American or Western trained physicians follow something called "Evidence Based Medicine." This means that a treatment is only used if there is science to back it up. The medical community has decided that there are different levels of "evidence." The best evidence comes from rigorous studies at major teaching/research facilities with the results confirmed by further studies at a second such institution. The studies are meticulously controlled through a process called a randomized double blind placebo based method. The results are carefully reviewed by a detailed statistical mathematical process. If the results demonstrate that there is "statistical significance" that treatment A works for disease B, then it is claimed that the treatment is "Evidence Based." The results are "Peer Reviewed" by experts in the particular area under study and published in a major, prestigious journal. Voila: Science has shown that the particular hypothesis which was tested is true. Physicians should use the results in clinical practice in order to follow the "Standard of Care." This was a legal concept which doctors have readily adopted for some unknown reason.
When there is no such research based evidence, a panel of "Experts" may be convened to offer opinions and recommendations. This sort of information acts as a surrogate for information obtained through a scientific process and is frequently referred to as evidence based as well. The evidence is based on opinions and conjecture of experts, who are held in high esteem in the community of physicians at large. These opinions and recommendations also become woven into the standard of care fabric.
The above process is open to criticism. Most medical research is funded by monied interests such as big Pharma. Typically only new drugs or therapies which are patentable and potential "blockbusters" get studied. Frequently the efficacy of the new therapy can only be proven by statistical analysis. This means the benefit may be small. Medical research is difficult because it involves many variables which are hard to control: does the cohort studied really have the same disease, are there genetic differences, do they follow different diets, do they exercises the same amount? and so on. Of course all of these differences are supposed to come out in the wash when the group is studied so that individual differences balance out. Then what does this mean for an individual patient who is not an "average" of the group, but has unique characteristics?
How can opinions substitute for science and be called "evidence based?"
Most questions which clinicians would like answers to are never studied out all. Diseases may be complex and nuanced. The same can be said for treatments. These things are not amenable to the scientific process as described above.
It turns out that patients instinctively distrust this process.
Studies showed that consumers (patients) were spending more money on so called alternative medicine they they were on science based Western medicine, called allopathic medicine.
Patients were taking herbs, consulting with herbalists and homeopaths, taking vitamins and supplements by the handful, going for body therapies of all sorts, going to chiropractors, massage therapists, acupuncturists and seeking out many other alternative and complementary therapies.
Physicians and institutions became cynically aware of the lost revenues. The bastions of scientific medicine like Harvard opened alternative and complementary medicine clinics. Of course they thought it was a bunch of nonsense, they just wanted to capitalize on the potential profits.
If a doctor prescribes herbs and mind-body medicine he is considered a crackpot and left alone.
When doctors start prescribing real medicines, like antibiotics for a supposedly fictitious disease that was another matter.
Most Lyme doctors come from an alternative medical background. That is why many heavily promote herbs, electromedicine and other "off beat" therapies. I approach Lyme from an allopathic perspective. I believe this is more threatening to the status quo. There are limited studies which show that long term antibiotics are beneficial for chronic Lyme. There are no studies showing that prolonged therapy for clinically diagnosed Babesia and other co-infections works. There are certainly no studies which support the use of vitamins and supplements as recommended by many LLMDs. Many therapies commonly used in the "Lyme community" come from word of mouth and anectdotal reports. Lyme clinicians over time, develop an experiential sense of what works. Medicine used to be considered an art and a science. Those physicians who with to rely solely on the science have unfortunately thrown out the baby with the bath water.
IDSA recommendations are opinion, not fact. They have been discredited.
Texts which mainstream physicians follow not only ignore this fact, but they fail to discus the legitamate controversy which has been swirling around the Lyme issue for years.
Hundred of articles and studies related to Lyme disease have been published. The IDSA and mainstream medicine have cherry picked those articles which support their pre-existing conclusions.
Science is a word which in this case without meaning. It is used to cloak an agenda of mysterious origins and purpose. The cynics and disbelievers should at least consider the profit motive. I have a dream that a major teaching institution will open a Lyme treatment center. LLMDs, neurologists, infectious disease experts, immunologists, psychologists, psychiatrists, radiolologists and others will cooperate to treat and research this terrible disease.
You can stop a guy from dreaming can you?
The whole IDSA vs. ILADS thing has been very hard for me as a patient. I know there are more false negatives on Lyme test that false positives, and that the Lyme testing is problematic. At the same time some of the symptom complexes used by some ILADS docs to "clinically diagnose lyme" are too broad in my opinion. Some docs look for the symptoms to fit the pattern, forgetting that they are medical doctors in general, and that they might also be still helping the patient if they find WHAT they do have.
ReplyDeleteAnyhow, as for the IDSA/ILADS divide, I want to be 'sensible' and accept that 6 weeks of PICC line treatment should have eliminated my lyme, but also will not dismiss the experience of patients and docs who have had experience and success with extended antimicrobial treatment.
