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Dialogue: an overview of Lyme testing and treatment: Steven Harris, MD, and Mischa Grieder, ND.

Context

There have been scarcely two generations of medical practitioners and researchers in the scientific effort to decipher Lyme disease. At present, the CDC estimates 300,000 new cases are infected in the United States alone, every year. For the past twenty years the number had been listed at 30,000 cases with admitted underestimates by at least a factor of ten. (1) In the United States, this may amount to six million people infected in the last twenty years. In other parts of the world, prevalence is in unknown numbers, but Lyme is documented to now be endemic in Scandinavia, Russia, Nepal, China, Japan, Australia, New Zealand, South America, Mexico, Canada, Scotland, England, France, Germany, and Eastern Europe.

A recent study by Johns Hopkins showed 65% of patients still have Lyme symptoms after treatment with standard therapies. (2) This leaves millions of patients diagnosed with Lyme disease still with symptoms. Many of the patients with Lyme disease or post-treatment Lyme syndrome (PTLS) are remarkably ill. Most are quite proficient in the state of their knowledge regarding Lyme treatments and are desperate for any progress, evidence-based or not. How do we approach these patients? What about the patients who have Lyme disease, but have not been diagnosed?

Diagnostic Considerations

Dr. Harris: In the diagnosis of Lyme, we want as much hard evidence as possible in order to have statistical probability that we will be able to help the patient--to have a reasonable assurance that the clinical diagnosis is supported by high-quality scientific evidence. There are also medical and legal issues, and we want to maximize the possibility that our patients will be reimbursed by insurance.

Dr. Mischa Grieder: With the instant availability of content online, we now have access to an enormous amount of information on emerging treatments. Everyone learns very quickly of new developments, right down to specific herbs, herbalists, and protocol. We know those. What I believe is of interest for us as practitioners is to get a better grasp on how we organize and use those resources --how we integrate that information into a meaningful treatment plan for each specific patient.

Ms. Nancy Faass: If you think of this as a multiple matrix like a hologram, it's a chessboard in three or four dimensions. You have the individual genetics, their phenotype, all these infectious agents (and all the associated commensals and pathogens in the human microbiome). Then there are treatment successes and treatment failures, plus the patients' economics and what they bring to the treatment. How do you organize all that in an individual patient?

Dr. Harris: We're hopefully thinking about all of that all the time: we're thinking about the bugs, we're thinking about the patients' nutritional status, their phenotype or epigenetics, their detox pathways, and environmental factors (toxins, metals, etc.). We're thinking about their travel history and the risk of parasites and infections, including viruses. We're thinking about their psychological and emotional state, their history of interpersonal relationships, and any history of abuse, as well as their health history, birth history, and past experience with medications, trauma, and surgeries. As practitioners we consider all these factors, and we internalize them, regarding them as a gestalt in relationship to that patient to create a meaningful plan.

Differential Diagnosis

Dr. Harris: I think we should include differential diagnoses in the work-ups for Lyme patients. Standard tests need to be done. Lyme testing needs to be done, and it should not all be done based on non-validated tests. There still needs to be a strong scientific approach.

We can employ a three-tiered paradigm of testing and treatment for Lyme disease and other infectious disorders (such as Dr. Horowitz' MSIDS, multiple systemic infectious disease syndrome): this could be described as a hard-evidence model, a soft-evidence model, and an alternative model. The hard evidence includes prospective, randomized trials, clear causality, and a well-defined endpoint. Whenever we can use this approach, I feel that this should be a goal. There are many patients with Lyme who do not utilize or adhere to integrative medicine, who are not going to be reached if hard scientific evidence is not the basis of their diagnostic and treatment approach. In addition, whenever we can develop cogent research studies and treatment approaches to raise the state of the science, more universal acceptance of the disease is probable.

Dr. Grieder: Although we're going to use all the hard evidence we have, we also need to use data points that are less well-established. This is a multifaceted approach. The solution is going to require deepening our investigation and our understanding of the multiple layers of the disease process--and then integrating that into clinical practice.

