1. Effect of prolonged antibiotic treatment on cognition in patients with Lyme borreliosis
- Author
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Roy P. C. Kessels, Anneleen Berende, Hadewych J. M. ter Hofstede, Michiel L. Vogelaar, Andrea W M Evers, Fidel J. Vos, Henriët van Middendorp, and Bart Jan Kullberg
- Subjects
Adult ,Male ,medicine.medical_specialty ,Alzheimer`s disease Donders Center for Medical Neuroscience [Radboudumc 1] ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,Neuropsychological Tests ,Placebo ,Article ,law.invention ,03 medical and health sciences ,Cognition ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Clarithromycin ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Doxycycline ,Lyme Disease ,Neuro- en revalidatiepsychologie ,business.industry ,Ceftriaxone ,Neuropsychology and rehabilitation psychology ,Hydroxychloroquine ,Middle Aged ,Anti-Bacterial Agents ,3. Good health ,LYME ,Regimen ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Chronic Disease ,Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5] ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
ObjectiveTo investigate whether longer-term antibiotic treatment improves cognitive performance in patients with persistent symptoms attributed to Lyme borreliosis.MethodsData were collected during the Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) trial, a randomized, placebo-controlled study. Study participants passed performance-validity testing (measure for detecting suboptimal effort) and had persistent symptoms attributed to Lyme borreliosis. All patients received a 2-week open-label regimen of intravenous ceftriaxone before the 12-week blinded oral regimen (doxycycline, clarithromycin/hydroxychloroquine, or placebo). Cognitive performance was assessed at baseline and after 14, 26, and 40 weeks with neuropsychological tests covering the cognitive domains of episodic memory, attention/working memory, verbal fluency, speed of information processing, and executive function.ResultsBaseline characteristics of patients enrolled (n = 239) were comparable in all treatment groups. After 14 weeks, performance on none of the cognitive domains differed significantly between the treatment arms (p = 0.49–0.82). At follow-up, no additional treatment effect (p = 0.35–0.98) or difference between groups (p = 0.37–0.93) was found at any time point. Patients performed significantly better in several cognitive domains at weeks 14, 26, and 40 compared to baseline, but this was not specific to a treatment group.ConclusionsA 2-week treatment with ceftriaxone followed by a 12-week regimen of doxycycline or clarithromycin/hydroxychloroquine did not lead to better cognitive performance compared to a 2-week regimen of ceftriaxone in patients with Lyme disease–attributed persistent symptoms.ClinicalTrials.gov identifierNCT01207739.Classification of evidenceThis study provides Class II evidence that longer-term antibiotics in patients with borreliosis-attributed persistent symptoms does not increase cognitive performance compared to shorter-term antibiotics.
- Published
- 2019
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