Pediatric & Adult
55 Walls Dr., Fairfield, (203) 259-7070
500 Monroe Tpk, Monroe, (203) 445-1960
Dr. Kenneth Backman, Dr. Irena Veksler, and Dr. Katherine Bloom
Nasal irrigation appears beneficial in symptom improvement for patients with chronic sinusitis, according to a study published online July 18 in CMAJ, the journal of the Canadian Medical Association.
Paul Little, M.D., professor of primary care research at the University of Southampton in the United Kingdom, and colleagues followed 871 patients in England who had a history of chronic or recurrent sinusitis. Participants were assigned one of four treatments: daily nasal irrigation with saline plus use of an instructional video; daily steam inhalation; a combination of both; or their usual treatment. Usual care was at the discretion of the patient's physician and could include the use of antibiotic medications. The team assessed Rhinosinusitis Disability Index (RSDI) scores as the primary outcome.
At three months and six months, the researchers found that patients who used nasal irrigation had improved RSDI scores. Fewer participants in the nasal irrigation group (compared to no-irrigation patients) took over-the-counter medications, had headaches, or intended to consult a doctor in future episodes. Those using steam inhalation said headaches had eased, but had no significant improvement in RSDI scores. Adverse effects were similar in both intervention groups.
"Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective," the authors write. "A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit."
Source: Little P, Stuart B, Mullee M, et al. Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial [published online July 18, 2016]. CMAJ. doi: 10.1503/cmaj.16
Dr. Katherine Bloom of Allergy & Asthma Care comments: "Saline irrigation has been found to be effective in controlling symptoms and improving outcomes in sinusitis. This study adds to the evidence that nasal saline irrigation is a worthwhile intervention."
Prenatal supplementation with omega-3 (n-3) long-chain polyunsaturated fatty acids (LCPUFA) does not reduce immunoglobulin E (IgE)-associated allergic disease in children, according to a study published online May 25 in Pediatrics.
Karen P. Best, R.N., Ph.D., from the South Australian Health and Medical Research Institute in Adelaide, and colleagues assessed 706 children with a family history of allergic disease from the Docosahexaenoic Acid to Optimize Mother Infant Outcome trial at six-year follow-up. Women enrolled in the trial were randomized to n-3 LCPUFA-rich fish oil capsules or vegetable oil capsules.
The researchers found that the percentage of children with any IgE-associated allergic disease did not differ between the n-3 LCPUFA and control groups (31.5 versus 31.5 percent; adjusted relative risk, 1.04; 95 percent confidence interval, 0.82 to 1.33). The percentage of children sensitized to house dust mite Dermatophagoides farinae was reduced in the n-3 LCPUFA group (13.4 versus 20.3 percent; adjusted relative risk, 0.67; 95 percent confidence interval, 0.44 to 1.00).
"Prenatal n-3 LCPUFA supplementation did not reduce IgE-associated allergic disease at 6 years of age," the authors write. "Secondary outcomes were suggestive of a protective effect of the intervention on the incidence of D. farinae sensitization."
Source: Pediatrics 2016
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While some reduction in dust mite sensitization (IgE production to dust mite) was seen in children of mothers who took fish oil during pregnancy, the actual incidence of allergic disease did not appear to be reduced by fish oil. There are certainly many benefits of fish oil, but this study suggests that prenatal prevention of allergic disease does not appear to be one of them."
The safety of long-acting beta-agonists (LABAs) such as salmeterol and formoterol, in medications such as Advair, Symbicort, Dulera, and Breo, has been widely debated. Large, poorly structured trials in the past have shown increased risk of serious asthma related events in patients on LABAs, but many patients were on these without adequate asthma controller medication.
A new study published in the New England Journal of Medicine (May 12 2016) addresses this issue. A multicenter, randomized, double-blind trial of adolescent and adult patients with persistent asthma randomized patients to either fluticasone with salmeterol or fluticasone alone for 26 weeks. All patients had a history of a serious asthma exacerbation in the year before study onset, though not the previous month. Patients were excluded if they had life threatening or unstable asthma. The primary end point was the first series asthma related event (death, incubation, or hospitalization.)
Of 11,679 patients enrolled, 67 had 74 serious asthma related events, with similar numbers in both groups and no statistically significant different between them. There were no asthma related deaths, and only 2 intubations, both in the fluticasone group. The risk of asthma exacerbation was 21% lower in the fluticasone-salmeterol group vs. the fluticasone only group.
The conclusions of the study were that salmeterol in fixed dose combination with fluticasone did not lead to a significantly higher risk of serious asthma-related events, and patients on fluticasone-salmeterol combination therapy had fewer severe asthma exacerbations than the fluticasone only group.
(N Engl J Med 2016;374:1822-30)
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "There has been concern about the safety of LABAs since a couple of poorly designed studies over a decade ago. Several smaller studies have shown no danger of LABAs when combined with inhaled corticosteroid, but this large, very well designed study is the most reassuring so far that inhaled steroid-LABA combination therapy is safe and puts asthma patients at no increased risk of exacerbations or adverse effects. In fact, the combination therapy actually reduced the risk of exacerbations. There is still a need for further studies, because this study did not include children under 12, and excluded patients with very severe, life-threatening asthma."
Although anaphylaxis accounts for an increasing percentage of all pediatric emergency department (ED) visits, early use of epinephrine before ED arrival is associated with a lower likelihood of requiring multiple doses of epinephrine in the ED, Canadian researchers report.
Epinephrine use before ED arrival was the only factor associated with a reduced risk for multiple ED epinephrine doses among pediatric patients with anaphylaxis, write Elana Hochstadter, MD, from the Department of Pediatric Emergency Medicine at the University of Toronto's Hospital for Sick Children, Ontario, Canada, and colleagues. The researchers reviewed 965 anaphylaxis cases from Montreal Children's Hospital that were included in the Cross-Canada Anaphylaxis Registry (C-CARE), which tracks individuals presenting to EDs or emergency medical services with the condition.
