1. In this randomized, double-blind placebo controlled trial, patients with persistent symptoms attributed to Lyme disease did not receive additional benefit of health-related quality of life with a longer duration of antibiotics.
2. Adverse event rates were similar across all treatment groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with Lyme disease often report persistent symptoms like pain, fatigue, and neurological or cognitive issues despite receiving antibiotic therapy. There is no prior randomized data to suggest that longer duration of antibiotic therapy improves persistent symptoms, however the issue remains contentious. This randomized-controlled trial aimed to compare shorter-term with longer-term antibiotic treatment regimens and placebo on persistent symptoms attributed to Lyme disease.
The three intervention groups did not significantly differ on the physical component of the RAND SF-36 scores at the end of the treatment period or at subsequent study visits. There was a significant increase in RAND SF-36 scores in all groups from baseline to end of treatment period. Rates of adverse events were also similar across all study groups. Limitations of this study include the open-label prescription of IV ceftriaxone and thus one cannot study whether this 2-week regimen is better than withholding any therapy (as was done in prior studies).
Click to read the study, published today in NEJM
Relevant Reading: Study and treatment of post-Lyme disease (STOP-LD)
In-Depth [randomized controlled trial]: This randomized, double-blind, placebo-controlled trial was conducted from October 2010 to June 2013 at two sites in the Netherlands. The study population included patients with persistent symptoms attributed to Lyme disease (including MSK pain, arthralgia, cognitive disorders or fatigue) if these symptoms temporally related to a proven case of symptomatic Lyme disease or accompanied by B. burgdorferi IgG or IgM antibodies. These patients were randomly assigned 1:1:1 to 12-week courses of doxycycline, clarithromycin-hydroxychloroquine or placebo. All patients received IV ceftriaxone for 14 days prior to randomization. The primary endpoint of interest was health-related quality of life as assessed by the physical-component summary score of the RAND-36 Health Status Inventory (RAND SF-36) measured at the end of the IV ceftriaxone, at the end of the 12-week course of placebo or antibiotic, and 14 weeks post-randomization. Data was analyzed using a modified intention-to-treat analysis.
A total of 280 patients underwent randomization and were included in the modified intention to treat analysis (86 patients in the doxycycline group, 96 in the clarithromycin-hydroxychloroquine group and 98 in the placebo group). The SF-36 physical component scores did not differ significantly across all treatment groups (p=0.69). Mean scores were 35.0 (95% [CI], 33.5-36.5) in the doxycycline group, 35.6 (95% [CI], 34.2-37.1) in the clarithromycin-hydroxychloroquine group and 34.8 (95% [CI], 33.4-36.2) in the placebo group. In each study group, however, the RAND SF-36 score increased significantly from baseline to end of treatment study period (p<0.001).
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