Jerry Stine: Guest commentary: Lyme initially has the appearance of a straightforward infectious disease, but in practice, it often does not respond in that way. In mainstream medicine, a standard approach is to render down the treatment into identifiable steps in diagnosis, treatment, and follow-up. Lyme does not consistently respond in that fashion. As a result, practitioners dealing with this on an ongoing basis are compelled to broaden their focus to see what other resources and issues need to be brought to bear that may have some relevance to the patient. This doesn't mean abandoning traditional, medical evaluative and treatment approaches, but for the sake of patients with persistent symptoms, practitioners have to be open to other kinds of analytical assessments to develop an effective treatment plan.

In the evaluation of possible Lyme infection, there are levels of diagnostic approach and those start with commonly recognized lab tests. Depending upon what's learned and how well people respond, a practitioner may be pushed into looking at other considerations beyond that. It is not that the data lacks rigor or specificity; rather it is a response to the demands of the case, based on the patient's health status and the outcome of treatment. Information the provider learns from the initial round of tests and interventions moves the clinical process to the next phase of therapy. If those work, that is cause for celebration. If they do not, then the investigation goes to the next level. The table describes considerations and steps at those various levels.

Genetic Testing

Ms. Faass: Do either of you use genetics and do you see any subsets within the genetics. Dr. Grieder, you have mentioned 23 and Me.com.

Dr. Grieder: I use methylation panels to help support the process, but I haven't seen that approach work by itself alone--genetic information is a useful tool in fine tuning treatment approaches, but genetic data alone does not define the pathophysiological process. We should be reminded of the old adage "treat the patient, not the paper," which is also emphasized by methylation pioneers such as Ben Lynch and Paul Anderson.

DNA methylation patterns that act as a bridge between genotype and phenotype are highly responsive to environmental and extracellular data. In the future, when we understand the causal relationships between environment and DNA methylation better, we may be able to be more targeted with our therapies. Until then, we have the patient and their phenotypic expression right before us, so we can learn from those patterns, because they give us hints as to the underlying processes.

Dr. Harris: I agree. We're certainly looking at the MTHFR gene and some of the methylation panels, the more complex ones such as those featured on the HolisticHeal. com website of Amy Yasko's work. They do help guide us as to how aggressively we can treat and how much we need to consider detox, and bypass certain enzyme mutations.

Treatment

Diagnostic Trials

Dr. Harris: Many times the diagnosis will trail the treatment. It's not very elegant, but the strategy is to do empirical treatment, and then see how the body responds. Ultimately it comes down to a risk-benefit analysis. What is the risk of using a certain treatment? What is the potential benefit? And what is the likelihood that the patient actually has that condition. Sometimes you don't know the full answer until you have initiated controlled empirical treatment and assessed response. For example, the tests for bartonella spp. miss more than half of the likely cases. When a patient presents with hallmark symptoms of bartonellosis, using a low dosage of a botanical formula such as A-BART, BLT, Bar 1, or Bar 2, or a medication such as Septra or Rifampin can really clarify the diagnosis.

Dr. Grieder: When I start seeing a patient, I have an initial set of information, and I begin initial treatment. The next time the patient comes back, there is a specific response that I'm going to compare with the patient's prior health status before the initial treatment. That response can give me distinct pieces of information. At that point, my goal is to determine which issue(s) are most on the surface. That way I can begin to move forward into increasingly complex processes, but always maintaining a sense of direction by looking at what issue is most on the surface and then focusing deeper as we go through the treatment process. We need to approach the Lyme by looking at the individual before us, using the information we have available. We also want to remember that herbs and antimicrobials and support therapies and detox therapies all have interactions. We can't just use individual data points--we also need to look at the bigger picture.

Dr. Harris: I agree. This is the way the most successful practitioners engage patients who have these very complex conditions--by gathering information, initiating treatment, keeping the patient safe, and delicately advancing treatment. The key is to make something happen, watch the response, and based on that response, make something else happen. It's a slow, steady process with periodic dips in the road.

