Allergies

The most common approach for the management of allergic conditions is the use of medications and avoidance. Neither of these approaches will lead into a cure. Avoidance is difficult to implement and at times not realistic. The use of medication to treat an allergy is like using a bucket to “treat” a ceiling leak. In this case, the “symptom” of the leak is the wet floor. The bucket may work great to keep the floor dry, but in any case, the bucket will not fix the leak. In a similar fashion, medication(s) may or may not help with the symptoms but will never fix the allergic reaction.

The only way to really control the allergic reaction is with allergy immunotherapy, a technical name for allergy vaccines.

Allergy Vaccines are traditionally known as “allergy shots”, a very effective but involved treatment modality that can have potential complications, occasionally very severe. There are other much safer modalities, with equal or even better results that are Sublingual Immunotherapy (SLIT) and Low Dose Allergen Immunotherapy (LDA).

The diagnosis of the allergic condition should be clinical. In other words, based on the history and physical exam the doctor should be able to determine that the patient has allergies.

The role of the allergy test should just be confirmatory, but more importantly, the real role of the test is to help determine which allergens need to be included in the treatment vaccine.

The results of the test will not have any influence as to which medications will be prescribed.

For more information about the management of allergic conditions read: You have allergies but medications do not help you enough; SLIT or LDA.

Allergies are usually associated with sneezing, runny nose and itchy eyes. These symptoms, which can be triggered by exposure to any allergen, are characteristic of exposure to pollen. Exposure to dust and to mold sometimes gives symptoms that are not usually associated with allergies:

• Persistent or recurrent headaches, pressure on your sinuses, persistent nasal obstruction, recurrent sinus infections, throat pain or burning, recurrent bronchitis or asthma, frequent or recurrent cough mostly at night, feeling tired, skin rash (persistent or recurrent).

One or more of these symptoms can be present, with or without the “classic” symptoms of allergy.

The history of the patient is very important, because the usual allergy tests are notorious for failing to diagnose reactivity to dust and/or mold. For the management of allergic conditions click here or read You have allergies but medications do not help you enough; SLIT or LDA.

This is a very common occurrence. While the explanation is simple, it is elusive to most people. For an in-depth discussion on this issue please see “Management of the Allergic Patient. The Role of Different Diagnostic Tests” published by Dr. Saporta in the Townsend letter. Succinctly, the most common tests used to diagnose allergies have very poor diagnostic capability.

Even the blood tests for allergy fail to diagnose many allergens as they usually only determine the presence of IgE which is not the only marker of allergies. If the vaccine contains only the allergens evidenced by a test of poor diagnostic capability, the result of the treatment will be, at best, mediocre.

A good quality allergy test is difficult to perform at the present time due to increasing insurance company regulations. These regulations even interfere with the proper administration of allergy immunotherapy. (For more information on the impact of insurance companies’ guidelines on the practice of allergy see here).

For this reason, any patient that is interested in treating their allergies should consider Sublingual Immunotherapy (SLIT) or Low Dose Allergen immunotherapy (LDA)

Allergy describes symptoms that occur when your body encounters certain substances in the surrounding environment. These substances or particles, called allergens, will stimulate the immunological system. The result of such stimulation will be the production of symptoms. The mechanism that leads into production of symptoms is the allergic reaction.

When the symptoms develop in response to exposure to allergens floating in the air, it is called an inhalant allergy. Inhalant allergens include dust, animal dander, mold and pollen.

Symptoms can occur also as a response to food allergens (in this case the allergen is ingested) or even as a response to touching an allergen or chemical substance (contactant allergy).

Summary: the concept of allergy implies a reactivity of your body’s immune system against something in the surrounding environment. The reaction triggers inflammation. The inflammatory molecules produce the symptoms when affecting the different organs of the body.

