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The objective was to conduct a systematic review and meta-analysis of randomized feeding trials to assess the effect of dietary pulses (beans, chickpeas, lentils, peas) on established lipid targets of cardiovascular disease (CVD) and perform a secondary analysis of our randomized feeding trial to assess whether dietary pulses as a means of lowering the glycemic index offer further CVD protection by reducing oxidative stress. The meta-analysis of 26 trials (n=1013) found dietary pulse interventions significantly lowered LDL-C compared with isocaloric control interventions (mean difference=-0.17mmol/L [95% CI: -0.25, -0.09]; p<0.0001). No treatment effects were observed for Apo-B and non-HDL-C. Our feeding trial found no significant differences between the high-dietary pulse diet and high-fibre control diet on markers of oxidative stress, including thiobarbituric acid reactive substances (TBARS), conjugated dienes (CDs), and protein thiols. Overall, the results suggest dietary pulses reduce LDL-C but not oxidative stress as a means of reducing cardiovascular risk.

The objective was to conduct a systematic review and meta-analysis of randomized feeding trials to assess the effect of dietary pulses (beans, chickpeas, lentils, peas) on established lipid targets of cardiovascular disease (CVD) and perform a secondary analysis of our randomized feeding trial to assess whether dietary pulses as a means of lowering the glycemic index offer further CVD protection by reducing oxidative stress. The meta-analysis of 26 trials (n=1013) found dietary pulse interventions significantly lowered LDL-C compared with isocaloric control interventions (mean difference=-0.17mmol/L [95% CI: -0.25, -0.09]; p<0.0001). No treatment effects were observed for Apo-B and non-HDL-C. Our feeding trial found no significant differences between the high-dietary pulse diet and high-fibre control diet on markers of oxidative stress, including thiobarbituric acid reactive substances (TBARS), conjugated dienes (CDs), and protein thiols. Overall, the results suggest dietary pulses reduce LDL-C but not oxidative stress as a means of reducing cardiovascular risk.

Motivation: Cardiovascular heart disease (CVD) is the leading cause of death worldwide. Risk markers for CVD include, amongst others, the haemostatic factors tissue-type plasminogen activator (t-PA), plasminogen activator inhibitor type 1 (PAI-1), factor VII (FVII) and fibrinogen and more recently, C-reactive protein (CRP), a sensitive marker of inflammation. Epidemiological studies have demonstrated an inverse association between dietary fibre (DF) consumption and risk factors for CVD and CVD prevalence. Some research indicates that this protection may be related to favourable changes in the haemostatic profile and inflammatory markers. This is applicable for the consumption of total DF, as well as soluble and insoluble fibre. However, clinical intervention trials report conflicting data on the effects of DF on t-PA, PAI-1, FVII, fibrinogen and CRP. In addition, available literature is not clear on the mechanisms through which DF may have favourable effects. Objective: The main objective of this study was to review the results of randomised controlled trials systematically on the effects of DF on the above-mentioned selected haemostatic variables and CRP in healthy adults and subjects with hypertriglyceridaemia and the metabolic syndrome. Methods: Human adult intervention trials, at least two weeks in duration, with an increased and measurable consumption of DF were included. Electronic databases were searched from the earliest record to May/July 2006 and supplemented by crosschecking reference lists of relevant publications. From the literature search, two reviewers identified studies that were rated for quality based on the published methodology. No formal statistical analysis was performed due to the large differences in the study designs of the dietary intervention trials. The primary outcome measures were percentage changes between intervention and control groups, or baseline to end comparisons for t-PA, PAI-1, FVII, fibrinogen and CRP. Results t-PA activity increased significantly (14-167%) over the short and long-term following increased fibre intakes. PAI-1 activity decreased significantly between 15-57% over periods ranging from two to six weeks. These favourable changes in t-PA and PAI-1 occurred in healthy, hypertriglyceridaemic and metabolic syndrome subjects following consumption of diets containing ≥3.3 g/MJ DF and ≥4.5 g/MJ DF respectively. Mechanisms through which DF may affect t-PA and PAI-1 include its lowering effect on insulinaemic and glycaemic responses, decreasing triglycerides which are a precursor of very-low-density lipoproteins, fermentation of DF to short-chain fatty acids, which may reduce free fatty acid concentrations, as well as the role of DF in promoting weight loss. High DF intakes did not have a significant effect on fibrinogen concentrations possibly because of relatively little weight loss, too low DF dosages and maintaining a good nutritional status. Inadequate study designs deterred from meaningful conclusions. Significant decreases in FVll coagulant activity (6-16%) were observed with DF intakes of ≥3.3 g/MJ and concomitant decreased saturated fat intakes and weight loss in healthy and hypertriglyceridaemic subjects. Confounding factors include weight loss and a simultaneous decreased intake of saturated fats. The type of fibre seems to play a role as well. Mechanisms through which DF may reduce FVll concentrations include its effects on triglyceride-rich lipoproteins, insulin and weight loss. Increased DF consumption with dosages ranging between 3.3-7.8 g/MJ were followed by significantly lower CRP concentrations (25-54%), however, simultaneous weight loss and altered fatty acid intakes were also present in all the studies. Mechanisms are inconclusive but may involve the effect of DF on weight loss, insulin, glucose, adiponectin, interleukin-6, free fatty acids and triglycerides. Conclusions: Epidemiological evidence indicates an association between DF and the CVD risk factors t-PA, PAI-1, FVII, fibrinogen and CRP. In general, the risk of CVD may improve with high-fibre intakes as indicated by the favourable changes in some of the parameters. However, simultaneous reduced fat intakes and weight loss presented difficulties in separating out the effects of specific components. Furthermore, DF is consumed in a variety of different forms and different dosages that may have different effects. Overall, the study designs used in the intervention trials prevented significant conclusions. DF did, however, play a role in modifying t-PA, PAI-1, FVII and CRP. Potential effects on fibrinogen were not quantifiable. Recommendations: The results from this investigation provide the motivation for additional controlled clinical research to establish the effect and mechanisms of DF on haemostatic variables and CRP. A critical aspect of future studies would be to set up suitable protocols. The amount of subjects, duration of the trials, confounding factors such as weight loss and altered fat intakes and differentiation between types and dosage of DF are important. DF supplemental studies are recommended as they may be the most suitable method to reach meaningful conclusions. / Thesis (Ph.D. (Nutrition))--North-West University, Potchefstroom Campus, 2007

