HOW MANY LYME DISEASE PATIENTS DON’T MEET STRICT DIAGNOSTIC CRITERIA?
In a recent article published in Open Forum Infectious Disease, Kobayashi and colleagues suggest that Lyme disease is often mistakenly diagnosed as causing various illnesses, which has led to the unnecessary use of antibiotics. The authors conducted a retrospective study of patients with possible Lyme disease, who were referred to an infectious disease clinic in Maryland between 2000 and 2013. ¹
Kobayashi and colleagues concluded that nearly 3 out of 4 patients referred to the clinic did not have Lyme disease. They did not interview the referring doctor at Johns Hopkins University School of Medicine. Instead, they conducted a chart review.
However, to be included in the study, patients had to meet the Infectious Diseases Society of America’s (IDSA) guidelines or the Centers for Disease Control and Prevention’s (CDC) clinical and serological criteria.
The authors found that out of 1,261 patients, all but one were symptomatic when they presented to the clinic, with a median duration of complaints of 558 days, ranging from 1 day to 51 years.
“The 5 most commonly identified symptoms were arthralgia (71.3%), fatigue/malaise (66.8%), headache (42.1%), myalgia (40.8%), and sleep disturbance (34.3%),” writes Kobayashi.
Only a few patients had abnormal physical findings.
“The 5 most common abnormal physical findings were rash other than erythema migrans (6.6%), joint swelling (5.9%), tender points (3%), objective sensory abnormality (2.1%), and motor weakness (1.5%),” the authors explain.
The researchers did not report a number of clinical presentations that can occur in Lyme disease, including:
It may be that many physicians do not recognize or document these types of manifestations, given that the authors didn’t mention any of these presentations.
Approximately 1 in 10 patients had a history of co-infections.
“Although 139 (11%) co-infections were diagnosed before evaluation at the infectious diseases clinic, none of these infections were confirmed or treated based upon the evaluations performed in this study,” writes Kobayashi.
“Of these 139 putative co-infections, 61 (44%) were said to be caused by Babesia microti or B. duncani, 40 (29%) by Epstein-Barr virus, 30 (22%) by Bartonella, 11 (8%) by Ehrlichia spp., and 32 (23%) were attributed to other infectious agents,” writes Kobayashi.
Takaaki Kobayashi, Yvonne Higgins, Roger Samuels, Aurasch Moaven, Abanti Sanyal, Gayane Yenokyan, Paul M Lantos, Michael T Melia, Paul G Auwaerter, Misdiagnosis of Lyme Disease With Unnecessary Antimicrobial Treatment Characterizes Patients Referred to an Academic Infectious Diseases Clinic, Open Forum Infectious Diseases, Volume 6, Issue 7, July 2019.
Logigian EL, Kaplan RF, Steere AC. Chronic neurologic manifestations of Lyme disease. N Engl J Med. 1990;323(21):1438-1444.
Fallon BA, Nields JA. Lyme disease: a neuropsychiatric illness. Am J Psychiatry. 1994;151(11):1571-1583.
Sigra S, Hesselmark E, Bejerot S. Treatment of PANDAS and PANS: a systematic review. Neurosci Biobehav Rev. 2018;86:51-65.
Muehlenbachs A, Bollweg BC, Schulz TJ, et al. Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden Cardiac Death Associated with Lyme Carditis. Am J Pathol. 2016.
Kanjwal K, Karabin B, Kanjwal Y, Grubb BP. Postural orthostatic tachycardia syndrome following Lyme disease. Cardiology journal. 2011;18(1):63-66.
Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. 2003;60(12):1923-1930.
Simons LE. Fear of pain in children and adolescents with neuropathic pain and complex regional pain syndrome. Pain. 2016;157 Suppl 1:S90-97.
Klempner MS, Hu LT, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001;345(2):85-92.
Krause PJ, Telford SR, 3rd, Spielman A, et al. Concurrent Lyme disease and babesiosis. Evidence for increased severity and duration of illness. Jama. 1996;275(21):1657-1660.
