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Thursday, February 18, 2010

Fallon and fatigue

An NIH study published in Neurology, 2008, lead investigator Brian Fallon has been misinterpreted by many in the Lyme community. The study was carefully performed using the highest level of scientific procedures. Patient selection was meticulous. The study was a randomized, placebo controlled study for Lyme encephalopathy (neuroborreliosis) and the results were published in a prestigious, peer reviewed journal. Dr. Fallon reported that the studied patient population suffered with... "moderate cognitive impairment, physical dysfunction comparable to patients with congestive heart failure, and fatigue comparable to patients with multiple sclerosis." The treatment arm of the study evaluated patients with established Lyme disease, seropositive by the CDC requirement of 5/10 positive IgG bands, who had previously been treated with 3 weeks of IV Rocephin. Patients were treated with 10 additional weeks of Rocephin. The study found significant short term improvements in cognitive dysfunction, but not memory in the treated group. A sustained improvement in fatigue was shown.

The investigators reported a 19% rate of complications. This does not comport with my clinical experience.

Dr Fallon recommended against the use of 10 weeks of Rocephin followed by 14 weeks of no therapy. He does report antibiotic associated improvement with regard to disabling symptoms such as pain and fatigue, particularly in patients who suffered the most at the outset of the trial. This was not a primary end point of the study, but the results were significant. Fallon also noted that the Krupp study showed significant improvement in fatigue.

"Conclusions regarding the benefit of repeated IV antibiotic therapy for this set of symptoms must await further investigation."

The IDSA still concludes that this study conclusively demonstrates that chronic Lyme disease does not exist. This is not true. Further study is needed. With regard to cognitive improvements several other conclusions might be suggested: the patients needed longer courses of antibiotic or perhaps gains could be sustained when IV therapy was followed up with oral therapy.

Of course, this study does not address the subject of co-infections. It does not address the need to treat L-forms and especially cyst forms which have been shown to be prominent in the brain.

Yesterday I had the opportunity to discus these issues with a Hopkins professor of infectious disease. He claimed that ALL the good science proves that chronic Lyme does not exist. He was steadfast in his opinion. When queried, he admitted he knows nothing about the Columbia/Fallon study. He asked if it was"good" science. He was oblivious to the fact that the Fallon study was third NIH-sponsored study cited by his colleagues to support the absolute belief that chronic Lyme does not exist. Apparently only the Klempner and Krupp studies are worthy of consideration. But what about that pesky Krupp study?

I have a simple question: how does Rocephin improve fatigue, demonstrated in clinical trials, the best science? If the patients do not have persistent infection with Borrelia burdorferi, what is the mechanism by which antibiotics help fatigue?

Sleep helps fatigue. Caffeine and stimulants help fatigue. Antibiotics?

Maybe when I needed to pull those all nighter to cram for chemistry finals in college I should have been popping penicillin instead of gulping down pots of coffee.


Unknown said...

Another excellent post. It belies belief that someone in such a prestigious position seems to be ignorant of Fallon's study.

I have long thought that many studies and statistics are manipulated at all stages to suit the purposes of authors and readers to fit with their own hypothesizes.

I am sorry it is my own ignorance, but I thought Western blot was to identify actual Borrelial infection? How then does it show Ig response?

Recently, interesting study out of Denmark into lower back pain. Boney infections shown on MRIs
and advocate 90days of antibiotics.Causative organisms not cited as Borrelia.

Thanks for pointers re seronegativity.

Are you aware that in 'Limitations of Procedure' of Trinity Biotech test system (ELIZA?)that early use of antibiotics may prevent antibody response? Further, in a paper by Wilske, it is stated that antibiotics may abrogate the IgM/IgG class switch? The implications for all tests is obvious.

glytzhkof said...

The usual Chronic-Lyme skeptics seem to get stuck in the notion that long term antibiotics treatment is "always bad" - it can do no good for anyone. I suppose it centers around the fear of antibiotics-resistant bacterial strains and the sometimes toxic effects of antibiotics as well as other issues that I don't understand. For anyone who's suffered symptoms of Lyme disease they have felt first hand that medicine does indeed do damage, but much less so than continuing to suffer unrestrained Chronic infection. I often get blood-work all over the place, but always worse when off antibiotics. My liver enzymes, thyroid- hormones and antibodies all go haywire whenever I stop antibiotics for too long. Skin symptoms with rashes, pimples and paresthesia return even quicker and the longer I stay off antibiotics the worse it gets with cardiac and neuro-problems following soon.

