Results From the Persistent Lyme Empiric Antibiotic Study
The researchers observed no significant difference in the RAND-36 Health Status Inventory among the three study groups at the end of the treatment period
HealthDay News - Results from the Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) trial suggest that additional 12-week treatment with either doxycycline or clarithromycin plus hydroxychloroquine after 2 weeks of ceftriaxone treatment did not result in significant changes in certain measures of health-related quality of life, according to a study published in the New England Journal of Medicine.
Anneleen Berende, MD, from the Radboud University Medical Center in the Netherlands, and colleagues randomized patients with persistent symptoms attributed to Lyme disease to receive a 12-week oral course of doxycycline (86 patients), clarithromycin plus hydroxychloroquine (96 patients), or placebo (98 patients). Before initiating the randomized regimen, all study groups received open-label intravenous ceftriaxone for two weeks.
The researchers observed no significant difference in the RAND-36 Health Status Inventory (SF-36) among the three study groups at the end of the treatment period, with mean scores of 35.0, 35.6, and 34.8 in the doxycycline, clarithromycin plus hydroxychloroquine, and placebo groups, respectively.
At subsequent study visits the score also did not differ (P =.35). From baseline to the end of the treatment period there was an increase in the SF-36 physical-component summary score in all study groups (P < .001). Similar rates of adverse events were seen among the study groups.
Summary and Clinical Applicability
In this trial, additional 12-week treatment with either doxycycline or clarithromycin plus hydroxychloroquine after 2 weeks of ceftriaxone treatment did not result in significant changes in measured SF-36.
"In patients with persistent symptoms attributed to Lyme disease, longer-term antibiotic treatment [after initial ceftriaxone treatment] did not have additional beneficial effects on health-related quality of life beyond those with shorter-term treatment," the authors stated.
Limitations and Disclosures
Patients enrolled in this study received open-label ceftriaxone for 2 weeks before the randomized phase.
The study was supported by a grant from the Netherlands Organization for Health Research and Development. A study coauthor disclosed investor status for a Lyme disease diagnostic test licensed with Oxford Immunotec
Berende A, Ter hofstede HJ, Vos FJ, et al. Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease. N Engl J Med. 2016;374(13):1209-20.