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**Comment**
This article brings up very important points – many patients do not meet the stringent CDC diagnostic criteria to even be accepted into research studies much less be diagnosed with Lyme/MSIDS. For 40 years we’ve had blood serology that misses half of all cases as well as the fact many patients do not present with the “classic” EM rash but either have no rash at all or a rash that presents differently. https://madisonarealymesupportgroup.com/2019/02/22/why-mainstream-lyme-msids-research-remains-in-the-dark-ages/
You’d have to be blind to not see how patients are immediately set up for failure.
While they continue to shout about unnecessary antibiotics, most patients are denied care. Trust me when I say we all have much better things to do besides taking expensive, painful treatment!
Until the CDC/IDSA/NIH admit that they only have a very partial picture of how Lyme/MSIDS presents patients are doomed to the same suffering they’ve been suffering for over 40 years.
It is important as one of the nation’s leaders in chronic Lyme disease complex, and after nearly two decades of helping patients, to point out how the CDC has missed the mark entirely with their current study and publication on prolonged treatment for Lyme disease. Unfortunately this information is quite literally too little and too late. Too little, because it is old information and too late, because it offers nothing new to help the many patients that have been suffering. On its face, this small study is designed to discourage physicians from helping their patients.
Recently, Centers for Disease Control and Prevention (CDC) released statements regarding the treatment of chronic Lyme disease based on a few published studies on a small number of patients and conducted a case study that ultimately provided no new information not already known by most Lyme literate physicians. In the statement, the CDC states that antibiotics were shown not to provide long-term benefits for chronic Lyme patients and rather gave rise to other complications such as CDIF infections.
The CDC inferred, based on these outcomes, that doctors should not treat these patients but rather refer them to other specialists. Referring to the same old rheumatology, psychiatry, pain management, and neurology treatments that never eliminate the root cause which is the infections.
This lack of proper treatments ultimately leaves the patients in a life-time of suffering and in a condition that only worsens over time. That is exactly the opposite direction to health and healing that our team is dedicated to achieving with our patients. But the devil is in the details, and to the untrained physicians and patients, the CDC statements sound reasonable and conclusive. However, IV antibiotics were never effective for numerous reasons as we mentioned in our peer-reviewed published article from 2014 in the Open Journal of Medical Microbiology Chronic Lyme Disease: Persistent Clinical Symptoms Related to Immune Evasion, Antibiotic Resistance and Various Defense Mechanisms of Borrelia burgdorferi.
It is something we hear daily from our new patients when they first walk in, the antibiotics they had taken in the past only provided temporary relief. Therefore, the important question and case study work should help answer why the IV antibiotics alone do not work. This is a topic in which we have done a great amount of medical work and have been speaking and teaching about for years. In fact, we wrote about this: Top 7 Overlooked Factors for Treating Lyme Disease.
We will discuss in this article why personalized integrative medicine and a detailed diagnosis and treatment plans make all difference for chronic Lyme disease patients. As clinicians working in the field, we believe the CDC chose this study with a pre-established belief in the results but this mindset is only a distraction to real advancements that are being made in treating this disease. Let’s take a look at the facts.
Chronic Lyme disease Complex, Not Just Chronic Lyme
Patients with chronic Lyme never have just the one infection, they have multiple infections that have gone untested and untreated for extended periods of time. Antibiotics are not even effective for many of these infections, such as with viral, fungal, and parasitic infections.
When chronic Lyme disease is mentioned, most often they are actually referring to chronic Lyme disease complex which involves the spirochete which causes Lyme, Borrelia burgdorferi, and also associated co-infections, which enter the body with Borrelia in the initial tick bite: Babesia, Ehrlichia, Bartonella, Rocky Mountain Spotted Fever etc. Chronic Lyme disease complex can also include secondary infections which occur as a result of a compromised immune state. This is important to keep in mind because antibiotics do not work against viral infections and similarly, fungal infections require antifungal medication and so on. The secondary and co-infections must be identified in order for treatment to be effective. This is the number one reason why antibiotics alone cannot be used to treat these patients.