Patients with mechanical heart valves who present with intracranial haemorrhage are initially treated by reversing their coagulopathy. However, these patients will ultimately require that their oral anticoagulant be restarted. The time at which oral anticoagulants are restarted is critical since restarting too early may increase the risk of recurrent bleeding, while withholding anticoagulants increases the patient’s risk of thromboembolic events. The ideal time to restart patients on their oral anticoagulant medication is defined as the time at which all these risks are minimized. This thesis includes a systematic review and meta-analysis of the literature. The main outcomes were recurrent haematoma, valve thrombosis, stroke and peripheral emboli. Results were stratified by types of intracranial haemorrhage. We also conducted a survey to gain insight into current practices of neurosurgeons and thrombosis experts in Canada and USA when they are faced with deciding on anticoagulant restart times in patients with ICH. Results were stratified by type of intracranial bleed and participants’ characteristics and demographics. The systematic review identified that the ideal time for restarting anticoagulant therapy in patients following an ICH is unknown. Meta-analysis was limited by the heterogeneity of the studies. The survey results indicated that physicians had a wide range of practice and that their practice was dependent on the patient’s clinical features, but many physicians would restart oral anticoagulants between 4 and 14 days after the haemorrhage. For this reason we have proposed a multi centre cohort study to investigate the safety and efficacy of restarting patients on anticoagulation therapy between day 5 and 9 post haemorrhage. A full study protocol is presented in this thesis.

The potential that telemedicine interventions may have in effectively delivering remote specialized cardiovascular care to large numbers of patients with heart diseases has recently come under question. In the first phase of this thesis, a systematic review and meta-analysis was conducted to compare the impact of a basic form of telemedicine that is regular patient follow-up by telephone, with usual care for individuals with coronary artery disease following their discharge. In the second phase of this thesis, a network meta-analysis, using Bayesian methods for multiple treatment comparisons, was conducted to compare the more complex forms of telemedicine for patients with heart failure. In the third and final phase of this thesis, a randomized controlled trial was designed to compare the impact of two forms of telemedicine, identified in the earlier two phases as being the most promising, on clinical outcomes, cardiac risk factors and patient reported outcomes.

