin X, Lin K, Wang J, Gao Y, He L
Medicine (Baltimore) · 2020 Nov · PMID 33181668 · Full text
BACKGROUND: With the rapid development of modern society, people's dietary structure has been changing accordingly. Diets high in salt, fat, and sugar have led to an increase in the incidence of diabetes year by year, po...
BACKGROUND: With the rapid development of modern society, people's dietary structure has been changing accordingly. Diets high in salt, fat, and sugar have led to an increase in the incidence of diabetes year by year, posing a great threat to human health. More than 90% of diabetic patients have type 2 diabetes mellitus (T2DM). It is currently believed that the onset of T2DM is mainly related to factors such as genetics, insulin resistance, impaired insulin cell function, and obesity. The main mechanisms are as follows:The dominant flora of normal intestinal tract is mainly anaerobic bacteria which are beneficial to the human body. Under certain conditions, when intestinal flora is maladjusted, harmful bacteria and opportunistic bacteria become the dominant intestinal bacteria, resulting in metabolic disorders. Ingestion of probiotics can correct the imbalance of intestinal flora, and then, have a therapeutic effect on T2DM. Therefore, we designed this study to evaluate the effects of probiotics on blood glucose control and intestinal dominant flora in patients with T2DM. METHODS: The retrieval period of meta-analysis literature is set from January 1, 1990 to September 2020. We will mainly search five English electronic databases, including Cochrane Library, Pubmed, Excerpt Medical Database (EMBASE), Science Direct and Web of Science, and search the following four Chinese databases: China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Science Journal Database (VIP), Wanfang Database, and so on. At the same time, the two reviewers will independently conduct research selection, data extraction and deviation risk assessment, and use Review Manager 5.3 software provided by the Cochrane Collaboration for meta-analysis and heterogeneity assessment. RESULTS: This study will demonstrate an evidence-based review of probiotics on glycemic control and intestinal dominant flora in patients with type 2 diabetes mellitus. CONCLUSION: This study can be used to evaluate the efficacy and safety of probiotics on glycemic control and intestinal dominant flora in patients with T2DM. REGISTRATION NUMBER:: is INPLASY202090104.
Preventable medication harm across health care settings: a systematic review and meta-analysis.
Hodkinson A, Tyler N, Ashcroft DM … +8 more , Keers RN, Khan K, Phipps D, Abuzour A, Bower P, Avery A, Campbell S, Panagioti M
BMC Med · 2020 Nov · PMID 33153451 · Full text
BACKGROUND: Mitigating or reducing the risk of medication harm is a global policy priority. But evidence reflecting preventable medication harm in medical care and the factors that derive this harm remain unknown. Theref...
BACKGROUND: Mitigating or reducing the risk of medication harm is a global policy priority. But evidence reflecting preventable medication harm in medical care and the factors that derive this harm remain unknown. Therefore, we aimed to quantify the prevalence, severity and type of preventable medication harm across medical care settings. METHODS: We performed a systematic review and meta-analysis of observational studies to compare the prevalence of preventable medication harm. Searches were carried out in Medline, Cochrane library, CINAHL, Embase and PsycINFO from 2000 to 27 January 2020. Data extraction and critical appraisal was undertaken by two independent reviewers. Random-effects meta-analysis was employed followed by univariable and multivariable meta-regression. Heterogeneity was quantified using the I statistic, and publication bias was evaluated. PROSPERO: CRD42020164156. RESULTS: Of the 7780 articles, 81 studies involving 285,687 patients were included. The pooled prevalence for preventable medication harm was 3% (95% confidence interval (CI) 2 to 4%, I = 99%) and for overall medication harm was 9% (95% CI 7 to 11%, I = 99.5%) of all patient incidence records. The highest rates of preventable medication harm were seen in elderly patient care settings (11%, 95% 7 to 15%, n = 7), intensive care (7%, 4 to 12%, n = 6), highly specialised or surgical care (6%, 3 to 11%, n = 13) and emergency medicine (5%, 2 to 12%, n = 12). The proportion of mild preventable medication harm was 39% (28 to 51%, n = 20, I = 96.4%), moderate preventable harm 40% (31 to 49%, n = 22, I = 93.6%) and clinically severe or life-threatening preventable harm 26% (15 to 37%, n = 28, I = 97%). The source of the highest prevalence rates of preventable harm were at the prescribing (58%, 42 to 73%, n = 9, I = 94%) and monitoring (47%, 21 to 73%, n = 8, I = 99%) stages of medication use. Preventable harm was greatest in medicines affecting the 'central nervous system' and 'cardiovascular system'. CONCLUSIONS: This is the largest meta-analysis to assess preventable medication harm. We conclude that around one in 30 patients are exposed to preventable medication harm in medical care, and more than a quarter of this harm is considered severe or life-threatening. Our results support the World Health Organisation's push for the detection and mitigation of medication-related harm as being a top priority, whilst highlighting other key potential targets for remedial intervention that should be a priority focus for future research.