It is important to understand that Borrelia has a number of mechanisms both for evading and distracting the immune system and that Borrelia is capable of burrowing and spreading throughout most of the body’s tissues, including the blood-brain barrier. Antibiotics cannot easily pass the blood-brain barrier which allows borrelia and others infections like babesia to attack the brain and central nervous system unimpeded. Borrelia implants itself in tissues and within individual cells to avoid being consumed and lysed by the immune system. The microbe is also adept at countering the adaptive immune system through constant variation in its surface proteins, or antigens, a feat enabled by its complex single chromosome and its circular DNA plasmids. Usually, by the time the body can create antibodies to target Borrelia, its surface has already changed so much that the new antibodies are no longer effective. In serum, Borrelia has the ability to inactivate C3, a protein marker which would normally trigger the immune response for free floating microbes. When Borrelia does find a place to settle down and multiply, the microbe secretes a protein mesh called biofilm which shields it and its progeny from direct exposure to many antibiotics and other compounds that might otherwise harm the infection. Our team has published on this subject extensively and we have assembled a great deal of information on the biology and survival mechanisms used by Borrelia in our published study Borrelia burgdorferi: Cell Biology and Clinical Manifestations in Latent Chronic Lyme.
While the spirochete Borrelia is responsible for causing primary Lyme disease, it is usually not the only factor to consider when approaching treatment for chronic Lyme disease, or more commonly, Lyme disease complex. When a tick bites, various bacteria and parasites enter the wound besides just Borrelia. These simultaneous infections are called co-infections and can include Babesia, HHV-6, Epstein-Barr, and Rocky Mountain Spotted Fever, just to name a few. These co-infections are able to gain a firmer foothold in the body and potentially become chronic since Borrelia excels at distracting and depressing the host immune system. Secondary infections can also be picked up after the initial bite due to a depressed immune response from the infected person. The result is a condition that is chronic and can linger for months or even years, typically worsening over time without proper treatment.
In our published study, Chronic Lyme Disease Complex and Its Commonly Undiagnosed Primary and Secondary Co-Infections, we discuss the various co-infections which can coincide with Lyme to form Lyme disease complex. The presence of multiple different infections in the body simultaneously seriously complicates any potential treatment as is discussed below. Many of these other infections complicate treatment and increase the risk for auto-immune diseases depending on the patient’s genetic background and can also be a precursor to various cancers. Treating these infections in their totality is essential to full recovery and for the patient to achieve health which is why often antibiotics alone don’t work clinically.
Single Antibiotic Treatments Inevitably Fail against Lyme Complex
The organism Borrelia has multiple strategies for evading, inactivating, and depressing the immune response including the ability to insulate itself inside tissues and biofilm to avoid contact with substances which might kill it, like antibiotics. A critical flaw with the four randomized trials funded by the CDC to study chronic Lyme disease is that they all used a single antibiotic regimen (ceftriaxone) compared against placebo. As well, this is not typically the antibiotic of choice with a resistant chronic Lyme. Patients’ co-infections also need to be identified in a case of chronic Lyme disease complex. Each patient should receive a personalized regimen based on their infection profile, neurological involvement, immune state and genomics. Also, their ability to eliminate toxins from the body should be evaluated.
With the advent of multi-drug resistant (MDR) strains of bacteria, we have found in our clinical experience that chronic Lyme disease will not respond effectively to antibiotic regimens without the addition of MDR blockers. In chronic patients, these infections have often become “super bugs” and blocking MDR is essential. Also, multiple organisms can survive and propagate within biofilm communities formed by the Borrelia bacteria. This enables Lyme disease to essentially shield other infections from treatment. Adding compounds which are designed specifically to break up biofilm is part of the treatment often needed to help chronic Lyme disease complex. The signs and symptoms of chronic Lyme and the ways in which it evades treatment by antibiotics is outlined in our published paper Chronic Lyme Disease: Persistent Clinical Symptoms Related to Immune Evasion, Antibiotic Resistance and Various Defense Mechanisms of Borrelia burgdorferi.
