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Karen Dahri - One of the best experts on this subject based on the ideXlab platform.
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long acting muscarinic antagonists lama added to combination long acting beta2 agonists and inhaled corticosteroids laba ics versus laba ics for adults with asthma
Cochrane Database of Systematic Reviews, 2016Co-Authors: Karen DahriAbstract:BACKGROUND: Maintenance treatment with long-acting beta2-agonists and inhaled corticosteroids (LABA/ICS) can relieve asthma symptoms and reduce the frequency of exacerbations, but there are limited treatment options for people who do not gain control on combination LABA/ICS. Long-acting muscarinic antagonists (LAMA) are a class of inhaled drug which have been effective for people with chronic obstructive pulmonary disease and are now becoming available for people with asthma to take alongside their LABA/ICS inhaler. OBJECTIVES: To assess the effects of adding a long-acting muscarinic antagonist (LAMA) to combination long-acting beta2-agonists (LABA) and inhaled corticosteroids (ICS) in adults whose asthma is not well controlled by LABA/ICS. SEARCH METHODS: We identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to January 2016. We also searched ClinicalTrials.gov, the WHO trials portal, and reference lists of other reviews, and we contacted trial authors for additional Information. Selection CRITERIA: We included parallel randomised controlled trials (RCTs) of at least 12 weeks' duration. Studies met the inclusion criteria if they compared LAMA as an add-on to LABA/ICS versus LABA/ICS alone for adults with asthma. We included studies reported as full text, those published as abstract only, and unpublished data. Primary outcomes were exacerbations requiring oral corticosteroids (OCS), validated measures of asthma control, and serious adverse events (including mortality). DATA COLLECTION AND ANALYSIS: Two review authors screened searches and independently extracted details on risk of bias and numerical data. We analysed dichotomous data as odds ratios (ORs) and continuous data as mean differences (MD) using a random-effects model. We rated all outcomes using GRADE. MAIN RESULTS: We found four double-blind, double-dummy trials comparing LAMA to placebo, including 1197 people with asthma taking combination LABA/ICS. One of the trials was designed to study glycopyrronium bromide but was withdrawn prior to enrolment, and the other three all studied tiotropium bromide (mostly 5 µg once daily via Respimat) over 48 to 52 weeks. People in the trials had a mean forced expiratory volume in one second (FEV1) of 55% of their predicted value, indicating severe asthma.People randomised to take tiotropium add-on had fewer exacerbations requiring oral corticosteroids than those continuing to take LABA/ICS alone, but the confidence intervals did not rule out no difference (OR 0.76, 95% CI 0.57 to 1.02; moderate quality evidence). Over 48 weeks, 328 out of 1000 people taking their usual LABA/ICS would have to take oral corticosteroids for an exacerbation compared with 271 if they took tiotropium as well (95% CI 218 to 333 per 1000). Analyses comparing the number of exacerbations per patient in each group (rate ratio) and the time until first exacerbation (hazard ratio) were in keeping with the main result. Quality of life, as measured by the Asthma Quality of Life Questionnaire (AQLQ) was no better for those taking tiotropium add-on than for those taking LABA/ICS alone when considered in light of the 0.5 minimal clinically important difference on the scale (MD 0.09, 95% CI - 0.03 to 0.20), and evidence for whether tiotropium increased or decreased serious adverse events in this population was inconsistent (OR 0.60, 95% CI 0.24 to 1.47; I(2) = 76%).Within the secondary outcomes, exacerbations requiring hospital admission were too rare to tell whether tiotropium was beneficial over LABA/ICS alone. There was high quality evidence showing benefits to lung function (trough FEV1 and forced vital capacity (FVC)) and potentially small benefits to asthma control. People taking tiotropium add-on were less likely to experience non-serious adverse events. AUTHORS' CONCLUSIONS: Tiotropium add-on may have additional benefits over LABA/ICS alone in reducing the need for rescue oral steroids in people with severe asthma. The effect was imprecise, and there was no evidence for other LAMA preparations. Possible benefits on quality of life were negligible, and evidence for the effect on serious adverse events was inconsistent. There are likely to be small added benefits for tiotropium Respimat 5 µg daily on lung function and asthma control over LABA/ICS alone and fewer non-serious adverse events. The benefit of tiotropium add-on on the frequency of hospital admission is still unknown, despite year-long trials.Ongoing and future trials should clearly describe participants' background medications to help clinicians judge how the findings relate to stepwise care. If studies test LAMAs other than tiotropium Respimat for asthma, they should be at least six months long and use accepted and validated outcomes to allow comparisons of the safety and effectiveness between different preparations.
