"There is NO PLACEBO effect in animals!" received this preeminent ILADS info on Lyme Disease following our extensive coverage of the disturbing facts on canine and human Lyme Disease.





The following information is slightly edited and condensed for layman readers.


Dear Editor, as authors of the International Lyme and Associated Disease Society (ILADS) guidelines, which address the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans (EM) treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease, we are appreciative that Kullberg et al included our recommendations in their State of the Art Review in the British Medical Journal.


We encourage readers to study ILADS guidelines and render their own judgment regarding their validity. The (rigorously peer-reviewed) guidelines were transparently produced … and conform to the National Academy of Medicine standards for trustworthy guidelines… and were listed on the National Guidelines Clearinghouse. … Although faulted by some for making treatment recommendations on low or very low- quality evidence, we utilized the same trial evidence as the IDSA [4] but reached different conclusions regarding the strength of that evidence. … We are not outliers in determining that the evidence quality was low or very low; other GRADE-based assessments, including the exquisitely detailed National Institute for Health and Care Excellence (NICE) assessments and another by Centers for Disease Control and Prevention (CDC) epidemiologists also found that the evidence was of low or very low quality.[5,6]


Despite the high incidence and severity of Lyme disease, little research has been done regarding treatment of those with persistent manifestations of Lyme disease. The result has been a stagnant research environment— in the US, only three grants have been funded by the National Institutes of Health (NIH) to assess treatment response in patients who remained ill after a short course of antibiotics—the last was funded over 20 years ago.


In the absence of accurate diagnostic testing for patients with persistent manifestations of Lyme disease, the caution regarding the potential of diagnostic anchoring bias is not unfounded. Given the exclusion of some pertinent evidence and a one-dimensional discussion of other evidence regarding persistent infection and the utility of antibiotic retreatment, we are concerned that the authors have fostered the potential for confirmation bias. Specifically, Kullberg et al fail to inform readers regarding the growing body of evidence that documents, via positive culture and/or PCR, persistent infection in humans following antibiotic therapy, evidence which is discussed in detail in ILADS’ paper on chronic Lyme disease.[… recent research findings such as the National Institutes of Health xenodiagnostic study suggesting the need for antibiotic combination therapy that would have helped physicians in their decision making.


The value of antibiotic retreatment has been demonstrated in EM trials conducted in Europe and the US….These trials relied on average treatment effects, employed small samples, and excluded over 89% of patients who sought to enroll. … As a result, the trials’ findings and conclusions are not generalizable to most patients seen clinically, and are too small for subgroup analysis which would permit more targeted treatment approaches. … Krupp - Fallon found the improvement in fatigue encouraging and recommended additional studies of less expensive and invasive therapies. Furthermore, in a subsequent paper, Fallon supported the use of antibiotic retreatment on a case-by-case basis.


…In the absence of high-quality evidence, evidence-based medicine holds that therapeutic decisions should strongly consider clinician expertise and patient values. The National Academy of Medicine (NAM) reaffirms the role of clinical judgment and patient preferences, as does the widely used evidence assessment scheme, GRADE. As NAM notes, conflicting guidelines most often arise when evidence is weak, organizations use different assessment schemes, or when evidence developers place different values on the benefits and harms of intervention.


Such is the case here. Using the same evidence base, the IDSA overstates the quality of the evidence and based on its values provides no care for patients who remain ill. ILADS recognizes the heterogeneity of patients’ prior treatment history, ongoing manifestations, comorbidities and therapeutic responses as well as the heterogeneity of their values and goals.


ILADS … share concerns about the limitations of the current testing, the low quality of evidence, and recognize the role of clinical judgment when assessing whether to treat or to continue treatment. The ILADS guidelines encourage clinicians to individualize care by engaging in shared decision-making with their patients and to closely monitor patients during retreatment, adjusting therapies when necessary. Perhaps this is why only 6% of US patients with persistent Lyme disease report being treated by IDSA clinicians… with the rest choosing to be treated by clinicians who are more willing to provide further treatment utilizing innovative approaches.


Instant Information References provided by ILADS International Lyme and Associated Disease Society.

Copyright 20S06



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