ABSTRACT
BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.
Subject(s)
Food Hypersensitivity , Quality of Life , Humans , Delphi Technique , Food Hypersensitivity/diagnosis , Food Hypersensitivity/therapy , Immunoglobulin E , Outcome Assessment, Health Care , Research Design , Treatment Outcome , Clinical Trials as Topic , Observational Studies as TopicABSTRACT
A large amount of published research points to the interesting concept (hypothesis) that magnesium (Mg) status may have relevance for the outcome of COVID-19 and that Mg could be protective during the COVID disease course. As an essential element, Mg plays basic biochemical, cellular, and physiological roles required for cardiovascular, immunological, respiratory, and neurological functions. Both low serum and dietary Mg have been associated with the severity of COVID-19 outcomes, including mortality; both are also associated with COVID-19 risk factors such as older age, obesity, type 2 diabetes, kidney disease, cardiovascular disease, hypertension, and asthma. In addition, populations with high rates of COVID-19 mortality and hospitalization tend to consume diets high in modern processed foods, which are generally low in Mg. In this review, we review the research to describe and consider the possible impact of Mg and Mg status on COVID-19 showing that (1) serum Mg between 2.19 and 2.26 mg/dL and dietary Mg intakes > 329 mg/day could be protective during the disease course and (2) inhaled Mg may improve oxygenation of hypoxic COVID-19 patients. In spite of such promise, oral Mg for COVID-19 has thus far been studied only in combination with other nutrients. Mg deficiency is involved in the occurrence and aggravation of neuropsychiatric complications of COVID-19, including memory loss, cognition, loss of taste and smell, ataxia, confusion, dizziness, and headache. Potential of zinc and/or Mg as useful for increasing drug therapy effectiveness or reducing adverse effect of anti-COVID-19 drugs is reviewed. Oral Mg trials of patients with COVID-19 are warranted.
ABSTRACT
Objective: Although the studies have shown the beneficial effects of diet, nutrition, and supplementation as an independent treatment modality, their roles are underestimated in the treatment of peripheral nerve injuries. This is in great part due to the development of efficient nerve repair techniques, combined with physical treatment and stimulation. To achieve the best possible functional recovery diet, nutrition, and supplementation should be implemented within a multidisciplinary approach. The aim of the study is to provide insight into the potentially beneficial effects of diet, nutrients, and supplementation, in the limitation of nerve damage and augmentation of the functional recovery after surgery in a review of human and animal studies. Methods: The data relating to the diet, nutrients, and supplementation effects on peripheral nerve injuries and their treatment was extracted from the previously published literature. Results: General balanced diet as well as obesity influence the initial nerve features prior to the injury. In the period following the injury, neuroprotective agents demonstrated beneficial effects prior to surgery, and immediately after the injury, while those potentiating nerve regeneration may be used after the surgical repair to complement the physical treatment and stimulation for improved functional recovery. Conclusions: Standardized diet, nutrition, and supplementation recommendations and protocols may be of great importance for better nerve regeneration and functional recovery as a part of the multidisciplinary approach to achieve the best possible results in surgically treated patients with peripheral nerve injuries in the future.
ABSTRACT
The relationship between magnesium and hypertension has been intensively investigated in the last few decades. Most of the so far reviews were focused on either dietary magnesium or serum magnesium or magnesium supplements. Our goal was to merge these findings with a more comprehensive approach. Internet search was performed in PubMed database without date limits, using the following search terms "dietary magnesium," "serum magnesium," "magnesium supplements," "hypertension," "drinking water," "food," "endothelial dysfunction," "arterial smooth muscle," and "arterial spasms." In general, there exists an inverse dose-dependent relationship between dietary magnesium intake and serum magnesium and the risk of hypertension. A negative correlation has been found between the serum magnesium concentration and Framingham risk score and intima-media carotid thickness and cardiovascular mortality. On the other hand, concentration of extracellular magnesium in the normal range acts as a natural calcium channel blocker, eliminates endothelial dysfunction, increases nitric oxide, and induces direct and indirect vasodilatation. In conclusion, an average magnesium dietary intake is below the recommended values and magnesium supplementation in the prevention and treatment of hypertension might be justified.
Subject(s)
Hypertension , Magnesium , Carotid Arteries , Diet , Humans , Hypertension/drug therapy , VasodilationABSTRACT
The objective of this study was to examine the changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential hypertension. The single-arm non-blinded intervention study comprised 48 patients (19 men; 29 women) whose antihypertensive therapy was not changed for at least one month. The participants were asked to consume (daily at home) 300 mg of oral magnesium-oxide supplementation product for one month and to have their blood pressure and hemodynamic parameters (thoracic fluid content, stroke volume, stroke index, cardiac output, cardiac index, acceleration index, left cardiac work index and systemic vascular resistance index, heart rate) measured in the hospital before and after the intervention. Measurements were performed with impedance cardiography. After magnesium supplementation, systolic and diastolic pressures were significantly decreased (mean ± standard deviation (SD)/mmHg/from 139.7 ± 15.0 to 130.8 ± 13.4 and from 88.0 ± 10.4 to 82.2 ± 9.0, respectively; both p < 0.001). The two significant hemodynamic changes were the decrease of systemic vascular resistance index (dyn s m²/cm5) and left cardiac work index (kg m/m²)/mean ± SD from 2319.3 ± 753.3 to 2083.0 ± 526.9 and from 4.8 ± 1.4 to 4.4 ± 0.9, respectively; both p < 0.05). The observed hemodynamic changes may explain lowering blood pressure after magnesium supplementation.