Gluten

A very sick Lyme, a middle age male with: Babesia/ neuroborreliosis/abnormal SPECT scan is now feeling normal off antibiotics after 2 years of treatment. He also has "gluten sensitvity." Two children and a sister have celiac disease. He has tested negative for celiac. His TtG Iga is negative (supposedly an accurate screening test). Two gastric biopsies, the "gold standard" for celiac were negative. Nonetheless, tiny amounts of gluten cause symptoms: pains, fatigue, rash, neuropathy, and gastrointestinal symptoms, including GERD. Gluten free diets are difficult. Food advertised as gluten free may contain trace amounts of gluten and rapidly set off symptoms. Conclusion: gluten sensitivity exists along a continuum. Standard tests only reveal gross disease with macroscopic loss of intestinal villae. Other patients may have ultra-microscpic changes, not observed with standard tests. In predisposed individuals, gluten causes extreme immune reactivity. These symptoms must be teased out from those of Lyme

Co-morbidity

I had a recent conversation with a patient. I told her we need to sort out other co-morbidities. Co-infections? No. This was a new term for this very Lyme literate patient. I was not saying the patient did not have Lyme disease. Not at all. Patients with Lyme disease frequently have a variety of other medical problems which contribute to their illness to varying extents. And, in some cases, it is not Lyme which is making the patient ill, regardless of what the Western Blot says: if the signs and symptoms do not fit -- Lyme may not be the primary issue. Or, perhaps Lyme's contribution to the illness is minor. For example:

Fatigue--profound fatigue, is almost invariably a prominent symptom. What else causes this? Other causes include hypothyroidism, B12 deficiency, anemia, depression and insomnia. After these are excluded, my patients are sent for sleep studies. Sleep disorders are a major cause of fatigue. Lyme patients have higher rates of sleep disorders compared to the general population. Patients may have obstructive sleep apnea (OSA) or central sleep apnea, a brain disease. Sleep apnea is associated with numerous other medical disorders: cardiovascular disease, diabetes and others. Sleep apnea is also associated with neuro-cognitive dysfunction -- sound familiar? And sleep apnea is associated with alterations of immune function. Specifically, high levels of inflammatory cytokines, TNF alpha, interleukins have been measured in these patients. Sleep apnea is a significant co-morbidity which interfers with the healing process.

Oher sleep orders are common as well. Restless leg syndrome is a common cause of poor quality, non-restorative sleep. This condition may be respond to supplementation with high doses of iron, sometimes intravenously, based on ferritin levels (it is not clear why these patients have profound depletion of iron). This movement disorder shares common features with Parkinson's disease, a movement disorder mediated by dopamine deficiency in the basal ganglia, a deep area of the brain. Both disorders are treated with dopamine agonists such as Mirapex. This should not be confused with cortical brain dysfunction--loss of executive dysfunction--related to insufficient dopamine activity in the cerebral cortex. This is treated with dopamine agonists such as stimulants which work in these areas of the brain.

A second sleep test, an MSLT can evaluate for narcolepsy and other disorders. Narcolepsy has been considered a disorder of arousal but is now understood to be a disorder of sleep. This may be effectively treated with Xyrem, a drug which is safe but suffers a bad reputation.

Sleep disorders: a common co-morbidity, cause fatigue and cognitive impairments, as well as mood changes and irritability. Not to say I don't start Lyme therapy early in the process - I must also fix the "non-Lyme" to see what remains.

This is but one example of numerous potential co-morbidities.

Patients may have: rare genetic disorders, rare metabolic disorders - or acquired mutisytem-disorders. One of my patient suffers with stiff man syndrome. This is a rare autoimmune disease caused by destruction of a GABA precursor. Another suffers with a toxic yeast syndrome which mimics chronic Lyme. Neuro-cognitive changes and new onset headaches may be caused a brain tumors or other cancers. It is know that Lyme may be associated with brain tumors.

Medical texts are ripe with esoteric diseases: mystery diagnoses. These are the patients that seek our help. It is not always Lyme.

Text book

A new patient walked in: a youthful 29 year old female. She wasn't feeling as good as she looked. She suffered with diffuse, migratory muscle and joint pain. She had tingling in her hands, shortness of breath, night sweats, headaches and pain on the soles of her feet. Her brain was foggy: poor concentration, focus and slow processing. She asked me if I thought she might have Lyme disease. I replied: "My G-d, you are right out of the textbook." Then I realized: " Well no, there actually is no text book." One has to be written.

She had a tick bite, a small "seed" tick, 2 years ago. It was accompanied by a red rash, maybe 5cm in size based on her description. "It wasn't a bulls eye."

She saw her family doctor. He told her she was just getting old (29?), that's why she had the symptoms. I asked how old the doctor was. Ancient. She talked her doctor into ordering a Lyme test. The Western Blot showed 28 and 41 bands only. Not Lyme disease.

