Chronic Lyme Disease – Another Negative Study

Vince

Super Moderator
https://www.sciencebasedmedicine.org/chronic-lyme-disease-another-negative-study/

While Lyme disease itself is a real and often serious infectious illness, the existence and proper treatment of so-called chronic Lyme disease is dubious, and some would say controversial. However, like many controversies we cover, the science itself is not very controversial, but the topic is made so by a persistent minority of outliers who refuse to accept the scientific consensus.
The issue has been raised yet again by a study published recently in The New England Journal of Medicine: “Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease.” The study was negative, but I will get into the details below.
[h=2]Lyme disease[/b]Lyme in an infection caused by the bacteria Borrelia burgdorferi, and related species. In Europe the infecting species are B. afzelii and B. garinii. These bacteria are spirochetes, which refers to their spiral shape. They are related to the bacterium which causes syphilis, Treponema pallidum, which is also a spirochete.
Syphilis and Lyme both have three stages of illness – a primary infection, secondary symptoms, and then a persistent tertiary syndrome. With Lyme disease, stage 1 involves local infection, including headache, fever, chills, and local arthritis. Stage 2 is disseminated Lyme, including the classic target- or bullseye-shaped rash at the site of the bite, pain, weakness, fatigue, and diffuse arthritis. Stage 3 is persistent late stage infection, and includes ongoing stage 2 symptoms, heart involvement, and neurological involvement.
As you might suspect, treating the infection early is important and most effective. The bacterium is sensitive to a number of antibiotics. Doxycycline is an oral antibiotic most often given in the early stages. Tertiary Lyme often requires IV antibiotics.
Lyme can be diagnosed by a combination of presenting with the classic clinical features, and a positive antibody titer, which can be confirmed with a western blot test. Antibodies can show an acute infection, or can have a profile that reflects a past infection.
[h=2]Chronic Lyme disease[/b]Fortunately, most patients will recover from Lyme disease after an appropriate course of antibiotics. The evidence shows that antibiotics are capable of eradicating the infection, and there is no evidence that the spirochete can evade treatment by hiding out somewhere in the body, going dormant, or resisting the antibiotics.
However, 10-20% of patients diagnosed and treated for Lyme disease will continue to have chronic symptoms of fatigue, muscle aches, poor sleep, and cognitive fog. Experts believe in some cases this may be due to a post-Lyme syndrome – the effects of inflammation or perhaps an activation of the immune system. There is also the possibility that symptoms in some cases are not due to the infection itself but to another cause, which may or may not have been triggered by the infection. Possibilities include disturbed sleep, deconditioning, and depression.
There are also patients who never had confirmed Lyme disease but have a similar syndrome of pain, fatigue, poor sleep, and mental fog.
This is where the controversy comes in – there are some patients and practitioners (who sometimes call themselves “Lyme literate MDs”) who believe that these chronic symptoms are due to persistent infection with the Lyme bacteria, and that the proper treatment is recurrent and long term treatments with antibiotics, often intravenous (IV).
Their only real source of evidence for this claim is the apparent response of such patients to courses of antibiotics, and the only real published evidence is case reports and case series or uncontrolled studies. However, responses are subjective and temporary, and often patients require ongoing treatment. This has all the hallmarks of a placebo response.
Physicians and scientists skeptical of this claim (myself included) will point to the fact that patients with alleged chronic Lyme disease are often seronegative (they don’t have antibodies, or their antibodies reflect only past infection), and often lack classic clinical features of Lyme disease.
In other words, chronic Lyme advocates are claiming that their patients have seronegative, atypical, treatment-resistant Lyme disease. That is a lot of special pleading, very much like Sagan’s invisible, floating, heatless, noncorporeal dragon. The more parsimonious interpretation is that these patients do not have Lyme disease.
This is a critical distinction for two reasons. The first is that treatment with antibiotics, especially IV antibiotics, is not benign. There is tremendous potential for complications.
The second is that these patients, if they don’t have chronic Lyme disease, have something else which is being missed because they and their practitioner are distracted by the false diagnosis. This is a missed opportunity to treat the real cause of their symptoms. If there is no treatable cause, it is then better to focus on symptom management and quality of life, rather than chase a fictitious infection.
