Abstract
Background
Controversy exists over the significance and even the existence of post-Lyme disease
symptoms because of the high rate of similar background symptoms in the general population.
Methods
A European, prospective clinical trial in which doxycycline and cefuroxime axetil
were compared in the treatment of adult patients with erythema migrans included a
control group to address this question. Evaluations of patients were conducted at
baseline, 14 days, and 2, 6, and 12 months after enrollment. Control subjects were
evaluated at baseline and at 6 and 12 months. Subjective symptoms that newly developed
or intensified since the onset of erythema migrans or the date of enrollment for controls
were referred to as “new or increased symptoms.”
Results
Doxycycline and cefuroxime axetil had comparable efficacy. At both 6 and 12 months,
the frequency of new or increased symptoms in patients with erythema migrans did not
exceed the frequency of such symptoms in a control group of individuals of similar
gender and age without a clinical history of Lyme disease. At 12 months after enrollment,
only 5 (2.2%) of 230 evaluable patients reported new or increased symptoms, and in
none of the patients were these symptoms of sufficient severity to be functionally
disabling.
Conclusion
No significant differences were identified between doxycycline and cefuroxime axetil
in the treatment of European patients with erythema migrans. The frequency of nonspecific
symptoms in patients did not exceed that of a control group at ≥6 months after enrollment.
We advocate inclusion of appropriate non-Lyme disease control groups in future studies
in which nonspecific subjective symptoms are assessed after antibiotic therapy.
Keywords
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Article info
Footnotes
Funding: Slovenian Research Agency.
Conflict of Interest: None of the authors have any conflicts of interest associated with the work presented in this manuscript.
Authorship: All authors had access to the data and played a role in writing this manuscript.
Identification
Copyright
© 2010 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
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