Another factor which is not considered in any of the published studies listed by the CDC is the genetic variation in the patients. Each person responds to medication in a slightly different way. A lot of this variation is due to Single Nucleotide Polymorphisms (SNP’s) which also make up a large portion of physical differences between humans. SNP’s will cause each patient to metabolize drugs at a greater or lesser rate than the “average person” which is an amalgamate based off of data from thousands of studies rather than a patient’s own particular medical history. Treating patients based off national averages is always risky, which is why people continue to have adverse reactions to medications prescribed by doctors. This personalized testing is essential for several reasons. Finding blocked genes and variations in HLA-DR are highly common in chronic Lyme disease patients, which is why this disease is often linked to autoimmune diseases. Knowing how to access a genetic profile in the Lyme patient is essential to better tailor the therapy and support pathways of elimination as dealing with biotoxins and neurotoxins is a complex problem.
Other than the terribly flawed placebo-driven studies released, the CDC would have you believe that treatments for chronic Lyme disease complex are risky and potentially life threatening. Below, we point out that…
Treatments for Chronic Lyme Are Not Any More Dangerous than Other IV Therapies
The CDC listed five cases of patients who sought treatment for chronic Lyme disease and experienced adverse events due to intravenous therapy. While the article seems to imply that the resulting infections were due to the treatment for chronic Lyme disease, an impartial reader will notice that each of these adverse events occurred after the installation of a permanent port, in particular PICC’s or Peripherally Inserted Central Catheter. The PICC is essentially an open line directly into a central artery near the heart and thus is extremely prone to infection when proper care is not adhered to. That is why at Envita, our physicians and specialized nursing staff do not prefer to use PICC’s with our patients. Instead, if the patient is to undergo extended intravenous therapy for their condition, an implanted subcutaneous port is recommended and we work with the best interventional radiologist to ensure safety. The implanted port is a soft silicone tube inserted below the skin into which a small needle can be used to deliver drugs in a similar way to a PICC. However, a subcutaneous port is covered by skin which makes it lower maintenance for the patient and reduces the risk of infection drastically. Our nursing staff works in this environment daily and excel at making sure patients ports are properly accessed and maintained.
Whenever the skin is broken for any reason, however, there is always a risk for infection, even in a hospital with trained staff; and nowadays, you may be at greater risk of a MDR infection while in a hospital than not. This risk is reduced when doctors and staff follow rigid sterilization protocols while adverse events tend to occur when discipline relaxes. While the risk continues over a greater length of time in treating a chronic ailment like Lyme, the risk does not inherently grow as a result of the duration and just like at any medical facility, the risks are managed with careful attention to detail and patient compliance. As a facility with many years of helping patients we rarely see any infections because our team is very good at what they do and our facility is clean.
There is nothing inherent about therapy for Lyme that places patients at greater risk than other kinds of treatment. The antibiotics and nutritional IV, immune modulators, phytotheraptics and other medications that are prescribed are commonly used as required. At Envita, we prioritize attention to detail and patient safety, that’s why we personalize our treatments to each individual patient and are confident in our work and outcomes.
The articles released from the CDC seem to imply also that chronic Lyme disease is not even a real phenomenon at all and insist that other factors must be the cause for the patients’ symptoms. However the CDC is sadly mistaken. In our many years of work with these infections, we know that they are the cause of many auto-immune diseases and neurological problems. The message the CDC wants everyone to take home is to get “real” medical care for your problem, to keep using pain medications, neurological drugs, steroids, and deal with being bed ridden while suffering and letting your health decline because the conventional approach is best. The fact is these infections are real and patients can improve. Real hope exists when you treat the cause of your disease and not just the symptoms.
Yet curiously, the CDC does not deny that these symptoms do exist and cause detrimental harm to people’s lives, up to and including hospitalization for pain, fatigue, and neurological problems. The CDC does not discuss why, if Lyme disease is not a contributing factor to these symptoms, the patients do not recover after traditional therapy and why these cases continue to appear in areas prone to tick infestations. To dismiss out of hand a potential explanation with inadequate evidence is unusually irresponsible of this institution responsible for guarding the public against infectious agents. Therefore, in our professional opinion, it’s too little (not enough helpful detailed information), too late (leaving patients to suffer and still question the cause of their illness). Maybe the CDC should read our published studies and look at our materials to help them better design studies for the future instead conducting studies of which they already know the outcomes only to mislead and misdirect the public. We make this statement as the CDC has had a very untrusting relationship with chronic Lyme disease issue in this country.