Because allergy medications will not cure the allergic condition, rather only treat the symptoms, patients interested in attaining a cure or significant reduction of their symptoms should consider Allergy Immunotherapy. Information on Allergy Immunotherapy, and specifically on Sublingual Immunotherapy (SLIT) and Low Dose Allergen immunotherapy (LDA) follows. Asthma, or symptoms affecting the lungs are very common in allergy sufferers. You will find more information of these in Asthma. Controversies in diagnosis and management.

Allergy immunotherapy consists of the repeated and frequent administration of the same allergens that produce the symptoms. The treatment starts with very small doses that increase over a long period of time. The objective of the treatment is to lead to symptom-resolution and to attain long-term relief after treatment discontinuation. This type of treatment is the only one that can modify the reactivity of the immunological system so that the allergic condition disappears. Allergy Immunotherapy has the potential to cure allergies.

This treatment can be provided by injections (Injectable immunotherapy or “allergy shots”), by oral drops administered under the tongue, (Sublingual Immunotherapy or SLIT), or by a modality that uses ultra-low doses of allergens (Low Dose Allergen Immunotherapy or LDA).

Safety depends on the route of administration: injectable vaccines carry a risk for a reaction, potentially severe. Oral vaccines (SLIT) and LDA are extremely safe.

Allergy vaccines are completely natural. They contain exactly the same allergens that you inhale, ingest or touch. Allergens are proteins, complex structures capable of stimulating the immunological system. These allergens are extracted from the pollen, mold, food etc., and once extracted, they are diluted in saline water or in glycerin. When diluted in saline, a minimal amount of phenol is added, to prevent bacterial growth. Glycerin is a very common substance used in the food industry and a component of multiple household products. It acts as a preservative of the allergenic proteins so they do to deteriorate over time.

Please note: Allergy vaccines are not the same as the usual vaccines given to decrease the chance of an infectious disease. These vaccines, manufactured by the big pharmaceutical companies, characteristically carry chemicals that act as preservatives or adjuvants, including heavy metals (mercury or aluminum), PEG, etc.

Allergy vaccines do not carry any preservatives or adjuvants.

Allergy vaccines do not contain prednisone or any type of steroid. Steroids are frequently used for control of allergy symptoms in acute circumstances. Sometimes these steroids are given as a shot (once or twice per year) and are frequently called an “allergy shot” but these steroid injections or oral steroids are just medications and they will not lead into a cure or long-term control of the problem.

Asthma Diagnosis

Asthma diagnosis is elusive. Often patients with all the symptoms and even using inhalers are told by their doctors that they do not have asthma. The situation complicates when patients have only one or a couple of the symptoms above detailed.

The term “Cough Variant Asthma” was coined to describe mostly children that cough during exertion, sometimes also with shortness of breath. This asthmatic cough responds to the usual asthma medications, but because these patients do not wheeze, they are not called asthmatic.

The most important factor to be taken into consideration is that allergies trigger inflammation, which will lead into overproduction of mucous and hyperirritability of bronchial muscles leading into spasm (obstruction).

Controversies in asthma diagnosis and management.

Asthma is a frequent condition, consisting in a reversible obstruction of the lower airway.

Asthma symptoms include cough, shortness of breath, sensation of chest tightness and wheezing. Administration of a bronchodilator medication leads to a resolution of the symptoms. The reason why bronchi may constrict is due to inflammation, usually triggered by exposure to an allergen (yes, asthma is an allergic problem), but also by exposure to non-allergenic triggers like smoke, other chemicals or physical factors like exertion, cold or humidity.

The usual asthma inhalers can control the symptoms but do not cure the underlying condition.  Allergy Immunotherapy is the only treatment that can cure asthma.

Asthma and Immunotherapy

For the potential role of immunotherapy in the management of asthma see here.

Dr. Saporta has worked intensively on this issue and realized that the lower airway is very commonly involved (inflamed) in all allergic conditions.

In Dr. Saporta’s experience (see this paper), it was observed that up to 72% of the patients that denied having asthma had symptoms that suggested inflammation of the lower airway. It was also observed that the pulmonary function improved over time even in patients that did not have asthma, a fact that strongly suggests that the allergic reaction involves both the upper and lower airways (the nasal passages and the lungs) at all times.