It also doesn't help me that a number of Lyme docs seem to accept almost any alternative medical treatment-- as if operating outside the mainstream obligates one to be open to almost anything.
Oh, also, maybe you could do a post on your experience with Lyme and hormone levels. I am thinking in terms of testosterone (and for females estrogen) levels and proportionately low FSH/LH levels. I know Dr. Burrascano has mentioned a connection and claims that Lyme treatment raises levels in some patients.
ReplyDeleteIf you have Lyme and need IV antibiotics, 6 weeks will not work. See the recent studies published by Columbia University. Half a loaf is not always better than no loaf. You can't compromise between two concepts one of which is true and the other false. There is no evidence that the IDSA approach has any scientific validity. Look at the evidence. Patients regress after 12 weeks of IV therapy when it is stopped. They regain the benefits only when it is started again. The evidence that the germ resists long term antimicrobial therapy is solid. If you don't respond to treatment as expected then the diagnosis should be reconsidered. If you are not sure get a 2nd, 3rd or 4th opinion.
ReplyDeleteI am not sure about hormone levels. Many female patients report restarting menstrual periods when Lyme is treated. There is much discussion about adrenal fatigue. Chronic illness can impact the hypothalamic, pituitary axis which controls many hormones. Most of these imbalances are subtle and should correct when the underlying disease is treated.
ReplyDeleteAddendum: It is important that as a patient that you allow a physicians in whom you have confidence "run the show." If one physician is unable to help you perhaps you should seek care from another doc. You can't run your own care. You can't decide what antibiotic, by what route, for how long and so on. The doctor patient relationship should be collaborative, but the ship must have a captain. Even physicians cannot treat themselves. Remember: He who has himself as his doctor has a fool for a patient. I am concerned when a patient makes such comments about splitting the difference between an IDSA and an ILADS approach.There is nothing "sensible" about this. I would have to question a doctor who would cooperate with this half baked (in my opinion) approach. Either the doc follows IDSA or ILADS. If he compromises his principals on a whim where does he stand?
ReplyDeleteI wrote 'sensible' not "sensible" meaning to imply the ridicule with which some ID doctors speak about the LLMD world. What I was saying is that as a patient one can be torn between wanting to try the standard course and observing the outcome, or going all out into the parallel LLMD world.
ReplyDeleteAnyhow, I had 6 weeks on a PICC, and two months oral. I would say I had an open-minded ID who basically follows IDSA, but, believes that if the patients symptoms are improving, that an extension may be warranted.
I have seen an LLMD and am open to a longer course of treatment. That said, I am unlikely to get another PICC unless I start testing positive again. I went on the PICC with only a positive C6 ELISA and then three weeks into treatment I was IGM positive on a CDC test on all three bands so the ID allowed me a two weeks extension of the ceftriaxone.
I was thinking about my comments to you, I think they were overly harsh. The decision to treat and for how long, in my opinion, should never be based on lab results. The 3 IgM band WB is a terrible test. I recommend a 14 band WB from IgeneX. If you read up on this test you will discover that the 3 band test is part of a surveillance protocol and has little diagnostic value. The most important bands, 31 and 34 are ommitted. For instance, the 31 band shows reactivity to Osp A, which is down regulated in early disease and only shows up later in the illness. If it is positive it indicates that the infection has been present for a long time (years usually). If a doc suggests that treatment is based on a lab test I don't think he knows the disease well. CDC positivity is not relevant to treatment decisions. The fact that more antibodies showed up after treatment demonstrates that germs which were hidden are now being killed, causing an immune response. But this whole discussion about treating based on lab results is in humble opinion, absurd. Look at results of the recent published clinical trials from Columbia University. Patients with neuroborreliosis improved after 12 weeks of Rocephin but relapsed when it was stopped. If you are not very ill you may not need IV therapy. If you are very ill longer courses of Rocephin followed by intensive oral antibiotics is the best way to go.
ReplyDeleteI have had one igenex test. I got it because I wanted to know everything I was showing reactivity too, even if it is faint. My ID doc signed the order for the test, after I explained to him I just wanted to have a more complete picture. I got it two weeks before the IgM positive quest test, a few days after I started my PICC line. It turned out to be a good indicator of the coming CDC positive test i was to have two weeks later. It was IgM positive by their creiteria, not CDC, but it showed positives on 28, 31, 41. I was also positive on their IFA screening and 1.3 on the C6 test.
ReplyDeleteAnyhow, I saw three ID docs and only one agreed to treat me, as he said he would be inclined to treat based on my symptoms of years of idiopathic hypersomnia, headaches, tinnitus and lightheadedness, peripheral neuropathy and periodic issues with my joints. He used an 8 month old IgM positive WB test and got the insurance on board.
I put a lot of time and work into learning about Lyme. I even sent a blood sample to Germany for testing, as I grew up there, and wanted to rule out B. garinii or afzelii infections. Sending blood to Germany was a challenge... It came back negative, but in the meantime I had also spoken to Nick Harris who said his test would pick up those genospecies-- another reason I wanted it.
