The Case For Testing A Chronically Ill Patient’s
Adverse Reactions To Foods
(c) Jeffrey S. Zavik, from the Original Internist
From the Original Internist ,VOL. 11, NO. 1, March 2004, pages 5 – 11. Introduction
Health care costs in the US exceed $1.2 trillion per year, and a significant portion of these dollars are spent on over 2.9 billion prescriptions. According to a recent Journal of American Medical Association paper, 75% of all health care dollars are spent treating people with chronic conditions. This obviously leads to the conclusion that a lot of chronically ill Americans are taking a considerable amount of prescription medicine. But is it working? The purpose of this paper is to present a case for an alternative to treating the chronically ill by first testing them for adverse reactions to foods. It will further be argued that the safety and efficacy of this approach is worthy of further attention and may prove to be one of the ways doctors will offer their patients effective alternatives to prescription medicine – studies report these alternatives as something patients now seek. There is a major consumer trend providing insight into where consumers are heading to find relief of their chronic unsolved conditions. Consider these facts. A report in an American Medical Association (AMA) study found that there were 37 million more visits to alternative practitioners in a single year than the total number of visits to conventional medical doctors in the same year. The AMA report was a “heads up” to their doctor members because of another shocking fact: 60% more than half of a physicians’ patients — receive alternative forms of treatments and never tell their doctors. It could be argued that the single most powerful alternative therapy is diet. Simply put, every person eats something 2-6 times per day. To make a slight change in a patient’s diet potentially makes an exponential improvement in how the patient feels. The illusive link between what you eat and how you feel goes all the way back to the father of modern medicine, Hippocrates, when he observed thousands of years ago and noted that one person’s food was another’s poison. Today you can use a search engine on the World Wide Web, enter a phrase like “diet and disease,” and find over 923,000 different references! Assuming, for the moment, that Hippocrates’ observations were correct, that one person’s food is another’s poison, you are faced with a simple but tough question: which foods are the right foods for you? Which foods will your body readily digest and assimilate? If there was just ONE food that your body was going to toxically react to, you’d want to know it and avoid it. As a physician, reliably identifying toxic foods would provide a great service to your patients. Differing Definitions of Adverse Food Reactions
Adverse food reactions are classified in many ways. The following are some of the more common definitions: 1) Allergy refers to interrelationships between one or more exposures of a reactive substance and a specifically susceptible individual. 2) Food allergy is a classic reaction to food or food additives in which the immunologic activity involves IgE antibody and release of cell mediators. It ranges from mild single organ reactivity, such as rhinitis, asthma, and urticaria, all the way to extremes of anaphylaxis and death. This is the Gell and Coombs Type 1 reaction. 3) Food intolerance is almost any abnormal physiologic response to an ingested food or food additive not proven to have an immunologic relationship. It can include idiosyncratic, metabolic, pharmacologic, or toxic responses to the offending food or additive. 4) Food hypersensitivity is a non-immunologic reaction resulting from the ingestion of a food or food additive. In 1977, Doctors Gell and Coombs wrote the definitive textbook on allergy in which they classified reactions into four types. Type I: Anaphylactic or Immediate Hypersensitivity
Antigen binds to IgE antibodies attached to the surface of mast cells or basophils to bring on the release of mediators, such as histamine, leucotrienes, eosinophilic chemotactic factor of anaphylaxis (ECFA), and other mediators, that produce the clinical manifestations of allergy. Type I reactions include anaphylactic shock, allergic rhinitis, allergic asthma, urticaria, angioedema, acute gastrointestinal food allergy, and acute penicillin allergy. Type II: Cytolytic Reaction
Cytolytic reaction involves the binding of either IgG or IgM antibody to cell-bound antigen. Such antigen-antibody binding results in activation of the complement cascade and the destruction of the cell (cytolysis) to which the antigen is bound. Examples include immune hemolytic anemia and Rh hemolytic disease in the newborn. Type III: Immune Complex-Mediated Reaction
