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Allergy Drops and Sublingual Immunotherapy

 
Sublingual Immunotherapy (Allergy Drops) is an alternative way to  decrease allergen sensitivity by administering allergens by the oral route. This method has been used in several European countries for that last twenty years where it was initially made popular by practitioners of homeopathy. As of 07/13/2011, the only method proven repeatedly, in multiple studies, to decrease sensitivity to an allergen is to inject it under the skin in increasing amounts at regular intervals.
 
Some advocates of allergy drops call it immunotherapy, but the only FDA approved use of this term refers to allergy shots. Shots do involve a significant time commitment on the part of the patient, can be  slightly uncomfortable, and in rare instances, associated with severe life threatening allergic reactions. To overcome these obstacles, investigators have tried administering allergens by the oral route. In one method, the allergen is swished in the mouth and spit-out (expectorated). In a second method, which is more commonly used, the allergens are swallowed. Again, both methods have been championed in Europe, but have not gained widespread acceptance in the USA because of the poor results and few number of clinical studies showing effectiveness.
 
A few recent studies may have possibly shown slight efficacy  with dust mite and grass pollen allergies. In these studies, patients receiving doses up to three hundred time the conventional dose of injection therapy showed a slight reduction in allergy symptom scores.  Other studies have shown a statistically significant improvement in symptom scores, or composite scores defined as a clinical index.  It is not clear that the studies demonstrating statistical significance actually  affect the way a patients feels. In other words, statistical significance does not necessarily indicate clinical significance. Additionally, none of these studies normalize the symptoms to account for the daily pollen count or exposure to dust mite allergen.  There are also no controlled studies directly comparing the effectiveness of sublingual immunotherapy against conventional injection therapy.
 
The U.S. Food and Drug Administration does not  approve the use of Allergy Extracts for oral administration.  Its use is considered "off-label", because the risks and benefits are unknown. Several insurance companies regard allergy drops as "investigational" and "medically unnecessary" and therefore not covered by commercial insurance. Aetna in particular has labeled allergy drops as investigational.  The sublingual route of administration has not shown a decrease in allergy medication use compared to placebo (sugar pill) in at least twenty-one trials. No studies have documented the persistence of desensitization after sublingual therapy has been stopped, contrary to what has been shown with injection therapy. In addition, it is not known what the optimal dose of allergen is for this type of therapy, which is not the case with conventional injection therapy.
 
Major insurance companies do not reimburse for sublingual allergy therapy claiming it has not been proven to be more effective than standard  injection therapy. In addition, most allergy sufferers are sensitized to multiple allergens and the currently available allergen for oral therapy is limited to grass pollen. From an aesthetic view, the idea of oral mite feces in weekly drops to eliminate your allergies may be too much to swallow. While this type of therapy may be safer than injection therapy, there is no evidence that it is as effective as traditional immunotherapy. Until comparative trials are established, allergy injection therapy is the standard of care. Current proponents of oral therapy are more likely to be ENT trained and not as familiar with the immunology of standard therapy. There is currently a push for this form of treatment from non-Board Certified allergists without conclusive evidence and FDA approval. Recent claims that formalin allergy can be cured by drops have no scientific merit. Formalin allergy does not involve IgE. The mechanism of allergy is cell mediated, which is not modulated by oral drops.
 
From a immunological perspective, the mechanisms for oral tolerance are not well defined. It is not clear that allergens given by mouth survive in an immunogenic form once they reach the stomach. An immunogenic protein is one that can stimulate an immune response or create a state of tolerance.  Most allergy causing proteins, except for food allergens,  are digested or broken down by acid in the stomach and by enzymes in the gut. It  unclear if  these large molecular  weight allergens can be absorbed across the surface of the mouth cavity and  produce a state of tolerance. Conventional allergen immunotherapy is effective because it is taken up be a cell that resides in the skin called a dendritic cell, and is able to present it to the immune system in a recognizable form. If oral allergen desensitization were effective, it would be expected to be effective for food allergies, which has not been the case. There is no reason to suspect that aeroallergens would behave differently.
 
Because of these variables, sublingual immunotherapy is currently not a procedure approved by the Federal Government's Food and Drug Administration.  It is not a substitute for allergy injections. If you have not responded to standard desensitization, you are even less likely to respond to allergy drops.  Proven and effective treatment exists for allergies in the form of injection therapy. While it is comforting to think a painless form of desensitization will control ones allergies, at this point the evidence is not strong enough to replace current treatment practices.
 
Enzyme Potentiated Desensitization is performed by injecting extremely dilute solutions of allergens in combination with the enzyme beta glucoronidase to alter the immune response to allergens. A recent article in the British Medical Journal 2003 Aug2; 237 (7409):251-254 found this procedure was no better than a placebo. 
 
Autologous Urine Injection was a popular form of treatment for allergies by a fringe group about twenty years ago. It is mentioned only to be condemned and is not seriously considered to be a viable form of treatment by any professional medical society.
 
Acupuncture has no role in the treatment of allergies. While effective for pain relief, with scientifically identifiable effects on neurons and the gates controlling pain, there is not one iota of evidence that acupuncture affects the lymphocytes or cytokines producing the IgE that cause allergies.
 
Chiropractic is sometime touted for the relief of allergies, but no scientific mechanism can explain or postulate how manipulation of the spine can lead to specific immune tolerance. Chiropractic physicians do not have the expertise to diagnose allergic disease or the depth of training to to recognize allied disorders that masquerade as allergy. A board certified allergist has completed a residency in Internal Medicine or Pediatrics for three years after medical school, and a fellowship in allergic diseases for two or three years after residency to gain the knowledge necessary to treat your problem.
 
IgG Food Allergy Testing is a blood test, usually requested by non-allergy trained physicians to diagnose food allergies. At the present time, there is no evidence that IgG antibodies that can bind with food  can cause any illness or allergies. They are found in many normal individuals or may be a consequence and not cause of an underlying disorder of the gut. There is no known mechanism for IgG to cause an immediate hypersensitivity reaction to foods, except in mice. Many people who have never experienced an adverse reaction to the suspected food are needlessly harmed by elimination diets based on result of an IgG food antibody test.

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