In any case, in my one experience the Igenex test was good, correlated in large part with the CDC tests on the bands they do report.
Oh, while you're at it, any thoughts on the OspD, band 28? It is not considered a critical band by CDC or Igenex, but it quite specific to Lyme. When I asked Nick Harris he said good question, he was not sure, but guessed it just never made the cut statistically.
ReplyDeleteThe 3 most specific bands are 23 Osp C: 31 Osp B and Osp C. The C6 is another, larger Osp ViSE. All of the bands are antibodies found on the surface of Bb and related Borrelia species.You have collected too much data in my opinion. The question is: What are your symptoms? Are they compatible with latent Lyme? What does the evidence reveal about the nature of the organism: its abililty to cause illness and its ability to evade the immune system and antibiotics? What is the clinical experience of doctors who treat the disease? There are reported to be 12 ID docs in the US who are "lyme literate." These include Dr. Donata in Boston who is well published regarding chronic Lyme. All of your symptoms sound like typical late stage Lyme. Most LLMDS and their patients will tell you to avoid ID docs like the plaque. The are steeped in IDSA dogma. ID docs spend most of their time seeing critically ill patients in the hospital setting. They are not versed in treating ambulatory patients with chronic symptoms. If a doctor treats on the basis of largely discredited guidelines, as if were religion one should be skeptical of ad hoc recommendations. I would seek a physician who is open minded and versed in the science, who has treated hundreds of patients like you and gotten them better. See "Under Our Skin."
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ReplyDeleteI hear you. I DID collect a lot of data, perhaps too much. BUT, in the end it lead me to get treated by an ID doc who agreed there was good reason to suspect CNS lyme based on my symptoms AND intermittent testing support.
ReplyDeleteMy first ID doc told me to forget about the Lyme after two weeks doxy and a follow up negative WB. When I returned 6 months later he told me if I had picked up Lyme he might have to put me on a place to Germany to get tested there. In the end I worked around it, read a lot, and educated my second ID doc who gave me the PICC about the C6 test.
I have an LLMD, saw him for 3rd time this morning. I saw him first when I was one the PICC line--I suspected he was an LLMD but was not sure. He came to Lyme from the CFS side of things.
I think you may be putting too much of your doctor side into your responses to me here. I found this to be an interesting blog, and something I think is sorely lacking in all the recycled lyme babble out there. I am not using this as a substitute for care, don't worry. If I raise a topic about testing, for example, I am just talking about testing. Please don't read into it that their is a neglect of symptoms. Lyme symptoms are a tricky matter, and since this is not a consultation, I don't present my whole picture.
When I post, I hope it will benefit others. For example I JUST WISH others could find more support in using the C6 test, because in my case it was so useful, and would have saved the hassle of the international factor--because it seems to work for all Borrelia.
Some patients want a doctor's firm and confident orders only. I do tend then to think things over a lot, but these years of symptoms which could be due to Lyme have worked their way into the fabric of my life. Because of all I have encountered, the nuances of it all are very interesting to me.
We have only one universe and all truth and all doctors exist within that. The truth is always in the middle. Many IDSA doctors are making too much out of too little science (I can read the studies and interpret them as a doc). Some of the ILADS docs seem to be out on a limb with no science. Some seem to be quite middle of the road and clinically appropriate. As a doc of 17 years in an unrelated field with no vested interest, the patient tells you what you need to know in therapy- not a test or approach. If your six weeks plus two months has taken away all of your symptoms and they do not return, you have your answer. If they come right back, you have your answer. Therapy is either good enough or not reguardless of the current debate on the subject. Just a little clinical common sense. You have a lot of knowledge for a "patient". That is never a bad thing. There will be good and bad docs out there reguardless of what little letters go along with their name or field. If you are fixed, you have a good doc. If you are not, try again. "Sensible" is believing in how you are feeling vs how someone is telling you should be feeling based on what they have done. After understanding the point of view from a chronic Lyme patient I am very close too, it is very hard if you have not been right for a long time to even know what is right for you or not. You can compensate for and accept so much, you don't even know anymore. Even us "minor" patients like me, get used to things and don't worry about them. I hope everything goes well for you. Getting thru this system has been hard for me and I'm a doc who treats this disease in other animals besides humans. I can't imagine what it would be like to not to be able to read the studies and understand the terms and concepts used within easily. You seem to have done an excellent job. I just hope you are well. In the end, that is all that really matters. Medicine has so many ups and downs- every ten or twenty years it seems to change everything it knows. In the end, if you fix the problem, it doesn't matter what it was called or how it was diagnosed. If you don't fix it, there is a problem no matter how wonderful your tests are or how much you "know". Thats what 17 years in the "trenches" we docs call it has taught me. And I went to how many years of college to figure that one out in the end? I wish you the best of luck and I hope you have kicked this awful stuff. I am very early in treatment but this is not fun. I will attempt to provide more pain and ache relief to my patients from now on.
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