Laboratory Proof

Borrelia burgdorferi antigen release stimulation by nutraceutical formula as determined by Lyme Urine Antigen Testing (LUAT)

(Presented at the 1999 International Tick-Borne Diseases Conference, New York City, New York)

Abstract

It is understood that antigens are the cause of numerous sensitivities resulting in much of the symptomatology experienced in chronic illness. This clinical study was restricted to determining whether Borrelia burgdorferi specific antigen (Literally the dead pieces of Bb) could be purged from circulation by the use of a nutraceutical formula called Borrelogen. The results are very preliminary as more research is needed to rule out physiological interference. LUAT assay was utilized to determine antigen release after 68 subjects used the nutraceutical for one week. Results revealed 73% of the subjects released specific antigen to the degree of being considered positive or highly positive by LUAT. (Only seventeen of the 68 subjects were tested by Lyme Western Blot IgM/IgG prior to starting Borrelogen. All seventeen subjects were either Equivocal or Positive via this serological assay.) This study in itself cannot be used to make definitive statements about the efficacy of Borrelogen, only that an antigen was released from whatever mechanism. 

Note: IGeneX is not in any way endorsing this nutraceutical, nor is IGeneX associated in any way with Jernigan Nutraceuticals, Inc. IGeneX was blinded to the use of the nutraceutical and only performed the testing procedure. True research seeks to find the truth in an unbiased manner for the betterment of mankind.

Introduction

Bacteria contain many particulate and soluble antigens that evoke strong, often lasting immune responses, both humoral and cellular.193 According to Stedman’s Medical Dictionary, an antigen (allergen) is any substance that, as a result of coming into contact with appropriate tissues, induces a state of sensitivity.194 Antigens are understood to cause many of the symptoms experienced by Lyme Disease sufferers. It would stand to reason that decreasing the antigen load on the body would correspondingly decrease the number and severity of symptoms. A proprietary nutraceutical formulation was developed in 1998 to specifically target the functional release of spirochetal antigen from the tissues of the body. The historical and pharmacognostic data of the individual plant-based extracts reveal very low toxicity, while being functionally beneficial in many ways to the body. The research presented here was performed as a clinical study to aid in our understanding of the potential effectiveness of the nutraceutical formula Borrelogen. Lyme Urine Antigen Testing (LUAT) was chosen as a viable determinant due to its specificity to Borrelia burgdorferi antigens seen as a result of a release of antigen from an appropriately applied therapy. Because the body will, as a natural process, release Lyme specific antigen in about 30% of untreated cases, the nutraceutical formula was tested to see if the body could be stimulated to release a greater amount of antigen, with a higher percentage of positive LUATs. A nutraceutical is defined as a plant-based remedy that is specifically formulated to target specific body dysfunctions.195

Methods

Participants in this study were pre-selected based on positive Borrelia burgdorferi screening, using Bio-Resonance Scanning assay. The group consisted of 68 people residing in a non-endemic area of the United States. All were suffering from a range of 3 to 44 chronic problems based on a 55- question Lyme Disease symptom questionnaire. Lyme Urine Antigen Testing (LUAT) was utilized to monitor the release of antigen. LUAT testing is an antigen capture assay specific to detection of low levels of antigen, in spite of the presence of other proteins. The antibody being used in this antigen capture is a unique polyclonal antibody that is specific for the 31 kDa (OpsA), 34 kDa (OpsB), 39 kDa, and 93 kDa antigens of Borrelia burgdorferi. This assay appears to be very specific to these antigens with a reported false positive rate of less than 1% in a study of 408 controls.196 The reference range of a LUAT is based on P-values or confidence levels. Antigen levels reported as 32 ng/ml have a 95% confidence level of being positive and distinguishable from a negative population.197 A LUAT is a highly controlled and reproducible assay which is used in conjunction with patient history, symptoms and serum panels. The nice thing about LUAT assay is that it is positive throughout all three stages of infection: early, which is said to be <60 days (which is before you normally can get a seropositive result); second stage, which is defined as 60 – 360 days; and the third stage, >360 days.198

Results

Reporting only the highest score of the three-day urine collection, the majority of positive LUATs scored over 100 ng/ml. Out of the 68 LUATs, performed 44 were reported as positive or highly positive, while there were 4 borderline, and 18 negative results. The total percentage of positive scores was 73%. When the nutraceutical formula was used instead ofprescription antibiotics, the majority of positive LUATs were reported over 100 ng/ml, and as high as >400 ng/ml. Although a score of >400 does not indicate that a patient is more highly infected than a score of >45 ng/ml, it does indicate a high rate of antigen release which can only benefit the patient. An interesting side note: only 17 of these 68 cases were also tested by Lyme Western Blot IgM/IgG prior to taking the Borrelogen. All 17 subjects tested as positive or equivocal by Lyme Western Blot.