Her family doctor referred her to: a rheumatologist, a neurologist and an infectious disease specialist. She figured it must be one disease -- she only needed one doctor. Smart girl. An Internet search led her to Lyme disease and then to me.

Doxy failure

14 months ago, a 47 year old male first consulted with me. His illness started after a physical injury sustained working in his garden. He first developed low back pain -- diagnosed as a strain. He went on to develop knee pain, fevers to 102, a red streaky rash on his abdomen, sweating and color changes in his fingers. He went to the ER: he had been ill for 3 weeks. A two tier, CDC surveillance test was positive for Lyme. He was treated with 3 weeks of Doxycyline and felt better. His past medical history is positive for Chrohn's disease.

Three month later he developed recurrent, progressive symptoms -- muscle pain -- increasing joint pain -- profound fatigue, and, drenching night sweats. New neurological symptoms appeared: numbness and tingling, memory loss and cognitive dysfunction.

He presented to me for further care. A 13 band WB showed 3/3 IgM bands. Non diagnostic Bb IgG WB bands were present. He was seronegative for Babesia microti/duncani. He was treated for chronic Lyme disease and Babesiosis, diagnosed clinically.

After many months of antibiotic therapy his disease is in remission, still on antibiotics.

Additional data: C6 peptide ELISA had been 6.41 initially and is n0w 2.3. C4a levels have been elevated. CD 57 levels have been normal. A wet mount showed no bacteria.

His previously active inflammatory bowel disease is now quiescent. A recent colonoscopy was normal.

Three weeks of Doxy for acute Lyme failed. This may be more frequent that commonly held. It has been suggested by some that this is due to co-infections. I am not sure. The average person, with an intact immune system, should be able to throw off both Babesia and Bartonella.

Perhaps in some cases, Lyme is able to sequester itself quickly. Other explanations may be offered. Perhaps in some, already-infected asymptomatic patients, clinical Lyme is triggered by a new infection. The other possibility is a bit more frightening. Perhaps strains of Lyme are now resistance to Doxy. This could explain some Doxy failures with response to other treatments, such as Amox/Biaxin. This patient did respond to Doxy at first. But, partial resistance is know to occur with other bacteria. This is all thinking out loud conjecture.

Lyme disease is associated with a multitude of autoimmune diseases. Crohn's and ulcerative colitis are both autoimmune diseases. Coincidence?

Lyme Rage

A 36 year old female was treated for severe Lyme disease and neuroborreliosis. A course of IV antibiotics was successful 2 years ago. I explained to her the need for maintenance therapy. She took oral antibiotics for a few months, but tiring of the medicines, she sought alternatives, such as A Rife machine. She had been treated for Lyme, Babesia and Bartonella. Her case had been well documented: abnormal MRI, abnormal SPECT scan and multiple positive Western Blot Lyme bands. The aches and pains returned, slowly. The mental confusion returned, slowly. She returned for further treatment 6 months ago. This happy-go-lucky soul had turned into someone else. She was was filled with unbridled rage. She told me she literally felt like killing someone. She was just waiting for that someone to cross her path so she could act out her rage. She meant business.

Several months into therapy she returned to her normal self. The anger disappeared gradually, and then it was gone--after treatment with a second course of IV therapy. Now, several months off IVs, she is largely symptom free, the disease controlled with oral antibiotics. The smile has returned to her face. She is once again a kind and gentle soul.

Evidence based medicine: a critical appraisal

So called "evidence based medicine" has done more to harm medicine than anything else I can recall during my 30 year tenure in medicine. Doctors have become technicians, rather than practitioners following in the traditions of healers who have come before.

When I was in college, science as we know it, existed within a framework-a caste system-a pecking order. Mathematics was considered the purest science: provable with irrefutable equations. Physics took second place. It described fundamental properties of the world/universe around us, supported by mathematical equations. Chemistry followed next and then biology. The order of descent was based on how hard, irrefutable and provable the conclusions were. All science is validated by the scientific method: a theory or hypothesis is proved by well designed experiments which can be replicated in a variety of places, times and circumstances.

When I entered medicine in the 1980s, medicine was more than a job or ordinary profession. It was a commitment, a lofty avocation, a calling of sorts. (at least according to my father)--I agree. Medicine was a healing art, in the tradition of the many who had preceded us, predicated on science. It was not a science.

Sometime around 1995 the term "evidence based medicine" insinuated itself, increasingly into the verbiage of the profession. I suspect it was in large part driven by managed care companies, looking to control costs, and then, high powered medical institutions jumped onto the band-wagon, in the belief that medicine was really science, not art: throwing out the baby with the bathwater.