Asthma or asthmatic symptoms are very common.  Dr. Saporta’s experience is that with SLIT administration, the need for inhalers resolves quickly, even in children. Here is a report on the use of SLIT for the management of children with asthma.

SLIT is not a new treatment modality. As explained in this paper, the oldest reference about SLIT dates back to the year 1900 when Dr. Curtis published his experience with SLIT.

Because of a series of mortality cases after allergy shots in England during 1986, the use of injectable immunotherapy all over Europe plummeted. That explains why SLIT is more commonly used in Europe but rarely used in the USA, even though SLIT was developed in the USA by the early allergy practitioners.

SLIT has been used in our office for many years. Dr. Saporta has been a pioneer in the resurgence of SLIT in our country. He has created an extremely safe and highly effective protocol for the administration of oral vaccines (SLIT).

The first and perhaps most important feature of SLIT is that it is a very safe treatment modality.

What does “safe” mean?

Administration of allergy vaccines by injections carries the risk of eliciting an allergic reaction. This reaction has a relatively low incidence but if it were to occur, it could be severe, including the risk of death.

Such a severe reaction is known as an anaphylactic reaction. While deaths after allergy shots are not frequent, there are reported cases in the literature, mostly in asthmatic patients.

SLIT has the unique characteristic of being very safe. To this date, there are no known cases of mortality reported after the administration of Sublingual Immunotherapy.

Dr. Saporta has used SLIT for many years without any major problems. Dr. Saporta’s protocol for SLIT administration, published in 2005, proved to be absolutely safe and highly effective for the management of allergic conditions including asthma.

SLIT is absolutely safe to use in circumstances where shots are or could be contraindicated, like when treating the very young patient, the older patient, the patient on Beta-Blockers or the pregnant patient.

While it is very important that administration of SLIT is very safe, it would be of no practical significance if it was not, at the same time, a useful and efficacious treatment modality.

The results of many well-done clinical studies point to the fact that SLIT works, and works very well. The amount of evidence is overwhelming. The huge body of published literature includes many articles that demonstrate the usefulness of this treatment modality (SLIT) on different expressions of allergies like: Nasal allergies, Allergic conjunctivitis, Asthma, Urticaria.

In Dr. Saporta’s experience, SLIT’s safety and efficacy has been confirmed over the years for the successful treatment of nasal allergies, allergic conjunctivitis, itching of the skin, migraines and asthma. We found that the treatment results after SLIT administration are equivalent to those obtained after the administration of injectable immunotherapy (“allergy shots”). We have treated many patients including young children (as young as 2 years old) with many allergic conditions including asthma that have improved with this oral treatment (SLIT).

Young children may also suffer from allergies, even severe. The child’s quality of life may become significantly affected by the presence of cough, nasal obstruction, migraines, skin rash or asthma. Children as young as 2 years of age can easily receive SLIT.

For information on asthma, the asthmatic child, the child that requires sporadic use of a nebulizer or inhaler or that has only isolated symptoms suggestive of inflamed lower airway click here.

SLIT can be safely given at home therefore it is ideal for those patients that live far from the office, have a busy schedule or travel often as well as elderly patients with physical limitations in mobility or dependent on other people for transportation.

Because of the obvious difficulties for the elderly to come to and from the office, they are often deprived of a treatment that otherwise could be very useful.

For a multitude of reasons, dust concentration usually increases in elderly homes. It is a common occurrence that seniors are reactive to dust mites. Diagnostic tests are often negative and symptoms may not be strongly suggestive of an allergic condition (as the person may only develop or more one of the following: persistent nasal obstruction, chronic cough, recurrent headaches, post nasal discharge).

These patients are often chronically tired, with poor mood and/or decreased ability to concentrate. These symptoms are easily dismissed (“expected at this age”). A program of home-based immunotherapy like SLIT, avoiding involved transportation to and from the office, appears to be ideal in this situation.

