Lyme Disease Practice and Research

Lyme Disease Database leads to Publication

LymeProject’s database led to a publication titled “Consequences of treatment delay in Lyme disease, in the Journal of Evaluation in Clinical Practice 13 (2007) 470–472. The study focused on 100 consecutively treated adolescents and adults subjects in a community-based setting from July 1997 to January 2000. The paper reported that treatment delay is strongly associated with treatment failure for patients with Lyme disease. The average 1.8 years treatment delay recorded here is consistent with previous reports of treatment delays spanning 6 weeks to 3 years. Two-thirds of the delays occurred even though patients conformed to the well-defined CDC case definition. An additional third presented with well-described clinical presentations of Lyme disease, including fatigue, memory and concentration problems, irritability and headaches.

The poor outcome after treatment delay supported the hypothesis that treatment delay is a major risk factor for developing chronic Lyme disease. The failure rate for patients with treatment delay was significantly higher than the failure rate for patients who timely treatment (58% vs 24%, p<.002). The paper recommended that clinicians ensure that patients receive prompt treatment as delays cause unnecessary suffering and expense. The paper highlights the pressing need for doctor education programs to help clinicians recognize and treat Lyme disease at onset.

The LDPR closed the data base in 2000 in preparation for a double-blind randomized clinical trial. The clinical trial expanded the pioneering design described in the Lyme disease data base.

First Lyme Disease Trial Completed

The Lyme Disease Practice and Research (LDPR) initiated, coordinated, and published a double-blind clinical trial of amoxicillin versus placebo and published the trial in Minerva Med titled Severity of Lyme Disease with Persistent Symptoms – Insights from a Double-blind Placebo-controlled Clinical Trial. The Quality of Life (QOL) of chronic Lyme disease (CLD) in the clinical trial was far worse than a healthy population. The trial confirmed the poor QOL of CLD reported in previous NIH sponsored trials. The QOL in the trial was worse than many common illnesses including diabetes, recent myocardial infections, and depression. A significant gain in the QOL for subjects randomized to amoxicillin in this RCT without serious adverse events is consistent with the goal of improving patient’s QOL and consequently worthy of further study.

Pioneering Design

The LDPR initiated and is continuing to enroll patients in a clinical trial treating Lyme disease patients with recurrent Lyme disease with antibiotics to better understand the role of persistent infection and guide the development of innovative antibiotic treatment strategies.

Pioneering design include: enrollment of patients using clinical judgment without serologic evidence, "proof-of-concept" using oral antibiotics, and launch from a primary care office. LDPR reported the feasibility of clinical trials for chronic Lyme disease.

"Proof-of-concept"

LDPR has introduced "Proof of concept" clinical trials that are critical in understanding the treatment of chronic Lyme disease. LDPR is the largest primary care center to offer clinical studies (Phase IIa) in Lyme disease. These "Proof of concept" studies will help establish appropriate dosage, duration of treatment, and safety profile.