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1.
Effie Viguiliouk Cyril W. C. Kendall Sonia Blanco Mejia Adrian I. Cozma Vanessa Ha Arash Mirrahimi Viranda H. Jayalath Livia S. A. Augustin Laura Chiavaroli Lawrence A. Leiter Russell J. de Souza David J. A. Jenkins John L. Sievenpiper 《PloS one》2014,9(7)
Background
Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent.Objective
To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes.Data Sources
MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014.Study Selection
Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR.Data Extraction and Synthesis
Two independent reviewer’s extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI’s. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2).Results
Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = −0.07% [95% CI:−0.10, −0.03%]; P = 0.0003) and fasting glucose (MD = −0.15 mmol/L [95% CI: −0.27, −0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts.Limitations
Majority of trials were of short duration and poor quality.Conclusions
Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates.Trial Registration
ClinicalTrials.gov NCT01630980 相似文献2.
Background
Telephone helplines are frequently and repeatedly used by individuals with chronic mental health problems and web interventions may be an effective tool for reducing depression in this population.Aim
To evaluate the effectiveness of a 6 week, web-based cognitive behaviour therapy (CBT) intervention with and without proactive weekly telephone tracking in the reduction of depression in callers to a helpline service.Method
155 callers to a national helpline service with moderate to high psychological distress were recruited and randomised to receive either Internet CBT plus weekly telephone follow-up; Internet CBT only; weekly telephone follow-up only; or treatment as usual.Results
Depression was lower in participants in the web intervention conditions both with and without telephone tracking compared to the treatment as usual condition both at post intervention and at 6 month follow-up. Telephone tracking provided by a lay telephone counsellor did not confer any additional advantage in terms of symptom reduction or adherence.Conclusions
A web-based CBT program is effective both with and without telephone tracking for reducing depression in callers to a national helpline.Trial Registration
Controlled-Trials.com ISRCTN93903959 相似文献3.
Dieuwerke P. Bolhuis Ciarán G. Forde Yuejiao Cheng Haohuan Xu Nathalie Martin Cees de Graaf 《PloS one》2014,9(4)
Background
Previous research has shown that oral processing characteristics like bite size and oral residence duration are related to the satiating efficiency of foods. Oral processing characteristics are influenced by food texture. Very little research has been done on the effect of food texture within solid foods on energy intake.Objectives
The first objective was to investigate the effect of hardness of food on energy intake at lunch, and to link this effect to differences in food oral processing characteristics. The second objective was to investigate whether the reduction in energy intake at lunch will be compensated for in the subsequent dinner.Design
Fifty subjects (11 male, BMI: 21±2 kg/m2, age: 24±2 y) participated in a cross-over study in which they consumed ad libitum from a lunch with soft foods or hard foods on two separate days. Oral processing characteristics at lunch were assessed by coding video records. Later on the same days, subjects consumed dinner ad libitum.Results
Hard foods led to a ∼13% lower energy intake at lunch compared to soft foods (P<0.001). Hard foods were consumed with smaller bites, longer oral duration per gram food, and more chewing per gram food compared to the soft foods (P<0.05). Energy intake at dinner did not differ after both lunches (P = 0.16).Conclusions
Hard foods led to reduced energy intake compared to soft foods, and this reduction in energy intake was sustained over the next meal. We argue that the differences in oral processing characteristics produced by the hardness of the foods explain the effect on intake. The sustained reduction in energy intake suggests that changes in food texture can be a helpful tool in reducing the overall daily energy intake. 相似文献4.
Debbie L. Humphries Jere R. Behrman Benjamin T. Crookston Kirk A. Dearden Whitney Schott Mary E. Penny 《PloS one》2014,9(11)
Background
Relative to plant-based foods, animal source foods (ASFs) are richer in accessible protein, iron, zinc, calcium, vitamin B-12 and other nutrients. Because of their nutritional value, particularly for childhood growth and nutrition, it is important to identify factors influencing ASF consumption, especially for poorer households that generally consume less ASFs.Objective
To estimate differential responsiveness of ASF consumption to changes in total household expenditures for households with different expenditures in a middle-income country with substantial recent income increases.Methods
The Peruvian Young Lives household panel (n = 1750) from 2002, 2006 and 2009 was used to characterize patterns of ASF expenditures. Multivariate models with controls for unobserved household fixed effects and common secular trends were used to examine nonlinear relationships between changes in household expenditures and in ASF expenditures.Results
Households with lower total expenditures dedicated greater percentages of expenditures to food (58.4% vs.17.9% in 2002 and 24.2% vs. 21.5% in 2009 for lowest and highest quintiles respectively) and lower percentages of food expenditures to ASF (22.8% vs. 33.9% in 2002 and 30.3% vs. 37.6% in 2009 for lowest and highest quintiles respectively). Average percentages of overall expenditures spent on food dropped from 47% to 23.2% between 2002 and 2009. Households in the lowest quintiles of expenditures showed greater increases in ASF expenditures relative to total consumption than households in the highest quintiles. Among ASF components, meat and poultry expenditures increased more than proportionately for households in the lowest quintiles, and eggs and fish expenditures increased less than proportionately for all households.Conclusions
Increases in household expenditures were associated with substantial increases in consumption of ASFs for households, particularly households with lower total expenditures. Increases in ASF expenditures for all but the top quintile of households were proportionately greater than increases in total food expenditures, and proportionately less than overall expenditures. 相似文献5.
