A Reappraisal of the U.S. Clinical Trials of Post-Treatment Lyme Disease Syndrome



Brian A Fallon*, 1, Eva Petkova2, John G Keilp3, Carolyn B Britton4
1 Columbia University, Dept. of Psychiatry, Division of Clinical Therapeutics, USA
2 New York University, Dept. of Child and Adolescent Psychiatry, Division of Biostatistics, USA
3 Columbia University, Dept. of Psychiatry, Division of Neuroscience, USA
4 Columbia University, Dept. of Neurology, USA


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© Fallon et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at Columbia University 1051 River-side Drive, Unit 69, NYC, NY 10032, USA; Tel: 212-543-5487; Fax: 212-543-6515; E-mail: baf1@columbia.edu


Abstract

Four federally funded randomized placebo-controlled treatment trials of post-treatment Lyme syndrome in the United States have been conducted. Most international treatment guidelines summarize these trials as having shown no acute or sustained benefit to repeated antibiotic therapy. The goal of this paper is to determine whether this summary con-clusion is supported by the evidence.

Methods:

The methods and results of the 4 U.S. treatment trials are described and their critiques evaluated.

Results:

2 of the 4 U.S. treatment trials demonstrated efficacy of IV ceftriaxone on primary and/or secondary outcome measures.

Conclusions:

Future treatment guidelines should clarify that efficacy of IV ceftriaxone for post-treatment Lyme fatigue was demonstrated in one RCT and supported by a second RCT, but that its use was not recommended primarily due to adverse events stemming from the IV route of treatment. While repeated IV antibiotic therapy can be effective, safer modes of delivery are needed.

Keywords:: Lyme disease, Chronic Lyme disease, Lyme Encephalopathy, Post-treatment Lyme Disease Syndrome, Clinical Trials, Treatment Guidelines.