New Lyme Study: Possible NIH CFS Study Implications

[duncan]

Long-term follow-up of patients with Lyme disease: Longitudinal analysis of clinical and quality of life measures

1. Aprielle B. Wills1,2,†,
2. Alicen B. Spaulding1,2,†,
3. Jennifer Adjemian1,2,3,
4. D. Rebecca Prevots1,2,
5. Siu-Ping Turk2,
6. Carla Williams4, and
7. Adriana Marques2

+ Author Affiliations

1. 1Epidemiology Unit
2. 2Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA
3. 3United States Public Health Service, Commissioned Corps, Rockville, MD, USA
4. 4Clinical Monitoring Research Program, Leidos Biomedical Research Inc., National Cancer Institute, Frederick, MD, USA

I wanted to point out this study for a couple of reasons.

First, notice one of its authors is Adriana Marques, Head of NIH Lyme Team.

Second, the results seem to suggest that Lyme isn't all that bad after a period of time. The problem with that is that anyone remotely associated with Lyme knows that simply is not the case. Up to 20% of Lyme patients are conceded by the IDSA to be stricken with continued symptoms. Some say that number is much higher. For many of those 20%, the symptoms are debilitating. But this study suggests that Lyme patients after five years rate their QoL as better than the average healthy person.

Even laymen would likely know this is highly unlikely in the real world of Lyme sufferers.

If the NIH can do this with a disease with an acknowledged etiology, what might it do with ME/CFS?

This is indicative of why it is imperative that we work with the NIH to get this CFS study protocol right.

1. Corresponding author: Aprielle Wills, Epidemiology Unit, Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 8 West Drive, Quarters 15B-1, Bethesda, MD 20892; aprielle.wills@nih.gov, 301.761.6204.

1. Alternate corresponding author: Jennifer Adjemian, Epidemiology Unit, Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 8 West Drive, Quarters 15B-1, Bethesda, MD 20892; jennifer.adjemian@nih.gov, 301.761.5654.
   
   
2. ↵† Authors contributed equally to this work.

Abstract
Background. Lyme disease is the most common vector-borne disease in the United States. Some patients report persistent or intermittent subjective symptoms of mild to moderate intensity after antibiotic treatment for Lyme disease. We sought to evaluate trends in clinical and QOL measures in a cohort of patients with Lyme disease enrolled in a natural history study at the National Institutes of Health from 2001-2014.

Methods. QOL was measured using the self-administered 36-item short form health survey (SF-36) during study follow-up. Primary outcomes included mean physical (PCS) and mental (MCS) health QOL composite scores, and reporting long-term (≥2 years) symptoms, adjusted for Lyme disease stage and severity at diagnosis.

Results.  Overall, 101 patients with an average follow-up time of 3.9 years (range: 0.5-11.3 years) were included. At first visit, overall mean QOL scores were below the US population mean for both PCS (45.6±10.4) and MCS (47.3±11.5), but increased to just above the national average after three years of follow-up for both PCS (50.7±9.6) and MCS (50.1±10.0). Baseline QOL scores were lowest in those with late disease (p<0.01), but also increased by the end of follow-up to national averages. In multivariate analysis, the only factors significantly associated with long-term symptoms or lower QOL scores were other comorbidities unrelated to Lyme disease.

Conclusions.  Comorbid conditions can play a role in the reporting of long-term symptoms and overall quality of life of Lyme disease patients, and should be considered in the evaluation of these patients.

• Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.
  Oxford Journals, Clinical Infectious Diseases March 29, 2016
  
  

 

[duncan]

Sorry my italicized comments are in the middle of the study. I cannot figure how to positions them before or after. Hopefully, their misplacement won't interfere with with reading the abstract.

 

[Justin30]

Can someone chime in an explain what ghey are saying:

- so you get lyme then get rid of it
- but if you are part of the 20% group it sucks
- the 20% group gets comorbidities?

These comprbidities are what cause the symptoms.

So like a completely damaged immune system, CNS, PNS, ANS....great

NIH step it up and help us out, its getting pathetic.....why are you leaving your patient communities guessing on how to fix themselves when you would rather spend money on solving Male Pattern Baldness....

 

[msf]

Haha, their quality of life is better than the average healthy person?

Jeez, that tick bite gave me a real shot in the arm!

 

[duncan]

This is just the abstract, so there may be significant details embedded in the study - like how they define recovery or qualify symptom improvement - that we are not privy to yet

But if we take the abstract at face value, the NIH seems to be saying that years following diagnosis, a group of Lyme patients saw its symptom spectrum, specifically its Qol, recover to at least national average levels, and many within the cohort to better than national average.

Sounds good.