[h=2]Treatment trials[/b]Initial research trying to settle the question of whether or not chronic Lyme disease is a real entity focused on trying to find evidence for persistence of the spirochete in patients with symptoms diagnosed as chronic Lyme. Such efforts failed, but did not settle the controversy. Proponents of chronic Lyme just special-pleaded away this negative evidence.
Research efforts then shifted to seeing if such patient responded to courses of antibiotics, with double-blind placebo controlled trials. This is often a good strategy to addressing such questions, because it cuts right to the clinical management question – do these patients benefit from courses of antibiotics?
A 2013 systematic review of the major clinical trials of antibiotic use for patients with alleged chronic Lyme disease concluded:
On the basis of this analysis, the conclusion that there is a meaningful clinical benefit to be gained from retreatment of such patients with parenteral antibiotic therapy cannot be justified.
A 2015 review also concluded:
Prolonged courses of antibiotics neither prevent nor ameliorate these symptoms and are associated with considerable harm.
This brings us to the current study. I found the trial design to be a little unusual, but was justified as trying to replicate how chronic Lyme is often treated in real practice. The study occurred in Europe, and therefore involved the European Borrelia species which causes a slightly different clinical picture than the North American variant.
Enrolled patients did not need to have confirmed prior Lyme disease, so they could include both subjects with post-Lyme symptoms and subjects who never had Lyme. All subjects were given a course of IV antibiotics, ceftriaxone, for two weeks, followed by either placebo or a longer course of oral antibiotics (doxycycline and clarithromycin with hydroxychloroquine.)
The study showed no difference between the treatment and placebo groups, demonstrating that long term antibiotics are ineffective.
In an accompanying editorial, experts who were not part of the study concluded:
Critics may rightly say that this trial does not truly capture with certainty the consequences of bona fide Lyme disease. However, studies with more stringent inclusion criteria have already been conducted, and the approach used by Berende and colleagues probably reflects the common practice in ambulatory care settings, in which patient presentations of fatigue or nonspecific pain prompt serologic checks for Lyme disease, despite evidence suggesting that these tests will not identify a probable cause or result in a treatment benefit.
[h=2]Conclusion: Where are we now?[/b]If you look at the totality of scientific evidence, it does not support the existence of chronic Lyme disease or the approach of treating patients with long term or recurrent courses of antibiotics.
Patients who end up with this diagnosis tend to have non-specific symptoms that could have many causes, and lack a clinical picture specific to Lyme. They also lack serological proof of active Lyme (although may have had past Lyme). Most significantly, they do not respond to antibiotics in rigorous clinical trials.
Proponents of chronic Lyme essentially just dismiss the scientific evidence, and instead resort to anecdotal evidence of a subjective response to treatment in some patients.
As would be expected, when a group has a persistent belief that experts reject due to lack of scientific evidence, or even evidence of lack of efficacy, conspiracy theories proliferate. In this case the usual “Big Pharma” conspiracy won’t work, because the treatment being offered is pharmaceuticals. So a new enemy was invented, insurance companies. They were made the bogeyman for not wanting to pay for multiple courses of IV antibiotics.
The Infectious Disease Society of America (ISDA), a professional organization of experts who reject the claims made for chronic Lyme (and have been sued for holding that opinion), are also accused of being in on the conspiracy. What possible motive would an infectious disease society have for denying that a common illness is caused by an infectious illness?
This just shows how versatile conspiracy theories are. Villains and motives can be made up as needed out of whole cloth, without any burden of logic or consistency.
Unfortunately, gullible (or perhaps cynical) legislators have fallen for the conspiracy theory. In 2009, for example, my own state of Connecticut passed a law shielding health care providers who treat chronic Lyme with long term antibiotics from being held to any standard of care. Insurance companies and the ISDA were specifically pointed to as perpetrating a conspiracy against such providers.
At the time I argued that it is a folly for legislators to decide on what the standard of care is, let alone enshrine it into law. The standard of care is a moving target that shifts with the scientific evidence. Here we are, 7 years later, and the scientific evidence has only moved more in the direction of rejecting chronic antibiotic treatment for alleged chronic Lyme. There is no lobby, however, to get CT legislators to reconsider their past mistakes on this issue – which is precisely why you shouldn’t calcify a particular practice into law.
 
