Study and treatment of post Lyme disease,

 Neurology. 2003 Jun 24;60,12:1923-30. Comment in: Neurology. 2003 Jun 
24;60,12:1888-9.Study and treatment of post Lyme di sease, STOP-LD: a randomized double 
masked clinical trial. Krupp LB, Hyman LG, Grimson R, Coyle PK, Melville P, Ahnn S, 
Dattwyler R, Chandler B.
Department of Neurology, Stony Brook University Medical Center, Stony Brook, NY 11794-8121, 
63OBJECTIVE: To determine whether post Lyme syndrome, PLS, is antibiotic responsive.
METHODS: The authors conducted a single-center randomized double-masked 
placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 
or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV 
ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a 
change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive 
function, mental speed, defined by a change of 25% or more on a test of reaction time. The 
primary laboratory outcome was an experimental measure of CSF infection, outer surface protein 
A, OspA. Outcome data were collected at the 6-month visit. RESULTS: Patients assigned to 
ceftriaxone showed improvement in disabling fatigue compared to the placebo group, rate 
ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001. No beneficial treatment effect was observed for 
cognitive function or the laboratory measure of persistent infection. Four patients, three of whom 
were on placebo, had adverse events associated with treatment, which required hospitalization. 
CONCLUSIONS: Ceftriaxone therapy in patients with PLS with severe fat igue was associated 
with an improvement in fatigue but not with cognitive function or an experimental 
laboratory measure of infection in this study. Because fatigue, a nonspecific symptom, was the 
only outcome that improved and because treatment was associated with adverse events, this 
study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in 
post-treatment, persistently fatigued patients with PLS

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