Conclusion

Based on this study, it appears that this nutraceutical formula does indeed stimulate the purging of Borrelia burgdorferi antigens from the body. This antigen-detox can only be seen as a good thing as these antigens, when circulating throughout the body, cause a multitude of systemic sensitivities, which in turn causes increased suffering in the patient. An infected person does not release antigens daily or uniformly.199 It is significant that, 73% of the time, a high release of antigen was stimulated while using this nutraceutical. Further research must be performed to determine if a negative control group on the same protocol would yield a similar effect. However, based on positive patient symptomatic response and clinical observations, we are encouraged that this botanical formula may effectively stimulate and increase the tissue elimination of deleterious antigen via the urine. Further research may also result in increased probability of highly positive Lyme Urine Antigen Test confirmations.

Interference studies performed by IGeneX lab confirmed that Borrelogen does not cause a false positive LUAT when negative patient urines were spiked in various concentrations. This in vitro assay does not, however, effectively rule out the possibility of in vivo interference.

192 Glenn T. Shwaery, G. TPh. D., 99G-0905m 1999 Toxikon Corp. Sponsored by International Nutraceutical Research Group.

193 Coltran, Kumar, Robbins. Robbins Pathological Basis of Disease. 4th Edition; p.335. 194 Stedman’s Medical Dictionary. 25th Ed. Williams & Wilkins.
195 Journal of Nutraceuticals and Functional Foods, 1994.
196 Journal of Nutraceuticals and Functional Foods, 1994.

197 Journal of Nutraceuticals and Functional Foods, 1994.
198 Calllister SM, Schell RF. Laboratory Serodiagnosis of Lyme Borreliosis. J Spirochetal Tick-

borne Inf 1998; 1:21.
199 Harris NS. IGeneX Reference Laboratory Guide, 1998; 4.

When considering toxins, it must be recognized that toxins are poisonous substances that are irritating and sometimes permanently damaging to the tissues of the body. Toxins of any type must be avoided and eliminated at all costs. In this article, we will be going exhaustively through the primary types of toxins that I guarantee that you have: microbial toxins and environmental toxins. Microbial toxins, like the neurotoxins of Lyme disease, require a different and more targeted treatment approach than do the more common environmental toxins. Fifty percent of the health restoration every Lyme sufferer seeks will come from effectively eliminating the toxins and reducing the sources of the toxins, i.e., bacteria and toxic lifestyle products. The other 50% of healing will revolve around restoring structure and function and optimal coherence within the body, mind, and spirit.

Research and clinical studies have determined that there are neuro-toxins released by the Borrelia burgdorferi (Bb) spirochete [Klinghardt 2002]. Neurotoxins are nerve poisons. These toxins, according to research, are the cause of most, if not all, the symptoms of Lyme disease. It is also believed that tissue damage is not caused by Lyme bacteria directly; in other words, the bacteria are not “eating” your tissues. It is the accumulation of Bb toxins in your body that is most likely responsible for the symptoms experienced by Lyme sufferers.

In the scheme of facilitating healing in the body, mind, and spirit, toxins are poison in the body. In that the body, mind, and spirit are all interconnected and interdependent, if the body is poisoned, then the mind and spirit must necessarily be poisoned as well. These toxins are a major interference to your body’s ability to heal itself.

An astonishing new finding was released by John Travis in Science News (July 2003;164). Travis reported that research performed by John F. Prescott found that certain antibiotics, such as the fluoroquinolones, the class of antibiotics that includes the name-brands and generic brands of Levaquin[R], Cipro[R], Tequin[R], and Avelox[R], actually are known to trigger a type of virus called bacteriophages (viruses that can infect bacteria) to change the genetic sequencing of the bacteria, causing the bacterium they have infected to start producing toxins. These viruses can act as genetic delivery vans, invading bacteria, such as spirochetes, often lying dormant, until activated by a change in the host (your body’s) environment. Once activated, these viruses insert their toxin-generating genes into the bacterial chromosomes. These viruses can turn basically harmless bacterium into killers through this genetic sequencing of toxins (Travis 2003).

So now we see that not only are these toxins released through bacteria die-off and not only can antibiotics actually increase the production of the toxins, but these viruses can cause the bacteria to rupture, spilling their toxins into the body (Waldor 2004).

When a doctor uses an antibiotic and kills some Lyme spirochetes, there is a resultant Jarish-Herxheimer (Herx) reaction–i.e., a worsening of the patient’s symptoms in response to the increased release of bacterial die-off toxins. The toxins are dumped into the bloodstream and circulated throughout the body, until they can either be eliminated by the body or lodged in areas of weakened tissues. As neurotoxins, they are preferentially taken up by nerve tissue. These lodged toxins are one reason why symptoms can persist even after the actual Bb infection is gone, because the toxins can remain as an irritant in the tissues for years.

In truth, a severe Herxheimer reaction is a sign of poor elimination pathway drainage, poor organ support, and poor treatment by your doctor. The bodies of most chronic Lyme sufferers are toxic dumps to start with, therefore, if a doctor does not get the pathways of elimination open and working, the body grows even more toxic as the bacteria begin to die and their toxins dump. Many doctors think good treatment is indicated by the fact that you feel like crap, i.e., worse than usual, which they feel confirms that they have selected an effective antibiotic. Most of my chronically ill patients cannot afford to feel worse just from the treatment. The person with Lyme disease has already suffered enough; they don’t need to go through a “herx” just to prove they have Lyme disease.