The use of betablocker-medications is nowadays very common, as these medications are used for the management of high blood pressure, heart conditions, or migraines.

Present guidelines for the administration of injectable immunotherapy suggest that if possible, the patient taking betablockers should avoid receiving injectable immunotherapy because if an Epi-Pen® is required, the betablocker might impair the action of the Adrenaline in the Epi-Pen® and patient’s life could be jeopardized.

With SLIT, a severe reaction requiring the use of Adrenaline, is not expected to develop, therefore there are no problems in treating a patient on beta blockers with SLIT.

The guidelines for the administration of allergy shots advise not to start allergy immunotherapy in a pregnant patient and, if she is already receiving allergy shots, not to increase the dose until after delivery. The reason for this is the uncertainty, in case of a severe reaction, of the effect of Adrenaline on the pregnancy.  Because there are no severe reactions to SLIT, sublingual drops appear to be the ideal management for the pregnant patient on immunotherapy.

Dr. Saporta has treated pregnant patients uneventfully: When patients on shots became pregnant, weekly allergy shots were changed into SLIT.

SLIT is so safe that treatment can be started during pregnancy.

There are papers that show that sublingual immunotherapy is safe when administered during pregnancy and that it is also safe when initiated for the first time in a pregnant patient:

Shaikh WA, Shaikh SW. A prospective study on the safety of sublingual immunotherapy in pregnancy. Allergy. 2012 Jun;67(6):741-3. doi: 10.1111/j.1398-9995.2012.02815.x. Epub 2012 Apr 5. PMID: 22486626.

and

Shaikh WA. A retrospective study on the safety of immunotherapy in pregnancy. Clin Exp Allergy. 1993 Oct;23(10):857-60. doi: 10.1111/j.1365-2222.1993.tb00264.x. PMID: 10780893.

An interesting observation in the second paper, is that a control group composed of those pregnant women that declined immunotherapy had “a higher incidence of abortion, prematurity and toxemia as compared with those treated with immunotherapy”.

Because drops are mixed in Glycerin, the allergens will not deteriorate for many months. With Dr. Saporta’s SLIT protocol, the bottles containing the vaccine will last no more than 6 weeks.

Again because of the stability provided by the glycerin there is no need for refrigeration, even though there is no problem in keeping the bottles refrigerated. On the other hand, it is strongly advised that the drops not be kept next to a window or in the glove compartment during hot days as heat can denature the protein, leading to a lack of efficacy.

The protocol designed by Dr. Saporta is very easy to understand, easy to follow and highly effective. Instructions are provided by Dr. Saporta and his assistant and in writing which make compliance easy to implement.

SLIT is not approved by the FDA. Its use is defined as an “off-label use of the allergenic extracts”. It is important to understand that approval by the FDA is not a requisite for a doctor to use a treatment modality. It only means that studies were not submitted to the FDA for its approval. Of note is that SLIT is used extensively in Europe and not only is it approved by the European Medicines Agency (EMA) – the European equivalent of the FDA -, but it is also reimbursed by European Health plans. In the US, insurance companies consider SLIT an experimental treatment modality and therefore do not reimburse for it.

On the other hand, the pharmaceutical companies in conjunction with allergenic extract companies have produced allergy tablets also administered sublingually, with only 1-2 allergens and these tablets, often called “sublingual immunotherapy” were approved by the FDA.

For the significance of 1-2 allergens versus many allergens see here.

Reported reactions after SLIT administration include itching of the tongue or the lips, gastro-intestinal symptoms like nausea or vomiting, skin rash usually in the lip area or face and more rarely headaches. Dr. Saporta reviewed all problems occurring in his practice over a period of 5 years and no significant problem had developed. For the complete review of this topic, see here.

LDA is an injectable treatment modality based on the observations by a British researcher (Dr. Mc Ewen) in the late 1960’s. Dr. Wildhem Shrader brought this treatment to the US in 1971.