Properly designed controlled medical studies were carefully analyzed by statisticians. Sometimes multiple studies were combined and analyzed-- meta-analysis. Problem. Only a few potential questions were addressed. Most studies were funded, at least partly, by big Pharma, with pre-existing agendas, undoubtedly tied to feathering the pockets of CEOs and stock holders (follow the money). Medical research, by its very nature, is simplistic. In truth, it is impossible to do proper science when it comes to studying something as complicated as people. Newer studies replace and refute older ones on a regular basis. It is impossible to control the variables, many of which are unknown, poorly understood or yet to be discovered. If it takes a room of statisticians, as is frequently the case, to prove a point, it should give one pause.

The single biggest problem: data obtained from a single study is extrapolated widely, to support wide ranging conclusions, based on faulty logic superimposed on bad science.

To makes things worse, evidence, as it were, is now broken down into levels/categories-- again, a pecking order. Most in the profession have accepted this new and improved medicine without giving its precepts a second thought.

First we have placebo controlled, double blinded, randomized studies, the results of which are statistically validated and replicated in subsequent studies.
Then we have non blinded controlled studies, non-controlled studies, head to head studies, published studies, clinical reports published in journals and lastly recommendations of a body of experts--my perennial favorite.

How can opinion be science?

So, let us get back to Lyme, the subject of this blog. The Klemper, Krupp and Fallon studies, are in my mind, weak science at best. They also all have somewhat different study designs and conclusions. The limitations of these studies has been discussed in detail elsewhere. The "experts" put these findings together and give us a final product: evidence based guidelines.

The better science is what physicians seem to dismiss and ignore: test tube science and other forms of "basic" science. Borrelia has been shown to convert from spirochete to cyst forms in the laboratory and back the other way. Spirochetes have been shown to exist as L-forms. Research in immunology support beliefs that infected hosts cannot be sterilized of Lyme. Human and animal models have proved that Lyme persists in the face of massive doses of antibiotics. This sort of science can control the variables. It can be replicated in multiple settings over time. The same cannot be said for clinical studies, the type of science clinical doctors rely upon, which are pooled into meta-analyses, looking for statistically significant conclusions. I could go on, write a book about this subject, with foot notes and citations. Not here.

This post is a about "evidence based medicine." In my opinion, this is a sham, a fraud. Perhaps it works for HMO physicians who are required to see patients in 6 minutes: cookbook medicine. It is not a useful tool for thoughtful, curious physicians, intent on practicing their art to the best of their ability. Patients are all different as are all physicians. Diseases are nuanced and complex.
The practice of medicine is a mosaic of science, judgment, clinical experience and yes-intuition, a clinical nose, the product of years of practice.

So yes, this dumbed down version of medicine has now framed the basis for the national debate about lower cost, higher quality medicine. According to national political "experts", electronic medical records and evidenced based medicine (the mantra), will solve systemic problems with our health care system.

Who decides which evidence we use? Ivory tower physicians. Iconic figures. The Gary Wormsers of the world. Doctors for the most part, are reassured by practice guidelines: complex decisions have already been decided for them. A few other physicians, the outliers, and their demanding-annoying patients, just won't go away. It is no wonder that many readers shudder when the hear the words: evidence based medicine.

Every pre-med student is ultimately asked the question: why do you want to become a doctor. Inevitably, they all give the same, banal answer: I want to help people.

For those of us who want to be included amongst healers who use science, the state of the art as it exists at any particular point in time, as a basis, but only a starting point for the practice of their art: the art of healing; this answer turns out, in the final analysis, to not be so banal after all.

Evidence based medicine? Thumbs down.

H. pylori

My patient, age 32: "This is the best I have felt in five years. I feel like a whole organism. Rashes on my body, face-circles under my eyes, they have all cleared. My abdominal pain is all gone. My acid reflux is gone. Total body stiffness and pain are gone--after 5 years. Fatigue is gone: I am so energetic. My body has changed. My middle section has reduced in size. The bloating and swelling is gone. My appetite is better: I am know longer hungry all the time. My taste buds work better. My neighbors have so much energy, now I am like them. Thank you."

"Did you have any side effects from the medicine?"

"For the first two weeks I had nightmares--mild headaches, then everything went away."

One month prior to this visit, a test for H. pylori was positive: the IgM ELISA. Most labs only perform the IgG ELISA. I request the IgA, IgM and IgG antibodies for H. pylori (Helicobacter pylori). Any one could be positive. IgA goes along with mucosal disease and IgM indicates active disease.

This patient has a number of chronic medical problems. The test was ordered because of persistent heartburn (GERD). Her treatment: Nexium 40mg 2x daily, Biaxin 500mg 2x daily and Amoxil one gram 2x daily, for 30 days. She has been off therapy for a week and is continuing to improve. I told her if symptoms return maybe we should retreat.

I leave this vignette for you to interpret.