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Previous Volume 345:85-92 July 12, 2001 Number 2 Next

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ABSTRACT

Background It is controversial whether prolonged antibiotic treatment is effective for patients in whom symptoms persist after the recommended antibiotic treatment for acute Lyme disease.

Methods We conducted two randomized trials: one in 78 patients who were seropositive for IgG antibodies to Borrelia burgdorferi at the time of enrollment and the other in 51 patients who were seronegative. The patients received either intravenous ceftriaxone, 2 g daily for 30 days, followed by oral doxycycline, 200 mg daily for 60 days, or matching intravenous and oral placebos. Each patient had well-documented, previously treated Lyme disease but had persistent musculoskeletal pain, neurocognitive symptoms, or dysesthesia, often associated with fatigue. The primary outcome measures were improvement 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 study.

Results After a planned interim analysis, the data and safety monitoring board recommended that the studies be discontinued because data from the first 107 patients indicated that it was highly unlikely that a significant difference in treatment efficacy between the groups would be observed with the planned full enrollment of 260 patients. Base-line assessments documented severe impairment in the patients' health-related quality of life. In intention-to-treat analyses, there were no significant differences in the outcomes with prolonged antibiotic treatment as compared with placebo among either 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 treatment for acute Lyme disease. However, in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo.

Source Information

From New England Medical Center and Tufts University School of Medicine, Boston (M.S.K., L.T.H., C.H.S., G.M.J., R.P. T., J.M.); Yale–New Haven Hospital, New Haven, Conn. (J.E., D.W.), New York Medical College, Valhalla (D.N., L.L., A.W.); and Quality Metric, Lincoln, R.I. (M.K.).

Because of its potential importance in the treatment of Lyme disease, this article was published at www.nejm.org on June 12, 2001.

Address reprint requests to Dr. Klempner at the Department of Medicine, Boston University School of Medicine, 715 Albany St., Boston, MA 02118, or at klempner{at}bu.edu.

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