More than 25% of moderate/severe anaphylaxis cases did not receive epinephrine inside or outside the hospital, and "[o]nly 50.7% (95% CI, 45.9-55.4) of those who had an epinephrine autoinjector used it before arrival to the ED," the authors write in a letter to the editor published online April 20 in the Journal of Allergy and Clinical Immunology. Factors associated with an increased likelihood of receiving multiple doses of epinephrine in the ED were older age, a severe reaction, and anaphylaxis cases triggered by peanuts, tree nuts, and milk .
The percentage of anaphylaxis cases among all ED visits more than doubled from April 2011 to April 2015, going from 0.20% to 0.41%, with the largest annual increase seen between 2013-2014 and 2014-2015 (0.11%). The median age of patients was 5.8 years. Almost half of patients reported a known food allergy, and asthma and eczema were reported in almost 20% of patients. Most cases (85.3%)were referred to an allergist after the ED visit or already had consulted with an allergist. Food was the most common trigger of anaphylaxis in the study, responsible for 80% of cases, with peanut responsible for 22.2%. Most reactions were moderate in severity; asthma (OR, 2.3) and eczema (OR, 2.1) were associated with severe reactions.
Although the results are from just one center, "they suggest a worrisome increase in anaphylaxis rate that is consistent with the worldwide reported increase," the authors note. "Both our study and US studies reveal that a higher percentage of pediatric ED visits are due to anaphylaxis in North America compared with European centers. This likely reflects differences in the prevalence of food allergies between North America and Europe."
From J Allergy Clin Immunol. Published online April 20, 2016.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This study reinforces the importance of early administration of epinephrine in all cases of anaphylaxis. While anaphylaxis is on the rise, we have an extremely effective treatment in epinephrine, and it is important that it be administered as soon as anaphylaxis is suspected."
As another potentially bad pollen season approaches, clinicians can help patients with allergies manage their symptoms with recommendations from the American College of Allergy, Asthma, and Immunology (ACAAI).
“Unfortunately, it's true that in the past few years, the amount of pollen in the air during spring allergy season seems to have gotten worse,” says allergist Bryan Martin, DO, president of the ACAAI. “One of the reasons is the effects of climate change. Increased carbon dioxide from longer growing seasons as a result of warmer weather has a positive effect on pollen production. That means a negative effect on those suffering from pollen allergens.”
To help patients with allergies combat their symptoms, the ACAAI has released a number of tips.
The most effective treatment for allergies is immunotherapy (also known as allergy shots), though treatment is gradual with a therapy duration of 3 to 5 years, according to the ACAAI. The organization rates it as a good option for patients seeking a natural treatment for their allergies, though immunotherapy is usually only recommended for patients who are selectively sensitive to several allergens.
Although many patients with allergies self-medicate using over-the-counter options, clinicians are advised to suggest prescription medications. A recent study found that prescription medications were more effective than over-the-counter options for alleviating allergy symptoms. To make these medications even more effective, the ACAAI recommends encouraging patients to start taking their prescription allergy medication 2 to 3 weeks before their symptoms usually manifest. This can help reduce overall symptom severity.
If patients are looking for small, easy changes that can help manage their symptoms, clinicians can recommend the following:
Source: www.clinicaladvisor.com, March 23, 2016
Infants who are fed peanuts within the first 11 months of life are less likely to develop peanut allergies, even if they take a break from eating the nuts when they're older, according to a new study.
Called the LEAP-on study, it followed a study called LEAP (Learning Early About Peanut Allergy) in which approximately 600 high risk children were examined for peanut allergies. In the LEAP study, about half of the children avoided peanuts and the other half were advised to eat peanuts during their first year of life. Researchers found out that among the children who avoided peanuts, 35 percent tested positive for a peanut allergy with a skin prick test, whereas among the children fed peanuts regularly, just 11 percent tested positive for the allergy.
For the LEAP-on study, which was published today in the New England Journal of Medicine, researchers examined 556 children involved in the LEAP study to see if there were effects of avoiding peanuts for a year later in life. Researchers had both groups -- those who ate peanuts early in life and those who did not -- stop eating any peanut products for a year starting at age 5. About 18.6 percent in the peanut-avoidance group and 4.8 percent of the peanut-consuming group showed an allergy to peanuts at the beginning of the second study. "The aim of our study was to find out whether infants who had consumed peanut in the LEAP study would remain protected against peanut allergy after they stopped eating peanut for 12 months," Professor Gideon Lack, lead author of the study and head of pediatric allergy at King's College London and head of the Children's Allergy Service at Guy's and St. Thomas' National Health Service Foundation Trust, said today. "LEAP-on clearly demonstrates that the majority of infants did in fact remain protected and that the protection was long-lasting," he said.
The study authors found that there was no statistically significant increase in the number of children who developed a new peanut allergy after avoiding peanuts for a year. Three children from each group developed a peanut allergy by the end of the year. The study authors said more work is needed to be done to understand how the amount of peanuts consumed affects allergy risk. "We need more research to better understand the mechanisms behind the development and prevention of allergic responses to peanut, and how this might translate to other food allergies," Dr. George Du Toit, co-investigator of the study and consultant in pediatric allergy at Guy's and St. Thomas' NHS Foundation Trust, said in a statement. "However, it is reassuring that the highly protective intervention demonstrated in LEAP was not only safe, nutritionally favorable and acceptable to participant families but also sustained even with cessation of peanut consumption for 12 months," he said. Peanut allergy has been a growing problem in the U.S., according to the American College of Allergy Asthma and Immunology.
Dr. Lolita McDavid, a pediatrician at University Hospitals Rainbow Babies and Children’s Hospital, said the study reaches some important findings. "Why these studies are important is the global allergy to peanuts has been growing," McDavid said. "This was not seen in the past. There are a lot of cultures where peanut is a staple in the diet." Parents who want to desensitize high-risk children to peanuts should talk to a doctor so that children don't have a dangerous reaction to eating peanuts, she said. "Talk to a pediatric allergist and they can do a skin prick test and you can find out whether they’re allergic or not," McDavid said. Exposure to peanuts in high risk children or those with signs of peanut allergies needs "to be done under a doctor’s supervision. You have to have an epipen available."
