Need for Research

The medical community has not widely recognized the diagnosis of post-treatment Lyme syndrome. Patients suffering from such symptoms as fatigue, cognitive impairment, and joint pain may not receive an accurate diagnosis. Patients may be incorrectly diagnosed with depression or labeled with a syndrome without a specific diagnosis. The accuracy of the currently proposed diagnostic criteria for post-Lyme disease syndrome3 has not been fully and scientifically evaluated. Thus the true burden of human illness from post-treatment Lyme syndrome remains unknown.

Intense controversy surrounds the cause of post-treatment Lyme syndrome. The bacteria causing Lyme disease, Borrelia burgdorferi, is difficult to identify by standard clinical methods and is being studied by only a few researchers in the United States[5]. Because of these difficulties the facts known about the infection are rudimentary. The ability of the bacteria to cause persistent infection is still poorly understood, and the factors that increase the severity of infection have not been identified. Different strains of the bacteria Borrelia burgdorferi exist in Maryland, but it is unknown what role this may play in the variable severity of the disease that is observed[6].

Understanding the human immune response to infection with Borrelia burgdorferi is central to solving the mystery of post-Lyme disease syndrome.

The immune response in the majority of infected patients is inadequate to control infection. After antibiotic treatment, the immune system’s response might be involved in perpetuating symptoms, through an abnormal inflammatory response. Only by understanding the role of the immune response can novel approaches to therapy be proposed and tested.

Today, there is no standardized and successful approach to managing patients with post-treatment Lyme syndrome. There is confusion about how to treat patients who continue with symptoms after completing the standard antibiotic therapy. Lyme disease can significantly decrease the quality of life for previously healthy, highly energetic, and productive members of society. Patients can search endlessly for accurate diagnosis and successful treatment that result in a confusing, exhausting and lengthy process. Once treatment has begun for chronic symptoms, it can last from months to years. Discovery of effective therapy for post-treatment Lyme syndrome will decrease human suffering and restore lost productivity to these previously vibrant members of our society.

Objectives

The Lyme Disease Research Foundation is the first community-based, university-affiliated Lyme disease evaluation center devoted to the study of post-treatment Lyme syndrome. It will work to accomplish the following:

• Analyze the clinical variables and severity of illness in patients referred for evaluation of persistent symptoms of Lyme disease:

  • Establish the prevalence of post-treatment Lyme syndrome in Dr. John Aucott’s Maryland infectious disease referral practice.

  • Evaluate the accuracy of different diagnostic strategies for detecting post-treatment Lyme syndrome.

  • Identify clinical risk factors in patients who have developed post-treatment Lyme syndrome.

• Identify biologic variables that are associated with the development of post-treatment Lyme syndrome in patients with acute Lyme disease:

  • Examine elements of the human immune system associated with development of persistent symptoms after the standard course of antibiotic therapy.

  • Examine properties of the infectious bacteria Borrelia burgdorferi that correlate to the severity of infection and types of symptoms presented in patients.

• Test strategies for the treatment of post-treatment Lyme syndrome by carrying out randomized clinical trials for the scientific evaluation of potential treatment protocols for post-treatment Lyme syndrome.

• Work toward establishing a consensus within the medical community on strategies for the diagnosis and treatment of post-treatment Lyme syndrome patients

Strategies

• Create clinical database

  • Researchers will concentrate on a growing database of more than 500 adult patients from Maryland who are and were treated for Lyme disease by Dr. John Aucott, an infectious disease specialist. Additional adult patients in Maryland who present acute and chronic symptoms of this disease will also be recruited. Since the data are gathered from a high-risk area of the country, research findings from this database will have significant impact on the treatment of Lyme disease nationwide.

  • Patients will be followed over time to study long-term outcomes related to the treatment and evaluation of symptoms in terms of fatigue, cognitive impairment, joint pain, and neuropathy.

  • A clinical research nurse will design and in conjunction with a database manager will maintain the database as follows: (1) construct a patient database and recording forms for recording and entering data and (2) review patient charts and supervise patient data into the Statistical Package for the Social Sciences database. Researchers will analyze data to identify patient characteristics related to development of chronic symptoms, misdiagnosis of the disease, and poor clinical outcomes.

• Collaborate with basic scientists in immunology and microbiology

  • Basic scientists, in collaboration with the Foundation staff, will collect and analyze clinical specimens on new patients. To do so, Borrelia burgdorferi bacteria will be cultured from patient blood samples and analyzed for factors related to virulence. Blood samples will be collected and stored for analysis of the human immune system’s reaction to infection and markers of inflammatory response. Microbiologic and immunologic measures will be correlated with patient outcomes, especially the development of the post-treatment Lyme syndrome.

• Test promising therapies for patients

  • Dr. John Aucott’s Maryland referral infectious disease practice will investigate treatment alternatives for patients with post-Lyme disease syndrome. Patients with post-treatment Lyme syndrome will be identified by applying a standard definition of the syndrome. Treatment strategies will be tested using scientific standards of double-blinded controlled trials.

• Expand knowledge of physicians and patients

• The Foundation’s research studies and findings will be shared through publications and lectures, to expand the knowledge of Lyme disease and all of its manifestations.

[1] Post-treatment Lyme syndrome, Post-Lyme disease syndrome, and chronic Lyme disease are names used by different medical organizations at different times that generally refer to the same group of patients. It should not be implied that the use of Post-treatment Lyme syndrome by the Foundation implies an endorsement by this Foundation of any one exclusive view regarding causation, diagnosis or treatment.

[2] Patients diagnosed at the beginning stages through the presentation of a bulls-eye or circular rash or by identification of compatible symptoms confirmed by diagnostic testing.

[3] The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America CID 2006:43 (1 November)

[4] Failure of treatment with cephalexin for Lyme disease. Arch Fam Med 2000; 9:563–7.

[5] Two-Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definite Diagnosis of Lyme Disease. Coulter P, Lema C, Flayhart D, Linhardt AS, Aucott JN, Auwaerter PG, Dumler JS. J Clin Micro, Oct 2005, p 5080-84

[6] Borrelia burgdorferi ospC Heterogeneity among Human and Murine Isolates from a Defined Region of Northern Maryland and Southern Pennsylvania: Lack of Correlation with Invasive and Noninvasive Genotypes. Alghaferi MY, Anderson JM, Park J, Auwaerter PG, Aucott JN, Norris DE, Dumler JS. JCM April 2005, 1879-84 Vol 43