At the same time, we're still gathering hard evidence to accumulate as much data as possible, because we need to know the underlying dynamics: How is liver function, how is kidney function? Which infections are testing positive, and is that in DNA testing or antibody testing? What's going on with the immune system? We need to accumulate all this data, but the data still don't tell us the treatment priorities at that particular moment. We have a multitude of treatments that might address the various problems, but how do we triage--in what order do we sequence them? There is no single test that we can use. That's why some people shift to alternative approaches, such as bioenergetics, applied kinesiology, or some other intuitive approach.

Multifactorial Treatment

Dr. Harris: Many of us compare the process of treating Lyme to peeling an onion. From this perspective, the layer on the surface is different for each patient. Uncovering those layers and determining which one to treat is also a very personal process. Sometimes we might find for example, that helminths are the primary issue, and that parasites are at a deeper layer, but that Borrelia burgdorferi is at the core. There may be numerous ways to get into the so called core, but choosing the correct layer to address in sequence may hasten the recovery. Each practitioner, through his or her experience, openness, and pure intention to help is going to find ways to get into those layers.

Dr. Grieder: I begin by identifying what is most on the surface. There are many very subtle symptom pictures associated with various aspects of molds, the coinfections, environmental toxins, and even the psychospiritual/psychoemotional aspects of the disease. Depending on what comes up in the visit, that is what will be addressed in the coming weeks. That way we narrow down the issues to set priorities.

Dr. Harris: I essentially take a by-any-means-necessary/safe-approach. I have several patients on IV antibiotics, on multiple IV antibiotics, and on IV antibiotics combined with oral antibiotics. I pulse certain antibiotic regimens, or use antibiotics with herbs, I use numerous homeopathic blends, homeopathic nosodes, and also combination remedies, as well as immune supportive agents. For certain types of infections such as babesia, I'll stack one treatment on top of another on top of another. For other infections such as bartonella, I'll rotate drugs fairly rapidly. With Lyme, I might pulse the treatment at one point, then become more consistent, and then make a surgical strike with heavy antibiotics at another time. If it seems that there is a predominance of one symptom complex reflecting specific disease activity over another, that is the one I am usually going to treat the most assertively at that time. I do think it is difficult to treat Lyme and all the infections simultaneously, so there is often a rotation of treatments. I treat fairly aggressively to knock the bugs out; at the same time, I try to keep the body as safe as possible, and protect the gut. I also address other issues such as molds, toxins, heavy metals, and hormonal imbalances at the same time.

Ms. Faass: Are these patterns that you carry in your own intuitive knowledge base, that you've defined or codified? Has anyone codified them and made them available to other providers, for example as decision trees? Is there consensus on either genetics or symptom patterns in subsets of patients, and do other providers find them relevant?

Dr. Harris: I think there are definitely decision trees. If you look at the work of Klinghardt, he has a multilayered approach and often does things in a certain order. Some people will test for mold, and will try to address mold issues before they deal with some of the other infections. Many of us will try to detox patients before we kill more bugs and create more inflammation. Other providers will just go in and kill the bugs, straight away. Some will make sure that the patient is nutritionally replete before detox. Others will try to drain toxins before they detox more, rather than just move the toxins around, and all this before they kill organisms. We may determine that we want to treat coinfections first, or viruses first, or parasites first. Many of us create models that seem to work in a certain order. I do think the treatment plan needs to be individualized. In my experience over the last 15 years, I have not found a cookbook approach that works across the board. There has to be openness.

Ms. Faass: How often do you see people and how do you organize all this information so you can keep track of where you are with that individual and so that they don't get into trouble?

Dr. Harris: We try to see patients every four to eight weeks. There are obviously patients who are out of the country and out of town that we can't see that frequently, so we may have to talk on the phone or skype. All our patients are generally required to have a primary care doctor as well, to help them address issues that come up day-to-day, especially if they're out of town. We measure liver function and blood count on an ongoing basis and give patients information on the side effects and risks of taking certain medications. It takes time to sort out when someone is having a die-off or Herxheimer reaction or a side effect from a medication, or whether the disease itself is getting worse, or if another infection is becoming predominant, coming up as the "top layer of the onion." Essentially all Lyme-literate practitioners track those types of issues.