Why ILADS 2014 treatment guidelines are important
by Dr. Daniel Cameron - Monday, August 04, 2014
http://danielcameronmd.com/ilads-2014-treatment-guideline-important/
The ILADS 2014 treatment guidelines for Lyme disease identified a number of key issues in making
these recommendations:
Lyme disease is a complex illness and patients may experience both acute and persistent
manifestations
Persistent manifestations may produce profound quality-of-life impairments, yet the mechanisms
that produce persistent manifestations are poorly understood.
The available evidence regarding the treatment of known tick bites, erythema migrans (EM)
rashes and persistent disease is limited.
Grading of Recommendations Assessment, Development and Evaluation-based analyses found the
evidence regarding these scenarios was of very low quality due to limitations in trial designs,
imprecise findings, outcome inconsistencies and non-generalizability of trial findings.
It is impossible to state a meaningful success rate for the prevention of Lyme disease by a
single 200 mg dose of doxycycline because the sole trial of that regimen utilized an
inadequate observation period and unvalidated surrogate end point.
Success rates for treatment of an EM rash were unacceptably low, ranging from 52.2 to
84.4% for regimens that used 20 or fewer days of azithromycin, cefuroxime, doxycycline
or amoxicillin/phenoxymethylpenicillin (rates were based on patient-centered outcome
definitions and conservative longitudinal data methodology).
In a well-designed trial of antibiotic retreatment in patients with severe fatigue, 64% in the
treatment arm obtained a clinically significant and sustained benefit from additional
antibiotic therapy.
The optimal treatment regimen for the management of known tick bites, EM rashes and persistent
disease has not yet been determined. Accordingly, it is too early to standardize restrictive
protocols.
Given the number of clinical variables that must be managed and the heterogeneity within the
patient population, clinical judgment is crucial to the provision of patient-centered care.
Based on the Grading of Recommendations Assessment, Development and Evaluation model,
International Lyme and Associated Diseases Society recommends that patient goals and values
regarding treatment options be identified and strongly considered during a shared decision-making
process.
Research is needed to better define the disease process, to identify variables associated with poor
outcomes and to establish highly effective therapeutic regimens for known tick bites, EM rashes
and persistent disease.
 

Vince

Super Moderator
Uploaded on Jul 11, 2008
News coverage on CNN News on award-winning Lyme Disease documentary. This film chronicles the controversy and debates surrounding the disease and its treatment within the medical community.
 

Re-Ride

Member
If you are bitten...
"Get a single shot of doxycyline within 72 hours of the bite to prevent Lymes"

This is what I am now being told by my local medical foundation one month after reporting to them that I had discovered a deeply embedded tick. Too bad they waited almost a month to advise me of this. My doc who is part of the foundation merely suggested that I come in to have the head surgically removed. He failed to mention the importance of taking the antibiotic within 72 hours.

On the day of discovery in mid March I reviewed the literature on line. I do not recall reading about any such "72hr window" for early treatment.

Lymes is not the only disease to consider after a tick bite. Here is a summary of tick-borne diseases, diagnose and treatment;
http://www.cdc.gov/lyme/resources/TickborneDiseases.pdf
 
Interesting find. CDC is changing their view and recognizing the dangers of Lyme and coinfections. They still seem to be behind DRs in the trenches that deal with this. I noted they show antibiotic treatments of up to 14 days for a lot of the infections. Daughter went through 2 quack MDs and a ND in Atlanta and a LOT of $$$$$ before we found a DR in Mobile Alabama that truly understands Lyme and the coinfections. He spent over 2 hours with her going over all the test that were already done and doing a clinical eval. Started her off with Minocycline and said she could be on it for a year based on his eval of her condition. He ordered some additional test for possible coinfections, and when we get the test back there may be a change to the treatment plan. Daughter is unable to work and 2 weeks of an antibiotic would not even register on her infection. One quack MD in Atlanta said they did not treat Lyme with antibiotics because it messed up the gut flora. They use supplements and other crap....
 