Benedict Griffiths - One of the best experts on this subject based on the ideXlab platform.
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intravenous magnesium sulfate for treating children with acute asthma in the emergency department
Cochrane Database of Systematic Reviews, 2016Co-Authors: Benedict GriffithsAbstract:BACKGROUND: Acute asthma in children can be life-threatening and must be treated promptly in the emergency setting. Intravenous magnesium sulfate is recommended by various guidelines for cases of acute asthma that have not responded to first-line treatment with bronchodilators and steroids. The treatment has recently been shown to reduce the need for hospital admission for adults compared with placebo, but it is unclear whether it is equally effective for children. OBJECTIVES: To assess the safety and efficacy of intravenous magnesium sulfate (IV MgSO4) in children treated for acute asthma in the emergency department (ED). SEARCH METHODS: We identified studies by searching the Cochrane Airways Review Group Specialised Register up to 23 February 2016. We also searched ClinicalTrials.gov and reference lists of other reviews, and we contacted study authors to ask for additional Information. Selection CRITERIA: We included randomised controlled trials of children treated in the ED for exacerbations of asthma if they compared any dose of IV MgSO4 with placebo. DATA COLLECTION AND ANALYSIS: Two review authors screened the results of the search and independently extracted data from studies meeting the inclusion criteria. We resolved disagreements through discussion and contacted study authors in cases of missing data and other uncertainties relating to the studies.We analysed dichotomous data as odds ratios and continuous data as mean differences, both using fixed-effect models. We assessed each study for risk of bias and rated the quality of evidence for each outcome with GRADE and presented the results in a 'Summary of findings' table. There was insufficient evidence to conduct the planned subgroup analyses. MAIN RESULTS: Five studies (182 children) met the inclusion criteria, and four contributed data to at least one meta-analysis. The included studies were overall at low risk of bias, but our confidence in the evidence was generally low, mainly due to the small sample sizes. Treatment with IV MgSO4 reduced the odds of admission to hospital by 68% (odds ratio (OR) 0.32, 95% confidence interval (CI) 0.14 to 0.74; children = 115; studies = 3; I(2) = 63%). This result was based on data from just three studies including 115 children. Meta-analysis for the secondary outcomes was extremely limited by paucity of data. We performed meta-analysis for the outcome 'return to the emergency department within 48 hours', which showed a very imprecise effect estimate that was not statistically significant (OR 0.40, 95% CI 0.02 to 10.30; children = 85; studies = 2; I(2) = 0%). Side effects and adverse events were not consistently reported and meta-analysis was not possible, however few side effects or adverse events were reported. AUTHORS' CONCLUSIONS: IV MgSO4 may reduce the need for hospital admission in children presenting to the ED with moderate to severe exacerbations of asthma, but the evidence is extremely limited by the number and size of studies. Few side effects of the treatment were reported, but the data were extremely limited.
Clare Michell - One of the best experts on this subject based on the ideXlab platform.
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intravenous magnesium sulfate for treating adults with acute asthma in the emergency department
Cochrane Database of Systematic Reviews, 2014Co-Authors: Liza Kirtchuk, Clare MichellAbstract:BACKGROUND: Asthma is a chronic respiratory condition characterised by airways inflammation, constriction of airway smooth muscle and structural alteration of the airways that is at least partially reversible. Exacerbations of asthma can be life threatening and place a significant burden on healthcare services. Various guidelines have been published to inform management personnel in the acute setting; several include the use of a single bolus of intravenous magnesium sulfate (IV MgSO4) in cases that do not respond to first-line treatment. However, the effectiveness of this approach remains unclear, particularly in less severe cases. OBJECTIVES: To assess the safety and efficacy of IV MgSO4 in adults treated for acute asthma in the emergency department. SEARCH METHODS: We identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to 2 May 2014. We also searched www.ClinicalTrials.gov and reference lists of other reviews, and we contacted trial authors to ask for additional Information. Selection CRITERIA: We included randomised controlled trials (RCTs) of adults treated in the emergency department (ED) for exacerbations of asthma if they compared any dose of IV MgSO4 with placebo. DATA