However, at Envita, we have taken the time to specialize and gather all available information about Lyme disease and its impact on the body. We are proud and blessed to see our patients return to health and we let our success stories speak for themselves. If you are interested in learning more about the risks of Lyme disease, feel free to give us a call at 1-866-457-9956 and one of our trained patient care coordinators will be more than happy to answer your questions. You can also learn more about Lyme disease at our webpage here.
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**Comment**
Envita puts out great materials and we are the better for them. I just love how this article essentially states that the CDC is full of crap – something we all know but it’s nice to hear it from professionals treating this complex disease(s).
This short 7 min. video from Envita explains:The helper T-cells come along and pick up the processed antigen off the dendritic cell and then passes it along to the killer T cells. The Killer T cells follow the spirochete throughout the body and proceeds to destroy healthy tissues and organs because they can’t differentiate between the antigen of the spirochete and the antigen of healthy tissue.As the killer T cells come into contact with the antigen on the healthy tissue it becomes inflamed and destroys healthy tissue and is autoimmune in nature.
A total of 127 Amblyomma ticks (A. helvolum, A. varanense and A. geoemydae) were collected from reptiles: water monitors (Varanus salvator), Bengal monitors (Varanus bengalensis), Burmese pythons (Python bivittatus), yellow-spotted keelbacks (Xenochrophis flavipunctatus), keeled rat snakes (Ptyas carinata) and elongated tortoises (Indotestudo elongata) from nine provinces in Thailand. The presence of Borrelia spp. of the 16S rRNA, flaB, glpQ, groEL and gyrB genes was examined by conventional, semi-nested and nested PCR. Phylogenetic analyses using maximum likelihood method of housekeeping genes showed that most sequences of Borrelia spp. in these Amblyomma ticks belonged to the clade of reptile-associated (REP) borreliae. Interestingly, one Borrelia sp. in an A. geoemydae tick collected from an elongated tortoise clustered in the same clade as a Borrelia sp. detected from an A. geoemydae-infested turtle in Japan (it may belong to the same species given the identical sequences of their 16S rRNA, flaB and glpQ genes) and formed the same group with tick-borne relapsing fever (RF) borreliae of B. miyamotoi and B. theileri.
Our findings are the first report on the presence of Borrelia spp. in A. helvolum and A. geoemydae ticks from reptiles in Thailand adding to the geographic distribution of Borrelia spp. in Asia.
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**Comment**
Please note the turtle found with a relapsing fever borrelia in the same group as B. miyamotoi and B. theileri – both pathogens that infect humans as well as animals.
RESEARCHERS WORKING AT FORT MCCOY NEAR SPARTA, AS PART OF A MULTI-UNIVERSITY PROJECT MICHIGAN STATE ECOLOGIST JEAN TSAO LEADS, HAVE COLLECTED DEER TICKS FROM FIVE-LINED SKINKS AND SNAKES.
It would appear that the ability of the Lyme spirochete to evade host immune responses, resist antimicrobial treatment, alter systemic metabolic functions and destroy mitochondrial function hinges upon the enhanced activity of hypoxia-inducible transcription factors HIF-1 and HIF-2, where HIF-1 alters metabolic pathways to favor glycolysis, and HIF-2 decreases osteoblast formation, resulting in chronic unresolved inflammation, bone loss and reduced mitochondrial functions.
Hypoxia-inducible transcription factors (HIF) are also heavily implicated in tumorigenesis, where HIF1a is found to be overexpressed in many cancers. Yet HIF is our body’s primary response to fluctuations in cellular oxygen levels. How do our bodies control HIF regulation and why is Vitamin C, ascorbic acid, indispensable in the regulation of HIF? ……… To Be Continued ……..
Antiparasitic and Antifungal Medications Targeting Cancer Cells: Repurposing Drugs for Cancer
Dr. Simon Yu, MD, Medical Director at Prevention and Healing,Inc.
Is it possible to treat cancer as a neglected infectious disease? Is cancer a metabolic disease, with tumors growing – and metastases spreading – like a metabolic parasite? It may sound farfetched, but there is growing evidence to support this novel idea that can change the way we treat many types of cancers.