Inflammation and Pain

Dr. Grieder: Everyone working in this field tends to develop a particular focus, based on their insight and the patterns they see. My own recent interest has been a focus on the inflammatory processes that often underlie the manifestations Lyme patients experience, which can be a major factor in pain and cognitive dysfunction. One of my interests is how we strengthen and stimulate the immune system, and at the same time downregulate it to normalize immune function and reduce proinflammatory damage. We have some herbal tools: curcumin is well studied and can reduce cytokine expression. Fish oil has an effect on prostaglandins and can be used to attenuate the immune system without suppressing it as steroids tend to do.

When a patient comes in with pain, there is a tremendous amount of information we can learn from that pain. Is it neurologic or inflammatory pain, for example? Does it come from a specific location in the body or is it a more generalized pattern? This information will lead to a broader range of choices--choices that are more interesting and potentially more successful than simply looking at biochemical or pharmaceutical aspects of pain.

Low-Dose Immunotherapy Therapy

Dr. Grieder: I've also been interested in LDI, based on an allergy treatment (LDA or EPD), that was originally brought to the U.S. by Dr. Butch Shrader. Over the past three years, Dr. Ty Vincent in Alaska has been looking at an approach using extremely low-doses of antigen groups in combination with beta glucuronidase--an enzyme abundant in the human gut that appears to act as an immune attenuate without suppressing normal immune responses. Lyme involves chronic infection but also over the years, the potential for developing immune dysfunction. Low-dose immunotherapy appears to address immune-dysregulatory aspects of the Lyme disease complex.

Ms. Faass: What do you see when you use this approach with your patients-do you see a subset of people who do better? Is there any pattern to the people who are more responsive with this approach?

Dr. Grieder: As with any treatment, often there will be a subset of people who respond better. In this case it tends to be those who are experiencing true immune regulatory dysfunction. When I find the correct dose, the optimal concentration of the antigen with the enzyme, within a matter of hours or days patients have reduction in pain or inflammation, and they begin to sleep well.

Some patients say they awaken the next morning feeling as if a switch had been flipped. They wake up and feel normal. I'm still exploring how to develop this as a lasting treatment. Currently there are certain rules associated with its use: until recently we believed that we could not use it more often than every seven weeks because of the eight-week life cycle of white blood cells; the logic was that giving shots too frequent could trigger a symptom flare, so we had to wait for a new generation of cells. However, we are now finding that there is a way to speed up that process dramatically as long as we don't exceed a certain total antigenic load. This is exciting, because as we all know, it has always been difficult to find a way to sustainably calm inflammatory processes.

Ms. Faass: In terms of linking these outcomes to a subset of patients, is there any hard data on markers that might correlate with that improvement, such as elevated CD-57 or CRP or others?

Dr. Grieder: With that treatment, we don't yet have additional specific datasets available, but I would expect elevated C4a complements to normalize. In terms of chronic fatigue, for example, a study just published by Lipkin and Montoya (3) showed that certain cytokines are elevated and others are depressed in the presence of chronic fatigue, but these patterns change over time, and it does not occur equally in all patients. One set of studies doesn't fit all properties. There are Lyme patients, for example, who have immune dysregulation, but others who do not.

Psychoneuroimmunology

Dr. Grieder: There is also the psychoemotional aspect of the condition. It is well established that the inflammation associated with Lyme disease can affect the CNS profoundly and cause neuro-psychiatric symptoms such as depression, anxiety, and cognitive impairment. There is another related aspect that tends to be underestimated and that is the psychological trauma that develops from having to live with an often debilitating and poorly understood disease. Many of the patients that I see have been sick for many, many years and therefore have seen a number of doctors. Shuffling from one specialist to the next, getting frequent dismissals, and then landing in the psychiatrist's office is traumatizing in itself. That creates a dynamic that makes the treatment process more complicated. Yet we can't simply recommend a psychotherapist in the first visit, because the patient may feel we are suggesting that the disease is "all in their head."

Dr. Harris: We can't just kill the bugs. We can't just offload the toxins. We also have to address all the psychoneuroimmunological factors that have been at play. You can use whatever methodology you want. Engaging with deep psychological processes is one of the key tenets in achieving wellness. It doesn't have to be our Western model of psychotherapy. There are a thousand other ways to engage the mental, emotional, psychological, and spiritual aspects of the patient.