The problem is, I think the Lyme community as a whole knows better. The NIH should know better, but I cannot say for sure; theirs is a peculiarly insulated little medical island in some ways. I'm pretty sure Marques knows better since she inherited a study that oversees 500 Lyme patients with chronic Lyme or PTLDS. Many of these patient remain very sick, and the study still operational.

I'm even confused about why they bring in co-morbidities. Are they trying to reach outside this study and say, "So, we've just proven Lyme won't cause persistent symptoms, so any persistent symptoms in other patients must be caused by something other than Lyme?"

Not that I would ever suggest cherry-picking, but how did they come upon these specific patients? I want to know where they got these patients, how long each was sick, and who selected them. Who charted their symptomology? Was there any waxing and waning of symptoms? Did any remain sick out of their "average" cohort? What is buried in those averages?

Naw, I don't even need to know that. This is obvious. Is Marques pretending the Lyme wars don't exist? The legal maneuverings, the legislative efforts, the clinical witch hunts...Geez, even the media loves the polemics. Maybe someone should hand her a copy of the just released and already hotly contested PLEASE results, a study ostensibly dedicated to demonstrating protracted abx don't help persistent Lyme symptoms.

To summarize the battle over Lyme symptoms: You have a powerful private organization saying a set regimen of limited abx cures Lyme. Any residual symptoms - which most of its members begrudgingly acknowledge exists - must be due to a construct called PTLDS. This group even admits the number of symptom-laden suffers could be as high as 20% of 300,000 cases each year. (Although, to be fair, many members believe that sufferers only imagine the severity of their aches and pains - but even these accept that the delusions exist and they are associated with Lyme)

You have another private organization that says by virtue of the intensity and number of continued Lyme symptoms, Lyme is in fact sometimes very difficult to eradicate and may require a protracted regimen of abx treatment. This group thinks that 20% value may be low, and it sides with the patients by describing persistent symptoms as pernicious and disabling.

Either way, both polarized groups recognize to a varying degree persistent symptoms.

So this study at first glance might strike some as a head-scratcher.

Until perhaps you factor in the release of the new Lyme Guidelines, scheduled for this Fall. I will be surprised if this study does not show up in some way in those Guidelines, even though at least one of its authors has made it very clear on several occasions what school she aligns with when it comes to any symptoms after recommended abx treatment. I doubt the Guidelines authors will consider that a conflict of interest.

This is why I am concerned about the ME/CFS study in Bethesda. Just because it has the NIH's involvement doesn't insulate it from inside (or outside) influences, from politics, from someone's personal agenda in a broader struggle.

So it becomes essential we know who will be involved, and we ensure any that may wish to hijack the process and/or its results for their own ideologies or purposes, are not allowed to participate. I know we have been assured that Bias could never breach the broad NIH gates, but, well, history may say otherwise.

I fear it is simply too easy to use the NIH brand for something other than Science.

ETA: I just love this study. "Persistent symptoms? What persistent symptoms?"

 

[jimells]

Are they trying to reach outside this study and say, "So, we've just proven Lyme won't cause persistent symptoms, so any persistent symptoms in other patients must be caused by something other than Lyme?"

Yup. They are all suffering from psychosomatic something-or-other. Anyone notice the cohort size? Does anyone else in the world run 15 year studies that include only 100 participants?

 

[medfeb]

@duncan
From the study methods:
"Self-reported pre-existing comorbidities were recorded for all patients at baseline during medical history and physical review; comorbidities were validated by clinical staff or by prescribed medications. Pre-existing comorbidities were categorized as chronic pain, mental/behavioral health (and separately, “mental/behavioral health medication use”), and high-risk conditions for cardiovascular disease and metabolic syndrome, including obesity (body mass index [BMI]>29.5). "

From the discussion:
"In our longitudinal analysis, the association between self- reported comorbidities and long-term symptoms suggests a contributory relationship; patients with mental/behavioral health and/or cardiovascular-related risk factors, especially obesity, may be more sensitive to symptoms of fatigue, joint pain and sleep disturbances, which may be exacerbated and/or prolonged in this group. It is possible that patients with post-Lyme disease symptoms may have other comorbidities present that have either gone undiagnosed or were not reported over concerns of stigmatization."

 

[duncan]

Wow. Good catch, @medfeb.

Talk about possible overreach - even joint pain is shrugged off as unrelated to Lyme, and that pretty much is the lone symptom this gang will give a nod to. And the emphasis on mental/behavioral health...and the strange hints at comorbidities that somehow may carry "concerns of stigmatization"...

And this is about people with a confirmed pathogen.

Everybody sure they're ok with Marques and Company mucking around a CFS study?

