The latest estimates and analyses from the Global Burden of Disease Study 2015 (GBD 2015)1-7 provide a vital link between the Millennium Development Goals (MDGs) and the Sustainable Development Goals ...(SDGs) for 2016-30. The GBD 2015 investigators report global and national trends in various health metrics, from 1990 to 2015, and their association with levels of national development measured through a Socio-demographic Index (SDI), and profile epidemiological and health transitions across the world. GBD 2015 also measures progress on specific MDG-related indicators and non-MDG-related indicators that are included in the SDGs.1-7
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Background
There is increasing evidence that both green and black tea are beneficial for cardiovascular disease (CVD) prevention.
Objectives
To determine the effects of green and black tea on the ...primary prevention of CVD.
Search methods
We searched the following databases on 12 October 2012 without language restrictions: CENTRAL in The Cochrane Library, MEDLINE (OVID), EMBASE (OVID) and Web of Science (Thomson Reuters). We also searched trial registers, screened reference lists and contacted authors for additional information where necessary.
Selection criteria
Randomised controlled trials (RCTs) lasting at least three months involving healthy adults or those at high risk of CVD. Trials investigated the intake of green tea, black tea or tea extracts. The comparison group was no intervention, placebo or minimal intervention. The outcomes of interest were CVD clinical events and major CVD risk factors. Any trials involving multifactorial lifestyle interventions or focusing on weight loss were excluded to avoid confounding.
Data collection and analysis
Two review authors independently selected trials for inclusion, ed data and assessed the risk of bias. Trials of green tea were analysed separately from trials of black tea.
Main results
We identified 11 RCTs with a total of 821 participants, two trials awaiting classification and one ongoing trial. Seven trials examined a green tea intervention and four examined a black tea intervention. Dosage and form of both green and black tea differed between trials. The ongoing trial is examining the effects of green tea powder capsules.
No studies reported cardiovascular events.
Black tea was found to produce statistically significant reductions in low‐density lipoprotein (LDL) cholesterol (mean difference (MD) ‐0.43 mmol/L, 95% confidence interval (CI) ‐0.56 to ‐0.31) and blood pressure (systolic blood pressure (SBP): MD ‐1.85 mmHg, 95% CI ‐3.21 to ‐0.48. Diastolic blood pressure (DBP): MD ‐1.27 mmHg, 95% CI ‐3.06 to 0.53) over six months, stable to sensitivity analysis, but only a small number of trials contributed to each analysis and studies were at risk of bias.
Green tea was also found to produce statistically significant reductions in total cholesterol (MD ‐0.62 mmol/L, 95% CI ‐0.77 to ‐0.46), LDL cholesterol (MD ‐0.64 mmol/L, 95% CI ‐0.77 to ‐0.52) and blood pressure (SBP: MD ‐3.18 mmHg, 95% CI ‐5.25 to ‐1.11; DBP: MD ‐3.42, 95% CI ‐4.54 to ‐2.30), but only a small number of studies contributed to each analysis, and results were not stable to sensitivity analysis. When both tea types were analysed together they showed favourable effects on LDL cholesterol (MD ‐0.48 mmol/L, 95% CI ‐0.61 to ‐0.35) and blood pressure (SBP: MD ‐2.25 mmHg, 95% CI ‐3.39 to ‐1.11; DBP: MD ‐2.81 mmHg, 95% CI ‐3.77 to ‐1.86). Adverse events were measured in five trials and included a diagnosis of prostate cancer, hospitalisation for influenza, appendicitis and retinal detachment but these are unlikely to be directly attributable to the intervention.
Authors' conclusions
There are very few long‐term studies to date examining green or black tea for the primary prevention of CVD. The limited evidence suggests that tea has favourable effects on CVD risk factors, but due to the small number of trials contributing to each analysis the results should be treated with some caution and further high quality trials with longer‐term follow‐up are needed to confirm this.