Introduction: Based on the perceived risk to newborns and pregnancy outcomes associated with certain drugs, women may be hesitant to prescribe and take drugs during pregnancy. In cases like these, pregnant women may seek treatment using natural health products (NHPs) as alternatives to drugs. Unfortunately, evidence of safety in pregnancy and lactation is unknown for many NHPs. Objectives: To review the present state of evidence on the safety of NHPs during pregnancy and lactation. To create a new system to validate evidence on NHPs during pregnancy and lactation designed to affect medical decision. Methodology: NHPs were systematically reviewed and in some cases, meta-analyzed for evidence of safety during pregnancy and lactation. Results: In total, 79 NHPs were systematically reviewed and 2 NHPs were meta-analyzed in order to determine the evidence of safety in pregnancy and lactation. Despite the presence of data (72/79 NHPs in pregnancy and 53/77 NHPs in lactation), the quality of the data was generally poor. Using evidence-based medicine principles, a new system of evaluating evidence was established for studies involving NHPs in pregnancy and lactation. A number of NHPs were identified as being of potential risk in pregnancy. A number of NHPs were identified as potentially being apparently safe in pregnancy and lactation. Blue cohosh is of potential concern for harm in pregnancy given an apparent dose-dependant relationship. Conclusion: There is a large knowledge gap on the safety of NHPs in pregnancy, even more so in lactation. The new system for evaluating NHP safety in pregnancy and lactation will require validation. In order to improve the knowledge gap, future studies are proposed on NHPs in pregnancy and lactation as part of the newly formed MotherNature research network.

Introduction: Based on the perceived risk to newborns and pregnancy outcomes associated with certain drugs, women may be hesitant to prescribe and take drugs during pregnancy. In cases like these, pregnant women may seek treatment using natural health products (NHPs) as alternatives to drugs. Unfortunately, evidence of safety in pregnancy and lactation is unknown for many NHPs. Objectives: To review the present state of evidence on the safety of NHPs during pregnancy and lactation. To create a new system to validate evidence on NHPs during pregnancy and lactation designed to affect medical decision. Methodology: NHPs were systematically reviewed and in some cases, meta-analyzed for evidence of safety during pregnancy and lactation. Results: In total, 79 NHPs were systematically reviewed and 2 NHPs were meta-analyzed in order to determine the evidence of safety in pregnancy and lactation. Despite the presence of data (72/79 NHPs in pregnancy and 53/77 NHPs in lactation), the quality of the data was generally poor. Using evidence-based medicine principles, a new system of evaluating evidence was established for studies involving NHPs in pregnancy and lactation. A number of NHPs were identified as being of potential risk in pregnancy. A number of NHPs were identified as potentially being apparently safe in pregnancy and lactation. Blue cohosh is of potential concern for harm in pregnancy given an apparent dose-dependant relationship. Conclusion: There is a large knowledge gap on the safety of NHPs in pregnancy, even more so in lactation. The new system for evaluating NHP safety in pregnancy and lactation will require validation. In order to improve the knowledge gap, future studies are proposed on NHPs in pregnancy and lactation as part of the newly formed MotherNature research network.

Background: Laparoscopic surgery for colorectal cancer is a novel healthcare technology, for which much research evidence has been published. The objectives of this work were to compare the oncologic outcomes of this technology across different study types, and to define patterns of adoption on the basis of the literature. Methods: A comprehensive systematic review of the literature was conducted using 1) existing systematic reviews, 2) randomized controlled trials (RCTs), and 3) observational studies. Outcomes of interest were overall survival, and total lymph node harvest. Outcomes were compared for congruence. Adoption was evaluated by means of summary expert opinions in the literature. Results: 1) Existing systematic reviews were of low to moderate quality and displayed evidence of overlap and duplication. 2) Laparoscopy was not inferior to open surgery in terms of oncologic outcomes in any study type. 3) Oncologic outcomes from RCTs and observational studies were congruent. 4) Expert opinion in the literature has been supportive of this technology, paralleling the publication of large RCTs. Conclusions: The evaluation of laparoscopic surgery for colorectal cancer in RCTs and observational studies suggests that it is not inferior to open surgery. Adoption of this technology has paralleled RCT evidence.