Either way, I fear Science can be manhandled by scientists at times, and the NIH probably is no exception.

ETA: I must admit this gang confuses me at times, and this study is reflective of that. Is she saying that some members of this group of Lyme patients have psychological problems, and those problems explain their symptoms? If so, would their psych problems also explain why they reported QoL values higher than average healthy patients? OR did they just get over their wackiness and are better now, and no longer are burdened by stigmatizing stuff?

How would you like to have been one of the volunteers for this study, and read their write-up of the results?

 

[panckage]

Yup. They are all suffering from psychosomatic something-or-other. Anyone notice the cohort size? Does anyone else in the world run 15 year studies that include only 100 participants?

jimells its not a 15 year study. Look at the range of follow up times: (range: 0.5-11.3 years) average: 3.9 years
It looks to be some sort of retrospective study

 

[jimells]

jimells its not a 15 year study. Look at the range of follow up times: (range: 0.5-11.3 years) average: 3.9 years
It looks to be some sort of retrospective study

We sought to evaluate trends in clinical and QOL measures in a cohort of patients with Lyme disease enrolled in a natural history study at the National Institutes of Health from 2001-2014.

 

[Justin30]

So...i watched a video a ways back....and what was a verterunarian who was finding all these weird bacterias in dogs and cats. These bacterias were tick type bacteria Borrellia.....

The craziest part about it was that these bacteria were being transfered from bugs outside to the animals the to humans...like EBOLA....

this Dr linked up with a Dr in a University and sure enough they found these lyme type bacterias in humans...the patients were having siezures, fatigue, vision problems, etc. All ME type stuff

The craziest part was that the bacteria were found to be in mosquitoes, flees and I think Hoarse flies.....

ABX worked to get rid of the bacteria.

LYME = ME and comorbidities
EBV = ME and comorbitdities
Vacines = ME and comorbidities

As long as the NIH keeps dumping collosal ammounts of money into Male Patter Baldness, Cancer, HIV, etc.

Then the hidden epedemics ME, CFS, LYME, POTS etc. Will be left behind. Its these diseases that need more money. Better testing and better treatments.

 

[valentinelynx]

This is just the abstract, so there may be significant details embedded in the study - like how they define recovery or qualify symptom improvement - that we are not privy to yet

To read entire study, click here (sic-hub.io).

 

[duncan]

Thank you, @valentinelynx .

I have a couple things I have to do today so I cannot analyze the full study right now.

But I scanned it.

I find myself thinking of pharmas that might conduct three studies for a proposed drug, and two of those three show the drug doesn't work. One shows it works, and they report the findings of that one study.

The NIH has a long-standing group of Lyme patients to draw from that is composed of patients whose treatment has failed them, at least in terms of persistent symptoms. This study has been up and running since the late 90's. It is still running. These are all qualified via the 2T protocol; they were confirmed Lyme patients. Literally hundreds of them. They are still recruiting as patient churn occurs. I believe all have had treatment that reportedly falls short; most have been plagued by pernicious symptoms for an extended period.

How can anyone in good conscious sign a study like this 2016 one, knowing about this captive population of patients who have suffered with persistent symptoms for years?

The study just released includes Lyme patients. The study that has been running since the 1990's has chronic Lyme/PTLDS patients that were at one time simply Lyme patients, too. Even though participants in the two groups had to either have a documented EM or satisfy the 2T, or both, maybe they are claiming PTLDS patients are not Lyme patients?? Even though it seems individuals would have had to satisfy similar criteria?

Who knows?

But the new study has been released just in time to be able to reference for the new Guidelines.

 

[duncan]

I think this study is rife with possible problems. I also worry this may be suggestive of the type of effort that could be employed for the CFS study.

Some observations:

If accepted at face value, this study seems to blow out of the water any claim that persistent symptoms are only in a minority (10 - 20%) of patients. This mentions patients with symptoms well beyond 24 months in closer to 50% of the studied population. That they seem indifferent to possible inherent contradictions is concerning.

The authors appear to be trying to disassociate continued symptoms with Lyme - and I'm not sure they pull it off. They really don't make a convincing case for ascribing comorbid condition causes vs Lyme. In fact, to me their "Comorbidity Analysis" section has a contrived and forced feel to it.

Far too much emphasis was placed on mental aspects for my taste. Seems like they are trying awfully hard to plant a seed here.

BTW, odd comments pepper this effort. For instance, placing multiple EMs as symptoms on a par with neurologic and cardiac involvement. Trust me when I tell you patients wouldn't equate their severity.