Prophylactic application of clotting factor concentrates is the basis of modern treatment of severe hemophilia A. In children, the early start of prophylaxis as primary or secondary prophylaxis has ...become the gold standard in most countries with adequate resources. In adults, prophylaxis is reasonably continued when started as primary or secondary prophylaxis in childhood to maintain healthy joint function. Initial data support that adult patients with already existing advanced joint arthropathy benefit from tertiary prophylaxis with significantly lowered number of bleeds, almost complete absence of target joints, and less time off from work. Current prophylactic regimens, although very effective, do not completely prevent joint disease in a long-term perspective. Joint arthropathy in primary prophylaxis develops over many years, sometimes over a decade or even longer time periods. The ankle joints are the first and most severely affected joints in those patients and thus may serve in outcome assessment as an indicator of early joint arthropathy when followed by ultrasound or magnetic resonance imaging. Optimized outcome and best use of available resources is expected from individualization of therapy regimens, which comprises the individual’s bleeding pattern, condition of the musculoskeletal system, level of physical activity and the pharmacokinetic profile of the substituted coagulation factor, and most recently includes novel products with extended half-lives.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Risk assessment is a critical step in the current approach to primary prevention of atherosclerotic cardiovascular disease. Knowledge of the 10-year risk for atherosclerotic cardiovascular disease ...identifies patients in higher-risk groups who are likely to have greater net benefit and lower number needed to treat for both statins and antihypertensive therapy. Current U.S. prevention guidelines for blood pressure and cholesterol management recommend use of the pooled cohort equations to start a process of shared decision-making between clinicians and patients in primary prevention. The pooled cohort equations have been widely validated and are broadly useful for the general U.S. clinical population. But, they may systematically underestimate risk in patients from certain racial/ethnic groups, those with lower socioeconomic status or with chronic inflammatory diseases, and overestimate risk in patients with higher socioeconomic status or who have been closely engaged with preventive healthcare services. If uncertainty remains for patients at borderline or intermediate risk, or if the patient is undecided after a patient-clinician discussion with consideration of risk enhancing factors (e.g., family history), additional testing with measurement of coronary artery calcium can be useful to reclassify risk estimates and improve selection of patients for use or avoidance of statin therapy. This special report summarizes the rationale and evidence base for quantitative risk assessment, reviews strengths and limitations of existing risk scores, discusses approaches for refining individual risk estimates for patients, and provides practical advice regarding implementation of risk assessment and decision-making strategies in clinical practice.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background
Diet plays a major role in the aetiology of cardiovascular disease (CVD) and as a modifiable risk factor is the focus of many prevention strategies. Recently vegan diets have gained ...popularity and there is a need to synthesise existing clinical trial evidence for their potential in CVD prevention.
Objectives
To determine the effectiveness of following a vegan dietary pattern for the primary and secondary prevention of CVD.
Search methods
We searched the following electronic databases on 4 February 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Web of Science Core Collection. We also searched ClinicalTrials.gov in January 2021. We applied no language restrictions.
Selection criteria
We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). A vegan dietary pattern excludes meat, fish, eggs, dairy and honey; the intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow‐up periods of 12 weeks or more, defined as the intervention period plus post‐intervention follow‐up.
Data collection and analysis
Two review authors independently assessed studies for inclusion, extracted data and assessed risks of bias. We used GRADE to assess the certainty of the evidence. We conducted three main comparisons:
1. Vegan dietary intervention versus no intervention or minimal intervention for primary prevention; 2. Vegan dietary intervention versus another dietary intervention for primary prevention; 3. Vegan dietary intervention versus another dietary intervention for secondary prevention.
Main results
Thirteen RCTs (38 papers, 7 trial registrations) and eight ongoing trials met our inclusion criteria. Most trials contributed to primary prevention: comparisons 1 (four trials, 466 participants randomised) and comparison 2 (eight trials, 409 participants randomised). We included only one secondary prevention trial for comparison 3 (63 participants randomised).
None of the trials reported on clinical endpoints. Other primary outcomes included lipid levels and blood pressure.
For comparison 1 there was moderate‐certainty evidence from four trials with 449 participants that a vegan diet probably led to a small reduction in total cholesterol (mean difference (MD) −0.24 mmol/L, 95% confidence interval (CI) −0.36 to −0.12) and low‐density lipoprotein (LDL) cholesterol (MD −0.22 mmol/L, 95% CI −0.32 to −0.11), a very small decrease in high‐density lipoprotein (HDL) levels (MD −0.08 mmol/L, 95% CI −0.11 to −0.04) and a very small increase in triglyceride levels (MD 0.11 mmol/L, 95% CI 0.01 to 0.21). The very small changes in HDL and triglyceride levels are in the opposite direction to that expected. There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI −1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD −0.27 mmHg, 95% CI −1.67 to 1.12; 3 trials, 372 participants) (low‐certainty evidence).
