Low-Dose Immunotherapy (LDI), Part 2: Clinical Considerations

Ty Vincent, MD

Based on an interview with NJ Faass, MSW, MPH

Low-dose immunotherapy is relevant to virtually any condition that has an immunological, inflammatory basis. This encompasses an extremely broad range of chronic illness, including the following:

• Autism spectrum disorders;

• Chronic fatigue syndrome and fibromyalgia syndrome;

• Crohn’s disease, IBS, parasitic inflammation, SIBO, ulcerative colitis, yeast sensitivity;

• Food allergies and sensitivities;

• Lyme disease and other coinfections, including those triggered by Babesia, Bartonella, Ehrlichia, and Mycoplasma;

• Multiple sclerosis;

• Reactions caused by Clostridia and Streptococcus, as well as those due to the Epstein-Barr virus and herpes simplex;

• Responses to environmental allergens including animal dander, chemicals, molds, and pollen;

• Rheumatoid arthritis and other inflammatory arthritic conditions; and

• Skin disorders of all types including acne, dandruff, discoid lupus, eczema, hidradenitis, psoriasis, pyoderma gangrenosum, rosacea, tinea, and all manner of unexplained dermatitis conditions.

This therapy, initially termed EPD (enzyme-potentiated desensitization), was developed by a British allergist, Leonard McEwen, MD, in the 1960s. Here in the US that treatment (known as LDA) was modified by W.A. Shrader, MD, who conducted extensive clinical trials to gain permission from the FDA for American use. I apply essentially the same treatment protocol and the same concepts and have discovered new antigens to use in the same manner. Modifying the protocol, we get better responses, more quickly, that are sustained longer. To date, I have been able to successfully address over 40 autoimmune or inflammatory conditions with this technique. Additionally, the use of autologous antigens has yielded encouraging success in the treatment of persistent disorders of the skin, joints, nervous system, conjunctiva, sinuses, mouth, GI tract, bladder, and vagina. Prior to this therapy, there was no effective intervention for some of these conditions. (For more information on clinical outcomes achieved with this treatment, see part 1 of this article, “Low-Dose Immunotherapy,” Townsend Letter, June 2017.)

Clinical Focus

In clinical practice, I spend at least an hour with every new patient, with three primary goals in mind. The first is to determine whether or not there is an immunological basis for their symptoms. If there is, I must identify the underlying target antigen(s) that is triggering the excessive immune activity. Frequently there is more than one trigger, so I develop a list of possible suspects and decide which antigen to prescribe first, using a diagnostic process of elimination. The third question is the starting dosage or dilution to use for that specific individual. Ultimately these are the primary considerations on the initial visit: Is this an immunological issue? If so, which antigen should be given first—and at what dosage? This becomes an iterative process to determine additional antigenic target(s) and the proper dosage of each antigen to neutralize that immune response.

The process involves giving a diluted sublingual dosage of one particular antigen (or a mixture of related antigens such as Borrelia and the coinfections) and then tracking the response to that antigen or antigenic mix. The patient needs to pay attention to the particular symptoms that occur in response to each dose and report back to me as to whether their symptoms got better, worse, or stayed the same. This means working through different dosages of that antigen or antigen mixture until the patient has a significant improvement, and then working with that dilution within the rules and the time schedule inherent in this technique. The experience of the practitioner helps to sort through the variables more efficiently.

Differentiation of LDI from Conventional Allergy Treatment

For decades, conventional allergists have treated hay fever and other allergy conditions using dilutions of the very antigen to which the patient is reacting. However, the dilution range used is stronger than LDI, relatively speaking, and initially must be given by injection twice a week. Conventional dilutions typically range from one part per million to as high as one in ten.

In the approach I take to LDI, the antigen is almost always administered sublingually. Microbial samples are procured from a sample warehouse and include bacteria, fungi, viruses, and parasites that have been inactivated via electron beam irradiation to assure that there is no possibility of infection. To treat acne, for example, I often employ an inert sample of Propionibacterium acnes, along with a collection of other skin bacteria, all diluted to a strength of approximately one trillion to one (6C), a typical dosage in LDI. When we give acne patients the right dilution of the appropriate bacterial mixture, their acne will resolve quickly and dramatically, often within a week.

