METHODS AND FINDINGS: We included all prospective controlled studies (randomised and non-randomised) comparing rooming-in to nursery care that reported full or partial breastfeeding up to six months. We used the 2016 search results of the Cochrane review and updated the search to August 2018 using OVID MEDLINE. Duplicate data extraction and assessment of risk of bias were performed. Meta-analyses were performed using REVMAN 5. The GRADE approach was used to assess quality of evidence. Seven studies were included, five had 24-hour-per-day, one daytime only and one 8-hours-per-day rooming-in. Four studies had at least one additional co-intervention: Differences in delivery room management, and educational packages. All studies contributing to meta-analyses had 24-hour rooming-in. There was no difference in the proportion of infants on full breastfeeding at 3 months (RR 1.14; 95% CI 0.84 to 1.54; very-low-quality evidence), 4 months (RR 0.99; 95% CI 0.73 to 1.33; very-low-quality evidence) and 6 months (RR 0.95; 95% CI 0.57 to 1.58; low-quality evidence). The proportion of infants on partial breastfeeding at 3-4 months was higher with rooming-in (RR 1.31; 95% CI 1.06 to 1.61; very-low-quality evidence).
CONCLUSION: The addition of non-randomised prospective controlled studies to existing evidence did not add further information on the effects of rooming-in on breastfeeding duration but resulted in lower quality of evidence. Uncertainty about the effects of rooming-in on breastfeeding duration remains.
METHODS: PACKNOW is a two-arm, open-label randomised controlled trial of adjunctive paracetamol versus no paracetamol in patients aged ≥ 5 years with knowlesi malaria, conducted over a 2-year period at four hospital sites in Sabah, Malaysia. The primary endpoint of change in creatinine from enrolment to 72 h will be evaluated by analysis of covariance (ANCOVA) using enrolment creatinine as a covariate. Secondary endpoints include longitudinal changes in markers of oxidative stress (plasma F2-isoprostanes and isofurans) and markers of endothelial activation/Weibel-Palade body release (angiopoietin-2, von Willebrand Factor, P-selectin, osteoprotegerin) over 72 h, as well as blood and urine biomarkers of AKI. This study will be powered to detect a difference between the two treatment arms in a clinically relevant population including adults and children with knowlesi malaria of any severity.
DISCUSSION: Paracetamol is widely available and has an excellent safety profile; if a renoprotective effect is demonstrated, this trial will support the administration of regularly dosed paracetamol to all patients with knowlesi malaria. The secondary outcomes in this study will provide further insights into the pathophysiology of haemolysis-induced oxidative damage and acute kidney injury in knowlesi malaria and other haemolytic diseases.
TRIAL REGISTRATION: Clinicaltrials.gov, NCT03056391 . Registered on 12 October 2016.
DATA SOURCES: MEDLINE, EMBASE and CENTRAL were systematically searched from their inception until December 2018.
REVIEW METHODS: All randomised clinical trials were included.
RESULTS: Sixteen trials (1634 patients) were included in this meta-analysis. Incidence of delirium was not significantly lower in patients who received melatonin, with an odd ratio, OR (95%Cl) of 0.55 (0.24-1.26); ρ = 0.16, certainty of evidence = low, trial sequential analysis = inconclusive. However, patients who randomised to melatonin had a significantly shorter length of stay in intensive care units, with a mean difference, MD (95%CI) of -1.84 days (-2.46, -1.21); ρ
AIMS: To investigate the effect of ketamine on emergence agitation in children.
METHODS: Databases of MEDLINE, EMBASE, and CENTRAL were systematically searched from their start date until February 2019. Randomized controlled trials comparing intravenous ketamine and placebo in children were sought. The primary outcome was the incidence of emergence agitation. Secondary outcomes included postoperative pain score, duration of discharge time, and the adverse effects associated with the use of ketamine, namely postoperative nausea and vomiting, desaturation, and laryngospasm.
RESULTS: Thirteen studies (1125 patients) were included in the quantitative meta-analysis. The incidence of emergence agitation was 14.7% in the ketamine group and 33.3% in the placebo group. Children receiving ketamine had a lower incidence of emergence agitation, with an odds ratio being 0.23 (95% confidence interval: 0.11 to 0.46), certainty of evidence: low. In comparison with the placebo, ketamine group achieved a lower postoperative pain score (odds ratio: -2.42, 95% confidence interval: -4.23 to -0.62, certainty of evidence: very low) and lower pediatric anesthesia emergence delirium scale at 5 minutes after operation (odds ratio: -3.99, 95% confidence interval: -5.03 to -2.95; certainty of evidence: moderate). However, no evidence was observed in terms of incidence of postoperative nausea and vomiting, desaturation, and laryngospasm.