Dr. Katherine Bloom of Allergy & Asthma Care comments: "This study builds on the original LEAP study, which demonstrated that peanut allergy can be prevented in high risk children through early introduction. It is exciting news that this beneficial preventive effect persists even if peanut is subsequently removed from the diet. While these studies only included children with moderate to severe eczema or egg allergy, it is suspected that early introduction may be beneficial for all infants. More research is needed in this exciting area."
Posted on March 05, 2016 | Permalink
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Children whose mothers took certain asthma drugs during pregnancy may have an increased risk of autism, a new study suggests. The study, published online Jan. 6 in Pediatrics, found a connection between autism risk and prenatal exposure to drugs called beta-agonists. They are most often used to control asthma, and include inhaled medications such as albuterol, salmeterol (Serevent) and formoterol (Foradil). Researchers said the findings do not prove cause and effect, and stressed that women with asthma should not simply abandon their medication during pregnancy.
"Uncontrolled asthma in pregnancy has been associated with poor birth outcomes, such as preterm birth, low birth weight and admission to the neonatal intensive care unit," said lead researcher Nicole Gidaya, of Drexel University, in Philadelphia. What's more, preterm delivery and low birth weight have been tied to an increased autism risk. Geraldine Dawson, director of the Duke Center for Autism and Brain Development at Duke University, in Durham, N.C., made the same point. Taking beta-agonists during pregnancy has both potential benefits and potential risks for the developing fetus, said Dawson, who wrote an editorial published with the study. "It's important for a woman taking these drugs to talk with her physician and make an individual decision based on her unique circumstances," Dawson said.
Beta-agonists come in both short-acting forms -- which are used to treat asthma attacks -- and long-acting forms, which are taken regularly to help prevent attacks. Gidaya said her study did not differentiate between the two. Scientists generally agree, though, that autism arises from a combination of genetic vulnerability and certain environmental exposures. Many genes have been linked to autism risk, and the list of environmental suspects is growing. Birth complications -- especially ones that cause oxygen deprivation -- are among them, according to the advocacy group Autism Speaks. So are prenatal exposures to certain infections, air pollution and some medications, such as the anti-seizure drug valproic acid, the group said. According to Gidaya, it's plausible that beta-agonists could affect fetal brain development in a way that raises the risk of autism. Given to pregnant lab rats, the drugs can affect fetal nerve cell development.
For the new study, Gidaya's team combed through Denmark's system of national databases to find information on 5,200 children diagnosed with an autism spectrum disorder. The researchers compared them with 52,000 children of the same age without autism. Overall, just under 4 percent of children with autism had been exposed to a beta-agonist, versus just under 3 percent of other kids. When the researchers controlled for other factors -- including mothers' asthma, parents' age and birth complications -- children exposed to beta-agonists in the womb were still 30 percent more likely to develop autism. But while that number might sound big, it is actually a "modest" increase in autism risk, Dawson said.
Plus, there are other factors the researchers could not account for, such as exposure to pollutants, Gidaya said. According to Dawson, more research is needed to confirm the link between beta-agonists and autism. If the drugs are a risk factor, Gidaya said, studying the biology behind it could help researchers gain a better understanding of how autism arises.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While this study is concerning, it does not imply causation but merely found an association between beta-agonist use and the risk of autism. Control of asthma is very important in pregnancy to protect both the mother and the developing child. This study emphasizes the importance of asthma control to avoid the need for quick relief, bronchodilator medications. We encourage any concerned patients to speak with their physician before making any medication changes."
People who experience occasional migraine headaches may be at greater risk of developing chronic migraine headaches if they also have asthma, according to a study published online in November in the journal Headache, a publication of the American Headache Society.
“Migraine and asthma are disorders that involve inflammation and the activation of smooth muscle, either in blood vessels or in the airways,” says Richard Lipton, MD, director of the Montefiore Headache Center and the Edwin S. Lowe Chair in Neurology at the Albert Einstein College of Medicine, New York City. “Therefore, asthma-related inflammation may lead to migraine progression.” The study, led by Vincent Martin, MD, co-director of the Headache and Facial Pain Program at the University of Cincinnati Neuroscience Institute, involved 4,500 individuals.
Researchers found that those diagnosed with asthma were more than twice as likely to progress to chronic migraine compared to those without asthma. Further, the risk of worsening migraine increases with the severity of asthma symptoms, Dr. Lipton says. Migraine headaches are chronic when they occur in an individual 15 or more days per month. About 12 percent of the U.S. population experiences migraine headaches, according to the American Migraine Prevalence and Prevention Study (AMPP), which was directed by Dr. Lipton. Migraines are three times more common among women than men.
According to Dr. Lipton, people with asthma who experience migraine headaches should do the following: 1) Manage each condition by learning to identify and avoid triggers for asthma flares and migraine headaches. “Migraine is often triggered by hormonal changes, stress, not enough sleep and a range of dietary factors,” he says. 2) Talk with your primary care doctor about preventive medications that can reduce the frequency of migraine headaches, especially if they increase to more than three or four per month. 3) Review all prescription and over-the-counter medications, as well as vitamins and supplements, with your healthcare team, as some might conflict. For instance, people with asthma should avoid certain migraine medications, including beta blockers (such as propranolol), which can impact lung function.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This confirms a trend others have reported about a connection between migraines and allergies and asthma. It is not clear whether better control of asthma will lead to improvement in migraines, but it is always important to keep asthma under good control. Speak with your doctor if you are using your rescue inhaler for symptom relief more than twice a week."
Posted on December 16, 2015 | Permalink
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Food allergy is common, especially in early childhood, and eczema, another allergic condition, often co-exists in children with food allergy. Food allergy has previously been associated with lower height and weight in cross-sectional studies in children. However, no previous studies have investigated the combined effect of food allergy and eczema on growth in early childhood. In addition, the effect of resolved and persistent food allergy and eczema on height and weight throughout early childhood has not been reported.
Beck et al report in The Journal of Allergy and Clinical Immunology: In Practice the analysis of growth parameters in children with persistent and resolved food allergy and eczema at ages 1 and 4 years. The Healthnuts study, a population based cohort of over 5,000 children from Melbourne, Australia, recruited infants at age 1 and followed them up at 4 years of age. All infants underwent skin prick testing at 1 year of age to peanut, egg, and sesame, and those sensitized went on to oral food challenges. Food challenges repeated at age 4 determined resolution or persistence of food allergy. Eczema status, as well as height and weight were collected at both ages.
Children with both food allergy and eczema at age 1 had lower weight and height at age 1 compared to those with neither condition. However, for children with only food allergy or only eczema there was no difference in growth parameters. By age 4, children who had grown out of their food allergy had caught up and had no differences in height or weight. Those who had persistent food allergy at age 4 were still shorter and lighter, irrespective of their eczema status.
This study indicates that children with both food allergy and eczema in infancy should be closely followed up. This is the case for children with any food allergy, not just those with allergies to nutritionally important foods. These children and their families should receive good dietary guidance and eczema management to ensure optimum growth. Parents should speak with their pediatricians about nutritional counseling.
From AAAAI and JACI-In Practice
Sanofi US, the manufacturer of Auvi-Q, has recalled all Auvi-Q devices from the market due to reports of malfunctions and inaccurate doses being administered. If you or your child has a life-threatening allergy and you have Auvi-Q devices, please call your doctor's office as soon as possible for a prescription for an alternative epinephrine auto injector. Patients of Allergy & Asthma Care of Fairfield County should contact our office, or your pharmacy (who will contact us,) as soon as possible.
Researchers in Dresden, Germany, have demonstrated that allergy immunotherapy can effectively prevent asthma in patients with allergic rhinitis in a realistic setting.
Doctors reviewed routine healthcare data from German National Health Insurance beneficiaries which helped them identify a cohort of about 118,754 patients who chronically suffered from allergy symptoms but did not have asthma. This means they had not been previously diagnosed with asthma, did not have documented physician contacts due to asthma symptoms and did not have prescriptions filled for corticosteroids. They used this information to track new appearances of asthma between 2007-2012 and compared patients who had been treated with immunotherapy against those who had never been exposed to immunotherapy.
“Counts and percentages were calculated for each confounding, outcome and exposure variable,” Jochen Schmitt, MD, MPH, said. “We discovered that allergy immunotherapy being used in routine clinical care effectively prevents the onset of asthma. Most pronounced preventive effects were observed for subcutaneous immunotherapy, immunotherapy containing native allergens, and immunotherapy administered for at least three years.”
Patients with allergic rhinitis are at increased risk for the development of asthma. Allergy immunotherapy is one method of treating allergic rhinitis and it’s recognized in the U.S. by the Food and Drug Administration in two forms. The first is subcutaneous immunotherapy or allergy shots. The second is sublingual immunotherapy or allergy tablets. Both are forms of long-term treatment that decrease symptoms for many people with allergic rhinitis, allergic asthma, conjunctivitis (eye allergy) or stinging insect allergy. They work to decrease sensitivity to allergens and often lead to lasting relief of allergy symptoms, even after treatment has ended.
In total, 2,431 patients had been exposed to allergy immunotherapy (2% of the cohort). The risk of incident asthma was significantly lower in these patients – only 33 out of 1,646 patients who had a new diagnosis of asthma were exposed to immunotherapy. Patients with asthma also received, on average, higher doses of antihistamines and had more physician contact due to allergic rhinitis or allergy symptoms.
“In patients with allergic rhinitis, allergy immunotherapy should be considered to prevent asthma. By reducing the primary risks for developing asthma, we can directly address and improve the burden of the disease for the patients and present significant cost savings for the healthcare system,” Schmitt concluded.
More information on asthma and immunotherapy is available at the AAAAI website. This study was accepted in September and currently appears as an article in press in The Journal of Allergy and Clinical Immunology.
Posted on October 01, 2015 | Permalink
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Seasonal allergic rhinitis (AR) is just one of many conditions that can cause nasal congestion, and the impact on sufferers and society is substantial, including lost work productivity and impairments in sleep and quality of life. Of the four main symptoms of AR (itchiness, sneezing, runny nose, and nasal congestion), nasal congestion occurs most often and is considered by people with AR to be more bothersome than the other symptoms. With limitations placed on the over-the-counter sale of pseudoephedrine (a decongestant shown to be effective) since 2006, Phenylephrine HCL (PE) has increasingly entered the marketplace and is widely used by consumers for the treatment of nasal congestion. Based on IMS Health Incorporated state-level data it is possible that the annual cost to American society of using PE for nasal congestion is upwards of half a billion dollars. Yet despite decades of widespread use and a Food and Drug Administration (FDA) indication of 10 mg every 4 hours for the temporary relief of nasal congestion, the most effective dose of PE and duration of action for nasal congestion are unknown. In fact, there have been no large-scale, well-conducted, peer-reviewed clinical studies published supporting the effectiveness of PE for the relief of nasal congestion.
In a recently published article in The Journal of Allergy and Clinical Immunology: In Practice, Meltzer and colleagues reported results from a clinical trial that randomly assigned 539 adults with seasonal AR who were suffering from nasal congestion but were otherwise healthy to receive one of four doses of PE (10 mg, 20 mg, 30 mg, or 40 mg) or placebo tablets that looked similar to the PE tablets. Participants took the study medication for 7 days, approximately every 4 hours, and recorded in a diary, using a 4-point scale, how congested they felt. These assessments included self-evaluation of symptom severity over the preceding 12 hours and at the moment of assessment prior to the next dose.
The results showed that even though PE was well tolerated at doses up to 30 mg, none of the doses (10–40 mg) showed any statistically significant difference in nasal congestion scores compared with placebo. It is likely that similar results would be seen in patients suffering from nasal congestion due to other causes such as nasal membrane swelling from irritants and the common cold.