Sublingual Antigens

With LDI, I am now able to prescribe 99% of the doses sublingually and that works as effectively as injections. In my practice, 95% of the people I see respond to sublingual doses just as they would if the antigen were injected. Perhaps 4% need a stronger sublingual dosage in order to benefit. Then there are a rare handful of individuals who do not seem to get a response unless we inject the antigen. Of the more than 1,000 people we have treated using these various techniques, only 1% still receive LDI by injection.

Effective sublingual administration was first reported by Gus Kotsanis, MD, a physician with a large clinic in Texas who sees children with autism spectrum diagnoses. It is well known that autistic kids are commonly afflicted by food and environmental allergies. He found, as many of us have, that those in the autism community benefit greatly from the LDA technique. When he experimented with sublingual antigens to achieve a better rate of compliance, he found that the degree of effectiveness was virtually the same.

Regarding autism and Lyme disease, we have discovered that for a large percentage of the autism population, the Lyme bacterium is one of the target antigens causing their inflammatory responses. The broad-spectrum Lyme/coinfection mixture that I have developed contains 74 total species in a formulation that includes Borrelia, Bartonella, Babesia, Ehrlichia, and Coxiella. This mixture of antigens has worked miraculously for some of the children and adults on the autism spectrum and also for those with symptoms of Lyme disease or coinfections.

Selecting the Initial Treatment Antigen

The choice of the first antigens to test with a given patient should be based primarily on an extensive history. I look for patterns in the symptoms they exhibit and clues in the circumstances surrounding the onset of their chronic problems. Often the most important information is how the patient responded to prior treatments, particularly if any form of antimicrobial therapy was used. The more clinical experience and better understanding of pathophysiology the practitioner has, the better they will be at sorting through the possibilities.

Some clinicians in the integrative medicine community use muscle testing, autonomic response testing, or bio-energetic devices. Although those techniques seem to have a certain degree of success in determining the right antigen, they are only marginally better than good clinical assessment, and they are not very successful at determining the right dosage or dilution for antigens. For instance, the difference between the Epstein-Barr virus and Candida yeast is significant, so that technique is fairly effective at differentiating between those two agents. However, if the antigen is Candida, for example, those technologies are not as useful in determining the difference between two dilutions, for example an 18C and a 21C dosage. The technology is unable to identify the dosage that will be most appropriate for a given patient.

Dilutions

Across clinical medicine, a variety of immunotherapy techniques are employed to desensitize patients to various antigens. In LDI and LDA, the strongest concentrations we typically use range from one part per hundred million to one part per trillion, depending on the antigen. Some antigens, such as yeast or Lyme organisms, may require far weaker dilutions, as far out as ten to the 80^th. Once the right dosage is found, it need only be taken once every seven weeks. Conventional immunotherapy, in contrast, uses injections that are usually one part per ten thousand or stronger, given twice a week. Provocation/neutralization, a desensitization technique commonly applied in environmental medicine, might use dilutions as strong as 1:125, and the dosage can be taken every day if needed to neutralize symptoms as soon as they return.

At a dilution of approximately one part per million, a change seems to occur in which the interaction between patient and antigen shifts from being purely molecular to more of an energetic phenomenon. Even at stronger concentrations of an LDI antigen such as 10^-10 or 10^-12, the effect is likely a harmonic interaction rather than a molecular interaction. The belief is that we continue to lose molecules as the antigen mixture becomes more dilute until we reach 10^-24. If you dilute a substance 10^-24 or further, you theoretically have eliminated all the molecules from that dilution. These solutions are described as dilutions beyond Avogadro’s number, because the antigen is no longer detectable by scanning electron microscopy. (Avogadro’s number refers to the number of atoms in one molecule of any given substance.) What is still functioning in the dilution is thought to be the harmonic signature or the vibrational frequency of that substance. When an antigen is diluted out to 10^-24 (12C) or beyond, theoretically that is energy medicine, which is the basis not only of LDI, but also of constitutional homeopathic prescribing.

