Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease.

Background: It is controversial whether prolonged antibiotic treatment is e ffective for patients in whom symptoms persist after the recommended antibi otic treatment for acute Lyme disease. Methods: We conducted two randomized trials: one in 78 patients who were se ropositive for IgG antibodies to Borrelia burgdorferi at the time of enroll ment and the other in 51 patients who were seronegative. The patients recei ved either intravenous ceftriaxone, 2 g daily for 30 days, followed by oral doxycycline, 200 mg daily for 60 days, or matching intravenous and oral pl acebos. Each patient had well-documented, previously treated Lyme disease b ut had persistent musculoskeletal pain, neurocognitive symptoms, or dysesth esia, often associated with fatigue. The primary outcome measures were impr ovement on the physical- and mental-health-component summary scales of the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) - a scale measuring the health-related quality of life - on day 180 of the stu dy. Results: After a planned interim analysis, the data and safety monitoring b oard recommended that the studies be discontinued because data from the fir st 107 patients indicated that it was highly unlikely that a significant di fference in treatment efficacy between the groups would be observed with th e planned full enrollment of 260 patients. Base-line assessments documented severe impairment in the patients' health-related quality of life. In inte ntion-to-treat analyses, there were no significant differences in the outco mes with prolonged antibiotic treatment as compared with placebo among eith er the seropositive or the seronegative patients. Conclusions: There is considerable impairment of health-related quality of life among patients with persistent symptoms despite previous antibiotic tr eatment for acute Lyme disease. However, in these two trials, treatment wit h intravenous and oral antibiotics for 90 days did not improve symptoms mor e than placebo. (N Engl J Med 2001;345:85-92.) Copyright (C) 2001 Massachus etts Medical Society.