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If you are ready to feel better and get healthier, we can help you. We will explain why our treatment is highly likely to work and a test is often not required.

Do you have a history of recurrent headaches (sinus pain and pressure, migraines); persistent nasal discharge or mucous with poor response to allergy medication and no response to antibiotics; did you have one or more surgical procedures on the nose and/or sinuses but symptom continue; do you develop itching “all over”, mostly at night; do you have a diagnosis of skin rash, eczema or urticaria; do you have a history of recurrent ear infections requiring multiple courses of antibiotics or even tubes?

If you said “yes” to any of the above, keep reading, as it is highly likely that you or your child have allergies

If any of the following situations apply to you or your child, it is likely related to allergies as it is not unusual for allergic conditions to go undiagnosed and even when diagnosed, often times immunotherapy treatments fail to offer good relief:

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 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. There are other much safer modalities, with equal or even better efficacy: SLIT or 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 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 mold. For the management of allergic conditions read see 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. 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 controlling their allergies should consider Sublingual Immunotherapy (SLIT) or Low  Dose Allergen immunotherapy (LDA)

About Allergy

Definition

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).

 

So, 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.  For the management of allergic conditions read You have allergies but medications do not help you enough and SLIT and LDA.

The proper management of allergic conditions

Because allergy medication will not cure the allergic condition, patients interested in attaining a cure or significant reduction of their symptoms should consider Allergy Immunotherapy

Allergy immunotherapy

Allergy immunotherapy consists of the administration of the same allergens that produce the symptoms. Usually, they are administered frequently in very small but increasing dosages, 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.

 

This treatment has the potential to cure allergies. It can be provided by injections (Injectable immunotherapy or “allergy shots”), by oral drops (because the drops are usually administered under the tongue, this modality is known as Sublingual Immunotherapy or SLIT), or by a modality that uses ultra-low doses of allergens (Low Dose Allergen Immunotherapy  or LDA). For more on Allergy and Immunotherapy see here .

 

Frequent questions about immunotherapy include: Are Allergy vaccines safe, are they natural, do they carry preservatives, do they contain steroids (“prednisone”). Read more here.

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, another chemical very common 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.

 

Allergy vaccines do not carry the type of preservatives that the usual vaccines do: heavy metals (mercury or aluminum), PEG, etc. They do not contain prednisone or any type of steroid. Steroids are frequently used for control of symptoms in acute circumstances. Sometimes these steroids are given as a shot (once or twice per year) and frequently called an “allergy shot”. Steroids are just a medication. Allergy vaccines do not contain steroids.

 

In regards to safety: safety depends on the route of administration: injectable vaccines carry a risk for a reaction, potentially severe. Oral vaccines and LDA are extremely safe.

Sublingual Immunotherapy - SLIT

Sublingual immunotherapy (SLIT) refers to the administration of the allergy vaccine orally (inside the mouth), usually under the tongue. The drops are kept there for a certain amount of time and then swallowed.

 

For information about the history and uses of SLIT, click here and here  and for an overall review of the role of Sublingual Immunotherapy in the management of allergic patients click here 

History and uses of SLIT

As explained in the following paper, SLIT is not a new treatment modality. 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 in 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.

 

In this article, you will be able to learn about the historical perspective of SLIT development, and its advantages, namely safety and efficacy. SLIT is ideal for young children, the weak and the elderly patient, and for patients living far away from the doctor’s office.

 

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)

Advantages of SLIT

Safety

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 rare, there are some cases reported in the literature, mostly in asthmatic patients.
Anaphylactic reaction is the type of reaction that occurs to some people that are reactive, for example, to bee stings or to peanuts, and that are exposed to those allergens. Sometimes, inhalant or food allergens injected in the vaccine, can trigger a similar type of reaction.
In this reaction, the throat can “close” or the bronchi (breathing lung tubes) can constrict leading to difficulty breathing. Other problems of this reaction include development of diffuse itching or even hives, swelling of the eye-lids, lips or even tongue (further compounding the difficulty breathing). It often requires administration of Adrenaline (medication contained in the Epi-Pen®), and other medications.

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

Dr. Saporta has used SLIT for many years without any major problems. 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.

See:

Leatherman BDKhalid ALee S et al. Dosing of sublingual immunotherapy for allergic rhinitis: evidence-based review with recommendations. Int Forum Allergy Rhinol. 2015 Sep;5(9):773-83. doi: 10.1002/alr.21561

Efficacy

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 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 mentioned above 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).

Allergy Immunotherapy is the only treatment that can cure asthma.

L. Jacobsen and E. Valovirta published a paper that demonstrated that immunotherapy (allergy vaccines) can prevent development of asthma in patients suffering from allergies and that immunotherapy is the only treatment for allergic diseases to be able to prevent worsening of disease and asthma development. (Lars Jacobsen, Erkka Valovirta. How Strong is the Evidence That Immunotherapy in Children Prevents the Progression of Allergy and Asthma? Curr Opin Allergy Clin Immunol. 2007;7(6):556-560.)

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. See here a report on the use of SLIT for the management of children with asthma

Useful in special populations:The very young patient

SLIT in the very young patient

Young children may also suffer from severe allergies, and the 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.

Asthma. Controversies in diagnosis and management

 

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

 

Lower airways include the breathing tubes called bronchi and other smaller tubes. These breathing tubes are surrounded by muscle that may constrict, producing obstruction and therefore difficulty breathing.

 

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.