One of the more popular herbal remedies on the market causes such a severe herx that it is advised that only one drop be taken. Because of my previous Lyme disease books, I have spoken to hundreds of people from all over the world who have taken natural products and/or pharmaceuticals and now not only have their old symptoms but many new symptoms as well. Remember, no matter what you decide to take, whether the resulting herx is a true bacterial die-off or is a direct toxic effect of the remedy/medication, these toxins must be given just as high a priority as the actual infection. Chronic Lyme sufferers do not have adequate detoxification mechanisms to detoxify these Bb toxins.

I worked for many years, sifting through and trying many of the world’s finest detoxification products with mediocre results at best. While I was presenting research at the 1999 International Tick-Borne Diseases Conference in New York City, I took a break one day and wandered through Chinatown. In my wanderings, I found a Chinese herbal pharmacy. It had a huge assortment of exotic herbs and medicines from China, all held in drawers that covered a long wall from floor to ceiling. Each drawer had three bins, each holding something different. Since I was on a quest to find the elusive solution to what would address the specific toxin of Lyme spirochetes, it dawned on me to use Bio-Resonance Scanning[TM] (BRS, a real-time, non-computerized testing technique I developed) to test these herbs to see if there was anything that would work. The BRS testing required only a few moments and resulted in four herbs testing as beneficial, out of the hundreds in the apothecary. The Chinese pharmacists were quite certain I was doing some sort of magic with my BRS testing. I must have been a rare spectacle to them, since my six foot-seven-inch frame towered over them, and the BRS testing is not like any conventional testing. I think they were glad to hand over the bags of herbs and be rid of me.

Upon arriving home again, I prepared my herbs into a hydroalcoholic extract as I had been taught by the anthroposophical medical doctors in Eckwalden, Germany. With great elation, I discovered that the final product tested out as highly beneficial for some of my Lyme patients who had previously hit a plateau in their healing. The new formula took these patients to another 25% improvement. I and they were elated. It wasn’t the end-all solution, but it definitely was a step in the right direction. Unfortunately, in their rush to be rid of me, the Chinese pharmacists, who spoke no English and had to look up the Pinyin (the English derivation of the Chinese name for an herb) name for the herbs, must have written down the wrong names. When I called to order more of the herbs from another supplier of Chinese herbs, one who did speak English, the herbs I received were not the same and would not work. Formula lost! Not to worry, in those days, no one knew what the exact Lyme neurotoxin was; it took me five more years to identify ammonia as the primary toxin, even though I could detect the general frequency of the Lyme toxin with the BRS during the days of the Chinese apothecary. This story is the reality of how I ultimately found better remedies for real people in my clinic.

Today, I am convinced that the newest formulations, the NeuroAntitox II formulas, are the most advanced Lyme-ammonia detoxification products on the market. I once again identified the herbs in these formulas using BRS. The herbs, Silphium and [salvia azurea], were both growing in my own pasture, and it was just my inborn curiosity, or more likely divine inspiration, that led me to pull up these herbs and carry them into the clinic to test them. Like all of the different formulas I make, the primary herbs cannot be purchased from any herbal supply house. I must grow, harvest, process, and bottle them each year. And each formula is the result of striving to help real people (over 3,000 patients) in my clinic, after trying, with minimal results, all the big-name, heavily marketed, nutritional supplements. Direct Resonance testing, a clinical research technique, along with the Functional Acuity Contrast Test (FACT) seem to verify that these formulas reach all the hidden reservoirs of ammonia in the body, even crossing the blood-brain barrier, restoring integrity to the body, mind, and spirit.

It must be remembered, however, that symptoms will not completely disappear just with the elimination of Lyme toxins, simply because health and healing entails more than the absence of toxins. The toxin-damaged tissues must be restored, the diseased mindset must be reset to that of positive affirmative health, and the spirit must learn and live the new insights gained during the illness.

The FACT™ test is a very good test for detecting the presence of neurotoxins in the brain. It is also known as a Visual Contrast Test (VCS). The FACT test has been successfully used in medical diagnosis and subclinical neurotoxicity detection. Produced by the Stereo Optical Company, the test is simple to use and can be used indefinitely without wearing out. If your doctor does not use this test, let him know about it, because it is well-researched, and for once, you can track your progress on a weekly basis if you so desire. As brain neurotoxin levels go down, your test should improve. To perform the test, you simply hold the apparatus in front of you, as the instructional sheet will indicate, and the degree to which you can visually see certain images on a card determines the level of neurotoxins.

Reading about the many general body detoxification nutritional and botanical supplements that are plentiful on the nutraceutical market can be confusing. These products are designed to be general detoxifiers of the liver and intestines. While these products are a very good idea for almost everyone, they are not designed to handle Lyme neurotoxins, nor do many, if any, of these products actually cross the blood-brain barrier to reach the ammonia in the brain.

COPYRIGHT 2007 The Townsend Letter Group

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