The Abstract concludes, “The information offered in this review suggests scientists should think of cancer not only as a metabolic disease but also as a metabolic parasite and should consider using antiparasitic medications under a new understanding of the role of inflammation, infection, and mitochondrial dysfunction in the development of cancer cells.”
The paper discusses how largescale administration of the antiparasitic medications albendazole, mebendazole, ivermectin, praziquantel and/or azithromycin in the early 2000’s – reaching over 1 billion people per year in Africa, Asia and Latin America for the original targets of parasitic diseases – had an unintended outcome of collateral health benefits. In addition to greatly reducing the incidence of parasitic diseases and disability and saving many lives on a mass scale, it provided a form of universal health coverage, including reducing transmission of malaria. A thought provoking idea!
Going back to our paper, chronic inflammation is a new catchphrase for the explanation of all chronic degenerative diseases, from asthma, arthritis, heart disease, autoimmune disease, and irritable bowel disease to cancer. Unrecognized low-grade infection is a main cause of inflammation from oncovirus, bacterial, fungal and lesser-known parasite infections that are driving forces in the cellular evolution and degeneration of cancer cells.
The observation that cancers, like parasites, feed off of our bodies without returning a benefit has been known for some time, and early in the 20th century, it was suggested that cancer is a parasite. The metabolism of some parasites shows a method of energy formation similar to that of cancer cells.
An approach using currently available medications that target both fungal and parasite metabolism appears to interfere with tumor growth and aggressiveness.
Due to the complexity of the behavior and biology of the cells, scientists’ primary focus should be on detection and elimination of sources of inflammation. Physicians should think of cancer not only as a metabolic disease but also as a metabolic parasite, and should also consider using antiparasitic and antifungal medications with the understanding of the role of inflammation, infection and mitochondrial dysfunction in the development of cancer cells.
I have also learned that there is much research to be done on how our cells and our ancestral microbes share commonalities as well as differences in how they function in health and disease to this day – providing potential new avenues for treatment. One of my favorite phrases is, “We are not so different, you and I.” It applies not only across people and cultures, but across cells, microorganisms, and all of God’s creatures, great and small.
Our position in the paper is analogous to NEJM’s recent article, “Collateral Benefits of Preventive Chemotherapy-Expanding the War on Neglected Tropical Diseases,” regarding the unintended outcome of extended collateral benefits of saving lives on a mass scale, if mainstream academic medicine is willing to embrace the concept of cancer as infectious diseases as if cancer is metabolic parasites.
In my cancer and complex chronic disease patients, I have been extensively using parasite medications (such as albendazole, mebendazole, ivermectin, and praziquantel), antibiotics and antifungal medications, and making referrals to biological dentists to eradicate hidden dental infections (especially Entamoeba and protozoal parasites). As patients recover healthy metabolic and immune functioning, it is not uncommon to witness the resolution of many chronic diseases, including asthma, autism, Lyme, persistent Lyme, psoriasis, neurologic disorders like MS and Parkinson’s, seizures, and cancers.
I am not in a position to claim that cancer is an infectious disease. I think it is worth asking the question if it is possible to treat cancer as a neglected infectious disease, as if cancer is a metabolic parasite. Dr. Guilford and I are interested in collaborating and testing our hypothesis for Preventive Chemotherapy using parasite medications for cancer. Time to think differently!
Dr. Simon Yu, M.D. is a Board Certified Internist. He practices Internal Medicine with an emphasis on Integrative Medicine to use the best each has to offer. For more articles and information about integrative medicine, patient success stories, and Dr. Yu’s new book, AcciDental Blow Up in Medicine: Battle Plan for Your Life, visit his website at www.preventionandhealing.com or call Prevention and Healing, Inc., 314-432-7802. You can also attend a free monthly presentation and discussion by on Integrative Medicine at his office on the second Tuesday each month at 6:30 pm. Call to verify the date. Seating is limited, arrive early.
Kobayashi and colleagues concluded that nearly 3 out of 4 patients referred to the clinic did not have Lyme disease. They did not interview the referring doctor at Johns Hopkins University School of Medicine. Instead, they conducted a chart review.
Madison Area Lyme Support Group 