The Clinical, Symptom, and Quality-of-Life Characterization of a Well-Defined Group of Patients with Posttreatment Lyme Disease Syndrome

Abstract

Background: The increased incidence and geographic expansion of Lyme disease has made it the most common vector-borne infection in North America. Posttreatment Lyme disease syndrome (PTLDS) represents a subset of patients who remain ill following standard antibiotic therapy for Lyme disease. The spectrum of symptoms and their impact on quality of life remain largely unexplored among patients with well-documented PTLDS.

Objective: To characterize a case series of patients with well-documented PTLDS compared to a sample of healthy controls.

Methods: Sixty-one participants met the proposed case definition for PTLDS. Twenty-six healthy controls had neither a clinical history of Lyme disease nor current antibodies to Borrelia burgdorferi. Participants with PTLDS and controls were evaluated by physical exam, clinical laboratory testing, standardized questionnaires, and a 36-item current symptom list.

Results: Compared to controls, participants with PTLDS reported significantly greater fatigue, pain, sleep disturbance, and depression (Fatigue Severity Scale: 50.0 ± 10.6 vs. 19.8 ± 8.6; Short-Form McGill Pain Questionnaire: 13.7 ± 8.3 vs. 0.8 ± 1.9; Pittsburgh Sleep Quality Index: 10.1 ± 4.7 vs. 4.1 ± 2.1; Beck Depression Inventory-II: 15.1 ± 7.7 vs. 2.2 ± 3.2; p < 0.001 for each), and significantly lower quality of life (SF-36 Physical Component Score: 33.9 ± 9.7 vs. 55.1 ± 6.2; Mental Component Score: 42.9 ± 10.1 vs. 54.2 ± 5.4; p < 0.001 for each). Nineteen non-PTLDS-defining symptoms were found to be significantly more severe among participants with PTLDS than controls, including sleep difficultly and visual complaints. Initial delayed or misdiagnosis was characterized in 59.0% of participants with PTLDS, and 32.2% had abnormal vibratory sense.

Conclusion: Although physical exam and clinical laboratory tests showed few objective abnormalities, standardized symptom questionnaires revealed that patients with PTLDS are highly and clinically significantly symptomatic, with poor health-related quality of life. PTLDS patients exhibited levels of fatigue, musculoskeletal pain, sleep disturbance, and depression which were both clinically relevant and statistically significantly higher than controls. Our study shows that PTLDS can be successfully identified using a systematic approach to diagnosis and symptom measurement. As the prevalence of PTLDS continues to rise, there will be an increased need for physician education to more effectively identify and manage PTLDS as part of integrated patient care.

Keywords: Lyme disease; case series; posttreatment Lyme disease syndrome; quality of life; signs and symptoms.

Figure 1

Participants with posttreatment Lyme disease syndrome (PTLDS) were compared to controls on the following: (A) Fatigue Severity Scale, (B) the Short-Form McGill Pain Index, (C) Pittsburgh Sleep Quality Index, (D) the Beck Depression Inventory-II, and the SF-36 (E) Physical and (F) Mental norm-based scores. The mean and 1 SD are shown by the solid lines. Clinically relevant cutoffs for each measure are shown by the dotted line.

Figure 2

Participants with posttreatment Lyme disease syndrome (PTLDS) and controls were asked about presence and severity of 36 signs/symptoms over the past 2 weeks. Displayed are the 25 signs/symptoms with a statistically significant difference in severity by group (p < 0.05), ordered by frequency within the PTLDS group. The nine signs/symptoms with a statistically significant difference at the p < 0.001 level are indicated with an asterisk.