Immune complex-mediated reactions form when antigens bind to antibodies of any class. They are usually cleared from the circulation by the phagocytic system. However, deposition of the complex in tissues or in vascular endothelium can produce immune complex-mediated tissue injury. Clinical examples of Type III are serum sickness, certain types of nephritis, and various features of bacterial endocarditis. Type IV: Cell-Mediated Immunity or Delayed Hypersensitivity
These reactions are mediated primarily by T-lymphocytes and other mononuclear cells. Classic examples of Type IV are the tuberculin skin test response and contact dermatitis. How To Determine the Potential of an Adverse Food
C. Everett Koop, MD, the Surgeon General of the United States Public Health Service during the Reagan administration, said, “Qualified health professionals should advise persons with food allergies and intolerances on the diagnosis of these conditions and on diets that exclude foods and food substances that induce symptoms.” The food allergies that Dr. Koop advises health professionals to diagnose have become a highly controversial subject. The approach of allergists who practice by conventional methods differs from those used by others when testing for clinical allergy. A variety of diagnostic techniques exist for checking adverse food reactions: skin patch testing, intradermal testing, sublingual testing, the elimination diet, fasting, RAST test, FAST test, MAST test, and the enzyme-linked immunosorbent assay (ELISA) test. Of this list, the RAST and ELISA tests have proven most popular among physicians specializing in environmental medicine. They are reportedly the most accurate and reliable. Both the RAST and ELISA test measure IgE or IgG in an individual’s blood serum by labeling the antigen-antibody reaction with a radioactive substance (RAST) or enzyme (ELISA). The intensity of the reaction is measured by a Geiger counter-like device (RAST) or laser-like optical scanner (ELISA). In a 1987 study of people with atopic and non-atopic skin reactions, their tests for IgG antibody to egg albumin found that their blood titer correlated very well with the clinical symptoms of the subjects. When IgG antibody is formed in large amounts in the blood, circulating immune complexes develop which deposit in certain tissues to elicit a Type III reaction. Of the two tests (RAST and ELISA) the enzyme-linked immunosorbent assay has greater advantages in application. The ELISA test methodology is now widely used in immunologic assays including the detection of IgG antibodies against food antigens. With environmental concerns growing, there is no perceived advantage of choosing the RAST test with its obvious disadvantage of producing radioactive waste. Why Test for Antibodies at All?
A common question raised with respect to IgG food sensitivity testing is, “Since everyone possesses IgG antibodies, why test for them?” John L. Rebello, PhD, comments, “Many diverse conditions — some clinically pathological — may allow food which is not completely digested in the stomach and gastrointestinal tract to pass into the blood vascular system. For example, the presence of leaky gut syndrome in a person may result in his or her peptides and low molecular weight oligosaccharides passing from the GI tract and being absorbed by the vascular system. These incompletely digested food molecules may act as antigens, causing the immune system to respond by forming IgG antibodies to these foods ... In some people, the presence of such antibodies may not cause a problem; and, as such, these antibodies are symptom-irrelevant. In most others, however, these antibodies cause a wide variety of symptoms, some of a very severe nature. In these sick individuals, the exclusion of such foods in their diet significantly reduces their symptoms.” The IgG Controversy Focuses on Accuracy and Reproducibility
In an edition of the Townsend Letter for Doctors, Sheryl Miller wrote an article entitled: “IgG Food Allergy Testing by ELISA/EIA - What Do They Really Tell Us?” (Jan 1998). Quoting from her paper, “Two of three labs tested had numerical variances outside acceptable laboratory standards and are not considered reliable. After preliminary investigation of food allergy testing panels offered by three different laboratories, it is this author’s suggestion that physicians give serious consideration to the aforementioned issues before ordering these panels for the diagnosis and management of patients with food allergies. If one does order these tests, it is highly recommended that reproducibility of these tests be investigated. At the very least, physicians should consider the possibility of sending split samples to their testing lab (at the cost of the lab) on a regular basis.” Addressing Accuracy, Reproducibility, and Quality Control of IgG Testing