COLLECTION AND ANALYSIS: All review authors screened titles and abstracts for inclusion, and at least two review authors independently extracted study characteristics, risk of bias and numerical data. Disagreements were resolved by consensus, and we contacted trial investigators to obtain missing Information.We analysed dichotomous data as odds ratios using study participants as the unit of analysis, and we analysed continuous data as mean differences or standardised mean differences using fixed-effect models. We rated all outcomes using GRADE and presented results in Summary of findings table 1.We carried out subgroup analyses on the primary outcome for baseline severity of exacerbations and whether or not ipratropium bromide was given as a co-medication. Unpublished data and studies at high risk of bias for blinding were removed from the main analysis in sensitivity analyses. MAIN RESULTS: Fourteen studies met the inclusion criteria, randomly assigning 2313 people with acute asthma to the comparisons of interest in this review.Most studies were double-blinded trials comparing a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes versus a matching placebo. Eleven were conducted at a single centre, and three were multi-centre trials. Participants in almost all of the studies had already been given at least oxygen, nebulised short-acting beta2-agonists and IV corticosteroids in the ED; in some studies, investigators also administered ipratropium bromide. Ten studies included only adults, and four included both adults and children; these were included because the mean age of participants was over 18 years.Intravenous MgSO4 reduced hospital admissions compared with placebo (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.60 to 0.92; I(2) = 28%, P value 0.18; n = 972; high-quality evidence). In absolute terms, this odds ratio translates into a reduction of seven hospital admissions for every 100 adults treated with IV MgSO4 (95% CI two to 13 fewer). The test for subgroup differences revealed no statistical heterogeneity between the three severity subgroups (I(2) = 0%, P value 0.73) or between the four studies that administered nebulised ipratropium bromide as a co-medication and those that did not (I(2) = 0%, P value 0.82). Sensitivity analyses in which unpublished data and studies at high risk for blinding were removed from the primary analysis did not change conclusions.Within the secondary outcomes, high- and moderate-quality evidence across three spirometric indices suggests some improvement in lung function with IV MgSO4. No difference was found between IV MgSO4and placebo for most of the non-spirometric secondary outcomes, all of which were rated as low or moderate quality (intensive care admissions, ED treatment duration, length of hospital stay, readmission, respiration rate, systolic blood pressure).Adverse events were inconsistently reported and were not meta-analysed. The most commonly cited adverse events in the IV MgSO4 groups were flushing, fatigue, nausea and headache and hypotension (low blood pressure). AUTHORS' CONCLUSIONS: This review provides evidence that a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes reduces hospital admissions and improves lung function in adults with acute asthma who have not responded sufficiently to oxygen, nebulised short-acting beta2-agonists and IV corticosteroids. Differences in the ways the trials were conducted made it difficult for the review authors to assess whether severity of the exacerbation or additional co-medications altered the treatment effect of IV MgSO4. Limited evidence was found for other measures of benefit and safety.Studies conducted in these populations should clearly define baseline severity parameters and systematically record adverse events. Studies recruiting participants with exacerbations of varying severity should consider subgrouping results on the basis of accepted severity classifications.
Van Woensel J. B. M. - One of the best experts on this subject based on the ideXlab platform.
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Prophylactic antibiotics for preventing early central venous catheter Gram positive infections in oncology patients