In young children, LDA can be administered orally, but injections appear to work better so they are the preferred method of administration.

It consists in the administration of a solution containing ultralow doses of many allergenic extracts. The allergens are diluted so many times that they literally attain homeopathic levels. At the time of administration, these ultra-low allergen-solutions are mixed with a natural enzyme called Beta-Glucuronidase, which is also significantly diluted. LDA does not contain any type of preservatives (not even phenol or glycerin). Administering allergens that are so diluted, without any type of preservatives, prevent the possibility of a severe reaction to the administration of these allergens. This is an outstanding feature of LDA that is in opposition to the administration of the usual “allergy shots” or injectable immunotherapy.

LDA offers the possibility of treating reactivity to inhalant allergens, to food allergens and it can also manage reactivity to chemical triggers. It can even be used for the management of autoimmune problems.

Most allergic conditions can be helped by LDA. While the most common perception is that allergies are mainly produced by our body’s reactivity to the airborne particles (inhalant allergens), the reality is that patients can develop allergy symptoms by the foods in their diet or by chemicals in their environment. Actually, it is very rare to find a patient that reacts to only inhalant particles. Most patients, knowingly or unknowingly, have some reactivity to foods in their diets.  LDA treatment has the unique characteristic of combining most allergens in the surrounding environment (inhalant allergens) with food allergens.

Treatment results are excellent. Dr. Saporta reviewed treatment results on patients on traditional injectable immunotherapy versus patients on LDA and LDA performed the same or even better than injectable immunotherapy.

The most common use of LDA is for the management of patients with symptoms of allergies including asthma and eczema or urticaria. 

An allergy test is not required to administer LDA. This is another difference between LDA and the traditional “allergy shots” (injectable immunotherapy) or SLIT, where the quality of the treatment-result is intimately related to the results of the allergy test.

Because LDA injections includes a very large number of allergens, not only inhalants but also foods, even chemicals and others, and because it does not require an allergy test, LDA is ideal for all allergy patients but of special interest for the very sick patients like the uncontrolled asthmatic, where testing or treatment with usual “allergy shots” can be dangerous, and the patient with severe skin rashes or food intolerance for whom usual allergy treatments do not provide any help.

LDA treatment vials contain the following mixtures:

• Inhalant allergens: This vial contains a mixture of all the allergens found in the environment, like pollen, dust, mold and animal dander.
• Food allergens: This vial contains a mixture of food allergens. Most foods consumed in a western-style diet are included.
• Chemicals: This vial contains a mixture of different chemicals to which affected people may be exposed (either in the working environment or less commonly at home)
• There are other vials containing dilutions (again, ultra weak dilutions) of allergens derived from some bacteria that are involved in the development of some chronic diseases affecting the bowel or the immunological system.

Initially, LDA is administered once every 2 months. While there are no problems in delaying the treatment, time interval cannot be shortened as the symptoms may worsen. 

Most people feel better soon after the administration. This effect is initially short lived, not lasting the whole 2-month interval so that upon returning for the next treatment, the symptoms are usually back (even though in general not as bad as before starting LDA treatments. Dr. Saporta closely monitors all patients on any type of allergy treatment using validated questionnaires that show the symptom score.

After a variable period of time, the improvement starts lasting for 2 or more months. At that time, the interval between treatments starts to increase to once every 3 months, 4 months, etc. When interval between treatments reaches 1 year, the patient is advised to come once a year for 2-3 times and then as needed. Some people continue to receive a “booster” dose as needed, even at intervals of 2 to 3 years or even more. Most people attain symptom-relief.

LDA is highly efficacious but there is no knowledge as to the mechanism of action. There is no research in this area and without information, FDA approval cannot be granted.

In preparation for LDA administration, all patients are required to take vitamin D3 in a rather large dose, for 10 days prior to treatment.

All patients are required to follow a restrictive diet for 3 days: the day before the treatment, the day of and the day after the treatment.