I sat in on most of the eval with my Daughter and the DR. One comment he made was very interesting. I will paraphrase it: "If someone is diagnosed with MS out of the blue, they and their DR are idiots if they do not run a Lyme test to rule Lyme out." Lyme can mimic sooooo many other illnesses, and a few simple blood test can rule it out. Sort of goes along with the vid Vince linked above. The DR indicated that he has seen sooooo many patients that had already seen 5, 10 or more DRs with none testing for Lyme, when that was the problem all along...
 

Re-Ride

Member
Thanks for your updates and links Orrin. Wishing the best for your daughter.

Me:
10 weeks post bite: Sudden flare-up of severe lumbar pain on Friday and renewed eye redness although not as pronounced as first event which easily qualified me as a demon-extra for a Hollywood horror flick and which coincided with the flu symptoms last month. O.K. that's three symptoms including the flu-like symptoms. Maybe more if I include pain in arm, light sensitivity, bad headache and other weird stuff coinciding with the flu-like symptoms.

After those cleared up last month, and until this week end, I wanted to attribute the above to a respiratory bug which had been going around. Now, if infected, I'm hoping I haven't progressed to stage II or III loosing an early opportunity to wipe it out.

I was told that I they were proceeding with an antibody serum test when they drew labs last month. The test was never performed dammit! I'll get it as soon as possible.

All who read this thread should take it as a reminder to be aware of the highest risk weeks in your specific area and to check yourself thoroughly and frequently. The nymps in early spring are pin head size and easily overlooked. If you do find one attached let the ER remove it and *insist ask that the tick be saved for testing*!
If you are an outdoors-man who may have to remove it yourself make sure you carry good tweezers and are versed in proper procedure: (1) Never squeeze the abdomen or apply a match head or solvent as this could cause the tick to expel gut contents with the gametes in to your body (2) Grab as close to the head as possible and pull straight out. (3) If the mouth parts remain don't panic, they don't harbor the infection and can be removed later. (4) Save the sucker (5) start keeping a log of any symptoms

Understand the 72 hr window for initial single dose of doxycycline! It's controversial and not indicated for every bite

Weeks 1-4 if you have any of these classic symptoms: headaches, rashes, conjunctivitis, flu-like symptoms, aches and pains getting on antibiotics asap can prevent advancing to stage II or III and improve prognosis for a complete recovery. Having symptom-free periods is possible as the infection entrenches itself. Do not ignore mild symptoms.
 
Re-Ride,
The CDC link you posted gives some great info that ALL should be aware of. Lyme is in EVERY state!!!!!! Don't let some incompetent DR tell you that there is NO lyme in the area where you live so you could NOT possible have lyme (comment for others and NOT you). The CDC link misses the mark in a few place. Folks should go directly to the Western Blot or one of the other test (IGENX is one) as less false negs. 2 or 3 weeks on an antibiotic may help a few, but by the time most folks are miss-diagnosed the lyme has entrenched itself and one is looking at the possibility of a year or more on antibiotics and if co-infections are present multi doses of different antibiotics... AND that is AFTER you find a DR who understands lyme... They are few and far between all the other quacks that will tell you that you do not have lyme or want you to take THEIR supplements and take THEIR blood test and .... and get all your $$$$$ with no cure insight. I sure hope you do not have lyme..... Daughter is a bit better, but still can not work. We have our first follow-up next Thursday. Will see if the DR stays the course or changes antibiotics based on current condition.
 
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Re-Ride

Member

[TD="class: nameCol srchbl"]LYME DISEASE IGG/IGM
[/TD]
[TD="class: valueCol"]
[/TD]
[TD="class: rangeCol"] [/TD]
[TD="class: flagCol"][/TD]

[TD="class: srchbl, colspan: 4"]Note
REFERENCE RANGE: <=0.90
INTERPRETIVE CRITERIA:
<= 0.90 NEGATIVE
0.91-1.09 EQUIVOCAL
>= 1.10 POSITIVE
The use of purified VlsE-1 and PepC10 antigens in
this assay provides improved specificity compared
to assays that utilize whole cell lysates of B.
burgdorferi, the causative agent of Lyme disease,
and slightly better sensitivity compared to the
C6 antibody assay.
As recommended by the Food and Drug
Administration (FDA), all samples with positive
or equivocal results in a Borrelia burgdorferi
antibody EIA (screening) will be tested using a
blot method. Positive or equivocal screening test
results should not be interpreted as truly
positive until verified as such using a
supplemental assay (e.g., B. burgdorferi blot).
The screening test and/or blot for B. burgdorferi
antibodies may be falsely negative in early
stages of Lyme disease, including the period when
erythema migrans is apparent.
----
I resulted at < or = 0.90 . Therefore no Western Blot was done. I'm not clear if WB or tests for the other tick borne illnesses need to be done.


