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Prolonged Therapy for Persistent Lyme Disease Symptoms
Extending therapy for an additional 12 weeks did not improve quality of life.
Whether prolonged treatment reduces persistent Lyme disease symptoms is controversial. To resolve this issue, investigators in the Netherlands conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 280 Lyme disease patients with persistent musculoskeletal pain, arthritis, arthralgia, neuralgia, sensory disturbances, dysesthesia, neuropsychological disorders, or cognitive disorders, with or without persistent fatigue. The median duration of symptoms was longer than 2 years.
Patients received initial intravenous ceftriaxone for 2 weeks followed by one of three oral regimens: doxycycline (86 patients), clarithromycin plus hydroxychloroquine (96 patients), or placebo (98 patients) for 12 weeks. The primary outcome was health-related quality of life at the end of the treatment period, based on the physical-component summary score of the RAND-36 Health Status Inventory. A secondary outcome was fatigue, based on the fatigue-severity score of the Checklist Individual Strength tool.
Health-related quality-of-life and fatigue scores were similar among the groups, as was the rate of treatment discontinuation (5%). Four serious adverse events occurred, none of which were drug-related.
This important study showed that longer-term therapy did not benefit Lyme disease patients with symptoms that had been present for months to years following diagnosis.
Larry M. Baddour, MD reviewing Berende A et al. N Engl J Med 2016 Mar 31. Melia MT and Auwaerter PG. N Engl J Med 2016 Mar 31.
Berende A et al. Randomized trial of longer-term therapy for symptoms attributed to Lyme disease. N Engl J Med 2016 Mar 31; 374:1209.
[Free full-text N Engl J Med article PDF | PubMed® abstract]
Melia MT and Auwaerter PG. Time for a different approach to Lyme disease and long-term symptoms. N Engl J Med 2016 Mar 31; 374:1277.
[Free full-text N Engl J Med article PDF]
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