October 16, 2007
Fallon's Press Release: Re-Released

CLARIFIED AS OF:? October 16, 2007*

     (The Columbia University Medical Center (CUMC) press release
distributed on 10/10/07 regarding the publication of a study entitled,
A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic
Therapy for Lyme Encephalopathy, in the Oct. 10 online edition of
Neurology, has been clarified to reflect the conclusions noted in the
Neurology paper. To view the new version, visit CUMCs newsroom website
at
http://www.***.com/ )

Columbia University Medical Center Researchers Lead Placebo-Controlled
?Study of Cognitive Impairment Among Patients?With Previously Treated
Lyme Disease

NEW YORK Researchers at Columbia University Medical Center have added
to the body of literature on Lyme disease with the publication of a
study entitled, A Randomized, Placebo-Controlled Trial of Repeated IV
Antibiotic Therapy for Lyme Encephalopathy, in the Oct. 10 online
edition of Neurology.

The study, led by principal investigator Brian Fallon, M.D., M.P.H.,
director of the recently established Lyme and Tick-borne Disease
Research Center at Columbia University Medical Center, involved
screening 3,368 patients for potential inclusion.

Strict selection criteria included memory impairment and a positive IgG
Western blot for Lyme disease at study entry, as well as previous
antibiotic treatment for Lyme disease completed at least 4 months before
study entry. The research was funded by the National Institute of
Neurological Disorders and Stroke (NINDS).

Dr. Fallon and his research team identified patients with cognitive
problems that developed after diagnosis with Lyme disease and that
persisted or relapsed despite prior treatment. The goal was to determine
whether patients who have already received the standard course of
antibiotic treatment (three weeks of IV antibiotic therapy), would
benefit from an additional 10 weeks of antibiotic therapy. They also set
out to determine whether patients would relapse when taken off
antibiotics or whether the alleviation of symptoms is sustained or
enhanced with time.

After elimination of potential study subjects who did not meet inclusion
criteria, only 57 study participants remained ?(37 patients with a
history of Lyme disease and 20 healthy controls). They were divided into
three subject groups: patients with a history of treated Lyme disease
were randomized to IV treatment with an antibiotic called ceftriaxone
for 10 weeks; patients with a history of treated Lyme disease were
randomized to IV placebo for 10 weeks; and, healthy controls were tested
at the same time points as the patients to help to control for the
practice effect on neuropsychological testing.

We set out in this study to learn if a repeated course of antibiotics
relieves certain symptoms associated with post-treatment chronic Lyme
encephalopathy and to assess whether such symptom relief is sustained
after patients are taken off antibiotics, said Dr. Fallon. The sample
group of 23 patients who received 10 weeks of IV ceftriaxone therapy
initially showed moderate improvements in cognition when evaluated at
the primary outcome assessment point of 12 weeks; however, the
improvement in cognition was not sustained in the 6 month (24 week)
assessment.

According to the paper, patients with greater severity of pain, fatigue
or physical dysfunction at the start of the study who were randomized to
ceftriaxone treatment reported improvement in these symptoms at week 12,
as compared to those patients who were given IV placebo. For a subset of
patients who received IV ceftriaxone who started the study with higher
levels of pain or physical functioning impairments, the improvement in
pain and physical functioning was sustained to week 24. Whether reported
improvement was due to a direct antimicrobial effect of the antibiotic
or effects on neurotransmitters is unclear. Of concern in this study is
that IV ceftriaxone treatment was associated with serious side effects
in about one-quarter of the patients.

The paper concludes, ...considering both the limited duration of
cognitive improvement and the risks, 10 weeks of ?IV ceftriaxone and
then 14 weeks of no antibiotic is not an effective strategy for
sustained cognitive improvement.

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