As a scientist and pioneer in the development of the ELISA IgG test method, Dr. Rebello addressed these key issues: “I strongly believe that a good laboratory begins with a well-trained staff of technicians and technologists. It’s the director that must make sure that the laboratory possesses all current equipment, reagents, and testing procedures so that well-trained technicians can perform the accurate, reproducible assays every time, day in and day out. Since most of the lab procedures at Immuno Laboratories are not taught elsewhere, it’s important that these qualified people spend a lot of time in training before they’re ‘let loose’ in the lab to do actual testing … Training is essential to achieving excellence in a lab. It’s also important to have documentation of the training before you actually say, ‘Well, they finally know what they’re doing.’ I have a three-month training period in which new techs are monitored very closely before the results are actually given to physician clients. They’re not only trained by my supervisor and me, but their training must also be documented so that they are able to perform in a reproducible fashion the same test as a qualified, fully trained technician. So it’s extremely important for new techs to achieve the same level of accuracy and expertise as the techs that have been trained
previously. I’m convinced that training is essential to achieving excellence in a lab.” Dr. Rebello continues, “No outside commercial ELISA kit is presently available for IgG-mediated food allergy testing. You see, one of my very first duties when joining Immuno Labs was to make the IgG ELISA the highest quality inimunoassay in the laboratory industry. The resulting IgG ELISA, now called the Immuno 1 BloodprintTM, is the result of those early years of development and has become the single most requested test here in Immuno Labs. And none of the essential reagents we use in the immunoassay can be purchased ready-made from an outside manufacturer. None of the immunoassay components, including the 115-food antigen micro titer plates with positive and negative controls and the conjugates, are presently available in a commercial kit. Because you’re making or optimizing all of these components in-house, you have to be absolutely sure that the antigens you purchase are of consistently high quality. Then you have to make sure that the concentration of antigens used with each micro titer plate is optimized for the testing. Finally, not only do you have to make sure that the ELISA conjugate you use is the optimal one, you also have to be sure the concentration of the conjugate you’re using is always exactly correct. So, an extraordinary amount of research, development, and consistently high level of quality control goes into the in-house manufacturing of immunoassay components used in our ELISA protocol ... One of the major quality control steps is done prior to serum testing. Since the micro titer plates are being manufactured in-house, one of the areas of greatest concern is the observation that by changing the concentration of the food antigen that’s applied and bound to the well walls, the sensitivity of each food in the test is changed as well. On top of that is the problem of lack of standardization of food antigens; that is, worldwide only a handful of food antigens have been standardized to date. The final antigen products purchased from those companies is so different lot to lot that you must run special chemistry tests for the optimization of antigen concentrations prior to running the immunoassay. So, with each lot of the 115 food antigens I purchase, I have to optimize the concentration of each food antigen prior to its being used in the plate. This is one of the most important quality features in manufacturing the micro titer plates. What’s really quite unique here is when you introduce food antigens to each polystyrene well for binding you’re required to put the optimum concentration of each antigen each time rather than the same concentration... Keep in mind that what I’ve just said about the optimization of food antigens also applies in a similar way to the anti-IgG antibody conjugate we use in our ELISA protocol. The concentration of conjugate is very important. A highly concentrated conjugate gives you false positives while a weak conjugate gives you false negatives. As a consequence we have to optimize the conjugate used with the ELISA in-house prior to testing for the very same reasons antigen optimization must be done... The ELISA test is probably one of the most difficult tests to work with because it’s subject to so many, many variables; any one of which can be a source of error, especially in the areas of false positives because the ELISA by its very nature is so sensitive. Now with that said, there’s some good news to report. If you know what you’re doing, if you’re familiar with the intricacies and potential problem areas of the test, there are a number of proven ways in which you can very effectively control the quality and therefore reproducibility and accuracy of the ELISA. First of all, Immuno Labs tests the specificity of the test by including positive and negative control serum samples into wells on each separate micro titer place used to test individual patient serum. I want to stress that every patient serum tested in our lab includes both a positive and negative control. This