First study of cognitive impairment due to chronic Lyme disease

In the study, repeated intravenous (IV) antibiotic therapy was shown to be effective in treating cognitive dysfunction and the debilitating pain, fatigue and physical dysfunction associated with this disease.

The study, titled “A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic Therapy for Lyme Encephalopathy,” will be published on-line by the journal Neurology on Oct. 10, 2007. The study was 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 (http://www.cumc.columbia.edu/news/press_releases/fallon_lyme_center.html). The research was conducted jointly at the Columbia University Medical Center and New York State Psychiatric Institute and was funded by the National Institute of Neurological Disorders and Stroke (NINDS).

“These findings replicate results from a prior placebo-controlled trial of post-Lyme fatigue, which found positive treatment results from repeated antibiotic therapy. They also replicate the degree of physical impairment results demonstrated in another prior study of chronic Lyme disease,” said Dr. Fallon (*see citations below). “The door should be left open for physicians to prescribe medications as warranted, after a careful discussion with the patient of the potential risks and benefits.”

Dr. Fallon and his research team identified patients with cognitive problems that developed after being diagnosed with Lyme disease and which persisted or relapsed despite prior treatment, in order 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 relapse when taken off antibiotics or whether the alleviation of symptoms is sustained or enhanced with time.

Study participants (57 subjects: 37 patients with a history of Lyme disease and 20 controls) were divided into three subject groups: patients with a history of treated Lyme disease who were randomized to IV treatment with an antibiotic called ceftriaxone for 10 weeks; patients with a history of treated Lyme disease who were randomized to IV placebo for 10 weeks; and, healthy controls who were tested at the same time points as the patients to help to control for the practice effect on neuropsychological testing. All patients had to meet criteria for memory impairment at the start of the study and they were also required to have a positive IgG Western blot for Lyme disease at study entry. -Columbia University Medical Center