Research on the Effectiveness of Borrelogen

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.