Dr. Grieder: We want to think carefully about how and when we introduce this idea to the patient, in a delicate dance to avoid another layer of trauma. Psychotherapy, meditation, yoga, weekend retreats, EFT, or shamanism from various cultures can all be effective, depending on the patient. The beauty of this is that as human beings, we are multifactorial organisms, so there are many ways to treat. Finding an underlying process that fits that one particular patient is the key to treatment.

Dr. Harris: As the second tier of Lyme practitioners, we are standing on the shoulders of giants--the people who did the early work--physicians such as Burrascano, Drulle, Bach, Jones, Horowitz, and Liegner, to name a few of the integrative and naturopathic doctors who were early adopters. There is a great deal of communication between the naturopathic and integrative physicians and some of the scientists and researchers. Were it not for that foundation, we would not be able to do what we do.

Steven Harris, MD

Dr. Harris has been in private practice since 2001 and established Pacific Frontier Medical, Inc., a California medical corporation, in 2006. His work focuses on the diagnosis and treatment of chronic and persistent Lyme disease and other tick-borne co-infections, incorporating strategies from conventional, functional, and complementary medicine. Dr. Harris has taken a leadership role in lymedisease.org (formerly CALDA--the California Lyme Disease Association), a group focused on research and patient advocacy that has been largely responsible for spearheading favorable legislation, protecting patient rights, expanding Lyme disease awareness, and fostering continued public health education. He is also an active member of ILADS (the International Lyme and Associated Diseases Society), a professional medical society of physicians and scientists that has become the authority on effective treatment for chronic Lyme disease. Dr. Harris is a consulting associate professor at Stanford University School of Medicine.

Pacific Frontier Medical, Inc.

570 Price Avenue, Suite 200

Redwood City, California 94063

Phone: 650-474-2130

Fax: 650-716-0604

Web: www.pacificfrontiermedical.com

Mischa Grieder, ND

Dr. Grieder received his medical training at Bastyr University in Seattle and practices at the San Francisco Preventive Medical Center in collaboration with Paul Lynn, MD. Dr. Grieder is a member of the American Association of Naturopathic Physicians and the California Naturopathic Doctor Association and serves as an adjunct professor at the American College for Traditional Chinese Medicine in San Francisco. Lyme disease is a primary interest and specialty of Dr. Grieder, and he has worked collaboratively with Lyme-literate physicians that include Steven Harris, MD, Christina Green, MD, and Raphael Strieker, MD. Born and raised near Zurich, Switzerland, Dr. Grieder experienced a holistic lifestyle and the benefits of natural medicine early on. Frequent trips to Switzerland enable him to draw from a wealth of European research and leading-edge expertise in health care. He also regularly participates in conferences on the rapidly emerging findings in Lyme disease and associated complex chronic diseases.

San Francisco Preventive Medical Group

380 West Portal Avenue, Suite C

San Francisco, California 94127

Tel: 415-566-1000

Fax: 415-665-6732

Web: sfpmg.com

Editorial

This article is based on an interview and the writings of Steven Harris, MD, and Mischa Grieder, ND. Editorial services were provided by Nancy Faass, MSW, MPH, a writer and editor in San Francisco who has worked on more than 40 books for publishers that include Elsevier, Harper, McGraw-Hill, New World Library, and others. Director of the Writers' Group, she also provides articles, white papers, and writing for the Web and can be reached at info@HealthWritersGroup.com.

Thanks to Jerry Stine, NC, for insightful commentary. He can be reached at Lifespan Institute, 415-883-9033.

Selected Bibliography

Cameron, DJ. Lyme Disease Clinical trial: Effectiveness of retreatment on health-related quality of life. Abstract, Lyme & Other TBDs: Emerging Tick Borne Diseases, Oct 28th, 2005, Philadelphia, PA.

Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migraines rashes and persistent disease. Expert Rev Anti Infect Ther. Online, January 22, 2014.

Haupl T, Hahn G, Rittig M, Krause A, Schoerner C, Schonherr U, Kalden JR, Burmester GR. Persistence of Borrelia burgdorferi in ligamentous tissue from a patient with chronic Lyme borreliosis. Arthritis & Rheumatism. 1993; 36:1621-1626.

