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Columbia Lyme Encephalopathy Study

Treatment results from the Columbia Lyme Encephalopathy Study published in 2008. For a copy of the on-line abstract, please go to the following link. http://www.neurology.org/cgi/content/abstract/70/13/992

Treatment Study of persistent Lyme Encephalopathy published.

The study, titled “A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic Therapy for Lyme Encephalopathy,” was published in the journal Neurology in March 2008. 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. 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).

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 healthy volunteers) 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

Findings from this study, the first placebo-controlled study of chronic cognitive impairment after treated Lyme disease (also known as persistent Lyme encephalopathy), demonstrate that patients at the start of the study reported moderate cognitive impairment, physical dysfunction comparable to patients with congestive heart failure, and fatigue comparable to patients with multiple sclerosis. In the study, repeated intravenous (IV) antibiotic therapy was shown to have moderate short-term benefit in treating cognitive dysfunction compared to the two control groups together (healthy volunteers and Lyme patients given IV placebo), but this improvement was not sustained after the antibiotic was discontinued (p=.04).  The specific drug vs placebo comparison at the primary end point of week 12 fell at the margin of significance (p=.053), raising the risk slightly that this result may have occurred by chance.  Specific improvement in memory – the primary domain of interest in the cognitive battery – was not noted at either the primary end-point of week 12 or at the end point to assess longer-term sustained response (week 24). 

On secondary clinical outcome measures, the study investigators also found that, among those with greater impairment at the start of the study, longer term benefit from the IV antibiotic treatment occurred in improving pain and physical dysfunction and that this improvement was sustained when taken off antibiotics to the six month evaluation.   

The investigators reported that about 19% of patients did experience potentially serious side effects associated with IV antibiotic therapy, such as thrombi,  systemic infections, allergic reactions, and/or gall bladder disease.

Given the significant risk and the lack of sustained benefit, Dr. Fallon and his co-authors recommended against the use of a course of 10 weeks of IV ceftriaxone followed by 14 weeks of no antibiotics as a treatment strategy for a sustained improvement in cognition.  The acute and sustained antibiotic- associated improvement in pain and physical functioning among subgroups of patients with greater severity of symptoms was notable as these are among the most disabling symptoms experienced by patients; however, because these were secondary and not primary outcome measures, conclusions regarding the benefit of repeated IV therapy for this set of symptoms must await further investigation.    This NIH-funded study was published in Neurology on-line in October 2007 and in the journal itself in March 2008.

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