The study was conducted in response to calls by the FDA upon the pharmaceutical industry to conduct large, well-designed, dose-ranging studies to assess the effectiveness of PE for the relief of nasal congestion. The authors conclude that consumers and healthcare practitioners should be warned about the ineffectiveness of PE to relieve nasal congestion, and the FDA should revise their labeling for PE accordingly.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "For many years, pseudoephedrine was the main oral decongestant used in over-the-counter allergy and cold medications. When this was moved behind the counter (due to its use in the manufacture of "crystal meth") many pharmaceutical companies substituted phenylephrine into their products to allow them to remain OTC. Unfortunately, many patients have found these products to be less effective, and this study confirms that phenylephrine is not as effective as pseudoephedrine."
DBV Technologies recently announced it has received the green light from the Food and Drug Administration (FDA) to begin a global Phase III trial using Viaskin® Peanut (also known as the “peanut patch”). This is the first time that a drug for food allergy has reached Phase III – a step in the clinical trial process during which a drug or treatment is given to a larger group of people to confirm its effectiveness and collect information that will allow it to be used safely.
The anticipated Phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES), which will enroll children ages 4 to 11, is expected to begin later this year following submission of the final clinical trial protocol and review by the FDA. PEPITES is planned as a randomized, double-blind, placebo-controlled trial with about 260 patients from 35 sites in North America, Australia and Europe.
DBV Technologies’ primary goal is to show that its therapy significantly reduces an individual’s sensitivity to peanut; this would help them avoid a life-threatening allergic reaction from accidental ingestion. This endpoint could potentially increase the study’s clinical relevance by better showing that the therapy increases safety for people with peanut allergy. This is the first specific therapy for food allergy to be approved to enter a Phase III trial, which is the final phase before consideration by the FDA for approval in the market.
The company also plans to conduct additional separate clinical trials in younger and older patients.
Earlier this year, DBV Technologies presented clinical data on the company’s Phase 2b trial, the results of which continue to support the effectiveness and safety of the peanut patch. This data showed that 50 percent of children were able to tolerate an oral challenge of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The study’s authors say this threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions to potential peanut traces in foods.
(Source: FARE newsletter)
Dr. Kenneth Backman of Allergy & Asthma Care comments: "This product represents an exciting advance in the potential treatment of food allergies. It offers the possibility of reducing a patient's sensitivity to peanut without the potential risks of oral desensitization. We are hopeful that phase III trials will be successful and that the patch will be available within the next few years."
The AAAAI recently commented on the safety of asthma inhalers in patients allergic to soy and peanuts despite some concern based on misperceptions regarding ingredients in the inhalers. A similar concern has been raised regarding possible food allergens in intravenous medications used for anesthesia. Propofol is an intravenous medication used for anesthesia prior to some surgical and other medical procedures and for some people on ventilators. The propofol is mixed in a liquid containing soybean oil and a substance called egg lecithin. Lecithin is a fatty substance found in some plant and animal tissues.
Patients who are allergic to foods, including soy and egg, are allergic to proteins in the foods and are not allergic to the oils or fats in the foods. Soybean oil and egg lecithin may contain trace amounts of residual protein, however no allergic reactions have been demonstrated to be caused by this. Although peanuts and soybeans are both in the legume family, the overwhelming majority of peanut-allergic patients are not clinically allergic to soy, and even if they were, would not be expected to react to soybean oil.
There are reports of reactions to propofol involving hives or other symptoms of systemic allergic reactions (anaphylaxis). However, most reports of anaphylaxis to propofol have occurred in patients without egg allergy and the vast majority of patients with egg allergy receive propofol without reaction. Some patients may be allergic to the propofol itself. Also, most patients who react after receiving propofol have received other drugs at the same time that can cause or worsen anaphylaxis, including antibiotics, muscle relaxants and narcotic pain medications. Thus, although it is clear that propofol can cause anaphylactic reactions, the cause of these reactions is unclear and appears not to be related to soy or egg allergy.
The bottom line: Patients with soy allergy or egg allergy can receive propofol without any special precautions. Any patient, whether soy or egg-allergic or not, who has an apparent allergic reaction to propofol should be evaluated by an allergist.
Additional information on food allergies.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "Anesthesiologists have generally denied propofol to patients with a history of soy or egg allergy. It is reassuring to know that this useful anesthetic is safe in these patients."
New York Magazine has released its 2015 list of Top Doctors in the New York / Tristate area. Allergy & Asthma Care of Fairfield County is proud to announce that Dr. Kenneth Backman, the founder of Allergy & Asthma Care, is the only allergist in Connecticut included in this prestigious annual listing. To see the list of allergists in New York Magazine, click here. To learn more about Dr. Backman or our other health care providers, click on the link to the right. For an appointment with our office, please call 203-259-7070.
The recent publication of the LEAP study in the New England Journal of Medicine(click here for more) has led to recent guidance on the early introduction of peanut into the diet of high risk infants. Here is the recommendation offered by a collaboration of the American Academy of Pediatrics, American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology, and multiple international medical societies:
Based on data generated in the LEAP trial and existing guidelines, the following interim guidance is suggested to assist the clinical decision-making of healthcare providers:
• There is now scientific evidence (Level 1 evidence from a randomized controlled trial) that healthcare providers should recommend introducing peanut-containing products into the diet of “high-risk” infants early on in life (between 4 – 11 months of age) in countries where peanut allergy is prevalent, since delaying the introduction of peanut may be associated with an increased risk of developing peanut allergy.
• Infants with early-onset atopic disease, such as severe eczema, or egg allergy in the first 4-6 months of life may benefit from evaluation by an allergist or physician trained in management of allergic diseases in this age group to diagnose any food allergy and assist in implementing these suggestions regarding the appropriateness of early peanut introduction.
Rationale for evaluating and applying this policy to a high-risk population
The LEAP study demonstrates that early peanut introduction can be successfully carried-out in high-risk population (such as the population defined in the LEAP trial). However, without intervention by healthcare providers, there is the potential that such high-risk infants will remain at risk for delayed introduction of solids and allergenic foods into their diet, because of the widespread belief that such foods may exacerbate eczema.
