Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.
OBJECTIVE
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 fatigue 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.
Krupp
L B
LB
Department of Neurology, Stony Brook University Medical Center, Stony Brook, NY 11794-8121, USA. lkrupp@notes.cc.sunysb.edu
Hyman
L G
LG
Grimson
R
R
Coyle
P K
PK
Melville
P
P
Ahnn
S
S
Dattwyler
R
R
Chandler
B
B
D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000097:blood; D000954:Antigens, Surface / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000097:blood; D001428:Bacterial Vaccines; D025065:Borrelia burgdorferi / Q000276:immunology; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008074:Lipoproteins; D008193:Lyme Disease / Q000150:complications* / Q000188:drug therapy; D020852:Lyme Neuroborreliosis / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D011597:Psychomotor Performance; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000942:Antigens, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; C072045:OspA protein; D002443:Ceftriaxone