Oral Food Allergy Challenges

This is a very interesting article on food allergy. It involves the use of diagnostics used to declare ‘food allergy’ and how this declaration of a food allergy can be verified by doing a food challenge. This work was performed at National Jewish Hospital in Denver, Colorado. The reference for this is – Oral Food Challenges in Children with a Diagnosis of Food Allergy.  David M. Fleischer, Alan Bock, Gayle Spears, Carla Wilson, et al. Journal of Pediatrics 2011;158:578-583. Note that the link is to a synopsis. The article can be viewed if you are a subscriber to the journal, you have a medical library connection, or it can be purchased.

Usually when I review an article I go directly to that part of the introduction that deals with the purpose of the study. However, the background information provided in the introduction I thought was very helpful in understanding food allergy, noting the concerns regarding food allergy, and sharing how experts in the field of food allergy handle it (especially as they see a significant number of food allergic children in their referral center).

Identified problems with food allergy;

1.  Availability of serum IgE tests for foods
2.  Use of allergy tests to direct avoidance diets
3.  Consequences of avoidance diets
   • Poor weight gain
   •  Malnutrition
4.  Idea that food allergy is the exclusive cause of atopic dermatitis
5.  Food allergy focus leads to neglect of skin care

The allergy test result, whether by skin prick test or by serum IgE (formerly known as RAST) antibody levels, predict the chance of having a reaction with exposure to that food (they also demonstrate the presence of IgE directed against that food). These probabilities have been established for just a few foods; cow’s milk, hen’s egg, fish, peanut, and tree nuts. For all the other foods the levels that predict the chance of the child having a positive reaction have not been established.

Another significant issue that clouds the picture is that both allergic skin testing and serum specific IgE levels obtained from a blood test frequently detect sensitization that is not associated with any symptoms when the food is ingested. The false positive rate- when the test is positive and the story is that there were no problems with ingestion – is 50%! The gold standard for a food allergy is the double-blind placebo-controlled challenge. In other words, the best indicator is the history- what happens when the food is ingested.

The Purpose of the Study– was to raise awareness about the overreliance on serum immunoglobulin results as the primary indicator for establishing a food elimination diet in children (with atopic dermatitis).

Methods-This was a retrospective chart review of children who were seen for atopic dermatitis and food allergy. The number evaluated was 125.

Results

The median age of the children was 4 years. Most of had atopic dermatitis (96%). The severity of the atopic dermatitis varied- 30% were mild, 24% were moderate, and 42% were severe.

There were 364 oral food challenges performed on foods that were avoided at the time of the evaluation. That is almost 3 food challenges per child. Most of these challenges were negative- 325/364 (89%). Of note that during these food challenges, if there was a reaction, it occurred within a 2-hour observation period. Also, there were no documented flares of the skin condition.

Those 364 food challenges occurred in three different groups of children; 111 in whom foods were avoided due to a positive allergy test, 122 in whom a food was avoided due to a previous reaction to a food, and the last grouping was 131 children in whom a food was avoided for other reasons (not a history of a reaction or a positive allergy test). This last group included those who avoided a food because of lack of prior exposure, another family member with an allergy to that food, parental fear, refusal to eat the food, worsening of atopic dermatitis was uncertain with exposure, being too young for the food, and uncertain reasons.

In the group who avoided a food due to a positive allergy test (n=44 children) – with wheat being an exception (at 77% negative), 80% or more of the food challenges were negative. When there was a positive food challenge, the foods involved included egg, banana, peanut, soy, and wheat.

There were 122 food challenges done in a group of children (n=67 children) who had a history of a reaction to the food. When peanut and oats are excluded, more than 75% of the food challenges were negative. The positive food challenges were to; egg, chicken, milk, oat, peanut, soy, pea, wheat, beans, and pork & beans. This group of children had an array of food reactions by history; anaphylaxis (5%), gastrointestinal reactions (17%), lower respiratory tract reactions (8%), upper respiratory tract reactions (10%), and skin reactions (76%).

In the last group, those who avoided a food for other reasons, (n=131) more than 90% of the challenges were negative. There were 11 positive food challenges. The positive foods included egg, fruits (strawberry), meats (beef, chicken), milk, shellfish (shrimp), soy, barley, and Alimentum.

The levels of specific IgE antibody to the food were used to divide those who were challenged versus those who were not challenged. The following table shows the serum IgE level, the offering of a food challenge, and the result of the food challenge. When the serum IgE levels were elevated, no challenges were offered. For these three foods everyone who was below the critical cut-off point passed the food challenge. The decision levels for doing a food challenge were as follows- egg:< 2years of age -2 kU/L and >2 years of age 7 kU/l, Milk:< 2 years of age -5 kU/L and > 2 years of age a5 kU/l, peanut: 14 kU/L.

