Fatigue Clinical Trial
Official title:
Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
The aim of this randomised, double-blind crossover study was to determine whether Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the immune response and whether such an effect could influence the clinical outcome.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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