2007Co-Authors: Van De Wetering, M. D., Van Woensel J. B. M.Abstract:BACKGROUND: Long-term tunnelled central venous catheters (TCVCs) are increasingly used when treating oncology patients. Despite international guidelines on sterile insertion, appropriate catheter maintenance and use, infections still a complication of TCVC. These infections are mainly caused by Gram-positive bacteria. Antimicrobial prevention strategies aimed at these micro-organisms could potentially decrease the majority of TCVC infections. The aim of this review was to evaluate the efficacy of antibiotics in the prevention of early TCVC infections. OBJECTIVES: To determine the efficacy of administering antibiotics prior to insertion of a TCVC with or without vancomycin/heparin flush technique in the first 45 days after insertion of the catheter to prevent Gram-positive catheter-related infections in oncology patients. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) to July 2006. MEDLINE (1966 to 2006) and EMBASE (1966 to 2006). Reference lists from relevant articles were scanned and conference proceedings were hand searched. The authors of eligible studies were contacted to obtain additional Information. Selection CRITERIA: We selected RCTs which administered prophylactic antibiotics prior to insertion of the TCVC, and RCTs using the combination of an antibiotic and heparin to flush the CVC in oncology patients (both adults and children). DATA COLLECTION AND ANALYSIS: The studies identified were assessed and the data extracted independently by the two authors. Authors were contacted for details of randomization, and a quality assessment was carried out. The analysis was carried out using the standard Cochrane software package, RevMan 4.2. MAIN RESULTS: We included nine trials with a total of 588 patients. Four reported on vancomycin/teicoplanin prior to insertion of the TCVC compared to placebo, and five trials reported on antibiotic flushing combined with heparin, compared to heparin flushing only. The overall effect of administering an antibiotic prior to insertion of the catheter decreases the number of Gram positive TCVC infections (odds ratio [OR] = 0.42, 95% confidence interval (CI) 0.13 to 1.31), this effect is not significant.Flushing the TCVC with antibiotics and heparin proved to be beneficial (OR = 0.43, 95% CI 0.21 to 0.87). For intraluminal colonization the baseline infection rate is 15% which leads to a number needed to treat (NNT) of 13 (95 % CI 5 to 23). AUTHORS' CONCLUSIONS: Flushing of the catheter with a vanco/heparin lock solution leads to a positive overall effect. Depending on the baseline TCVC infection rate it is justified to flush the catheter with a combination of an antibiotic and heparin, if the catheter related infection-rate is hig
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Prophylactic antibiotics for preventing early central venous catheter Gram positive infections in oncology patients
'Wiley', 2003Co-Authors: Van De Wetering, M. D., Van Woensel J. B. M.Abstract:BACKGROUND: Long-term tunnelled central venous catheters (TCVC) are increasingly used in oncology patients. Despite guidelines on insertion, maintenance and use, infections remain an important complication. Most infections are caused by Gram-positive bacteria. Therefore antimicrobial prevention strategies aimed at these micro-organisms could potentially decrease the majority of the TCVC infections. OBJECTIVES: To determine the efficacy of administering antibiotics prior to insertion of a TCVC with or without vancomycin/heparin flush technique in the first 45 days after insertion of the catheter to prevent Gram-positive catheter-related infections in oncology patients. SEARCH STRATEGY: We searched MEDLINE, EMBASE,and CENTRAL up to July 2001. Reference lists from relevant articles were scanned and conference proceedings were hand searched. The authors of eligible studies were contacted to obtain additional Information. Selection CRITERIA: We selected randomized controlled trials giving prophylactic antibiotics prior to insertion of the TCVC, and trials using the combination of an antibiotic and heparin to flush the TCVC in oncology patients. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the studies for inclusion, extracted the data and assessed the quality. MAIN RESULTS: We included eight trials totalling 527 patients. Four reported on vancomycin/teicoplanin prior to insertion of the TCVC, and four reported on antibiotic flushing combined with heparin. The overall effect of an antibiotic prior to catheter insertion decreases the number of Gram-positive TCVC infections (odds ratio [OR] = 0.55, 95% confidence interval [CI] 0.29 to1.04). Given an expected infection rate of TCVC during the first 45 days of up to 30% this OR implies that the number needed to treat (NNT) will be 10 (95% CI 4 to13), this means vancomycin needs to be given to 10 patients to prevent one TCVC infection. Flushing the TCVC with antibiotics and heparin proved to be beneficial (OR = 0.35, 95% CI 0.16 -to 0.77). For intraluminal colonization the baseline infection-rate is 15% which leads to a NNT of 13 (95% CI 5 to 23). REVIEWER'S CONCLUSIONS: Both interventions lead to a positive overall effect but should be considered with care due to the small number of studies. Depending on the baseline TCVC infection rate it is justified to administer antibiotics prior to the TCVC insertion or to flush the catheter with a combination of an antibiotic and heparin, if the catheter-related infection rate is hig
Stephen J Thomas - One of the best experts on this subject based on the ideXlab platform.