For comparison 2 there was a lack of evidence for an effect of the vegan dietary intervention on total cholesterol levels (MD −0.04 mmol/L, 95% CI −0.28 to 0.20; 4 trials, 163 participants; low‐certainty evidence). There was probably little or no effect of the vegan dietary intervention on LDL (MD −0.05 mmol/L, 95% CI −0.21 to 0.11; 4 trials, 244 participants) or HDL cholesterol levels (MD −0.01 mmol/L, 95% CI −0.08 to 0.05; 5 trials, 256 participants) or triglycerides (MD 0.21 mmol/L, 95% CI −0.07 to 0.49; 5 trials, 256 participants) compared to other dietary interventions (moderate‐certainty evidence). We are very uncertain about any effect of the vegan dietary intervention on systolic blood pressure (MD 0.02 mmHg, 95% CI −3.59 to 3.62) or diastolic blood pressure (MD 0.63 mmHg, 95% CI −1.54 to 2.80; 5 trials, 247 participants (very low‐certainty evidence)).
Only one trial (63 participants) contributed to comparison 3, where there was a lack of evidence for an effect of the vegan dietary intervention on lipid levels or blood pressure compared to other dietary interventions (low‐ or very low‐certainty evidence).
Four trials reported on adverse events, which were absent or minor.
Authors' conclusions
Studies were generally small with few participants contributing to each comparison group. None of the included studies report on CVD clinical events. There is currently insufficient information to draw conclusions about the effects of vegan dietary interventions on CVD risk factors. The eight ongoing studies identified will add to the evidence base, with all eight reporting on primary prevention. There is a paucity of evidence for secondary prevention.
Although the prominent role of the microbiome in human health has been established, the early-life microbiome is now being recognized as a major influence on long-term human health and development. ...Variations in the composition and functional potential of the early-life microbiome are the result of lifestyle factors, such as mode of birth, breastfeeding, diet, and antibiotic usage. In addition, variations in the composition of the early-life microbiome have been associated with specific disease outcomes, such as asthma, obesity, and neurodevelopmental disorders. This points toward this bacterial consortium as a mediator between early lifestyle factors and health and disease. In addition, variations in the microbial intrauterine environment may predispose neonates to specific health outcomes later in life. A role of the microbiome in the Developmental Origins of Health and Disease is supported in this collective research. Highlighting the early-life critical window of susceptibility associated with microbiome development, we discuss infant microbial colonization, beginning with the maternal-to-fetal exchange of microbes in utero and up through the influence of breastfeeding in the first year of life. In addition, we review the available disease-specific evidence pointing toward the microbiome as a mechanistic mediator in the Developmental Origins of Health and Disease.
Background
The prevention of cardiovascular disease (CVD) is a key public health priority. A number of dietary factors have been associated with modifying CVD risk factors. One such factor is dietary ...fibre which may have a beneficial association with CVD risk factors. There is a need to review the current evidence from randomised controlled trials (RCTs) in this area.
Objectives
The primary objective of this systematic review was to determine the effectiveness of dietary fibre for the primary prevention of CVD.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Ovid MEDLINE (1946 to January 2015), Ovid EMBASE (1947 to January 2015) and Science Citation Index Expanded (1970 to January 2015) as well as two clinical trial registers in January 2015. We also checked reference lists of relevant articles. No language restrictions were applied.
Selection criteria
We selected RCTs that assessed the effects of dietary fibre compared with no intervention or a minimal intervention on CVD and related risk factors. Participants included adults who are at risk of CVD or those from the general population.
Data collection and analysis
Two authors independently selected studies, extracted data and assessed risk of bias; a third author checked any differences. A different author checked analyses.
Main results
We included 23 RCTs (1513 participants randomised) examining the effect of dietary fibre. The risk of bias was unclear for most studies and studies had small sample sizes. Few studies had an intervention duration of longer than 12 weeks. There was a wide variety of fibre sources used, with little similarity between groups in the choice of intervention.
