Abdominal pain is a frequent occurrence in IgE-mediated food allergy, for which evidence-based acute treatments remain limited. Salbutamol, a short-acting β2-adrenergic agonist, may induce relaxation of gastrointestinal smooth muscle. To evaluate the efficacy of inhaled salbutamol versus placebo for the treatment of moderate-to-severe IgE-mediated abdominal pain reactions METHODS: This randomized, double-blind, placebo-controlled trial enrolled patients aged 6 to ≤55 years who developed moderate-to-severe abdominal pain during an oral food challenge or oral immunotherapy dose administration. Participants were randomized (1:1) to receive 800 μg of inhaled salbutamol or placebo. Participants self-reported pain intensity at one-minute intervals for 30 minutes using the Numerical Rating Scale (NRS-11). The primary outcome was time to patient-perceived adequate analgesia (PPAA). Twenty-four participants (median age 11.5y, 37.5% female) were randomized at a single center. The median time to PPAA was 6.0 minutes in the salbutamol group and was not reached by 30 minutes in the placebo group (HR = 0.35 [95%CI 0.12 - 0.99], p = 0.034). The median time to complete resolution of abdominal pain was 10.0 minutes with salbutamol and was not reached by 30 minutes in the placebo group (HR = 0.33 [95%CI 0.12-0.92], p = 0.027). The trial was terminated early due to changes in clinical practice resulting in slower-than-expected recruitment. In this prematurely terminated randomized trial, inhaled salbutamol was associated with faster relief of IgE-mediated, food allergy-related abdominal pain compared with placebo. These findings require confirmation in a larger, multicenter study. NCT05653024.
Obesity is a complex, chronic, stigmatized disease whereby abnormal or excess body fat may impair health or increase the risk of medical complications, and can reduce quality of life and shorten lifespan in children and families. We developed this guideline to provide evidence-based recommendations on options for managing pediatric obesity that support shared decision-making among children living with obesity, their families, and their health care providers. We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We used the Guidelines International Network principles to manage competing interests. Caregivers, health care providers, and people living with obesity participated throughout the guideline development process, which optimized relevance. We surveyed end users (caregivers, health care providers) to prioritize health outcomes, completed 3 scoping reviews (2 on minimal important difference estimates; 1 on clinical assessment), performed 1 systematic review to characterize families' values and preferences, and conducted 3 systematic reviews and meta-analyses to examine the benefits and harms of behavioural and psychological, pharmacologic, and surgical interventions for managing obesity in children. Guideline panellists developed recommendations focused on an individualized approach to care by using the GRADE evidence-to-decision framework, incorporating values and preferences of children living with obesity and their caregivers. Our guideline includes 10 recommendations and 9 good practice statements for managing obesity in children. Managing pediatric obesity should be guided by a comprehensive child and family assessment based on our good practice statements. Behavioural and psychological interventions, particularly multicomponent interventions (strong recommendation, very low to moderate certainty), should form the foundation of care, with tailored therapy and support using shared decision-making based on the potential benefits, harms, certainty of evidence, and values and preferences of children and families. Pharmacologic and surgical interventions should be considered (conditional recommendation, low to moderate certainty) as therapeutic options based on availability, feasibility, and acceptability, and guided by shared decision-making between health care providers and families. This guideline will support children, families, and health care providers to have informed discussions about the balance of benefits and harms for available obesity management interventions to support value- and preference-sensitive decision-making.
Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.