 

Bronchodilator medications: Albuterol is the bronchodilator usually used to alleviate the obstruction of the lower airways. Because it is used when the patient has symptoms, it is known as a “rescue medication. It can be administered by a nebulizer (usually used by young children) or by inhalers. The inhalers come with the name of Albuterol, Pro Air®, Ventolin® and others. There are also inhalers that are anti-inflammatory that are used as maintenance medications.

 

Despite this simple definition, an asthma diagnosis is elusive. Often patients with all the symptoms and using inhalers are told they do not have asthma. The situation complicates when patients have only 1 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 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).

 

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 allergic conditions.

 

In Dr. Saporta’s experience, it was established that most patients that reported having no asthma still exhibited an improvement in pulmonary function if receiving immunotherapy. In his 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.

The older patient and the patient that lives far from the practitioner’s office

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.

More on The older patient here.

 

“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.

 

Due to 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 appears to be ideal in this situation.

Patient on Beta Blockers

The patient that takes beta-blocker medications for the management of high blood pressure, heart conditions, or migraines.

If a patient has a severe reaction to an allergy shot it may require administration of Adrenaline. The function of Adrenaline is to constrict the blood vessels (alpha effect-α-) and to dilate (open) the bronchi or breathing tubes (beta effect -β-). Administering Adrenaline to a person on Beta Blockers carries the risk of triggering an uncontrolled increase in the blood pressure while failing to open the breathing tubes.

This is the basis for the controversy on administering allergy shots to a patient on β-blockers. With SLIT it is not expected to develop a reaction severe enough to require Adrenaline, therefore there are no problems in treating a patient on beta blockers with SLIT.

The pregnant patient

Allergy immunotherapy guidelines advise not to start allergy shots in a pregnant patient and if she is already receiving shots, not to increase the dose until after delivery. The reason for this is that 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”.

About SLIT administration

Oral vaccines are applied under the tongue. In Dr. Saporta’s protocol, they are held under the tongue for approximately 20-30 seconds and are then swallowed.

 

For the proper administration, a mirror should be used as it is impossible to properly count the number of drops by “feeling them drop” in the mouth.

 

When treating a very young child or a non-cooperative child, it is enough to apply the drops anywhere in the mouth. The sublingual mucosa appears to yield better results but the whole oral mucosa is immunologically competent.

 

SLIT (oral vaccines) are prepared by Dr. Saporta in the office. The composition of the drops is determined by the results of an allergy test.

 

Different tests can provide different results. The information of all tests can be combined to determine the formula of the oral vaccines.

 

In cases of clear reactivity but a negative test (example: exposure to cat or dog triggers asthma or skin rash, or any other clear symptoms) a formulation can be prepared even when the test is negative (non-reactive).

 

All this will be clearly explained at the office visit or during the internet-based encounter.

Expiration date

Because drops are mixed in Glycerin, the allergens will not deteriorate even after many months.  The contents of a SLIT bottle lasts a maximum of 6 weeks so for practical purpose a SLIT bottle will not expire before it has been used.

Refrigeration

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.

FDA Approval

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 in Europe and not only it is approved by the European Medicines Agency (EMA) – the European equivalent of the FDA -, but it is also reimbursed by all health plans. In the US, insurance companies consider it 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 were approved by the FDA (for the significance of 1-2 allergens versus many allergens see here).

Problems related to SLIT administration

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.

Low Dose Allergen immunotherapy (LDA)

LDA is a 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.

Drshrader.com will provide more in-depth information on this treatment modality.

The characteristics of LDA are:

 

It is an injectable modality, but in young children, it can be administered orally. Injections appear to work better so they are the preferred method of administration.

 

Because it 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 can be dangerous, and the patient with severe skin rashes or food intolerance for whom usual allergy treatments do not provide any help.

 

It consists in the administration of ultralow doses of allergenic extracts. It literally reaches the level of dilutions found in homeopathies. At the time of administration, these ultra-low allergens are mixed with a natural enzyme called Beta-Glucuronidase.

 

LDA does not contain any type of preservatives.

How often is LDA administered.

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. Upon return for the next treatment symptoms are usually back. Still, it is usually observed that with each treatment, the symptoms are better. Dr. Saporta closely monitors all patients on any type of allergy treatment using validated questionnaires that show the symptom score

 

Symptom score:

a numerical value that represents the severity of the symptom

 

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.

FDA approval

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.

What conditions are treated by LDA

Most allergic conditions can be helped by LDA. While the most common perception is that particles in the air (dust and pollen) can trigger allergic symptoms, the truth is that very commonly patients also develop symptoms by foods in their diet or by chemicals in their environment. It is very rare to find a patient that reacts to inhalant particles only. LDA 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 injectable immunotherapy versus patients on LDA and both treatment modalities appear to perform equally.

Preparation for LDA administration.

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 and 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”.

Some patients may require a 5-day course of Prednisone, starting 2 days before the treatment, primarily patients actively using inhalers. 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.

Risks and complications

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.

 

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. It can swell and even produce a large wheal, involving a large portion 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 have a flare of the injected area if exposed to the allergens injected. This happens more often in the injection that contain food allergens.

 

Commonly, the injected area is itchy. Application of ice, alcohol or creams should be avoided.

 

Symptom-triggering

On occasion, the patient may develop worsening of some symptoms. When this happens, it more often involves respiratory 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 to treat 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 before acquiring tolerance to it, 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 but also for chemical smells. In this case, exposure to a food or chemical that previously was tolerated 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.