Version May 2024
| Inclusion criteria |
| • An adult or child with a documented episode of early or late Lyme disease fulfilling the case definition of the Centers for Disease Control and Prevention. If based on erythema migrans, the diagnosis must be made and documented by an experienced health care practitioner. |
| • After treatment of the episode of Lyme disease with a generally accepted treatment regimen, there is resolution or stabilization of the objective manifestation(s) of Lyme disease. |
| • Onset of any of the following subjective symptoms within 6 months of the diagnosis of Lyme disease and persistence of continuous or relapsing symptoms for at least a 6 month period after completion of antibiotic therapy: |
| - Fatigue |
| - Widespread musculoskeletal pain |
| - Complaints of cognitive difficulties |
| • Subjective symptoms are of such severity that, when present, they result in substantial reduction in previous levels of occupational, educational, social, or personal activities. |
| Exclusion criteria |
| • An active, untreated, well-documented coinfection, such as babesiosis. |
| • The presence of objective abnormalities on physical examination or on neuropsychologic testing that may explain the patient's complaints. For example, a patient with antibiotic refractory Lyme arthritis would be excluded. A patient with late neuroborreliosis associated with encephalopathy, who has recurrent or refractory objective cognitive dysfunction, would be excluded. |
| • A diagnosis of fibromyalgia or chronic fatigue syndrome before the onset of Lyme disease. |
| • A prolonged history of undiagnosed or unexplained somatic complaints, such as musculoskeletal pains or fatigue, before the onset of Lyme disease. |
| • A diagnosis of an underlying disease or condition that might explain the patient's symptoms (eg, morbid obesity, with a body mass index [calculated as weight in kilograms divided by the square of height in meters] ≥45; sleep apnea and narcolepsy; side effects of medications; autoimmune diseases; uncontrolled cardiopulmonary or endocrine disorders; malignant conditions within 2 years, except for uncomplicated skin cancer; known current liver disease; any past or current diagnosis of a major depressive disorder with psychotic or melancholic features; bipolar affective disorders; schizophrenia of any subtype; delusional disorders of any subtype; dementias of any subtype; anorexia nervosa or bulimia nervosa; and active drug abuse or alcoholism at present or within 2 years). |
| • Laboratory or imaging abnormalities that might suggest an undiagnosed process distinct from post-Lyme disease syndrome, such as a highly elevated erythrocyte sedimentation rate (>50 mm/hour); abnormal thyroid function; a hematologic abnormality; abnormal levels of serum albumin, total protein, globulin, calcium, phosphorus, glucose, urea nitrogen, electrolytes, or creatinine; significant abnormalities on urine analysis; elevated liver enzyme levels; or a test result suggestive of the presence of a collagen vascular disease. |
| • Although testing by either culture or PCR for evidence of Borrelia burgdorferi infection is not required, should such testing be done by reliable methods, a positive result would be an exclusion. |
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