Accidental exposures to peanut allergens in children are more likely to occur at home than at schools, and most events are managed inappropriately, according to study results. “We discovered that children are most at risk of exposure in their own homes,” Sabrine Cherkaoui, MD, division of allergy and clinical immunology, University of Montreal, said in a press release. “Furthermore, when children do have a moderate or severe reaction to an exposure, parents and medical professionals often do not know how to react appropriately.”
Cherkaoui and colleagues recruited 1,941 children with peanut allergy from two hospitals and allergy advocacy organizations between 2004 and 2014. Patient demographics, history of atopy and initial reaction to peanut were collected through questionnaires, and accidental exposures (AEs), including food ingested, signs, symptoms, location and treatment, were recorded. Five hundred and sixty-seven AEs occurred in 429 patients across 4,589 patient-years for an annual incidence rate of 12.4%. Initial reactions to peanut were considered moderate (50.1%), mild (26.3%) and severe (11.3%).
Thirty-seven percent of AEs occurred at the child’s home, 14.3% occurred at a relative or friend’s house, 9.3% occurred at a restaurant, and 31.6% took place at unknown locations. Exposures at school were minimal: 4.9% occurred at schools prohibiting peanut, and 3% took place at schools that allowed peanut. No epinephrine was administered to 36.5% of participants with mild AEs, 25.6% of participants with moderate exposures and 14.1% of participants with severe exposures. The researchers said longer disease duration, likely due to adjustments made over time, reduced the risk for an AE (adjusted HR = 0.9; 95% CI, 0.88-0.93).
“The most significant finding of this study is the discovery that most moderate and severe accidental exposures are managed inappropriately by caregivers and physicians,” Cherkaoui said in the release. “We believe that more education is required on the importance of strict allergen avoidance and the need for prompt and correct management of anaphylaxis.”
From: Cherkaoui S, et al. Clin Transl Allergy. 2015;doi:10.1186/s13601-015-0055-x.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: This is an interesting study that points out that accidental exposures can occur anywhere, particularly in the home. It is critically important that all patients/families have a written food allergy action plan that they have reviewed in advance."
The time a mother spends breast-feeding her child has no impact on the development of allergy sensitization in children at high risk for developing allergies, according to recent study results.
“Our thorough analyses have shown no effect of breast-feeding on the development of sensitization. This is contrary to the general opinion and current health recommendations,” Ea Cecilie Jelding-Dannemand, MSc, of the University of Copenhagen, and colleagues wrote. “This perception of breast-feeding as an important protection against allergy might cause mothers of children who are at high risk of allergy-associated diseases to feel guilty and distressed if they are not able to breast-feed exclusively for the recommended period of time.”
The researchers analyzed the data of 335 children from the Copenhagen Prospective Study on Asthma in Childhood 2000 birth cohort from August 1998 to December 2001. The children were born to mothers with a history of asthma. The researchers’ objective was to assess the effects of the duration of exclusive breast-feeding on the development of sensitization in preschool children.
Researchers observed no link between duration of breast-feeding and sensitization at 7 years based on skin prick test responses or specific immunoglobulin E levels during the study period. There also was no relation between duration of exclusive breast-feeding and outcomes in children aged 7 years such as eczema, asthma, and allergic rhinitis.
“This information should be communicated to the public, moderating the general recommendation of breast-feeding based on the lack of evidence for any protective effect against allergy in at-risk children,” the researchers wrote. From the Journal of Allergy and Clinical Immunology - Jelding-Dannemand E, et al. J Allergy Clin Immunol. 2015;doi:10.1016/j.jaci.2015.02.023.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "While the many benefits of breast-feeding are well-known, there has been conflicting evidence of its effects on the development of allergies in infants. This study is reassuring in that it shows that duration of breast-feeding is not related to the subsequent development of allergies. For many reasons, it is best if mothers breastfeed for up to a year if possible, but they should not feel that they have increased their child's risk of allergies if they must stop nursing sooner."
The American Academy of Allergy, Asthma and Immunology is calling for the more frequent use of penicillin skin testing to slow the development of antibiotic resistance, according to a press release. An allergy to penicillin, which is reported by approximately 10% of the U.S. population, is linked with an unrecognized hazard, which is receiving alternative antibiotics when penicillin would usually be the drug of choice. The problem with receiving alternative antibiotics, according to the release, is that they have been linked with higher costs, greater risk for adverse effects, longer hospital stays and encouraging resistant bacterial strains.
Almost nine out of 10 people with a suspected penicillin allergy have negative penicillin skin testing and can receive penicillin safely. “Without such testing, there is an unrealized opportunity to improve healthcare outcomes and reduce rising rates of antibiotic resistance,” Robert F. Lemanske, Jr., MD, FAAAAI, president of the American Academy of Allergy, Asthma, and Immunology said in the release. “Allowing many people to return to using penicillin antibiotics should slow the development of antibiotic resistance.”
The statement comes days after a 5-year strategy was released by the White House to combat antibiotic resistance nationally.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County, comments: "We have long known that most patients with a history of reaction to penicillin antibiotics, such as amoxicillin, will actually be able to tolerate penicillin. Penicillin skin testing is a quick, safe, effective way to determine who is not actually allergic, and allow patients to take safer and more targeted antibiotic therapy when needed. This will reduce the use of newer, broad spectrum antibiotics, and slow the development of resistance."
HOUSTON, TX – The first ever published data from the highly anticipated Learning Early About Peanut (LEAP) study offers proof that early introduction of peanuts may offer protection from the development of peanut allergies. The study was led by Professor Gideon Lack at King’s College London. “We believe the results from this trial are so compelling, and the problem of the increasing prevalence of peanut allergy so alarming that new guidelines should be forthcoming very soon,” Hugh A. Sampson, MD, FAAAAI, noted in an accompanying editorial. Sampson is a past-president of AAAAI and current Director of the Jaffe Food Allergy Institute with the Icahn School of Medicine at Mount Sinai.