Investigation of the efficacy of the short regimen for rifampicin-resistant TB from the STREAM trial.
Phillips PPJ, Van Deun A, Ahmed S … +6 more , Goodall RL, Meredith SK, Conradie F, Chiang CY, Rusen ID, Nunn AJ
BMC Med · 2020 Nov · PMID 33143704 · Full text
BACKGROUND: The STREAM trial demonstrated that a 9-11-month "short" regimen had non-inferior efficacy and comparable safety to a 20+ month "long" regimen for the treatment of rifampicin-resistant tuberculosis. Imbalance...
BACKGROUND: The STREAM trial demonstrated that a 9-11-month "short" regimen had non-inferior efficacy and comparable safety to a 20+ month "long" regimen for the treatment of rifampicin-resistant tuberculosis. Imbalance in the components of the composite primary outcome merited further investigation. METHODS: Firstly, the STREAM primary outcomes were mapped to alternatives in current use, including WHO programmatic outcome definitions and other recently proposed modifications for programmatic or research purposes. Secondly, the outcomes were re-classified according to the likelihood that it was a Failure or Relapse (FoR) event on a 5-point Likert scale: Definite, Probable, Possible, Unlikely, and Highly Unlikely. Sensitivity analyses were employed to explore the impact of informative censoring. The protocol-defined modified intention-to-treat (MITT) analysis population was used for all analyses. RESULTS: Cure on the short regimen ranged from 75.1 to 84.2% across five alternative outcomes. However, between-regimens results did not exceed 1.3% in favor of the long regimen (95% CI upper bound 10.1%), similar to the primary efficacy results from the trial. Considering only Definite or Probable FoR events, there was weak evidence of a higher risk of FoR in the short regimen, HR 2.19 (95%CI 0.90, 5.35), p = 0.076; considering only Definite FoR events, the evidence was stronger, HR 3.53 (95%CI 1.05, 11.87), p = 0.030. Cumulative number of grade 3-4 AEs was the strongest predictor of censoring. Considering a larger effect of informative censoring attenuated treatment differences, although 95% CI were very wide. CONCLUSION: Five alternative outcome definitions gave similar overall results. The risk of failure or relapse (FoR) may be higher in the short regimen than in the long regimen, highlighting the importance of how loss to follow-up and other censoring is accounted for in analyses. The outcome of time to FoR should be considered as a primary outcome for future drug-sensitive and drug-resistant TB treatment trials, provided sensitivity analyses exploring the impact of departures from independent censoring are also included.
Comparison of oral versus intravenous tranexamic acid in total knee and hip arthroplasty: A GRADE analysis and meta-analysis.
Sun C, Zhang X, Chen L … +4 more , Deng J, Ma Q, Cai X, Yang H
Medicine (Baltimore) · 2020 Oct · PMID 33126380 · Full text
BACKGROUND: The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with...
BACKGROUND: The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis. METHODS: We conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis. RESULTS: Ten RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA. CONCLUSIONS: Compared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions. REGISTRATION: The current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.
Traditional Chinese medicine for restless legs syndrome: A study protocol for a network meta-analysis.
Liu L, Xie R, Wang R … +1 more , Huang C
Medicine (Baltimore) · 2020 Oct · PMID 33126323 · Full text
BACKGROUND: Restless legs syndrome (RLS) is a sensory motor disorder. It mainly manifests as indescribable pain in the lower limbs at night or at rest, and the symptoms are reduced after activity or beating, which seriou...
