Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme

Claire Rummage, Mercer University College of Pharmacy

 

Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans through the bite of infected blacklegged ticks according to the Centers for Disease Control and Prevention (CDC). Symptoms of Lyme disease are stated to include fever, headache, fatigue, and rash. It is recommended that Lyme disease be treated with antibiotics. [1]

 

It is stated that after appropriate treatment for Lyme borreliosis, a small percentage of patients continue to have subjective symptoms, such as musculoskeletal discomfort, neurocognitive problems, or fatigue. This syndrome has been called “chronic Lyme borreliosis” or “post Lyme borreliosis syndrome”. [2]

Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease [3]
Design Randomized, double-blind, placebo-control; N= 280
Objective To assess whether longer-term antibiotic treatment of persistent symptoms attributed to Lyme disease leads to better outcomes than shorter-term treatment
Study Groups Doxycycline 100 mg twice daily (n= 86) versus clarithromycin-hydroxycholoroquine 500/200 mg twice daily (n= 96) versus placebo (n= 98)
Methods Patients with persistent symptoms attributed to Lyme disease were assigned to a 12 week oral course of doxycycline, clarithromycin plus hydroxychloroquine or placebo.   All groups received open-label intravenous ceftriaxone for two weeks before initiating the randomized regimen.
Duration N/A
Primary Outcome Measure Health-related quality of life assessed by the physical-component summary score of the RAND short form (SF)-36 Health Status Inventory (range, 15 to 61, with higher scores indicating better quality of life)
Baseline Characteristics Doxycycline (n= 86) Clarithromycin-hydroxychloroquine (n= 96) Placebo (n= 98)
Female, n 47% 44% 48%
Average age, yr 48.1 48.2 50.0
White race 98% 100% 100%
Previous antibiotic treatment 87% 90% 91%
RAND SF-36 score
Physical component summary 30.3 32.7 31.8
Results Doxycycline (n= 86) Clarithromycin-hydroxychloroquine (n= 96) Placebo (n= 98) p value Doxycycline vs placebo,

difference in score

Clarithromycin-hydroxychloroquine vs placebo, difference in score
RAND SF-36 physical component summary 35.0 35.6 34.8 0.69 0.2 0.9
Adverse Events Common Adverse Events: Diarrhea (32.5%), nausea (15.7%), rash (11.1%)
Serious Adverse Events: Allergy to ceftriaxone (3.2%)
Percentage that Discontinued due to Adverse Events: 6.8%
Study Author Conclusions In patients with persistent symptoms attributed to Lyme disease, longer-term antibiotic treatment did not have additional beneficial effects on health-related quality of life beyond those with shorter-term treatment.

Although this study did not show additional benefits with long-term antibiotic treatment, it could be asserted that 14 weeks of treatment is not enough to show a beneficial result. Also, the primary outcome of quality of life is challenging to test due to the subjectivity among the patients. Finally, the patients within this study are unavoidably heterogeneous with respect to the severity of their symptoms; however, this is not demonstrated among the baseline characteristics.

 

References:

[1] Lyme disease. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/lyme/. Updated November 18, 2015. Accessed April 1, 2016.

[2] Hengge UR, Tannapfel A, Tyring SK, Erbel R, Arendt G, Ruzicka T. Lyme borreliosis. Lancet Infect Dis. 2003;3(8):489-500.

 

[3] 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.

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