International Lyme and' Associated Diseases Society. Evidence-based guidelines for the management of Lyme disease. Expert Rev Anti-Infect Ther. 2004; 2(1),Suppl.

Johnson L, Stricker RB. Treatment of Lyme disease: a medicolegal assessment. Expert Rev Anti-infect Ther. 2004; 2(4):533-557.

Krupp, LB et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. 2003; 60(12):1923-1930.

Liegner KB. Lyme disease: The sensible pursuit of answers. J Clin Microbiol. 1993; 31:1961-1963.

Liegner KB, Agricola MD, Bayer ME, Duray PH. Chronic Lyme disease (CLD): A costly dilemma. Program and abstracts. Sixth International Conference on Lyme Borreliosis. Bologna, Italy. June 19-22, 1994. Abstract P012M.

Liegner KB, Rosenkilde CE, Campbell GL, Quan TJ, Dennis DT. Culture-confirmed treatment failure of cefotaxime and minocycline in a case of Lyme meningoencephalomyelitis in the United States. In: Program and abstracts of the Fifth International Conference on Lyme Borreliosis, Arlington, Va., May 30-June 2, 1992. Bethesda, MD: Federation of American Societies for Experimental Biology, 1992:A11.

Liegner KB, Shapiro JR, Ramsay D, Halperin AJ, Hogrefe W, Kong L. Recurrent erythema migrans despite extended antibiotic treatment with minocycline in a patient with persisting Borrelia burgdorferi infection. J Amer Acad Derm. 1993; 28:312-314.

Ma B, Christen B, Leung D, Vigo-Pelfrey C. Serodiagnosis of Lyme borreliosis by western immunoblot: Reactivity of various significant antibodies against Borrelia burgdorferi. J Clin Microbiol. 1992 Feb:370-376.

MacDonald AB, Berger BW, Shwan TG. Clinical implications of delayed growth of the Lyme borreliosis spirochete Borrelia burgdorferi. Acta Trop. 1990 Dec; 48(2):89-94.

Mursic VP, Wanner G, Reinhardt S, Wilske B, Busch U, Marget W. Formation and cultivation of Borrelia burgdorferi spheroplast L-form variants. Infection. 1996; 24(3):218-226.

Preac-Mursic V, Weber K, Pfister HW, Wilske B, Gross B, Baumann A, Prokop J. Survival of Borrelia burgdorferi in antibiotically treated patients with Lyme borreliosis. Infection. 1989 Nov-Dec; 17(6):355-359.

Straubinger RK, Straubinger AF, Summers BA, Jacobson RH, Erb HN. Clinical and serologic follow-up in patients with neuroborreliosis. Neurology. 1998 Nov; 51(5):1489-1491.

Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America. CID. 2006 Nov; 43:1089-1134.

References

(1) CDC--International Conference on Lyme Borreliosis, Boston MA, Aug 2013.

(2) Adrion ER, et al. Health care costs, utilization, and patterns of care following Lyme disease. February 4, 2015. Available at: plos.org/plosone/article?id=10.1371/journal.pone.0116767. Accessed 04/29/15.

(3) M. Montoya, J, Levine, S., Felsenstein, D., Bateman, L, Gottshalk, G, Lipkin. L. Sci Adv. Feb. 27, 2015.

an interview with Nancy Faass, MSW, MPH
Table 1. Differential Diagnosis: Selected Evaluations *

* This list will be determined by the patient's history,
health status, and presenting symptoms.