Using dilutions in the homeopathic range of the harmonic spectrum, such as a trillion to one or further, there seems to be a longer lasting effect on the immune response. For these doses, we must follow a different set of rules, and, as described, we find that we must delay the administration of the next dose by seven weeks or longer. Due to that essential seven-week window, the theory is that we are causing a tolerance reaction mediated by regulatory T lymphocytes. These particular lymphocytes are thought to live approximately 50 to 60 days, and a new dosage provides the educational signal to sustain that response. That is the working hypothesis behind LDA and LDI.

Contrasting LDI dosages with homeopathic remedies, note that dilutions in LDI are described literally. The higher the number of an LDI dilution (30C vs 6C), the more diluted the antigen, and the “weaker” the dose. In contrast, with homeopathic treatment, the more diluted remedies are referred to as “stronger” dosages. A homeopathic remedy of 30C is considered stronger than one of 6C, despite the fact that the 30C is much more diluted. In LDI terminology, the 6C dosage is much “stronger” than 30C, by a dilution difference of 48 zeros.

Timeline and Titration

Once an antigen dose is taken by the patient, one of three types of responses will occur:

1. If it is too weak, that dilution will do nothing and they will have no change in their symptoms. At that point, they can take the next stronger dosage at least ten days later.

2. If the dosage is on target, their symptoms will improve for some length of time. The same beneficial dose may be repeated, but one must wait at least seven weeks to reset the immune response. The immune system appears to have some form of memory function that is responsible for the necessity of waiting seven weeks. Only weaker “booster” doses may be taken within that seven-week period.

The titration process may initially require a series of doses every ten days to learn where your patient responds. How many doses it takes depends on how far off the starting dose was. The ideal dosage for the patient cannot be known in advance. Consequently, it can take months of dose titration or even a year until you determine the optimal effective dose. It is also possible to start in the middle of the range of dilutions or at a strong “diagnostic” dose. These are all style points that should be thoroughly discussed with the patient.

3. The dose may be too strong and cause a “flare” or worsening of their symptoms (whatever symptoms tend to be chronically associated with that antigen). The good news associated with a flare is that you have found the correct antigen for their treatment. In that event, they must wait at least seven weeks as a washout period, and back off to a weaker dose for the next cycle. How far to back off correlates fairly well with how long the flare lasts. The rule of thumb is that the appropriate dosage is diluted roughly 1C for every week that the flare persists. (Most dose titration proceeds by increments of 100:1 denoted by the letter C (100 in Roman numerals). Dilutions are often prepared in 1C increments (for example 30C, 31C, etc.). A flare that lasts three weeks, caused by an antigen of 30C strength, is therefore replaced by one diluted of 33C, taken after a full seven weeks from the initial dose.

A flare can also result if the patient inadvertently takes the proper dose of antigen before the seven-week washout has transpired. Consider the example of desensitizing someone to a milk allergy or to peanuts. If you find the right dilution of that specific antigen and give it every seven weeks, the person will find that they can eat dairy products or peanuts with no reaction. However, if you give them that food dilution at six weeks instead of waiting the full seven weeks, when they try to consume dairy products or peanuts again, they may have a temporary reaction that is worse than those they had before they initiated treatment. That is also true with all the autoimmune and chronic inflammatory disorders that we have treated, including Crohn’s disease, Lyme disease, and multiple sclerosis. When someone flares because they have taken a dose prematurely, you do not need to modify the dose; they just have to wait the full seven weeks before taking the next dosage.

The seven-week washout period required between doses to “reset” the immune system was initially worked out by Leonard McEwen, MD, more than 50 years ago. In 2015, I began experimenting with that timeline. Through clinical research, I found that it is not necessary to wait seven weeks between doses if you are going progressively stronger in an attempt to find an effective dose (i.e. 30C, 29C, 28C, etc.). Additionally, it is not necessary to wait seven weeks if you are giving a significantly weaker dose after improvement, once the previous dose has worn off. I call the first situation “dose titration” and the second situation, “booster dosing.”