LDA diet

The LDA diet is at this time is rather simple and there is no need to follow the complicated diet initially advised by Dr. Mc Ewen and Dr. Shrader. The patient is required to avoid dairy, grains and processed foods for 3 consecutive days, starting the day before the treatment, continuing on the day of treatment and the day after treatment.
In these 3 days, the patient is also advised to stop all vitamins and supplements and any medication that is not “life-saving”.

Prednisone requirement

Some patients, mainly with history of inhaler use, may require a 5-day course of Prednisone, starting 2 days before the treatment and ending 2 days after. The prednisone will hopefully avoid the need for inhalers. Obviously if during those 5 days of avoidance the patient requires inhalers, by all means, the inhalers should be used. It has been observed that following this diet increases the efficacy of LDA treatment.

All these steps in preparation for LDA administration are discussed in depth at the office and written instructions are also provided.

LDA uses completely natural allergens without any type of preservatives. It is impossible to develop a severe reaction as sometimes happens with usual injectable immunotherapy. The patient does not need to carry an Epi-Pen® (auto-injector of Adrenaline) at the time of LDA administration or after that administration. Dr. Saporta has never observed any severe reaction to the administration of LDA, neither does he know of any such type of reaction.  Still, like everything in medicine, there can be some problems related to its administration: 

Local reactions at the Injection area

LDA is administered in the skin of the forearm. The wheal (“swelling”) produced by the liquid entering into the skin may disappear, or may remain. The injected area can swell and even produce a large wheal, involving a large portion or most of the forearm. The skin can be pale or erythematous (red). Lines pertaining to lymphatic vessels may become evident.

This “swelling” usually resolves in hours but on occasion may last days. It is not unusual to develop redness in the previously injected area days after the wheal has resolved. This is usually related to exposure to some of the reactive allergens contained in the mixture. This happens more often in the injection that contain food allergens.

The injected area commonly is itchy. Application of ice, alcohol or creams should be avoided as this may interfere with the quality of the treatment-results.

Symptom-triggering

On occasion, the patient may develop worsening of some symptoms mainly cough, or worsening of skin problems (rash or itching). This may require additional treatment like inhalers or steroids.

Food or chemical related “unmasking” of symptoms

LDA is highly efficacious in treating food intolerances. When a patient is reactive to foods, the symptoms often get masked by the continued consumption of that food. If the person stops consuming that food, slowly a state of tolerance will ensue. When tolerance finally develops, the person will be able to consume the food without ill-effects. Before acquiring tolerance to the eliminated food, the person will go through a period of increased sensitivity. If during the time of increased sensitivity, that food is consumed, it will again trigger symptoms. During treatment with LDA a similar problem can develop, mainly for foods and for chemical smells. In this case, exposure to a food or chemical that previously was tolerated (symptoms were actually “masked”) now triggers symptoms. While this is a rare occurrence, it can certainly happen.

The management can be complicated and requires eating a very small amount of many different foods, and to continue with the treatment.

All these issues, precautions and instructions are discussed in depth before treatment and written instructions are provided.

• Safety: this is perhaps the main advantage. There is no possibility of a severe reaction to LDA administration. There is no need to carry an Epi Pen (which is different from the usual injectable immunotherapy given at weekly intervals ({allergy shots”)
• No need for an allergy test: Undergoing an allergy test is sometimes bothersome and sometimes implies an economical burden. But more importantly, the tests more commonly used for the diagnosis of the allergic conditions have a poor diagnostic ability so their results are often confusing and misleading. For example, when the patient knows there is reactivity to an allergen, like cat dander, or the pollen of the tree in the backyard, but the test is negative. This is even more important with foods, as the results of good testing are even more misleading with negative results to foods that the patient know there is reactivity and positive results to foods that the patient tolerates
• This treatment modality is capable of addressing reactivity to inhalant allergies, but also to reactivity to foods, to chemicals and even there is usefulness in certain autoimmune diseases
• Easy to comply: the treatment initially is administered only once every two months, later on, less often