None of the studies reported on mortality (total or cardiovascular) or cardiovascular events. Results on lipids suggest there is a significant beneficial effect of increased fibre on total cholesterol levels (17 trials (20 comparisons), 1067 participants randomised, mean difference ‐0.20 mmol/L, 95% CI ‐0.34 to ‐0.06), and LDL cholesterol levels (mean difference ‐0.14 mmol/L, 95% CI ‐0.22 to ‐0.06) but not on triglyceride levels (mean difference 0.00 mmol/L, 95% CI ‐0.04 to 0.05), and there was a very small but statistically significant decrease rather than increase in HDL levels with increased fibre intake (mean difference ‐0.03 mmol/L, 95% CI ‐0.06 to ‐0.01). Fewer studies (10 trials, 661 participants randomised) reported blood pressure outcomes where there is a significant effect of increased fibre consumption on diastolic blood pressure (mean difference ‐1.77 mmHg, 95% CI ‐2.61 to ‐0.92) whilst there is a reduction in systolic blood pressure with fibre but this does not reach statistical significance (mean difference ‐1.92 mmHg, 95% CI ‐4.02 to 0.19). There did not appear to be any subgroup effects by the nature of the type of intervention (fibre supplements or provision of foods/advice to increase fibre consumption) or the type of fibre (soluble/insoluble) although the number of studies contributing to each subgroup were small. All analyses need to be viewed with caution given the risks of bias observed for total cholesterol and the statistical heterogeneity observed for systolic blood pressure. Adverse events, where reported, appeared to mostly reflect mild to moderate gastrointestinal side‐effects and these were generally reported more in the fibre intervention groups than the control groups.
Authors' conclusions
Studies were short term and therefore did not report on our primary outcomes, CVD clinical events. The pooled analyses for CVD risk factors suggest reductions in total cholesterol and LDL cholesterol with increased fibre intake, and reductions in diastolic blood pressure. There were no obvious effects of subgroup analyses by type of intervention or fibre type but the number of studies included in each of these analyses were small. Risk of bias was unclear in the majority of studies and high for some quality domains so results need to be interpreted cautiously. There is a need for longer term, well‐conducted RCTs to determine the effects of fibre type (soluble versus insoluble) and administration (supplements versus foods) on CVD events and risk factors for the primary prevention of CVD.
IMPORTANCE: Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the ...Mediterranean diet may reduce the risk of breast cancer. OBJECTIVE: To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. DESIGN, SETTING, AND PARTICIPANTS: The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. INTERVENTIONS: Participants were randomly allocated to a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). MAIN OUTCOMES AND MEASURES: Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). RESULTS: After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.31 (95% CI, 0.13-0.77) for the Mediterranean diet with extra-virgin olive oil group and 0.53 (95% CI, 0.23-1.26) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). CONCLUSIONS AND RELEVANCE: This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies. TRIAL REGISTRATION: ISRCTN.org Identifier: ISRCTN35739639
Background
Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of CVD is an important goal of pharmacotherapy. Statins are ...the first‐choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with CVD. The case for primary prevention was uncertain when the last version of this review was published (2011) and in light of new data an update of this review is required.
Objectives
To assess the effects, both harms and benefits, of statins in people with no history of CVD.
Search methods
To avoid duplication of effort, we checked reference lists of previous systematic reviews. The searches conducted in 2007 were updated in January 2012. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2022, Issue 4), MEDLINE OVID (1950 to December Week 4 2011) and EMBASE OVID (1980 to 2012 Week 1).There were no language restrictions.
Selection criteria
We included randomised controlled trials of statins versus placebo or usual care control with minimum treatment duration of one year and follow‐up of six months, in adults with no restrictions on total, low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD.
Data collection and analysis
Two review authors independently selected studies for inclusion and extracted data. Outcomes included all‐cause mortality, fatal and non‐fatal CHD, CVD and stroke events, combined endpoints (fatal and non‐fatal CHD, CVD and stroke events), revascularisation, change in total and LDL cholesterol concentrations, adverse events, quality of life and costs. Odds ratios (OR) and risk ratios (RR) were calculated for dichotomous data, and for continuous data, pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated. We contacted trial authors to obtain missing data.
Main results
The latest search found four new trials and updated follow‐up data on three trials included in the original review. Eighteen randomised control trials (19 trial arms; 56,934 participants) were included. Fourteen trials recruited patients with specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). All‐cause mortality was reduced by statins (OR 0.86, 95% CI 0.79 to 0.94); as was combined fatal and non‐fatal CVD RR 0.75 (95% CI 0.70 to 0.81), combined fatal and non‐fatal CHD events RR 0.73 (95% CI 0.67 to 0.80) and combined fatal and non‐fatal stroke (RR 0.78, 95% CI 0.68 to 0.89). Reduction of revascularisation rates (RR 0.62, 95% CI 0.54 to 0.72) was also seen. Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no evidence of any serious harm caused by statin prescription. Evidence available to date showed that primary prevention with statins is likely to be cost‐effective and may improve patient quality of life. Recent findings from the Cholesterol Treatment Trialists study using individual patient data meta‐analysis indicate that these benefits are similar in people at lower (< 1% per year) risk of a major cardiovascular event.
Authors' conclusions
Reductions in all‐cause mortality, major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins.
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