To provide updated, evidence-based recommendations concerning the effects of dietary salt intake on the prevention and control of hypertension in adults (except pregnant women). The guidelines are intended for use in clinical practice and public education campaigns. Restriction of dietary salt intake may be an alternative to antihypertensive medications or may supplement such medications. Other options include other nonpharmacologic treatments for hypertension and no treatment. The health outcomes considered were changes in blood pressure and in morbidity and mortality rates. Because of insufficient evidence, no economic outcomes were considered. A MEDLINE search was conducted for the period 1966-1996 using the terms hypertension, blood pressure, vascular resistance, sodium chloride, sodium, diet, sodium or sodium chloride dietary, sodium restricted/reducing diet, clinical trials, controlled clinical trial, randomized controlled trial and random allocation. Both trials and review articles were obtained, and other relevant evidence was obtained from the reference lists of the articles identified, from the personal files of the authors and through contacts with experts. The articles were reviewed, classified according to study design and graded according to level of evidence. In addition, a systematic review of all published randomized controlled trials relating to dietary salt intake and hypertension was conducted. A high value was placed on the avoidance of cardiovascular morbidity and premature death caused by untreated hypertension. For normotensive people, a marked change in sodium intake is required to achieve a modest reduction in blood pressure (there is a decrease of 1 mm Hg in systolic blood pressure for every 100 mmol decrease in daily sodium intake). For hypertensive patients, the effects of dietary salt restriction are most pronounced if age is greater than 44 years. A decrease of 6.3 mm Hg in systolic blood pressure and 2.2 mm Hg in diastolic blood pressure per 100 mmol decrease in daily sodium intake was observed in people of this age group. For hypertensive patients 44 years of age and younger, the decreases were 2.4 mm Hg for systolic blood pressure and negligible for diastolic blood pressure. A diet in which salt is moderately restricted appears not to be associated with health risks. (1) Restriction of salt intake for the normotensive population is not recommended at present, because of insufficient evidence demonstrating that this would lead to a reduced incidence of hypertension. (2) To avoid excessive intake of salt, people should be counselled to choose foods low in salt (e.g., fresh fruits and vegetables), to avoid foods high in salt (e.g., pre-prepared foods), to refrain from adding salt at the table and minimize the amount of salt used in cooking, and to increase awareness of the salt content of food choices in restaurants. (3) For hypertensive patients, particularly those over the age of 44 years, it is recommended that the intake of dietary sodium be moderately restricted, to a target range of 90-130 mmol per day (which corresponds to 3-7 g of salt per day). (4) The salt consumption of hypertensive patients should be determined by interview. These recommendations were reviewed by all of the sponsoring organizations and by participants in a satellite symposium of the fourth International Conference on Preventive Cardiology. They have not been clinically tested. The Canadian Hypertension Society, the Canadian Coalition for High Blood Pressure Prevention and Control, the Laboratory Centre for Disease Control at Health Canada, and the Heart and Stroke Foundation of Canada.
Synthetic phenolic antioxidants have been added to foods for decades to retard the autooxidation of lipid that leads to rancidity. The major antioxidants, butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA), are used in foods world wide. Recent studies suggest that BHA, and perhaps BHT, are carcinogenic to rodents. International efforts, including those at the HPB in Ottawa Canada, have helped place the results of the chronic rodent studies into perspective. It seems likely that the neoplastic effects observed at very high dietary levels of BHA and BHT occur only after effective biological defense mechanisms are overloaded. The renewed interest in the toxicity of phenols is beneficial to an understanding of the complex biological effects of naturally occurring phenolics, including reduction of the levels of reactive oxygen species that are associated with various disease states in an aging human population.
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Over a 5-year interval, experiments were conducted to determine if Mycobacterium avium ssp. paratuberculosis (Map) is associated with in vivo and in vitro fertilized (IVF) embryos and whether it can be transmitted by embryo transfer. The present studies included: collection of embryos from five asymptomatic, naturally infected donors and transfer to uninfected recipients; collection of oocytes from two naturally infected donors with overt clinical signs; exposure of in vivo and IVF embryos to Map and transfer to uninfected recipients; and the inoculation (transfer) of "clean" IVF embryos to the uterine lumen of infected cows. The presence of Map was confirmed in the uterine horns of all asymptomatic, infected donors. None of the tested embryos, which were not used for embryo transfer, or unfertilized ova (two per batch), were positive for Map, as determined by culture (n = 19) or by PCR (n = 13). However, all in vivo fertilized embryos exposed to Map in vitro (and subsequently sequentially washed) tested positive for Map, by both culture (12 batches) and PCR (15 batches), whereas IVF embryos treated in the same manner tested positive on culture (51%, 18/35 batches) and by PCR (28%, 20/71 batches). Transferring both in vivo embryos and IVF embryos potentially contaminated with Map into 28 recipients resulted in 13 pregnancies and eight calves born without evidence of disease transmission to either the recipients or the offspring over the following 5-year period. In samples collected from one of the clinically infected animals, two of seven (28%) cumulus oocyte complexes (COC) and follicular fluid tested positive by PCR and 10/10 cumulus oocyte complexes on culture for Map. From the second clinically infected cow, three of five batches of IVF embryos (n = 20) were positive on PCR and two of four batches containing unfertilized oocytes and embryos were positive on culture. Only 10% of embryos reached the morula and blastocyst stage 10 days after fertilization. In conclusion, Map is unlikely to be transmitted by embryo transfer when the embryos have been washed as recommended by the International Embryo Transfer Society.