What were the actual comorbidities at the end of the study, and how did the investigators distinguish the causal agents, i.e, Lyme vs comorbidities, of the persistent symptoms? Are they, in effect, saying it is not the disease causing the symptom, it is the patient bringing the symptoms? Is this another "Let's blame the patient" exercise? If so, it's not altogether surprising given ex NIH executives emails concerning Lyme in the past.

It seems like they are saying most participants were diagnosed within 6 weeks. How many were true late stage? How many had severe manifestations? What portion had severe manifestations? So if you have 100 participants, and only 1 in 5 had severe manifestations, what does that tell you about averages throughout the study time frame, including at study closure? Does cherry-picking have a role here?

For some, maybe for many, this study arguably might have "Bias" written all over it. Possibly "Agenda", too. So, it may be prudent to keep that in mind when the NIH is cranking out assurances that there could not be any bias on its campus when it comes to ME/CFS. And no agenda at play either.

 

[jimells]

For some, maybe for many, this study arguably has "Bias" written all over it.

Bias? There's no bias at NIH - we know because Dr Nath said so.

 

[Justin30]

I wish the NIH would just man up and say that we don't have a clue about these multi system illness and be honest with patients.

From their they should get NIH Human Resources Team to hire top experts in Lyme, CFS, POTS, etc. to assist in running these studies.

Ego of these NIH hotshots needs to end and I feel the only way that will happen is through government imposed changes.

And the one I have said all along is=
*** HEAVY MEDIA EXPOSURE****

Ie. Protests, petitions, etc.

 

[duncan]

An article from Dr. Cameron, an ILADS exec, seems to suggest that an exclusionary condition for participation in this study were symptoms that resembled PTLDS.

If accurate, this is incredibly damning.

Remember, this study has the signatures of at least a couple of the NIH Lyme Team.

The IDSA/CDC/NIH really don't subscribe to persistent Lyme post-treatment. Hell, for that matter, they barely even talk about late stage Lyme anymore - talk about your inconvenient truths.

But back to Lyme post-treatment. Mainstream attitude is if you get Lyme and receive treatment for it, you get cured. Simple. But there are some (many, actually) who continue to suffer from sometimes severe symptoms. Mainstream Lyme pundits group these patients as Post-Treatment Lyme Disease Syndrome patients.

So, you get Lyme. You get treated for Lyme. If you STILL suffer with symptoms, you have PTLDS.

Now, this study which included the head of the NIH Lyme team, looked to measure QoL for people who have been treated for Lyme. But according to this ILADS exec, patients that complained of PTLDS symptoms were excluded. That's right, by definition, evidently if you still had symptoms and your QoL was diminished or in the toilet, you were EXCLUDED.

Accordingly, it would seem most if not all of the only people being asked about QoL were those who were cured. Those that were not cured, were not asked.

How's that for House odds?

 

[Research 1st]

Govt policy: Chronic Lyme doesn't exist, so patients must be neurotic but in denial due to mood disorder/childhood trauma. CBT/GET anti depressants recommended as 'proven' in CFS.

Future Science: Chronic Lyme isn't Classical Lyme disease, but an novel autoimmune brain disease (involving Borrelia) which is at epidemic levels due to being ignored and spread by Sexual Transmission/Blood transfusion. This is why it doesn't respond to 4 weeks of Doxycycline and why PTLDS doesn't exist in Chronic Lyme cases as the patients weren't treated for the autoimmune disease they had, primarily as they were all told they had ME CFS or were Somatizing and so never got a Lyme or Lyme co infection test panel (2 tier CDC or otherwise).

Govt: We'll agree to that idea when there's an evidence based pioneering treatment in 2020, however, with no current treatment for autoimmune novel Lyme at present (because we hid it within Fukuda CFS) we won't agree that anything other than Classical Lyme exists. Ergo, you still all have CFS, due to any reason you wish to pick, and which when tested never showed any association to any pathogen when we looked. When the new science is published by 2030 by multi groups globally about this autoimmune Lyme idea, we might fund some large scale definitive proof studies to determine if we agree or not. Until then, good luck.

 

[anciendaze]

While I have not read this paper, having more important things to deal with at the moment, I would hazard the guess that solving medical problems is not the strong suit for these researchers, but solving political problems might be. Anything that might require organizational change will be played down, and after a while inside such an organization it is not even conceivable to you. We might check if these researchers ever put their names on anything else that actually made a damn bit of difference outside NIH. I'm sure there are plenty of people available who have not.

Beside problems in criteria for selecting or excluding patients you need to check if the researchers were drawn from NILH, the National Institute of Learned Helplessness.

 

[duncan]

Marques, who heads the NIH Lyme Team, and whose name is on this "paper", is also listed as an Investigator for the NIH CFS study.