is a very critical quality control step … And most importantly, we don’t do the positive and negative controls one time at the beginning of each daily run, unfortunately like many laboratories do. We test both a positive and a negative control with each and every patient serum. And keep in mind that the positive and negative controls are just part of our quality control refinements. A second level of quality control is the positive external control done every day with each testing run. The serum used for the daily positive external control comes from a serum pool of patients previously tested, with anywhere from 16 to 20 positives in each serum... We perform our own weekly in-house split sample. In other words every week we’re doing what we advocate that the doctor should do at least once when trying to determine the quality of a new testing laboratory. Serum chosen for the split sample is serum chosen weekly by me, or in my absence, by the laboratory supervisor. The lab tech, not being informed of the serum’s source or which foods are reactive, is required to process the split sample as if two different & distinct specimens had just been received at our lab for testing. The split sample results are then compared. There should not be more than a 10% error between these duplicates. This is an absolute requirement of the laboratory... A split sample with 10% or less rate of error would give you the reproducibility. The doctor should demand that the laboratory in question routinely perform internal and external quality control steps — for example, a positive and negative control with each patient serum as we briefly discussed above. In addition, I think another excellent way one can check the accuracy is by asking about the availability of well-controlled clinical studies outside the laboratory setting that corroborate the clinical efficacy of the assay. Dr. Sidney Baker has successfully performed such controlled studies using Irnmuno Labs IgG ELISA. Ideally you should be able to ascertain in some scientific manner that the positive and negative foods identified in the test in fact do affect the clinical outcome of food allergic patients.” A Test So Powerful Doctors Test Themselves
One of the indicators of the value of lgG testing for adverse reactions to foods is that doctors often test themselves and have gone on record as to the personal benefits they received. Several examples illustrate this point. Case Report — Barton Sparagon, MD: “I was indeed very skeptical of the clinical value of food allergy testing, but I decided to try Immuno Labs based on the recommendation of a highly regarded colleague. I suffer from Crohn’s disease that was diagnosed in 1984, and I have been on numerous medications and several diets with mixed results at best. Prior to my sending my serum sample for the Immuno 1 Bloodprint text, I was having moderate gastrointestinal symptoms despite taking potent medications. I felt there was little downside so I decided to test for myself what impact eliminating the foods that scored positive for 30 days would have on my symptoms. As a research scientist and a physician, I was duly impressed by the significant reduction in my symptoms. I intentionally made no other changes in my treatment so as not to confound the results of the elimination diet. After 45 days, I went off the diet and my disease began to flare up so I went back on and the symptoms abated. Albeit, I am a sample of one and my experience would not qualify as experimental proof, nonetheless, I will continue to base my diet on the results obtained by Immuno Laboratories’ food allergy testing, and I will recommend it to my patients and colleagues. In addition to the value of the testing itself, I found the support staff very helpful in interpreting results and in developing a practical diet based on the results. As a conventional physician, skeptical of ‘alternative medicine,’ I am surprised that I feel confident in recommending Immuno Labs allergy testing. Most of all, I am deeply grateful the testing and diet has provided me with relief from a difficult, chronic disease.” Case Report — James M. Vanderloop, DC: “Losing the extra 15 pounds around my waist has made me feel like a new man! In the past, I would work out 4-5 days a week, running an average of 12 miles a week with no real results of losing weight. By avoiding the foods that came back positive, losing the extra pounds has never been easier. I didn’t even realize that every morning, by eating the eggs and bananas, that I was poisoning myself. The other section of the blood test that identifies airborne allergies is also a Godsend. Since moving to Houston, Texas, in the Clear Lake area, I’ve been suffering severe coughing spells, severe bronchitis, and severe sinus headaches. By looking at the blood tests, it helps me identify that I’m highly allergic to molds. So far I’ve been trying to regulate my allergic response with MSM and other alternatives that have helped down-regulate my allergic reaction. I’m