THE LYME DISEASE DEBATE
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
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 
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
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
email@example.com International Lyme and Associated Disease Society.
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