ILADS - Treatment Guidelines - Evidence Assesments and Guideline Recommendations in Lyme Disease

The Clinical Management of Known Tick Bites, Erythema Migrans Rashes and Persistent Disease
by The International Lyme and Associated Disease Society (ILADS)

The ILADS guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease.

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.

Reconciling divergent guidelines

The ILADS panel recommendations differ from those of the IDSA. Different guideline panels reviewing the same evidence can develop disparate recommendations that reflect the underlying values of the panel members, which may result in conflicting guidelines. The IOM explains that conflicting guidelines most often result ‘when evidence is weak; developers differ in their approach to evidence reviews (systematic vs non-systematic), evidence synthesis or interpretation and/or developers have varying assumptions about intervention benefits and harms. Conflicting guidelines exist for over 25 conditions and there is no current system for reconciling conflicting guidelines. Supplementary Appendix I reconciles the differences between the ILADS and IDSA treatment recommendations by clinical situation.

Click here for full access to the 2014 ILADS peer reviewed guidelines.

1. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. Jama, 301(8), 868-869 (2009).

2. Clinical Practice Guidelines we can trust , Available from http://www.nap.edu/catalog.php?record_id=13058

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