Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

1. For patients with IBS-D or -cyclic, how many/what percentage of patients have symptoms caused by non-IgE food allergies?
2. For patients with asthma or other allergy symptoms such as sinusitis or fatigue, how many/what percentage have symptoms caused by non-IgE food allergies? How many have symptoms caused by non-IgE inhalant allergies?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

1. For IBS-D and -cyclic, compare:

• an in vitro diagnostic test for immune reaction such as the LEAP test and dietary change as indicated versus
• medicating the symptoms and no dietary change.

2. For asthma and other allergy symptoms compare

• an in vitro test and dietary change as above for non-IgE food allergies versus
• medication only
• intradermal tests for inahalant allergies with delayed reactions noted and diagnosed versus
• intradermal tests for inhalant allergies with delayed reactions ignored.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

1. Patients with IBS-D or -cyclic
2. Patients with allergies who showed no or few reactions to the traditional 30-minute skin tests for IgE reactions. All ages and genders.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Patients with severe IBS, which is debilitating and demoralizing.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Non-IgE allergies have been ignored by the medical establishment for decades. They were confirmed by in vivo tests in Sweden in the early 1990's, but the allergy establishment didn't acknowledge them until 2009 and still does not endorse any tests or treatments - while thousands of people suffer from this. Non-IgE food allergies can easily cause IBS symptoms, but gastroenterologists are not trained to be aware of this, let alone treat it. If you look on the IBS support group at ibsgroup.org, you see people with severe IBS who would rather die than live this way. Again, thousands of people suffer while the medical establishment ignores information that could help them. The benefits would be to help many people be healthier, happier and more productive and save a lot of money in health care costs.

Describe any health-related risks, side effects, or harms that you are concerned about.

1. The in vitro test for non-IgE food allergies, a simple blood draw, is non-invasive and has only minimal risk. The patient changes their diet according to the test results to see if the symptoms improve. When I worked with the LEAP test there was 80% improvement in symptoms with this program. The only risk would be if the patient became ill from eating an unbalanced diet, but as long as they are educated and/or work with a dietitian this is not likely.
2. The risk from intradermal allergy tests is minimal.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Peptic ulcer disease and dyspepsia
• Pulmonary disease/asthma

AHRQ Priority Populations

Federal Health Care Program

• Medicaid
• Medicare
• State Children's Health Insurance Program (SCHIP)
• Other

Importance

Describe why this topic is important.

Thousands, maybe millions, of people suffer from undiagnosed non-IgE food allergies and inhalant allergies. The symptoms can be diagnosed as IBS-D or -cyclic, or as asthma or other non-specific allergy symptoms. Information about non-IgE allergies has been available for decades but it has been ignored. If it was used to treat patients they would stop suffering and be productive members of society and it would also save money on health care costs.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

I have non-IgE allergies and I was sick all the time until I was 29, when I figured out I'm allergic to soy. I had been to doctors all my life, but they either ignored or medicated my symptoms. I figured out my four non-IgE food allergies by myself. I went to an allergist in 2006 who did skin prick and intradermal tests. She tested for egg, one of my food allergies, because she wanted me to get flu shots. It was negative for IgE. I showed IgE allergies to mold and ragweed and the next day woke up with a delayed reaction to one of the intradermal tests. When I called the nurse said to ignore it, it didn't matter. I had to insist on knowing what this reaction meant. It turned out to be a t-cell reaction to dust, and it does matter very much! Non-IgE allergies are very important information that should be provided to every patient!

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Allergists are extremely resistant to accepting new information. In my experience they have not accepted any new information since the 1960's.

When I worked with the LEAP program we were taught not to even approach allergists because it was a waste of time.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

I'm hoping it will get allergists, GIs and other practitioners to incorporate the diagnosis and treatment of non-IgE allergies into their practice. It would be even better if it was sufficiently accepted to be taught in medical school.

Describe the timeframe in which an answer to your question is needed.

ASAP, of course! :) The sooner it's done, the sooner fewer people will suffer and health care costs will be reduced.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Right now the only practitioners treating this are the smarter, more open-minded private practice ones... If all practitioners including hospitals, Medicare and Medicaid were treating this, the poor and elderly would have greater access.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

I'm hoping it will get allergists, GIs and other practitioners to incorporate the diagnosis and treatment of non-IgE allergies into their practice. It would be even better if it was sufficiently accepted to be taught in medical school.

Are you making a suggestion as an individual or on behalf of an organization?

Individual

Please tell us how you heard about the Effective Health Care Program

I used to work at a medical consulting company and learned of AHRQ there.