BACKGROUND: Restless legs syndrome (RLS) is a sensory motor disorder. It mainly manifests as indescribable pain in the lower limbs at night or at rest, and the symptoms are reduced after activity or beating, which seriously affects the patients sleep. Nowadays, a large number of randomized controlled clinical studies have shown that Chinese medicine has the advantages of good curative effect and high safety in the treatment of RLS. However, due to the various treatment methods of Chinese medicine, its relative effectiveness and safety have not been verified. Therefore, this study will use a network meta-analysis method to verify the effectiveness and safety of different types of TCM therapies in the treatment of RLS. METHODS: Computer retrieval was conducted in PubMed, Cochrane Library, Web of Science, Embase, SinoMed, CNKI, WanFang-database, VIP. The retrieval period was until September 9, 2020, and all randomized controlled trials of TCM treatment of RLS were collected. To avoid omissions, we will manually search relevant references and conference papers. According to the inclusion and exclusion criteria, we conduct quality assessment and risk assessment of all retrieved documents. Methodological quality assessment and risk of bias will be assessed using Cochrane bias risk tool. All data analysis will use Revman5.3, WinBUGS 1.4.3, and Stata14.2 software. RESULTS: This study will directly or indirectly compare the effectiveness of different interventions on RLS outcome indicators, and rank the effectiveness. The main outcome indicators include total effective rate (total effective rate = rocovery + obvious effective + effective/total number of cases × 100%), International Restless Legs Syndrome Score Scale, secondary outcome indicators include visual analog scale, Pittsburgh sleep quality indicators and adverse events. CONCLUSION: Provide a basis for evidence-based medicine, and provide a basis for clinical researchers to choose more effective Chinese medicine treatment of RLS.
Danhong injection for the treatment of early diabetic nephropathy: A protocol of systematic review and meta-analysis.
Huang C, Huang C, Zhou G
Medicine (Baltimore) · 2020 Oct · PMID 33120767 · Full text
BACKGROUND: Diabetic nephropathy (DN) is the one that of the most common complications of diabetes mellitus (DM). Diabetic patients will experience a high mortality rate when DN progress to end-stage. So, it is extremely...
BACKGROUND: Diabetic nephropathy (DN) is the one that of the most common complications of diabetes mellitus (DM). Diabetic patients will experience a high mortality rate when DN progress to end-stage. So, it is extremely important to early treat DN. Although several interventions have been used to treat DN, a conclusive finding has not already been achieved. As one of the most common Chinese medicines, danhong injection (DHI) which has been shown to have various functions has also been prescribed to be as the alternative treatment option. However, no systematic review and meta-analysis has been conducted to objectively and comprehensively investigate its effectiveness and safety. Thus, we designed the current systematic review and meta-analysis to answer whether DHI can be preferably used to timely treat DN. METHODS: We will perform a systematic search to capture any potentially eligible studies in several electronic databases including PubMed, Cochrane library, Embase, China National Knowledgement Infrastructure (CNKI), Wanfang database, and Chinese sci-tech periodical full-text database (VIP) from their inception to August 31, 2020. We will assign 2 independent reviewers to select eligible studies, and assess the quality of included studies with Cochrane risk of bias assessment tool. We will perform all statistical analyses using RevMan 5.3 software. ETHICS AND DISSEMINATION: We will submit our findings to be taken into consideration for publication in a peer-reviewed academic journal. Meanwhile, we will also communicate our findings in important conferences. PROTOCOL REGISTRY: The protocol of this systematic review and meta-analysis has been registered at the International Plateform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) platform (https://inplasy.com/inplasy-2020-9-0005/, registry number: INPLASY202090005) and this protocol was funded through a protocol registry.
Efficacy and safety of spironolactone for the treatment of patients with acute heart failure: A protocol for systematic review.
Feng YL, Lu M
Medicine (Baltimore) · 2020 Oct · PMID 33120745 · Full text
BACKGROUND: This study will investigate the efficacy and safety of spironolactone for the treatment of acute heart failure (AHF). METHODS: The following electronic databases will be retrieved in PUBMED, EMBASE, Cochrane...