CONCLUSION: In this meta-analysis of 13 randomized controlled trials, high degree of heterogeneity and low certainty of evidence limit the recommendations of ketamine for the prevention of emergence agitation in children undergoing surgery or imaging procedures. However, the use of ketamine is well-tolerated without any notable adverse effects across all the included trials.
PROSPERO REGISTRATION: CRD42019131865.
METHODS: A systematic literature search was performed in electronic databases to identify randomized controlled trials comparing the clinical outcomes between intermediate/ therapeutic anticoagulation and prophylactic anticoagulation. Meta-analyses with random-effects models were used to estimate the pooled odds ratio (OR) for outcomes of interest at a 95% confidence interval (CI).
RESULTS: Eight randomized controlled trials were included, with a total of 5405 hospitalized patients with COVID-19. The meta-analysis revealed no statistically significant difference in the odds of mortality (pooled OR = 0.92; 95% CI 0.71-1.19) but a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.55; 95% CI 0.42-0.72), and significantly increased odds of development of major bleeding (pooled OR = 1.81; 95% CI 1.20-2.72) with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation. Subgroup analysis in patients with a severe course of COVID-19 observed a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.66; 95% CI 0.45-0.98) but no significant difference in the odds of development of major bleeding events (pooled OR = 1.37; 95% CI 0.74-2.56), with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation.
CONCLUSION: There could be net clinical benefits with higher-intensity dosing of anticoagulation relative to prophylactic-dosing of anticoagulation among hospitalized patients with severe COVID-19.
METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are game-based circuit exercise (experimental group) and conventional circuit exercise (control group). Based on sample size calculation using GPower, a total number of 82 participants will be recruited and allocated into either the experimental or the control group. Participants in the experimental group will receive a set of structured game-based exercise therapy which has the components of resistance, dynamic balance and aerobic exercises. While participants in the control group will receive a conventional circuit exercise as usually conducted by physiotherapists consisting of 6 exercise stations; cycling, repeated sit to stand, upper limb exercise, lower limb exercise, stepping up/down and walking over obstacles. Both groups will perform the given interventions for 2 times per week for 12 weeks under the supervision of 2 physiotherapists. Outcomes of the interventions will be measured using 30-second chair rise test (for lower limb strength), Dynamic Gait Index (for postural stability), 6-minute walk test (aerobic capacity), Intrinsic Motivation Inventory questionnaire (for motivation level), stroke self-efficacy questionnaire (for self-efficacy) and Short Form-36 quality of life questionnaire (for quality of life). All data will be analyzed using descriptive and inferential statistics.
DISCUSSION: This study will provide the information regarding the effectiveness of including game elements into circuit exercise training. Findings from this study will enable physiotherapists to design more innovative exercise therapy sessions to promote neuroplasticity and enhance functionality and quality of life among stroke survivors under their care.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN 12621001489886 (last updated 1/11/2021).
OBJECTIVES: The primary aim of this review was to investigate the effect of fibrinogen concentrate in postoperative blood loss in adult surgical patients.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Databases of MEDLINE, EMBASE and CENTRAL were searched from their start date until July 2019.
ELIGIBILITY CRITERIA: All randomized clinical trials comparing intravenous fibrinogen concentrate and placebo in adult surgical patients were included, regardless of type of surgery. Observational studies, case reports, case series and non-systematic reviews were excluded.
RESULTS: Thirteen trials (n = 900) were included in this review. In comparison to placebo, fibrinogen concentrate significantly reduced the first 12-hour postoperative blood loss, with a mean difference of -134.6 ml (95% CI -181.9 to -87.4). It also significantly increased clot firmness in thromboelastometry (FIBTEM) with a mean difference of 2.5 mm (95%CI 1.1 to 3.8). No significant differences were demonstrated in the adverse events associated with fibrinogen concentrate use, namely incidence of thromboembolism, myocardial infarction and acute kidney injury.
CONCLUSIONS: In this meta-analysis of 13 randomized trials, low level of evidence and substantial heterogeneity with small sample size limit strong recommendation on the use of fibrinogen concentrate in adult surgical patients. However, its use is tolerable without any notable adverse events.
TRIAL REGISTRATION: CRD42019149164.
AIMS: We aimed to perform a meta-analysis of randomized trials investigating the effect of colchicine in patients with COVID-19.
