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

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By Columbia University Medical Center • • October 26, 2007

NEW YORK, Released Oct 10, 2007 – 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 October 10 online edition of Neurology.

The study, led by principal investigator Brian Fallon, MD, MPH, 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.

n 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.

n 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:

n Patients with a history of treated Lyme disease were randomized to IV treatment with an antibiotic called ceftriaxone for 10 weeks;

n Patients with a history of treated Lyme disease were randomized to IV placebo for 10 weeks; and

n 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.”....

Patient Queries: To schedule a research evaluation for possible participation in a research study, please call the Lyme and Tick-borne Disease Research Center at 212-543-6510. [Note: Dr. Fallon’s team is currently recruiting for a study titled “SPECT Imaging of Chronic Lyme Disease vs. Other Disorders”]

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