BACKGROUND: This study will investigate the efficacy and safety of spironolactone for the treatment of acute heart failure (AHF). METHODS: The following electronic databases will be retrieved in PUBMED, EMBASE, Cochrane Library, Web of Science, CINAHL, CBM, CNKI, and VIP database from inception through present. Two researchers will independently screen and assess the obtained literatures and extract outcome data. All study methodological quality will be assessed using Cochrane risk of bias tool, and all statistical analysis will be performed by RevMan 5.3 software. Additionally, we will undertake a narrative synthesis if it is possible. RESULTS: This study will sum-marize most recent evidence to investigate the efficacy and safety of spironolactone for the treatment of AHF. CONCLUSION: This study will seek to assess the efficacy and safety of spironolactone for treating AHF. SYSTEMATIC REVIEW REGISTRATION: INPLASY202070053.
Banxia Xiexin Decoction in the treatment of chronic atrophic gastritis: A protocol for systematic review and meta-analysis.
Ji Q, Yang Y, Song X … +2 more , Han X, Wang W
Medicine (Baltimore) · 2020 Oct · PMID 33080670 · Full text
BACKGROUND: Chronic atrophic gastritis (CAG) is a common digestive disease. Without active treatment, it may induce gastric cancer. Western medicine has a certain effect on chronic atrophic gastritis, but there are many...
BACKGROUND: Chronic atrophic gastritis (CAG) is a common digestive disease. Without active treatment, it may induce gastric cancer. Western medicine has a certain effect on chronic atrophic gastritis, but there are many adverse reactions after long-term medication, and the disease is prone to relapse after treatment, which will affect the health and life of patients. Traditional Chinese medicine has obvious advantages in the treatment of chronic stomach diseases with reliable effect. A number of clinical data have also confirmed that Banxia Xiexin decoction has significant effect in the treatment of chronic atrophic gastritis, but there is no evidence of evidence-based medicine. Therefore, this study aims to explore the clinical efficacy and safety of Banxia Xiexin decoction in the treatment of chronic atrophic gastritis by means of systematic evaluation. METHOD: Databases including PubMed, The Cochrance Library, Embase, Web of Science, CNKI, VIP, and Wanfang were searched by computer. Besides, Baidu Scholar and Google Scholar were manually searched, and all randomized controlled trials of Banxia xiexin decoction for the treatment of chronic atrophic gastritis were collected. The retrieval time was from the establishment of the database to July 31, 2020. After 2 reviewers independently screened the literature, extracted the data and evaluated the bias risk of the included study, RevMan5.3 software (developed by the UK's International Cochrane Collaboration) was used to analyze the data. RESULTS: In this study, the effectiveness and safety of Banxia Xiexin decoction for the treatment of chronic atrophic gastritis were evaluated by the clinical efficiency, traditional Chinese medicine syndrome score (traditional Chinese medicine syndrome score), quality of life score, gastrin level, epidermal growth factor, eradication rate of helicobacter pylori and incidence of adverse reactions. CONCLUSION: This study will provide reliable evidence for the clinical application of Banxia Xiexin decoction in the treatment of chronic atrophic gastritis. 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. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/7K6QW.
The efficacy and safety of sulindac for colorectal polyps: A protocol for systematic review and meta-analysis.
Long Q, Ao L, Li K … +1 more , Li Y
Medicine (Baltimore) · 2020 Oct · PMID 33031275 · Full text
BACKGROUND: Sulindac has been used for treating colorectal polyps widely. However, the efficacy and safety of sulindac for colorectal polyps are unclear. This study aims to evaluate the efficacy and safety of sulindac fo...
BACKGROUND: Sulindac has been used for treating colorectal polyps widely. However, the efficacy and safety of sulindac for colorectal polyps are unclear. This study aims to evaluate the efficacy and safety of sulindac for colorectal polyps. METHODS: Randomized controlled trials of sulindac in the treatment of colorectal polyps will be searched in PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), WanFang, the Chongqing VIP Chinese Science, and Technology Periodical Database, and China biomedical literature database (CBM) from inception to August, 2020. And Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain more relevant studies comprehensively. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: This study will summarize the present evidence by exploring the efficacy and safety of sulindac in the treatment of colorectal polyps. CONCLUSION: The findings of the study will provide helpful evidence for the efficacy and safety of sulindac in the treatment of colorectal polyps, facilitating clinical practice and further scientific studies. ETHICS AND DISSEMINATION: The private information from individuals will not publish. 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. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/N5GDH.
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