[/TD]

 

Re-Ride

Member
Published June 3 2016: Is it normal for Lyme disease symptoms to return after stopping antibiotics? Paul Taylor, journalist for The Globe and Mail , a Canadian health advisor blog. http://www.theglobeandmail.com/life/health-and-fitness/health-advisor/is-it-normal-for-lyme-disease-symptoms-to-return-after-stopping-antibiotics/article30246135/

-
some Canadians getting U.S. tests but this has fueled debate on their accuracy
- "before the 1980's Lyme was unknown in Canada"
-
act establishing a Federal Framework on Lyme
-
May conference consensus: Canadian diagnostic assays need to be improved
 
From all that I have read the pre-test (for lack of a better word) all have a LOT of FALSE negatives and DRs then stop and say "You ain't got Lyme". If you could get a Western Blot that would be a clearer picture. If you are close to the US you might order the test yourself from Walkinlabs.com and get the blood draw here. IGENEX.COM is another one that will send you a draw kit and you take it to a hospital or where ever you can get a blood draw, and it is mailed back. Only problem with that is that IGENEX require a DR script to process.

Good basic article with mostly O.K. info.
"before the 1980's Lyme was unknown in Canada".. Most likely not true. Most likely folks were still getting it BUT misdiagnosed and never treated correctly.

Daughter had appointment last week. She is doing a little better but it appears the antibiotic is causing sides. She was told to stop for 5 -7 days and see if the sides go away and she will get a new a script for another antibiotic. We are looking for at least a year on meds....
 

Re-Ride

Member
Thanks Orrin, Anyone who has every taken AB has got to be sympathetic to your daughter and the prospect of extended therapy. I read about an advanced diagnostic lab affiliated with Stanford. Easy drive for me. Prol'y not covered. False positive concerns.

https://www.bostonglobe.com/lifestyle/health-wellness/2013/10/20/many-tests-diagnose-lyme-but-proof-they/ISjAcxmZxkk2disi94ENfI/story.html

-the FDA exemption from regulation Lyme testing labs enjoy
-false positives, false negatives
-culture from serum

- special section Bitten by Uncertainty
-
decade old method to grow the bacteria using Detroit tap water
 
Hmmm Bay Area Lyme Org sounds like an interesting group. It does sound like they may be marching to the drum of the CDC.... "Caught early, most cases of Lyme disease can be treated successfully with a full course of antibiotics.*" " * Typical antibiotic prescription is for a 14-21-day course. According to the CDC, antibiotics commonly used for oral treatment include doxycycline, amoxicillin, or cefuroxime axetil." They do list a verrrrry impressive list of support staff.... I hope that they are not shills for the CDC and do basic research and figure this out. The problem is that a significant number of folks do not get the "bull's eye" and end up getting misdiagnosed.... Some times for years and years.... Then 21 days of antibiotics is meaningless....
http://tbdalliance.org/index.php/getinformed/tbdablog/198-gregg-kirk-story
 

Re-Ride

Member
re: BayAreaLyme.org
Agents for the Agenda? No doubt. Funding dependency.

However, the first thing they say is: [ Actually, many never develop a skin rash and those that do may not get a bullseye rash.]
then,

[ MYTH: If the test is negative, you don't have Lyme. ]

[ Not so fast &#8230; The current “gold standard” diagnostic for Lyme disease is a two-tiered blood test requiring a positive ELISA result. The ELISA measures infection-fighting or memory antibodies against Borrelia burgdorferi, and it misses up to 60% of acute cases of Lyme when antibodies may not be high enough to detect. ]
---

Failure to preserve the tick flushes away a golden opportunity for early diagnosis. There is a need to enlighten the medical community as to this fact. Those at higher risk are advised to have a game plan in place. Discuss with your MD where you will take the tick. Standing orders are possible. They need to be renewed.
 
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