Patient Reporting

What complicates this process is that these people are often quite ill to begin with. Frequently that affects their cognitive processing, memory, and brain function, as well as their attention to detail and in some cases their ability to keep track of their symptoms. Many of these patients have symptoms that vary across a range of severity from day to day, so they do not have a stable baseline. Consequently, it is difficult for some of the patients, particularly in the Lyme disease community, to determine whether a dose had an effect on them or not, and whether they are actually better or worse. Many will give me a report that goes something like this: “For a couple of days I felt worse and then for a couple of days I felt better, and then I felt worse again, and then better.” Given that this is what they live with from week to week in any case, when they report that kind of up and down response after a dose, it probably means that the antigen itself had no effect. I prefer to then give them a little stronger dose to see if that causes a more obvious response from their baseline (i.e. 29C following 30C, etc.). But patients who are more fearful may interpret these “null” responses as “flares” and wish to back off to a weaker dose. One approach is to give progressively more diluted antigens through several dosing cycles of seven weeks each, moving away from the initial dose until it is clear that the dosage is not triggering a flare.

The interpretation of dose reports is the process we go through with every patient, case by case, week by week. This information is the basis used to determine adjustments in the dosage and therapy. The process is critical, and the success of LDI depends on how well the patient can perceive and interpret changes in their condition and report that back to the practitioner. There is no “protocol” for dosing LDI over time; it is 100% individualized, based on how the patient responds to every dose taken. There is never any plan beyond identifying the very next dose.

People in the Lyme disease population are the most complex patients I treat. Symptoms involving the same antigen may vary greatly from one patient to the next, one person suffering joint pain, peripheral nerve symptoms, numbness, and tingling and another struggling with headaches, brain fog, and night sweats. There is often a difference in the symptoms and response from one person to the next, even with the same antigen. Symptoms may be widely variable even in the same patient and require time to document carefully. That said, providers accustomed to careful symptom observation will find aspects of this approach fairly familiar.

Flares

There is always the possibility that the dosage we choose is too strong and may cause a flare in which related symptoms temporarily become worse rather than better. However, it is important to realize this is actually good news. It means that we have found an effective antigen mixture; and once the right dosage is identified, symptoms will get better. Although it is never the goal to cause a flare, when that happens it represents great progress.

One of the important concepts of LDI is the balance between the risk of a flare and the efficiency of the treatment. If the patient wants their answer quicker, they have to be willing to accept a higher chance of flaring. If they do not want a flare, they have to be willing to be patient. When our primary goal is to avoid a flare, we start the patient at a much weaker dosage, and it takes longer to find the effective dilution. However, we can move through progressively stronger doses every ten days until a beneficial response occurs. If you get a little over zealous and gives the patient a dose that is too strong and they flare, then you must wait seven weeks before giving another dose of that antigen. Consequently, there can be a longer delay recovering from a flare than there is when starting the dosage more conservatively.

I make an effort to avoid flares by building a 3C cushion into my estimation of the starting antigen dose. My rule of thumb is that flares tend to last roughly one week for every 1C we were off on the dilution. Information from the patient regarding the severity and duration of their flare is incredibly important in determining the right treatment for that person. I select the dose I think the patient will need based mainly on my experience with other people with the same condition and the severity of their symptoms. Then I start the patient at 3C weaker than the dosage I think they need, which gives me a larger margin of safety.

Long-Term Response

Many people obtain consistent relief from their full cycle dose within the first year. Hopefully everyone can maintain 100% symptom relief from then on. More than fifty years of EPD/LDA experience suggests that about one-third of patients are able to stop therapy after a matter of a few years and no longer need the antigens at all. It is too early to know if we will see similar success with the LDI autoimmune antigens. I think a key difference is that with LDI, we are often desensitizing patients to antigens that reside within their own bodies, antigens that cannot be avoided as external allergens can.