Tuberculosis is treated for a minimum of six months with some of the most potent antibiotics known to man - at least as far as I understand it. Why is this done if not because 1) it's a nasty and dangerous disease causing lots of suffering and often death, 2) it spreads and costs societies millions to manage and treat, 3) it is extremely hard to eradicate once settled in the body. It's a Chronic Infection - it's an understood and overt threat to public health. We are rightfully afraid of this damn disease - Australia, for example, is so afraid of tuberculosis that they demand a chest X-Ray of every visa applicant from certain countries or from people who have travelled to risk countries. This is serious stuff - with antibiotics resistance one of the key problems I suppose. Does this problem perhaps overshadow the need to treat other chronic infections as aggressively for sheer fear of resistance?

From a layman's perspective there seems to be a huge difference in the treatment of acute versus chronic infection - the latter seems to be much less studied and understood. Let it be said again that I don't know what I am talking about, but doesn't it seem remarkable that all these strange problems people experience with food allergies, chronic fatigue, inflammatory bowel diseases and similar seem to at least correlate somewhat with some type of chronic infection? How do food allergies just suddenly manifest themselves?

LymeMD - do you believe most of your patients have Lyme, or do you think you are actually treating a variety of chronic infections capable of causing a diverse but somewhat similar disease and symptom complex? It seems to me that what we call Lyme may be more of a disease complex acting like a immune deficiency trigger with cascading health problems from multiple infections, toxins and deficiencies. But I am just a computer guy :-) - just guessing and wondering what hit us all.

Michele said...

LymeMd: I would would really like to know your opinion on this? Why is the IDSA and others such as the professor you talked to so HELL BENT on believing that chronic lyme disease does not exist? Is it easier for them because to believe it does not exist no more research or studies need to be done? Is it the insurance companies again because chronic lyme is expensive to treat? What is it? I have a PhD in Engineering and am a logical thinker and I just cannot understand this. If it is not chronic lyme then what is it? That should be studied? What exactly is the cause of the continual joint pain, fatigue, memory loss and other? I would really like to know your understanding of this complete denial and block on the belief of the existance of chronic lyme infection in the face of massive documentation? I am outraged.

bobcat said...

What about the idea that the antibiotics could have helped by being anti-inflammatory?

I personally believe the culprit behind the fatigue is active infection, but how can we rule out that antibiotics like Rocephin or Bicillin aren't working because they are reducing inflammation (or somehow reducing the encephalopathy), which helps the fatigue?

That is a question that personally has been plaguing me. There is no doubt long term antibiotics help for people once infected (perhaps still infected) with Lyme....but why?

Or am I incorrect that Rocephin and/or Bicillin (two examples I chose) do reduce inflammation, or incorrect that that reduction in inflammation would result in real gains?

LYMEMJ said...

I would love to hear that conversation... the wise doesn't know about Lyme but he knows it is not real.... wow, the real medicine!

Incredible to find that medicine is an "interpretative" science, everything sooo relative to the judgment of the personal point of view of the wise...

The infectious Disease Specialists of Altamonte Springs don't treat Lyme. Why is that, I asked, the receptionist answered: "I don't know, they just don't"! So I went to one office of Infectious Disease Specialists in Downotwn where they said Doctors DO treat Lyme; so, after checking me, the old Doctor said: "certainly you do not have any type of infection, it probably is an allergy, you know woman certain age..."... I just thought God let me out of here fast, this Doctor has his nose dripping all over the patients, he probably doesn't have an allergy but an infection that is pouring all over! LOL!
So real medicine does not recognize the existence of an illness that is registered in CDC and some "wises" even say it is real. I bet this way is probably easier for them and for their partner insurances!

Life, history and God will tell!

Note: the 19% "complications" the study reported could be the reactions to the treatment that of course are strong symptoms but that we are used to look like part of the recovery process...?

Yes.. we are screwed!