duncan wrote:
Is there anyone that thinks this tidbit has nothing to do with the pending new Guidelines?
From Relative Risk's blog:
http://rel-risk.blogspot.ca/2016/04/co- ... -lyme.html
Sunday, April 3, 2016
Co-Morbidities and Post-Lyme
Notes from:
Wills AB, Spaulding AB, Adjemian J, Prevots DR, Turk SP, Williams C, Marques A. Long-term follow-up of patients with Lyme disease: Longitudinal analysis of clinical and quality of life measures. Clin Infect Dis. 2016 Mar 29.
Lyme disease is usually successfully treated with antimicrobial therapy, but patients with late-stage manifestations, such as Lyme arthritis or neuroborreliosis, may be slower to recover [16-24]. A minority of treated patients continue to report persistent or relapsing non-specific symptoms (i.e., fatigue, musculoskeletal pain, and cognitive issues); it is estimated that up to 20% of patients with EM have persistent or intermittent subjective symptoms of mild to moderate intensity 12 months after therapy completion. For these patients, a substantial reduction in quality of life (QOL) may result.
In this study, we present outcome data from a cohort of Lyme disease patients enrolled in a natural history study at the National Institutes of Health (NIH), Bethesda, MD.
From 2001-2014, patients diagnosed with Lyme disease were enrolled into the NIH natural history protocol NCT00028080, which was approved by the National Institute of Allergy and Infectious Diseases (NIAID) institutional review board (IRB). Written informed consent was obtained from all patients. For this analysis, only patients ≥18 years old with confirmed Lyme disease (based on the Centers for Disease Control and Prevention (CDC) case definition [27]) diagnosed at the NIH or within 6 weeks prior to enrolling, and with ≥6 months of follow-up, were included.
Patients were evaluated at NIH at the approximate time points: baseline, 1, 3, 6, and 12 months, and yearly thereafter. At baseline, demographic and clinical data were collected, including Lyme disease-specific manifestations, treatment history, and pre-existing comorbidities. At each follow-up visit, patients self-reported current symptoms from a standardized list, and completed a QOL survey using the 36-Item Short Form Health Survey.
From 2001-2014, 157 patients were enrolled in the study, of whom 101 (64%) met inclusion criteria. Median study follow-up time was 3.4 years (range: 0.5-11.3 years). Of the 101 included patients, 85% were white, 51% female, and mean age was 49±13 years.
In a cohort of patients with diverse manifestations of Lyme disease and detailed clinical follow-up, we found that both mental health and physical health scores increased to be at or above national average over time, regardless of Lyme disease stage or severity at diagnosis. However, patients with comorbidities unrelated to Lyme disease at baseline had lower QOL scores throughout follow-up and were significantly more likely to report long-term subjective symptoms.
While in our cohort patients with more severe manifestations of Lyme disease initially presented with lower PCS scores, this difference did not persist beyond 2 years of follow-up.
Although more than half of patients reported long-term symptoms at two years post- enrollment, the only significant predictor of long-term symptoms was the presence of other comorbidities. 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.
I would really love to see the full text on this one! There seems to be quite a bit of wild speculation in the reporting on the part of the study investigators, at least by the way RR has written this up. So, in this cohort of patients, those with more severe manifestations of Lyme disease initially presented with lower PCS scores. However, this difference did not persist beyond 2 years of follow-up. OK, so what happened,
given that more than half of patients reported long-term symptoms at two years post- enrollment? Aside from anything else, it seems to me that this reporting pretty much obliterates the CDC claim that only 10% to 20% have longer term problems after an early diagnosis and appropriate treatment for Lyme disease. As to why more than half the patients reported long-term symptoms after Lyme, well.......it couldn't be Lyme, so they all must have had some other comorbidity to have caused this to happen!
I really want to know what actual comorbidities were recognized at study onset or appeared in the patient's medical history prior to infection and which ones appeared the longer the patients were evaluated. I also want to know what these mysterious and speculative comorbidities were that were undiagnosed (or not reported over concerns of stigmatization).
Tara Moriarty and others including Wormser, as I recall, reported at some point (several years ago) that research on obese mice showed that they actually had more widespread infection with higher spirochetal burdens than mice that had not been overfed. It seems to be that this Marques study is suggesting that instead of obesity causing a predisposition for higher bacterial burdens and therefore more debilitating disease, that for other reasons this particular group "
may be more sensitive to symptoms of fatigue, joint pain and sleep disturbances, which may be exacerbated and/or prolonged". I guess it is all in how the investigators want to interpret and frame the data.
Gosh folks, Lyme is not the problem.......it's the people who get infected that are the problem. Oh good grief!
By the way, here is the link to the clinical trial study that this bit of fluff is based on, with a snip from the study criteria.
https://clinicaltrials.gov/ct2/show/NCT00028080
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
<snip>
Criteria
INCLUSION CRITERIA:
Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition.
Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.
EXCLUSION CRITERIA:
Post treatment Lyme disease syndrome.
Unacceptably poor compliance, which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.
ELIGIBILITY CRITERIA TO UNDERGO APHERESIS:
Age 18 years or above.
Weight greater than 110 pounds.
No known heart, lung, kidney disease, or bleeding disorders.
Negative HIV, HCV and HBsAg serologies.
Female subjects should not be pregnant or nursing.
Patients will have a CBC performed up to 2 weeks before the procedure. In order to be able to undergo the procedure, patient must fulfill all of the below:
Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females.
Platelets greater than 150 k/mm(3).
WBC greater than 3.5 x 10(3) uL.
MCV above 80.
Women who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure.