** Thyroid disease

** Parathyroid disease

** Autoimmune disorders

** Rheumatic fever

** West Nile virus

** Histoplasmosis

** Invasive fungal species and potential
fungal or mold sensitivity or reactivity

** Other bacterial Infections

** Amyloidosis

** Sarcoidosis

** Syphilis

** Guillain-Barre

** Glycogen storage disorders

** Neurofibromatosis

** Mitochondrial disorders

** Bone, blood, carcinoid tumors

** Heavy metal toxicity

The following can coexist with Lyme as
coinfections:

** Human herpes virus 6

** Epstein-Barr virus

** Cytomegalovirus

** Mycoplasma pneumoniae

** Chlamydia pneumoniae

** Candida spp.

** Coxsackie virus

** Relapsing fever borreliosis

Table 2. Approaches to Diagnosis and Treatment

Mainstream Diagnosis    Lyme-Literate Diagnosis

MDs, DOs                MDs, DOs, Integrative doctors, naturopathic
                        doctors, functional medicine doctors

Two-tiered approach:    Testing criteria open to broader but
strict testing          evidence-based criteria. Clinical diagnosis
criteria--a negative    is paramount-a negative test does not rule
test defines the        out disease. Screening ELISA not very useful;
absence of disease;     IFA or ELISA not necessary; bulls-eye rash
IFA or ELISA and WB;    not necessary.
clinical diagnosis      WB 2+ bands on IgM (inc. 23, 34, 39, 31 +/-31,
only if bulls-eye       83-93); or 2+ bands on IgG or PCR in blood or
rash present after a    tissue, or signs and symptoms consistent
tick bite or 2 of 3     with Lyme with likely exposure to ticks,
bands on IgM or 5 of    even in the absence of a positive test after
10 bands on IgG         other disorders have been ruled out

Primarily relies on     Primarily relies on validated laboratory
validated laboratory    data, history, physical evidence, statistics,
data, history,          differential diagnoses, and interpretation
physical evidence,
statistics,
differential
diagnoses, and
interpretation

                        Integrative Approaches

                        Use laboratory data, history, physical
                        evidence, statistics, differential diagnoses,
                        environmental factors, subtle nutritional
                        status, detoxification capacity, and
                        interpretation May utilize tests that do not
                        have the rigor to meet certain standards of
                        care.

                        Certain PCR tests that use less than 10
                        BP for primers; some Lyme culture tests;
                        lymphocyte transformation tests; over/
                        sensitized ELISA/IFA tests; quantitative PCR
                        test; dark field microscopy; some other
                        direct visualization tests

                        Some ancillary tests to address health status
                        include: salivary hormone testing,
                        nutritional profiles, provoked metal testing,
                        stool health tests, organic acids testing,
                        methylation testing, kryptopyrrole testing,
                        MELISA testing, CD57 testing, IgG allergy
                        testing, autoimmune testing, urine amino
                        acids testing, hair testing, saliva/stool
                        antigen testing, and mycotoxin testing

Mainstream Treatment    Lyme-Literate Treatment

Treat for 10-28 days    Treatment is based on clinical response.
with doxycycline 100    Treat with one or more antibiotic combination
mg bid or               as long as clinical picture is consistent
amoxicillin 500 mg      with active infections. Consider co-
tid. For severe         infections and treat as necessary for
cases (cardiac or       anaplasmosis, ehrlichiosis, or infections due
neurologic),            to babesia, mycoplasma, bartonella spp.,
penicillin G or         relapsing fever borrelia, rickettsia spp.
ceftriaxone 2 g qd x
30 days. Consider       Retreatment may be necessary; some adjunctive
co-infections and       testing such as co-infections testing is
treat as necessary:     important; management of other aspects of
human granulocytic      health may be related and necessary.
anaplasmosis, human
monocytic               Integrative Therapies
ehrlichiosis,
babesiosis              Use of non-pharmaceutical regimens; herbal
                        combinations; herbs in concert with
Retreatment is not      pharmaceuticals; probiotics; timing of herbs,
necessary. Scant        meds, probiotics, minerals; suppositories,
mention of              enemas, transdermals, sublinguals;
adjunctive testing      supplements to enhance detoxification;
and other complex       lifestyle choices to increase function of
management              chemical treatments; saunas, heat, exercise;
                        pulsing of medications and herbals.

                        Use of some studied adjunctive methods such
                        as oxidative therapies--H202, ozone,
                        ultraviolet irradiation; use of intravenous
                        herbal remedies; of hyperbaric oxygen in
                        concert with antibiotics; of acupuncture,
                        massage, colon hydrotherapy, meditation, or
                        fasting

Table 2. Approaches to Diagnosis and Treatment. (c) Steven Harris,
MD, 2015.
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