M de Bock JG Derraik CM Brennan JB Biggs GC Smith D Cameron-Smith CR Wall WS Cutfield 《PloS one》2012,7(7):e41735
Aims
We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population.Methods
This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15–16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test.Results
45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019), as well as a 0.12 mmol/l (6%) reduction in LDL cholesterol (p = 0.042). No associated adverse events were recorded.Conclusions
Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome) in an at risk population of adolescent males.Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12609000888268 相似文献6.
Background
A recent trial with PCV-7 in a rural Gambian community showed reduced vaccine-type pneumococcal carriage in fully vaccinated compared with control communities. We measured pneumococcal polysaccharide antibody concentrations in this trial to understand further the mechanisms underlying the observed changes.Methods
A single-blind, cluster-randomized (by village) trial was conducted in 21 Gambian villages. In 11 villages, all residents received PCV-7 (Vaccine group); in 10 control villages only children <30 months old or those born during the study received PCV-7. Subjects over the age of 30 months resident in vaccine villages received a single dose of PCV-7 whilst those in control villages received a single dose of a serogroup C meningococcal conjugate vaccine. Serum antibody concentrations against specific pneumococcal polysaccharides were measured in approximately 200 age-stratified subjects before, 4–6, 12 and 24 months following vaccination.Results
Baseline pneumococcal antibody concentrations were generally high and increased with age up to 10 years. One dose of PCV-7 increased geometric mean antibody concentrations (GMC) in vaccinated versus control villages for vaccine serotypes 6B and 18C, and 4 and 18C, in the young (under 5 years) and older age groups (5+ years) respectively. There were significantly higher proportions of subjects in the vaccinated than in the control communities with an antibody concentration believed to protect against carriage (>5.0 µg/mL) for all but serotype 9V of the PCV-7 serotypes in the older group, but not in the younger age group.Conclusion
Higher antibodies in vaccinated communities provide an explanation for the lower pneumococcal carriage rates in fully vaccinated compared to control communities.Trial Registration
Controlled-Trials.com ISRCTN51695599 51695599. 相似文献7.
8.
Jantien van Berkel Cécile R. L. Boot Karin I. Proper Paulien M. Bongers Allard J. van der Beek 《PloS one》2014,9(1)
Objectives
The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness.Methods
In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129) received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models.Results
There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference) and subgroups based on baseline work engagement scores showed no significant differences either.Conclusions
This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months.Trial registration
Netherlands Trial Register NTR2199 相似文献9.
Firnhaber C Azzoni L Foulkes AS Gross R Yin X Van Amsterdam D Schulze D Glencross DK Stevens W Hunt G Morris L Fox L Sanne I Montaner LJ 《PloS one》2011,6(6):e21450
Background
The clinical outcomes of short interruptions of PI-based ART regimens remains undefined.Methods
A 2-arm non-inferiority trial was conducted on 53 HIV-1 infected South African participants with viral load <50 copies/ml and CD4 T cell count >450 cells/µl on stavudine (or zidovudine), lamivudine and lopinavir/ritonavir. Subjects were randomized to a) sequential 2, 4 and 8-week ART interruptions or b) continuous ART (cART). Primary analysis was based on the proportion of CD4 count >350 cells(c)/ml over 72 weeks. Adherence, HIV-1 drug resistance, and CD4 count rise over time were analyzed as secondary endpoints.Results
The proportions of CD4 counts >350 cells/µl were 82.12% for the intermittent arm and 93.73 for the cART arm; the difference of 11.95% was above the defined 10% threshold for non-inferiority (upper limit of 97.5% CI, 24.1%; 2-sided CI: −0.16, 23.1). No clinically significant differences in opportunistic infections, adverse events, adherence or viral resistance were noted; after randomization, long-term CD4 rise was observed only in the cART arm.Conclusion
We are unable to conclude that short PI-based ART interruptions are non-inferior to cART in retention of immune reconstitution; however, short interruptions did not lead to a greater rate of resistance mutations or adverse events than cART suggesting that this regimen may be more forgiving than NNRTIs if interruptions in therapy occur.Trial Registration
ClinicalTrials.gov NCT00100646 相似文献10.