Typically, the duration of improvement becomes longer and longer with repetition of the correct dosage. Early on, people receive their dosage every seven weeks, but after approximately a year of treatment, for some patients we can space out the dosages to two, three, or four months so they only need a dose a few times a year. At that point, the therapy becomes lower maintenance and less expensive. A realistic expectation for everyone is that they only need a dose a few times a year; and I have developed methods for tweaking the dosage to achieve this in the great majority of patients. In conventional therapy, patients incur costs of hundreds of dollars per month. In contrast, maintenance dosing of LDI from my office should cost less than $500 per year.

The Art and the Science of LDI

The art of low-dose immunotherapy largely involves communicating effectively with the patient or their caregivers. Every adjustment in dose is based on how the patient responded to the previous dose. That requires a great deal of perception and effective description on the part of the patient. The practitioner needs to learn how to ask the right questions to gather the information needed to make good decisions. This skillset improves greatly with experience, but it can be frustrating. I equate learning LDI to playing an instrument. If you devote the proper time and focus, you can make “music” for many of your chronically ill patients.

Experienced integrative practitioners who have a broad knowledgebase and have developed their skills in empirical clinical observation and/or other forms of immunotherapy often utilize this tool quite well. Those who are Lyme-literate are likely to be astute observers and bring the requisite skills to the table in order to learn this therapy easily. If they practice it effectively, they have the opportunity to have an impact on many complex debilitating disorders with a safe, highly successful, and inexpensive form of treatment.

Ty R Vincent MD

Dr. Ty Vincent grew up in Alaska, graduated from the University of Alaska, magna cum laude, and earned his medical degree at the University of Washington. A family practice physician in Alaska for more than a decade, Ty has been a board member of the American Academy of Environmental Medicine and the American College for the Advancement of Medicine. With diplomate status from the American Board of Family Medicine, he has also completed additional training and fellowships in environmental medicine, medical acupuncture, and Chinese herbal medicine. Recognized as an expert and innovator in the field of low-dose antigen therapy, he has received awards from the American Academy of Family Practice, the Society of Teachers of Family Medicine, and the American Academy of Environmental Medicine. Dr. Vincent now provides training for professionals and co-management of patient care through his company, Global Immunotherapy, LLC, based in Kona, Hawaii.

Resources

LDI Training and Clinical Services

Global Immunotherapy offers distance provider training and patient care. Patients receive consultations with Dr. Vincent by phone or Skype in the comfort of their own home. Provider membership enables practitioners to receive the LDI Training Manual and to order LDI antigens, as well as customized autologous samples. Membership facilitates direct contact with Dr. Vincent, answers questions about LDI, supports case review, and gives practitioners the opportunity to converse with other professionals who are using LDI treatment. Global Immunotherapy also provides LDI antigens for healthcare professionals, to be diluted and used for the treatment of their own patient populations. We have had very good success treating all manner of allergies, autoimmune diseases, and chronic inflammatory disorders. Dr. Vincent also provides consultations and patient co-management in conjunction with local primary care physicians on medical needs beyond the parameters of LDI.

Global Immunotherapy LLC

Kona, Hawaii

Phone

: (907) 671-8255

Email:

customerservice@globalimmunotherapy.com

Web-based Information

We now have a series of short video clips on YouTube and linked to our Facebook page and website. Most of the videos are brief, conceptual discussions of 5 minutes or less on different aspects of LDI therapy. We are finding that this is a very effective tool for helping patients work with their provider on LDI treatment, and at this point the videos have received more than 10,000 views.

Website:

globalimmunotherapy.com

Book

: Thinking Outside the Pill Box (available through Amazon, Barnes and Noble, Google Books, etc.)

LDA Providers

Dr. W. A. Shrader maintains a website listing physicians he has trained who administer LDA, alphabetical by state in the US, Canada, the UK, and elsewhere, available at www.drshrader.com/lda_physicians.htm.

Editorial: Nancy Faass, MSW, MPH

Ms. Faass is a writer and editor in San Francisco who has participated on more than 50 books to date. Director of the Health Writers’ Group for the past 20 years, she works collaboratively with clients to develop books, articles, Web content, white papers, manuals, and blogs, and can be reached by emailing info@HealthWritersGroup.com or calling (415) 922-6234.