Relationship of magnesium intake from food and water with blood pressure, hemodynamic parameters and arterial function in patients with essential arterial hypertension

Rezultati dosadašnjih istraživanja o povezanosti magnezijuma unetog hranom i vodom i serumskog magnezijuma sa krvnim pritiskom, hemodinamskim parametrima i funkcijom arterija kao i efektima suplementacije magnezijumom na navedene parametre kod obolelih od esencijalne arterijske hipertenzije su heterogeni. Ovo je bio razlog za preduzimanje našeg istraživanja. Ciljevi istraživanja su bili: 1) Proceniti unos magnezijuma hranom i vodom kod ispitanika sa hipertenzijom; 2) Ispitati povezanost magnezijuma unetog hranom i vodom i serumskog magnezijuma sa vrednostima krvnog pritiska, hemodinamskim parametrima i funkcijom arterija kod ispitanika sa hipertenzijom i 3) Ispitati promene vrednosti krvnog pritiska, hemodinamskih parametara i funkcije arterija posle uzimanja oralnog preparata magnezijuma kod ispitanika sa hipertenzijom. Metod. Istraživanje se sastojalo iz dve faze, i to iz studije preseka (prva faza) i iz interventne studije (druga faza). Studija je sprovedena u Multidisciplinarnom centru za polikliničku dijagnostiku, ispitivanje i lečenje poremećaja krvnog pritiska Kliničkog centra Srbije u Beogradu, u periodu od septembra 2014. godine do juna 2016. godine. Interventna studija je registrovana u Iranskom registru kliničkih studija (www.irct.ir; Registracioni broj: IRCT2017081535716N1). Studija je sprovedena u skladu sa Helsinškom deklaracijom, i odobrili su je Etički odbor Kliničkog centra Srbije u Beogradu i Etički komitet Medicinskog fakulteta Univerziteta u Beogradu. U prvu fazu istraživanja uključeno je 434 ispitanika (154 muških i 280 ženskih), starosti od 18 do 65 godina, sa prosečnom dobi 47,7±12,9 godina, sa dijagnozom esencijalne arterijske hipertenzije. U studiju nisu uključeni ispitanici sa oboljenjem bubrega, bolestima gastrointestinalnog trakta, dijabetesom melitusom, oboljenjima nadbubrežne, tireoidne i paratireoidne žlezde, anginom pektoris, infarktom miokarda, kongestivnom srčanom insuficijencijom, koronarnom revaskularizacijom, tranzitornim ishemijskim atakom, koarktacijom aorte, alergijom na hranu i lekove, trudnice i dojilje, i sa oralnom suplementacijom magnezijumom u prethodnih mesec dana...The results of previous studies on the association of magnesium intake from food and water and serum magnesium with blood pressure, hemodynamic parameters and arterial function as well as the effects of magnesium supplementation on the mentioned parameters in patients with essential arterial hypertension are heterogeneous. This was the reason for undertaking our study. The aims of the study were: 1) To evaluate the intake of magnesium from food and water in subjects with hypertension; 2) To examine the association of magnesium from food and water and serum magnesium with blood pressure, hemodynamic parameters and arterial function in subjects with hypertension and 3) To examine changes in blood pressure, hemodynamic parameters and arterial function after oral magnesium supplementation in subjects with hypertension. Method. The study comprised two phases, a cross-sectional study (first phase) and an intervention study (second phase). The study was performed in Multidisciplinary Center for Polyclinic Diagnostics, Assessment and Treatment of Blood Pressure Disorders, Clinical Center of Serbia, Belgrade. The intervention study was registered by The Iranian Registry of Clinical Trials (www.irct.ir; Registration number: IRCT2017081535716N1). The study was conducted in accordance with the declaration of Helsinki, and the study protocol was approved by the Ethics Committee of the Clinical Center of Serbia, Belgrade and by the Ethics Committee of the Faculty of Medicine, University of Belgrade, Serbia. The first phase of the study included 434 subjects (154 male and 280 female), aged from 18 to 65 years, with an average age of 47.7 ± 12.9 years, with the diagnosis of essential hypertension. The study did not include subjects with kidney disease, gastrointestinal tract disorders, diabetes mellitus, adrenal, thyroid and parathyroid gland diseases, angina pectoris, myocardial infarction, congestive heart failure, coronary revascularization, transient ischemic attack, aortic coarctation, food and drug allergy, pregnancy and lactation and oral magnesium supplementation during the previous one month..

Core Outcome Set for IgE ‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘ COMFA ’

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

Changes of Blood Pressure and Hemodynamic Parameters after Oral Magnesium Supplementation in Patients with Essential Hypertension—An Intervention Study

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

COMFA Protocol

IgE mediated food allergy (FA) is a healthcare problem, affecting millions of children and adults worldwide. Although the most commonly used approach to FA management is avoidance, intervention strategies are being increasingly researched, for instance immunotherapy. However, there is little agreement on what outcomes should be assessed in FA research, and how they should be measured. The lack of a core outcome set (COS) for FA may impede the ability to reliably evaluate new product development, and as a consequence, may adversely affect patients and other key stakeholders. Therefore, there is a need to identify critical outcomes to be included in clinical trials of food allergy treatments and observational studies. To address this need, an international consortium COMFA was formed comprising representatives of different stakeholder groups across several continents