Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study|
- Improvement in persistent symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Doxycycline
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Placebo Comparator: Sugar pill
Capsule Placebo, 200 mg, once daily, for 21 days.
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Other Name: Sugar pill
Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is currently no evidence for improvement of symptoms after repeated or prolonged antibiotic treatment. However, clinical observations have indicated that some patients improve during treatment with doxycycline (DOX), but regain the symptoms some time after completed treatment. This may be due to an immunomodulatory effect of the drug. The aim of this randomised, double-blind crossover study was to determine whether DOX has an impact on the persistent symptoms through alterations in the immune response and whether such an effect can influence the clinical outcome.
A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were improvement of the persistent symptoms and physical and mental health, evaluated using the visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through physical examination with special emphasis on neurologic status at the follow-up visits. Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated cytokine responses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205464
|Clinic for Infectious Diseases, University Hospital|
|Linköping, Östergötland, Sweden, 58185|
|Principal Investigator:||Pia Forsberg, MD||Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden|