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Open Access Highly Accessed Research article

Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study

Johanna Sjöwall1*, Anna Ledel2, Jan Ernerudh3, Christina Ekerfelt3 and Pia Forsberg14

Author Affiliations

1 Clinic of Infectious Diseases, University Hospital, SE-58185, Linköping, Sweden

2 Center for Research in General Practice, Department of Health and Society, Faculty of Health Sciences, Linköping University, SE-58185, Linköping, Sweden

3 Division of Clinical Immunology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, SE-58185, Linköping, Sweden

4 Division of Infectious Diseases, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, SE-58185, Linköping, Sweden

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BMC Infectious Diseases 2012, 12:186  doi:10.1186/1471-2334-12-186

Published: 10 August 2012

Abstract

Background

Persistent symptoms after treatment of neuroborreliosis (NB) are well-documented, although the causative mechanisms are mainly unknown. The effect of repeated antibiotic treatment has not been studied in detail. The aim of this study was to determine whether: (1) persistent symptoms improve with doxycycline treatment; (2) doxycycline has an influence on systemic cytokine responses, and; (3) improvement of symptoms could be due to doxycycline-mediated immunomodulation.

Methods/Design

15 NB patients with persistent symptoms ≥6 months post-treatment were double-blindly randomized to receive 200 mg of doxycycline or a placebo for three weeks. After a six-week wash-out period, a cross-over with a three-week course of a placebo or doxycycline was conducted. The primary outcome measures were improvement of persistent symptoms assessed by neurological examinations, a symptom severity score and estimation of the quality of life. The secondary outcome measure was changes in systemic cytokine responses.

Results

All 15 patients finished the study. No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events.

Discussion

No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. To conclude, in this pilot study, doxycycline-treatment did not lead to any improvement of either the persistent symptoms or quality of life in post-NB patients. Accordingly, doxycycline does not seem to be the optimal treatment of diverse persistent symptoms post-NB. However, the results need to be confirmed in larger studies.

Trial registration

NCT01205464 (clinicaltrials.gov)

Keywords:
Neuroborreliosis; Post-treatment; Symptoms; Doxycycline; Immunomodulation; Randomized; Cytokines; Cross-over