84-93% of foods that were avoided for a variety of reasons were returned to the child’s diet after a successful food challenge.

Conclusions- the authors concluded that in the absence of a history of anaphylaxis, the primary reliance on serum food-specific IgE testing to establish the need for a food elimination diet is not sufficient, especially within the population of children with atopic dermatitis. Oral food challenges are indicated to confirm the presence of a food allergy.

Many of the children seen were on overly restrictive diets that were inclusive of foods they never had exposure to or foods that were eaten without a problem. This restriction was based on food blood test results. The successful food challenge demonstrated that specific food restriction was not necessary in most instances. A food challenge discerns sensitization from true allergy.

The authors point out that it is important to optimize skin care and clearing to accurately sort out the impact of a food on the condition. It is also stated that there is a significant overreliance on allergy test results in making the diagnosis of food allergy especially in the children with atopic dermatitis. Allergy test results, if not supported by a food challenge, can lead to unnecessary food restrictions. To quote the authors, ‘misinterpretation of food allergy immunoassays, for which there is no correlation between the level and the probability of reacting to a food, is leading       unnecessary dietary restrictions that could result in nutritional deficiencies.’

Reviewer’s Comments- After my first read of the article, I felt that this was a very strongly worded statement against the indiscriminate use of serum IgE testing.  After numerous reads, that opinion of the article has not changed. This work is a strong statement against serum IgE testing for allergy.

It is important to point out that the vast majority of children who were in the study had atopic dermatitis (aka eczema). This clinical condition is notorious for having many false positive food allergy tests. During the 1980’ there were many studies that linked food allergy with atopic dermatitis. During my fellowship at Duke we watched children with severe atopic dermatitis react during the double-blind placebo-controlled food challenges. These studies led to the observation that there were 6 foods commonly associated with the condition; egg, milk, wheat, soy, peanut, and fish. Subsequently, many children with a range of presentations of atopic dermatitis have undergone allergy testing both by the skin prick method and by serum testing.  That has led to the concerns presented in this article.

The current ‘state of the art’ noted in the NHLBI Guidelines for the Diagnosis and Management of Food Allergy  suggests that food allergy considerations should include egg and any other food that the family feels is causative to the skin condition.

The authors point out that the availability of immunoassay food allergy panels to identify possible food allergy has added to the ongoing potential for misinterpretation of the results.

We also have that issue that continuously plagues us- sensitization vs. allergy. The laboratory test tells us that IgE is being made. The significance of that IgE has to be determined by the clinician. Taking a history is one way to begin establishing significance. The food challenge would be the bottom line for establishing relevance and significance of a positive IgE test for a food.

There are many messages within this study. The concerns regarding restrictive diets and avidly pursing food allergy diagnostics can lead to;

1. Failure to thrive due to food restrictions
2. Parental perceptions about unclear messages about which foods must be avoided
3. Attempts to treat atopic dermatitis by diet alone and not proper skin care
4. Pressure from parents to get these blood tests for food allergy
5. Incomplete understanding about the class designations
6. Applying the well-established food specific IgE values to foods that have not been rigorously evaluated

These concerns are seen with parents, primary caretakers, and yes, even allergists.

 When an allergy test for a food is positive yet the food is eaten without any clinical reaction, the test was a false positive. We should not let the laboratory result dictate the care of the child. Specific food allergy testing can be done for the food of interest. Select the test based on the story that supports it.

I think the role of the allergist in the near future will be to clear many of these positive tests. Here at Riley hospital we have an extensive experience in doing food challenges. Most of the time we perform a food challenge to demonstrate that a food allergy has been outgrown. We offer them in a controlled clinical environment. Everything is in place to take care of a reaction. In the near future I am sure we will be doing more food challenges to demonstrate the irrelevance of positive allergy test results.

The serum tests for IgE to food have helped with the decision to offer a food challenge for some foods. I look to the serum tests for food to decide the chance of a reaction and whether or not an oral food challenge should be scheduled. It is always perplexing to have a child present who has had a panel performed. All too often we struggle with results deemed high due to the ‘H’ notation after the specific concentration. We struggle with positive results from foods that the child has never ingested. We very frequently struggle with results on foods that the child has eaten with impunity and never had a problem. The food challenge helps to sort the well from the worried well.

Many times I have witnessed the joy of having the yoke (not yolk) of a food allergy removed by doing the food challenge.

FEL