Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Treating Lyme Disease With Longer-Term Therapy

N Engl J Med; 2016 Mar 31; Berende, et al

Longer-term antibiotic treatment did not have additional beneficial effects on health-related quality of life beyond those with shorter-term treatment in patients with persistent symptoms attributed to Lyme disease. This according to a randomized trial of longer-term therapy for symptoms of Lyme disease that included 280 patients included in the modified intention-to-treat analysis (n=86 patients in the doxycycline group; n=96 in the clarithromycin-hydroxychloroquine group; and n=96 in the placebo group). After 12 weeks, researchers found:

• The SF-36 physical-component summary score did not differ significantly among the 3 study groups at the end of the treatment period.

• The score also did not differ significantly among the group at subsequent study visits.

• In all study groups, the SF-36 physical-component summary score increase significantly from baseline to the end of the treatment period.

• The rates of adverse events were similar among the groups.

Citation: Berende A, ter Hofstede HJM, Vos FJ, et al. Randomized trial of longer-term therapy for symptoms attributed to Lyme disease. N Engl J Med. 2016;374:1209-1220. doi:10.1056/NEJMoa1505425.

Commentary: Patients with persistent symptoms after the diagnosis of Lyme disease often present with a range of symptoms including pain, fatigue, neurologic, and/or cognitive dysfunction. This syndrome is treated by some clinicians with long courses of both oral and intravenous antibiotics, despite no evidence of efficacy and little support in the current literature. This study compared ceftriaxone 2 mgs daily x 14 days with two different 12-week regimens: 1) doxycycline 100 mg twice daily, or 2) clarithromycin 500 mg-hydroxychloroquine 200 mg twice daily. The study unequivocally supports that long-term treatment with antibiotics for persistent symptoms after a diagnosis of Lyme disease exposes patients to risk without evidence of benefit. This study supports the current recommendations by the Infectious Disease Society of America, which state in its Lyme guidelines, “Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (>6 months) subjective symptoms after recommended treatment regimens for Lyme disease.”1Neil Skolnik, MD

1. Wormser G, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006;43:1089–134. doi:10.1086/508667.