presently awaiting another alternative from China. Without this blood test done by Immuno Laboratories, I could have been suffering for numerous years without ever knowing the cause. I will make sure to spread the word to as many of my patients as possible about knowing the truth behind their allergies versus suffering a lifetime of agony.” Case Report — Penelope Brand, ND: “I had considered myself to be fairly healthy individual before doing the Immuno Bloodprint test. I have done the diet modifications for almost three months, with 85-90% adherence and with great results! My Immuno Symptom Checklist score went from 113 to 65. Within three days, I was aware that I was feeling quite different. I noticed that I was feeling much more calm ... much more able to manage difficult situations (this was just after the September 11 terrorist attacks). When I am following the diet and then ‘cheat,’ such as this past weekend ... I be-
come aware of a very non-specific anxiety, which I can now identify as the feelings and anxieties I was struggling with before I began the diet. Physically, I also find I do not need as much sleep and do not drag myself through the day as much. The desire for my daily indulgence in a cup of coffee is waning, especially when my diet is very clean. My body craves water and good wholesome foods ... beginning a very productive ‘vicious’ cycle as opposed to the vicious cycle of having blood sugars bounce around all over the place. Now that I have experienced and seen the benefits in my patients, I would love to have all my patients do the test to add that layer of specificity to their dietary recommendations. As we know, food is our primary medicine.” Case Report — Donald Lee McCabe, DO: “As we grow older, most of us assume that our functions will be compromised slowly. Also nature appears to protect us in a way by having us unwittingly getting used to deterioration of function without realizing it. This is in all due respect to the position that many of us have that when something goes wrong there is something that needs fixing. Over the past two years, I was aware of soft symptoms occurring in my health and somewhat accepted that as part of growing older. In late July of this year, I was definitely not feeling well and had less than desirable coordination and a dull headache. In checking my blood pressure I was abruptly surprised to find it 210/120. No wonder I did not feel good. This high blood pressure was out of sync with my rather lower blood pressure for years. Immediately, I started taking high blood pressure medicine, and in a couple of weeks the blood pressure stabilized within the norm. The elevated blood pressure was objective and could very well explain why I had not felt as good as I should. Even with the blood pressure under control and the abatement of some symptoms, I still did not feel as well as I should, nor was there a known cause of the hypertension. After thinking about possibilities, I decided to check for allergies, for I knew I had some. On August 1, 2001, blood was submitted to Imrnuno Labs for food allergy testing. Results were reactive or positive for amaranth, kidney beans, cranberry, egg, goat’s milk, oat, sweet potato, R. seed (canola), radish, wheat, yam and brewer’s yeast. These items were eliminated from my diet, and this was a jolt to my eating habits because I liked eggs and wheat products. Wheat occurs in many commonly used foods, such as bread, pies, pasta, pastries, cereals, and more. For the past two months or so I’ve had no blood pressure medicine and my blood pressure has remained normal, and this is subsequent to staying away from my food sensitivities. Blood pressure has stayed well within normal limits without blood pressure medication. It is apparent that antigen toxicity has pervasive deleterious effects on the autonornic nervous system, which explains the myriad of symptoms that may occur in allergic dysfunction. It has been three months since I had allergy testing and with abstaining from eating foods to which I am allergic. Now I feel better than I have felt in several years and many of the ‘soft’ symptoms are waning. I interpret these things as related to my undiscovered food sensitivities that effected neurovascular toxicity. My hypertension problem is definitely related to food allergy.” Summary
The purpose of this paper is to present a case for an alternative to treating the chronically ill by first testing them for adverse reactions to foods. Although the IgG testing is relatively new, there is encouraging published, clinical, and anecdotal evidence worthy of further attention. It is my sincere hope that physicians open themselves to the merits of testing for the adverse reactions to foods. About the Author
Jeffrey S. Zavik is the CEO of Immuno Laboratories, inc. in Fort Lauderdale Florida. He can he reached at (954) 691-2500. REFERENCES
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Publish date: 05/07/04
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