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early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications
Cochrane Database of Systematic Reviews, 2006Co-Authors: Henning Andersen, Stephen Lewis, Stephen J ThomasAbstract:Background This updated review from 2011 focus on early postoperative enteral nutrition after gastrointestinal surgery. Traditional management consist of 'nil by mouth', where patients receive fluids followed by solids when tolerated. Although several trials have implicated lower incidence of septic complications and faster wound healing upon early enteral feeding, other trials have shown opposite results. The immediate advantage of caloric intake could be a faster recovery with fewer complications, to be evaluated systematically. Objectives To evaluate whether early commencement of postoperative enteral nutrition compared to traditional management (no nutritional supply) is associated with fewer complications in patients undergoing gastrointestinal surgery Search methods We searched the Cochrane Central Register of Controlled Trials, PUBMED, EMBASE, and LILACS from 1979 (first RCT published) to November 2009. We manually scanned the references from the relevant articles, and consulted primary authors for additional Information. Selection criteria We looked for randomised controlled trials (RCT's) comparing early commencement of feeding (within 24 hours) with no feeding in patients undergoing gastrointestinal surgery. Early enteral nutrition is defined as all oral intakes (i.e. registered oral intake, supplemented oral feeding) and any kind of tube feeding (gastric, duodenal or jejunal) containing caloric content. No feeding is traditional management, defined as none caloric oral intake or any kind of tube feeding before bowel function. The definition 'no nutrition' includes non caloric placebo and water. Data collection and analysis The authors independently assessed the identified trials and extracted the relevant data. Primary end points of interest were: Wound infections and intraabdominal abscesses, postoperative complications such as acute myocardial infarction, postoperative thrombosis or pneumonia, anastomotic leakages, mortality, length of hospital stay, and significant adverse effects. We combined data to estimate the common relative risk of postoperative complications, and calculated the associated 95% confidence intervals. For analysis, we used fixed effects model (risk ratios to summarise the treatment effect) whenever feasible. The treatment effect on length of stay was estimated using effect size (presented as mean +/- SD). Some outcomes were not analysed but presented in a descriptive way. We used a random effects model to estimate overall risk ratio and effect size. Main results Fourteen randomised controlled trials representing a total of 1224 patients all undergoing gastrointestinal surgery. Individual clinical complications failed to reach statistical significance, but the direction of effect indicates that earlier feeding may reduce the risk of post surgical complications. Mortality was the only outcome showing a significant benefit, but not necessarily associated with early commencement of feeding, as the reported cause of death was anastomotic leakage, reoperation, and acute myocardial infarction. Authors' conclusions Although non-significant results, there is no obvious advantage in keeping patients 'nil by mouth' following gastrointestinal surgery, and this review support the notion on early commencement of enteral feeding.
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early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications
Cochrane Database of Systematic Reviews, 2006Co-Authors: Henning Andersen, Stephen Lewis, Stephen J ThomasAbstract:Background The role of early postoperative enteral nutrition after gastrointestinal surgery is controversial. Traditional management consist of 'nil by mouth', where patients receive fluids followed by solids when tolerated. Although several trials have implicated lower incidence of septic complications and faster wound healing upon early enteral feeding, other trials have shown opposite results. The immediate advantage of caloric intake could be a faster recovery with fewer complications, to be evaluated systematically. Objectives To evaluate whether early commencement of postoperative enteral nutrition compared to traditional management (no nutritional supply) is associated with fewer complications in patients undergoing gastrointestinal surgery Search strategy We searched the Cochrane Central Register of Controlled Trials, PUBMED, EMBASE, and LILACS from 1979 (first RCT published) to March 2006. We manually scanned the references from the relevant articles, and consulted primary authors for additional Information. Selection criteria We looked for randomised controlled trials (RCT's) comparing early commencement of feeding (within 24 hours) with no feeding in patients undergoing gastrointestinal surgery. Early enteral nutrition is defined as all oral intakes (i.e. registered oral intake, supplemented oral feeding) and any kind of tube feeding (gastric, duodenal or jejunal) containing caloric content. No feeding is traditional management, defined as none caloric oral intake or any kind of tube feeding before bowel function. The definition 'no nutrition' includes non caloric placebo and water. Data collection and analysis The three authors independently assessed the identified trials, and extracted the relevant data using a specifically developed data extraction sheet. Primary end points of interest were: Wound infections and intraabdominal abscesses, postoperative complications such as acute myocardial infarction, postoperative thrombosis or pneumonia, anastomotic leakages, mortality, length of hospital stay, and significant adverse effects. We combined data to estimate the common relative risk of postoperative complications, and calculated the associated 95% confidence intervals. For analysis, we used fixed effects model (risk ratios to summarise the treatment effect) whenever feasible. The treatment effect on length of stay was estimated using effect size (presented as mean +/- SD). Some outcomes were not analysed but presented in a descriptive way. We used a random effects model to estimate overall risk ratio and effect size. Main results We identified thirteen randomised controlled trials, with a total of 1173 patients, all undergoing gastrointestinal surgery. Individual clinical complications failed to reach statistical significance, but the direction of effect indicates that earlier feeding may reduce the risk of post surgical complications. Mortality was the only outcome showing a significant benefit, but not necessarily associated with early commencement of feeding, as the reported cause of death was anastomotic leakage, reoperation, and acute myocardial infarction. Authors' conclusions Although non-significant results, there is no obvious advantage in keeping patients 'nil by mouth' following gastrointestinal surgery, and this review support the notion on early commencement of enteral feeding.