MATERIALS & METHODS: We systematically searched electronic databases and clinical trial registries (up to October 17, 2021) for eligible studies. The outcomes of interest were all-cause mortality and duration of hospital stay. Meta-analysis with the random-effects model was used to estimate the pooled odds ratio (OR) of mortality and 95% confidence interval (CI). The pooled standardized mean difference of duration of hospital stay with 95% CI between colchicine users and non-colchicine users was estimated using Cohen's d index.
RESULTS: The meta-analyses revealed no significant difference in the odds of mortality (pooled OR = 0.76; 95% CI: 0.53-1.07), but a significant reduction in the duration of hospital stay with the use of colchicine (pooled standardized mean difference = -0.59; 95% CI: -1.06 to -0.13).
DISCUSSION AND CONCLUSION: The ability of colchicine to reduce the length of stay in hospitalized patients with COVID-19 is consistent with its potential to prevent clinical deterioration via inhibition of NLRP3 inflammasome. Nevertheless, such beneficial effects of colchicine did not translate into mortality benefits in patients with COVID-19.
DATA SYNTHESIS: We searched the following international databases from inception to January 2022: PubMed, Scopus, Web of Science and Embase, and Google Scholar. Our findings of eleven meta-analyses showed that cinnamon consumption can significantly improve total cholesterol (TC) (WMD = -1.01 mg/dL; 95% CI: -2.02, -0.00, p = 0.049), low-density lipoprotein-cholesterol (LDL-C) (WMD = -0.82 mg/dL; 95% CI: -1.57, -0.07, p = 0.032), and high-density lipoprotein-cholesterol (HDL-C) (WMD = 0.47 mg/dL; 95% CI: 0.17, 0.77, p = 0.002) levels but not triglyceride (TG) levels (WMD = -0.13 mg/dL; 95% CI: -0.58, 0.32, p = 0.570). Our results did not show any significant effect of cinnamon on malondialdehyde (MDA) levels (WMD = -0.47; 95% CI: -0.99, 0.05, p = 0.078) and C-reactive protein (CRP) levels (WMD = -1.33; 95% CI: -2.66, 0.00, p = 0.051) but there was enhanced total antioxidant capacity (TAC) in patients with type 2 diabetes (T2DM) and polycystic ovary syndrome (PCOS) (WMD = 0.34; 95% CI: 0.04, 0.64, p = 0.026) and increased levels of interleukin-6 (WMD = -1.48; 95% CI: -2.96, -0.01, p = 0.049).
CONCLUSIONS: Our results support the usefulness of cinnamon intake in modulating an imbalanced lipid profile in some metabolic disorders, particularly PCOS, as well as in improving TAC and interleukin-6. The review protocol was registered on PROSPERO as CRD42022358827.
METHODS: We systematically searched PubMed, Cochrane Central Register of Controlled Trials, Google Scholar, and preprint repository databases (up to February 28, 2021). Random-effects and inverse variance heterogeneity meta-analysis were used to pool the odds ratio of individual trials. The risk of bias was appraised using Version 2 of the Cochrane risk-of-bias tool for randomized trials.
RESULTS: Six randomized controlled trials were included in this analysis with a total of 658 patients who were randomized to receive ivermectin and 597 patients randomized in the control group who did not receive ivermectin. Of six trials, four had an overall high risk of bias. The estimated effect of ivermectin indicated mortality benefits (pooled odds ratio = 0.21; 95% confidence interval 0.11-0.42, n = 1255), with some evidence against the hypothesis of 'no significant difference' at the current sample size.
CONCLUSION: We observed a preliminary beneficial effect on mortality associated with ivermectin use in patients with COVID-19 that warrants further clinical evidence in appropriately designed large-scale randomized controlled trials.
METHODS: The study was conducted in two stages. First, the factors affecting nutritional behaviors associated with cardiovascular disease on 350 women who were referred to Fasa urban health centers were determined based on the TPB. In the second stage, based on the results of a cross-sectional study, quasi-expeimental study was performed on 200 women covered by Fasa health centers. The questionnaire used for the study was a questionnaire based on TPB. The questionnaire was completed by the experimental and control groups before and three months after the intervention. Data were analyzed by SPSS software using logistic regression, paired t-test, independent sample t-test, and chi-square test. The level of significance is considered 0.05.
RESULT: The constructs of attitude, subjective norms, and perceived behavioral control (PBC) were predictors of nutritional behaviors associated with cardiovascular disease in women. The constructs predicted 41.6% of the behavior. The results showed that mean scores of attitude, subjective norms, PBC, intention, nutritional performance related to the cardiovascular disease before intervention were, respectively, 24.32, 14.20, 18.10, 13.37 and 16.28, and after the intervention, were, respectively, 42.32, 25.40, 33.72, 30.13 and 41.38. All the constructs except the attitude in the intervention group were significantly higher (p