Suzanna E. Forwood Amy Ahern Gareth J. Hollands Paul C. Fletcher Theresa M. Marteau 《PloS one》2013,8(8)
Objective
Previous studies have shown that estimations of the calorie content of an unhealthy main meal food tend to be lower when the food is shown alongside a healthy item (e.g. fruit or vegetables) than when shown alone. This effect has been called the negative calorie illusion and has been attributed to averaging the unhealthy (vice) and healthy (virtue) foods leading to increased perceived healthiness and reduced calorie estimates. The current study aimed to replicate and extend these findings to test the hypothesized mediating effect of ratings of healthiness of foods on calorie estimates.Methods
In three online studies, participants were invited to make calorie estimates of combinations of foods. Healthiness ratings of the food were also assessed.Results
The first two studies failed to replicate the negative calorie illusion. In a final study, the use of a reference food, closely following a procedure from a previously published study, did elicit a negative calorie illusion. No evidence was found for a mediating role of healthiness estimates.Conclusion
The negative calorie illusion appears to be a function of the contrast between a food being judged and a reference, supporting the hypothesis that the negative calorie illusion arises from the use of a reference-dependent anchoring and adjustment heuristic and not from an ‘averaging’ effect, as initially proposed. This finding is consistent with existing data on sequential calorie estimates, and highlights a significant impact of the order in which foods are viewed on how foods are evaluated. 相似文献11.
JR Kim A Nandy AK Maji M Addy AM Dondorp NP Day S Pukrittayakamee NJ White M Imwong 《PloS one》2012,7(7):e39645
Background
The Plasmodium vivax that was once prevalent in temperate climatic zones typically had an interval between primary infection and first relapse of 7–10 months, whereas in tropical areas P.vivax infections relapse frequently at intervals of 3–6 weeks. Defining the epidemiology of these two phenotypes from temporal patterns of illness in endemic areas is difficult or impossible, particularly if they overlap.Methods
A prospective open label comparison of chloroquine (CQ) alone versus CQ plus unobserved primaquine for either 5 days or 14 days was conducted in patients presenting with acute vivax malaria in Kolkata. Patients were followed for 15 months and primary and recurrent infections were genotyped using three polymorphic antigen and up to 8 microsatellite markers.Results
151 patients were enrolled of whom 47 (31%) had subsequent recurrent infections. Recurrence proportions were similar in the three treatment groups. Parasite genotyping revealed discrete temporal patterns of recurrence allowing differentiation of probable relapse from newly acquired infections. This suggested that 32 of the 47 recurrences were probable relapses of which 22 (69%) were genetically homologous. The majority (81%) of probable relapses occurred within three months (16 homologous, 10 heterologous) and six genetically homologous relapses (19%) were of the long latency (8–10 month interval) phenotype.Conclusions
With long follow-up to assess temporal patterns of vivax malaria recurrence, genotyping of P.vivax can be used to assess relapse rates. A 14 day unobserved course of primaquine did not prevent relapse. Genotyping indicates that long latency P.vivax is prevalent in West Bengal, and that the first relapses after long latent periods are genetically homologous.Trial Registration
Controlled-Trials.com ISRCTN14027467 相似文献12.
Background
The cost and dietary choices required to fulfil nutrient recommendations defined nationally, need investigation, particularly for disadvantaged populations.Objective
We used optimisation modelling to examine the dietary change required to achieve nutrient requirements at minimum cost for an Aboriginal population in remote Australia, using where possible minimally-processed whole foods.Design
A twelve month cross-section of population-level purchased food, food price and nutrient content data was used as the baseline. Relative amounts from 34 food group categories were varied to achieve specific energy and nutrient density goals at minimum cost while meeting model constraints intended to minimise deviation from the purchased diet.Results
Simultaneous achievement of all nutrient goals was not feasible. The two most successful models (A & B) met all nutrient targets except sodium (146.2% and 148.9% of the respective target) and saturated fat (12.0% and 11.7% of energy). Model A was achieved with 3.2% lower cost than the baseline diet (which cost approximately AUD$13.01/person/day) and Model B at 7.8% lower cost but with a reduction in energy of 4.4%. Both models required very large reductions in sugar sweetened beverages (−90%) and refined cereals (−90%) and an approximate four-fold increase in vegetables, fruit, dairy foods, eggs, fish and seafood, and wholegrain cereals.Conclusion
This modelling approach suggested population level dietary recommendations at minimal cost based on the baseline purchased diet. Large shifts in diet in remote Aboriginal Australian populations are needed to achieve national nutrient targets. The modeling approach used was not able to meet all nutrient targets at less than current food expenditure. 相似文献13.