Lack and the LEAP study team randomly assigned 640 infants with severe eczema, egg allergy, or both, to either consume or avoid peanuts until 60 months of age. Additional clusters were identified in the cohort: children with sensitivity to peanut extract and children without sensitivity (as determined by skin prick tests). Remarkably, the overall prevalence of peanut allergy in the peanut-avoidance group was 17.2% compared to only 3.2% in the consumption group. The prevalence of peanut allergies in children with negative skin prick tests early in life was at 13.7% in the avoidance group and 1.9% in the consumption group. Similarly, children already sensitive to peanuts reflected a 35.3% prevalence of peanut allergy in the avoidance group, compared to only 10.6% in the consumption group.
“Early consumption is effective not only in high-risk infants who show no sensitivity to peanuts early on, but it is also effective in infants who already demonstrate peanut sensitivity,” first author George Du Toit, MB, BCh, also from Kings College London explained. While additional questions remain, researchers now wonder if the LEAP study – which has demonstrated that the early introduction of peanut dramatically decreases the risk of developing a peanut allergy by a staggering 70-80% – should prompt a change in food allergy guidelines.
“There appears to be a narrow window of opportunity to prevent peanut allergy,” says Lack. “As soon as infants develop the first signs of eczema or egg allergy in the first months of life, they should receive skin testing to peanut and then eat peanut products either at home if the test is negative or first under clinical supervision if the test if positive. Infants without such symptoms should be fed peanut products from four months of life.” Lack added that this advice applies to children in countries where peanut allergy is a problem and cautions that infants should not be fed whole peanuts because of the risk of choking.
The “Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy” was published in The New England Journal of Medicine and presented at a Keynote address for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston. Funding for the LEAP study was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and Food Allergy Research & Education (FARE).
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "Previous observational studies have suggested that early introduction may be better than delayed introduction. This is the first randomized, prospective study to show that early introduction of peanut can help prevent a peanut allergy. This is groundbreaking research that will likely change the advice we give to patients daily."
The World Allergy Organization has released conditional guidelines for the use of probiotics during pregnancy, breast-feeding and infancy to prevent allergic diseases. International clinicians and researchers gathered to develop recommendations about the use of probiotics in the prevention of allergy, and they issued the suggestions after reviewing randomized controlled trials of probiotics.
Alessandro Fiocchi, MD, director of allergy at the Pediatric Hospital Bambino Gesù in Rome, and colleagues issued three conditional recommendations for using probiotics:
•in pregnant women at high risk for allergy in their children;
•in women who breast-feed infants at high risk for developing allergy; and
•in infants at high risk for developing allergies.
While the panel did not find sufficient evidence to indicate probiotic supplements reduced the risk for developing allergy in children, the panel wrote that there is a likely benefit from using probiotics in the prevention of eczema.
Question 1: In determining if probiotics should be used by pregnant women, the researchers analyzed eight reviews and 21 randomized controlled trials (RCTs). Fifteen of the studies measured and reported development of eczema in children. The risk for eczema was reduced in children whose mothers received probiotic during pregnancy compared with placebo (RR = 0.72; 95% CI, 0.61-0.85). Development of asthma or wheezing was reported in eight studies and did not vary between the probiotic and placebo (RR = 0.93; 95% CI, 0.76-1.15).
The panel acknowledged the use of probiotics during pregnancy will most likely be determined by women’s preferences. “We agreed that the values and preferences of women regarding the use of probiotics during pregnancy are likely to depend on cultural and socioeconomic background,” the panel wrote. The European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy and Anaphylaxis Guidelines states there is no evidence to suggest women modify their diet or take supplements during pregnancy to prevent the development of food allergy.
Question 2: The panel asked if women who breast-feed should or should not use probiotics. Thirteen RCTs were analyzed to determine a conditional recommendation to use probiotics if the child is at great risk for developing allergy. The use of probiotics during breast-feeding reduced the rate of eczema in infants when compared with placebo (RR = 0.61; 95% CI, 0.5-0.64). But, there is some uncertainty because the analyzed research also included studies where the mothers took probiotics during pregnancy and the infants also were actively taking probiotics. The EAACI Food Allergy and Anaphylaxis Guidelines indicate there is no evidence to suggest women who breast-feed should take any supplements to prevent food allergy in their children.
Question 3: The panel asked if probiotics should be administered to healthy infants. The panel analyzed five reviews and 23 RCTs and suggested using probiotics in infants at risk for allergy. When given to infants, probiotics decreased the risk for developing eczema compared with placebo (RR = 0.81; 95% CI, 0.7-0.94). However, there was no indication probiotics affected the development of allergic rhinitis in children (RR = 0.83; 95% CI, 0.39-1.79). Although the panel suggested the use of probiotics during infancy, there was some uncertainty as to when they should be initiated. “If probiotics are used in infants, it is not clear when they should be started and how long they should be used,” the panel wrote.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "There has been mixed data on the benefit, if any, of probiotics in preventing or controlling allergic disease. While probiotics certainly have other benefits, it is still unclear if they are beneficial in allergies. Further studies are needed."
Long-term and/or high-dose use of a class of medications used for hay fever, depression and other ills has been linked in a new study to a higher risk of dementia. The drugs — called anticholinergics — include nonprescription diphenhydramine (Benadryl) and tricyclic antidepressants like doxepin (Sinequan). This class of medications also includes older antihistamines like chlorpheniramine (Chlor-Trimeton) and “antimuscarinic” drugs for bladder control, such as oxybutynin (Ditropan).
However, the study could only point to an association between long-term or high-dose use of these drugs and a higher risk of dementia, it could not prove cause-and-effect. Also, the relationship “did not occur at the lowest dosage range but did occur at higher dosages used long-term,” said one expert, Dr. Alan Manevitz, a clinical psychiatrist at Lenox Hill Hospital in New York City. He was not involved in the new study. Manevitz also stressed that consumers “should not abruptly stop any current medication treatment but rather should first consult with their physician.”
The new study was led by Shelly Gray of the Group Health Research Institute-University of Washington. Her team explained that the anticholinergic class of medications work by blocking a neurochemical called acetylcholine, in both the brain and body. Manevitz noted that people “suffering from Alzheimer’s disease typically show a marked shortage of acetylcholine.”
