Borrelia
burgdorferi antigen release stimulation by nutraceutical formula as determined
by Lyme Urine Antigen Testing (LUAT)
(Presented by Dr. David A. Jernigan, 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 of prescription 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, 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.
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