de Brouwer SJ Kraaimaat FW Sweep FC Donders RT Eijsbouts A van Koulil S van Riel PL Evers AW 《PloS one》2011,6(12):e27432
Background
Stress management interventions may prove useful in preventing the detrimental effects of stress on health. This study assessed the effects of a stress management intervention on the psychophysiological response to stress in patients with rheumatoid arthritis (RA).Methods
Seventy-four patients with RA, who were randomly assigned to either a control group or a group that received short-term stress management training, performed a standardized psychosocial stress task (Trier Social Stress Test; TSST) 1 week after the stress management training and at a 9-week follow-up. Psychological and physical functioning, and the acute psychophysiological response to the stress test were assessed.Results
Patients in the intervention group showed significantly lower psychological distress levels of anxiety after the training than did the controls. While there were no between-group differences in stress-induced tension levels, and autonomic (α-amylase) or endocrine (cortisol) responses to the stress test 1 week after the intervention, levels of stress-induced tension and cortisol were significantly lower in the intervention group at the 9-week follow-up. Overall, the response to the intervention was particularly evident in a subgroup of patients with a psychological risk profile.Conclusion
A relatively short stress management intervention can improve psychological functioning and influences the psychophysiological response to stress in patients with RA, particularly those psychologically at risk. These findings might help understand how stress can affect health and the role of individual differences in stress responsiveness.Trial Registration
TrialRegister.nl NTR1193 相似文献14.
Background
Distorted activity of the hypothalamic-pituitary-adrenocortical (HPA) system is one of the most robustly documented biological abnormalities in major depression. Lithium is central to the treatment of affective disorders, but little is known about its effects on the HPA system of depressed subjects.Objective
To assess the effects of lithium monotherapy on the HPA system of patients with major depression by means of the combined DEX/CRH test.Method
Thirty drug-naive outpatients with major depression (single episode or unipolar recurrent; SCID I- and II-confirmed) were treated with lithium monotherapy for four weeks. The DEX/CRH test was conducted directly before intake of the first lithium tablet and four weeks thereafter. Weekly ratings with the HDRS21 were used to determine response (≥50% symptom reduction) and remission (HDRS ≤7).Results
Lithium levels within the therapeutic range were achieved rapidly. Tolerability was good; no patient terminated the treatment prematurely. Response and remission rates were 50% and 33% respectively. Compared to the DEX/CRH test before the start of the treatment, a considerable and significant increase in all CRH-stimulated ACTH and cortisol parameters could be detected in the second DEX/CRH test. When analysed with particular regard to responders and non-responders, that significant increase was only present in the responders.Conclusions
We were able to demonstrate that lithium leads to a significant activation of the HPA system. This is possibly connected to stimulation of hypothalamic arginine vasoporessin (AVP), to direct intracellular effects of lithium on pituitary cells and to an induction of gene expression.Trial Registration
drks-nue.uniklinik-freiburg.de DRKS00003185 相似文献15.
Background
A Polypill is proposed for the primary prevention of cardiovascular disease in people judged to be at risk on account of their age alone. Its efficacy in reducing cholesterol and blood pressure is uncertain.Methods
We conducted a randomized double-blind placebo-controlled crossover trial of a Polypill among individuals aged 50+ without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs. Participants took the Polypill (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg and simvastatin 40 mg) each evening for 12 weeks and a placebo each evening for 12 weeks in random sequence. The mean within-person differences in blood pressure and low density lipoprotein (LDL) cholesterol at the end of each 12 week period were determined.Results
84 out of 86 participants completed both treatment periods. The mean systolic blood pressure was reduced by 17.9 mmHg (95% CI, 15.7–20.1) on the Polypill, diastolic blood pressure by 9.8 mmHg (8.1–11.5), and LDL cholesterol by 1.4 mmol/L (1.2–1.6), reductions of 12%, 11%, and 39% respectively. The results were almost identical to those predicted; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively.Conclusion
The Polypill resulted in the predicted reductions in blood pressure and LDL cholesterol. Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes.Trial Registration
Controlled-Trials.com ISRCTN36672232 相似文献16.