The new study tracked outcomes for more than 3,500 seniors who were followed for more than seven years. Gray’s group found that people who took at least 10 milligrams per day of Sinequan, 50 mg per day of Benadryl, or 5 mg per day of Ditropan for more than three years were at greater risk for developing dementia. Manevitz noted that occasional use of these medications did not seem to be tied to a rise in dementia risk. “The risk of dementia was due to a cumulative total of exposure, not to an acute short course of treatment,” he said.
And, Gray said in an institute news release, “Older adults should be aware that many medications — including some available without a prescription, such as over-the-counter sleep aids — have strong anticholinergic effects. And they should tell their health care providers about all their over-the-counter [drug] use,” she added. However, “no one should stop taking any therapy without consulting their health care provider,” said Gray, director of the geriatric pharmacy program at the University of Washington’s School of Pharmacy. Instead, “health care providers should regularly review their older patients’ drug regimens — including over-the-counter medications — to look for chances to use fewer anticholinergic medications at lower doses,” she advised.
The study, published Jan. 26 in JAMA Internal Medicine, is the first to link higher use of anticholinergic medications to increased risk of dementia, the researchers said. It is also the first to suggest that the dementia risk associated with these drugs may not be reversible even years after people stop taking them. Manevitz called the new study “well designed,” and said the reversibility issue is a troubling one. “The general view has been that mild cognitive impairment is reversible in discontinuation of anticholinergic medication therapy,” he said, but this study seems to find otherwise.
According to Manevitz, “we need to educate patients and their families about over-the-counter medicines and alternative therapies. Also, elderly people in nursing homes tend to have a long list of medicines that need to be reviewed periodically for need to continue, interactions and redundancy.” He believes doctors should think about substitutes for anticholinergics when possible, prescribe the lowest dose possible, and stop the medication as soon as is medically advisable.
Gray offered similar advice. “If providers need to prescribe a medication with anticholinergic effects because it is the best therapy for their patient, they should use the lowest effective dose, monitor the therapy regularly to ensure it’s working, and stop the therapy if it’s ineffective,” she suggested. She said that substitutes are available for some anticholinergic drugs, including a selective serotonin re-uptake inhibitor (SSRI) antidepressant like citalopram (Celexa) or fluoxitene (Prozac) for depression, or a second-generation antihistamine such as loratadine (Claritin), fexofenadine (Allegra), or cetirizine (Zyrtec) for allergy relief.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "In recent years we've discouraged the use of older, first-generation antihistamines, in favor of newer, second generation agents. This is due to the increased risk of side effects including drowsiness and dry mouth/ eyes (from the anticholinergic effects.) This study gives one more reason to avoid the older antihistamines, though of course further studies are necessary to confirm the findings."
Prenatal and early-life exposure to antibiotics does not seem to cause asthma in children, according to large new study. "Our results indicate that there doesn't seem to be a causal link between antibiotic treatment during pregnancy or early in life and childhood asthma," lead author Dr. Anne Ortqvist of the Karolinska Institute in Stockholm told Reuters Health by email. "Instead, we suggest that factors that are shared within families, such as genetic predisposition to respiratory infections and asthma, consultation patterns or other home and environmental factors, together with confounding by respiratory infections, have biased previous results."
Given that the rise in antibiotic use occurred in tandem with increases in asthma prevalence in children, several observational studies have been conducted to evaluate whether the two are related, but results have been mixed, Dr. Ortqvist and her team write in their report, published online November 28 in BMJ. In the new study, the researchers sought to account for familial factors by using sibling controls. To address the possibility of confounding by indication and reverse causation, they examined whether specific antibiotic types were linked to asthma. They looked at more than 493,000 children born in 2006-2010, and identified nearly 181,000 who were eligible for sibling analyses.
While prenatal exposure to antibiotics overall was linked to an increased risk of asthma (hazard ratio, 1.28), sibling analyses did not find an association (HR, 0.99), the researchers found. The risk associated with asthma was more pronounced when looking at antibiotics used to treat respiratory infections (HR, 4.12) versus antibiotics used to treat urinary tract or skin infections in children (HR, 1.54). However, sibling analyses reduced the association for exposure to antibiotics for respiratory infections (HR, 2.36), and there was no significant association between the use of antibiotics for urinary tract or skin infections and asthma risk (HR, 0.85).
"Our study suggests that antibiotics do not cause asthma, however, considering the threat of antibiotic resistance worldwide it is of great importance that antibiotics are used carefully," Dr. Ortqvist said. "So, if clinicians' use of antibiotics should change in any way that would be to consider the necessity of treatment with antibiotics for each patient one more time before prescribing it." She added: "We would like to emphasize the importance of correctly diagnosing children with respiratory symptoms, where suspected symptoms of asthma should be separated from respiratory infections, and treated according to guidelines. Also, as the majority of respiratory infections in young children are caused by viruses, the need of treatment with antibiotics in these children may be questioned."
Dr. Ortqvist said she and her colleagues are planning to use Swedish population-based data to investigate whether early antibiotic exposure is associated with other childhood illnesses.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "There have been many studies trying to determine the causes and risk factors for childhood asthma. While early life antibiotics have been implicated in some smaller studies, this well designed study did not identify an association. Many studies continue to try to identify the cause of the increase in asthma and allergies in children and adults."
A chemical called methylisothiazolinone, used as a preservative in many baby wipes, soaps, and other household products, is responsible for many cases of contact dermatitis, which can cause eczema of the hands and other areas. The compound, often referred to as MI, was named the 2013 allergen of the year by the American Contact Dermatitis Society. See this interesting article from the New York Times.
This contact allergy can be detected through patch testing. If you have eczema affecting your hands or other areas and suspect a contact allergy, Allergy & Asthma Care of Fairfield County can perform patch testing for the common contact allergens. Please contact our office at 203-259-7070.
Dr. Irena Veksler of Allergy and Asthma Care of Fairfield County comments: "This contact allergen has been on our patch test panel for some time, but it has been an underappreciated cause of contact allergies and hand eczema. Hand eczema is often due to irritants and not allergens, but it is always important to rule out contact allergens as a cause."