Objective
Patient involvement into medical decisions as conceived in the shared decision making method (SDM) is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered.Methods
The study investigated a nested cohort (N = 79) of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION) and patients'' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale).Results
OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations.Conclusion
Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement.Practice Implications
Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement.Trial Registration
Controlled-Trials.com ISRCTN25267500. 相似文献17.
Nick Wilson Nhung Nghiem Cliona Ni Mhurchu Helen Eyles Michael G. Baker Tony Blakely 《PloS one》2013,8(3)
Objective
Global health challenges include non-communicable disease burdens, ensuring food security in the context of rising food prices, and environmental constraints around food production, e.g., greenhouse gas [GHG] emissions. We therefore aimed to consider optimized solutions to the mix of food items in daily diets for a developed country population: New Zealand (NZ).Methods
We conducted scenario development and linear programming to model 16 diets (some with uncertainty). Data inputs included nutrients in foods, food prices, food wastage and food-specific GHG emissions.Findings
This study identified daily dietary patterns that met key nutrient requirements for as little as a median of NZ$ 3.17 per day (US$ 2.41/d) (95% simulation interval [SI] = NZ$ 2.86 to 3.50/d). Diets that included “more familiar meals” for New Zealanders, increased the cost. The optimized diets also had low GHG emission profiles compared with the estimate for the ‘typical NZ diet’ e.g., 1.62 kg CO2e/d for one scenario (95%SI = 1.39 to 1.85 kg CO2e) compared with 10.1 kg CO2e/d, respectively. All of the optimized low-cost and low-GHG dietary patterns had likely health advantages over the current NZ dietary pattern, i.e., lower cardiovascular disease and cancer risk.Conclusions
We identified optimal foods and dietary patterns that would lower the risk of non-communicable diseases at low cost and with low greenhouse gas emission profiles. These results could help guide central and local government decisions around which foods to focus policies on. That is which foods are most suitable for: food taxes (additions and exemptions); healthy food vouchers and subsidies; and for increased use by public institutions involved in food preparation. 相似文献18.
Objective
To determine whether information from genetic risk variants for diabetes is associated with cardiovascular events incidence.Methods
From the about 30 known genes associated with diabetes, we genotyped single-nucleotide polymorphisms at the 10 loci most associated with type-2 diabetes in 425 subjects from the MASS-II Study, a randomized study in patients with multi-vessel coronary artery disease. The combined genetic information was evaluated by number of risk alleles for diabetes. Performance of genetic models relative to major cardiovascular events incidence was analyzed through Kaplan-Meier curve comparison and Cox Hazard Models and the discriminatory ability of models was assessed for cardiovascular events by calculating the area under the ROC curve.Results
Genetic information was able to predict 5-year incidence of major cardiovascular events and overall-mortality in non-diabetic individuals, even after adjustment for potential confounders including fasting glycemia. Non-diabetic individuals with high genetic risk had a similar incidence of events then diabetic individuals (cumulative hazard of 33.0 versus 35.1% of diabetic subjects). The addition of combined genetic information to clinical predictors significantly improved the AUC for cardiovascular events incidence (AUC = 0.641 versus 0.610).Conclusions
Combined information of genetic variants for diabetes risk is associated to major cardiovascular events incidence, including overall mortality, in non-diabetic individuals with coronary artery disease.Clinical Trial Registration Information
Medicine, Angioplasty, or Surgery Study (MASS II). Unique identifier: ISRCTN66068876 URL. 相似文献19.
I Kuepfer C Schmid M Allan A Edielu EP Haary A Kakembo S Kibona J Blum C Burri 《PLoS neglected tropical diseases》2012,6(8):e1695
Objective
Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy.Design
Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator.Setting
Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda. Participants: Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded.Main Outcome Measures
The primary outcome measures were safety and efficacy at end of treatment. The secondary outcome measure was efficacy during follow-up after 3, 6 and 12 months.Results
The incidence of ES in the trial population was 11.2% (CI 5–17%) and 13% (CI 9–17%) in the historic data. The respective case fatality rates were 8.4% (CI 3–13.8%) and 9.3% (CI 6–12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalization time was reduced from 29 to 13 days (p<0.0001) per patient.Conclusions
The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No benefit could be attributed to the suramin pre-treatment.Trial Registration
Current Controlled Trials ISRCTN40537886 相似文献20.