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

Berende, Anneleen; Hofstede, H.J.M. ter; Vos, Fidel J.; Middendorp, Henriët van; Vogelaar, Michiel L.; Tromp, Mirjam; Hoogen, F.H. van den; Donders, A. Rogier T.; Evers, Andrea W M; Kullberg, Bart Jan

doi:10.1056/nejmoa1505425

Cited by 214 publications

(171 citation statements)

References 22 publications

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“…In the United States and Europe, placebo-controlled, randomized retreatment trials using either parenteral antibiotic therapy alone or followed by a course of oral antibiotics in patients with PTLDS did not show any clinical benefit, or showed a benefit that was so modest it was outweighed by the risk of adverse effects from the treatment (for example, intravenous-line sepsis) 160,161 . Evidence for the persistence of infection was not found in any of these studies and a recent editorial suggests that a different approach than prolonged treatment with antibiotics for PTLDS is required 162 .…”

Section: Managementmentioning

confidence: 99%

Lyme borreliosis

Steere

Strle

Wormser

et al. 2016

Nat Rev Dis Primers

607

697

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Lyme borreliosis is a tick-borne disease that predominantly occurs in temperate regions of the northern hemisphere and is primarily caused by the bacterium Borrelia burgdorferi in North America and Borrelia afzelii or Borrelia garinii in Europe and Asia. Infection usually begins with an expanding skin lesion, known as erythema migrans (referred to as stage 1), which, if untreated, can be followed by early disseminated infection, particularly neurological abnormalities (stage 2), and by late infection, especially arthritis in North America or acrodermatitis chronica atrophicans in Europe (stage 3). However, the disease can present with any of these manifestations. During infection, the bacteria migrate through the host tissues, adhere to certain cells and can evade immune clearance. Yet, these organisms are eventually killed by both innate and adaptive immune responses and most inflammatory manifestations of the infection resolve. Except for patients with erythema migrans, Lyme borreliosis is diagnosed based on a characteristic clinical constellation of signs and symptoms with serological confirmation of infection. All manifestations of the infection can usually be treated with appropriate antibiotic regimens, but the disease can be followed by post-infectious sequelae in some patients. Prevention of Lyme borreliosis primarily involves the avoidance of tick bites by personal protective measures.

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Section: Managementmentioning

confidence: 99%

Lyme borreliosis

Steere

Strle

Wormser

et al. 2016

Nat Rev Dis Primers

607

697

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“…These results will hopefully prevent discussions on the value of long-term antibiotic treatment for QFS and prevent patients from unnecessary prolonged antimicrobial therapy. This has already been seen in the treatment of prolonged symptoms attributed to Lyme disease, which eventually also proved ineffective [27]. In addition, most AEs occurred in the doxycycline group, including the highest median number of AEs per patient.…”

Section: Discussionmentioning

confidence: 78%

Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial

Keijmel

Delsing

Bleijenberg

et al. 2017

Clinical Infectious Diseases

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Background. Approximately 20% of patients with acute Q fever will develop chronic fatigue, referred to as Q fever fatigue syndrome (QFS). The objective of this randomized controlled clinical trial was to assess the efficacy of either long-term treatment with doxycycline or cognitive-behavioral therapy (CBT) in reducing fatigue severity in patients with QFS.Methods. Adult patients were included who met the QFS criteria according to the Dutch guideline: a new onset of severe fatigue lasting ≥6 months with significant disabilities, related to an acute Q fever infection, without other somatic or psychiatric comorbidity explaining the fatigue. Using block randomization, patients were randomized between oral study medication and CBT (2:1) for 24 weeks. Second, a double-blind randomization between doxycycline (200 mg/day, once daily) and placebo was performed in the medication group. Primary outcome was fatigue severity at end of treatment (EOT; week 26), assessed with the Checklist Individual Strength subscale Fatigue Severity.Results. Of 155 patients randomized, 154 were included in the intention-to-treat analysis (doxycycline, 52; placebo, 52; CBT, 50). At EOT, fatigue severity was similar between doxycycline (40.8 [95% confidence interval {CI}, 37.3-44.3]) and placebo (37.8 [95% CI,.2]; difference, doxycycline vs placebo, −3.0 [97.5% CI, −8.7 to 2.6]; P = .45). Fatigue severity was significantly lower after CBT (31.6 [95% CI,.1]) than after placebo (difference, CBT vs placebo, 6.2 [97.5% CI, .5-11.9]; P = .03).Conclusions. CBT is effective in reducing fatigue severity in QFS patients. Long-term treatment with doxycycline does not reduce fatigue severity in QFS patients compared to placebo.Clinical Trials Registration. NCT01318356.

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“…As a result, routine surveillance of the syndrome would not provide accurate and reliable data on which response actions can be designed, which is the reason why this is not included as a scenario. Specific studies should first provide more insight into the mechanisms that cause these persisting symptoms [36,37]. …”

Section: Discussionmentioning

confidence: 99%

Surveillance perspective on Lyme borreliosis across the European Union and European Economic Area

et al. 2017

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Lyme borreliosis (LB) is the most prevalent tick-borne disease in Europe. Erythema migrans (EM), an early, localised skin rash, is its most common presentation. Dissemination of the bacteria can lead to more severe manifestations including skin, neurological, cardiac, musculoskeletal and ocular manifestations. Comparison of LB incidence rates in the European Union (EU)/European Economic Area (EEA) and Balkan countries are difficult in the absence of standardised surveillance and reporting procedures. We explored six surveillance scenarios for LB surveillance in the EU/EEA, based on the following key indicators: (i) erythema migrans, (ii) neuroborreliosis, (iii) all human LB manifestations, (iv) seroprevalence, (v) tick bites, and (vi) infected ticks and reservoir hosts. In our opinion, neuroborreliosis seems most feasible and useful as the standard key indicator, being one of the most frequent severe LB manifestations, with the possibility of a specific case definition. Additional surveillance with erythema migrans as key indicator would add value to the surveillance of neuroborreliosis and lead to a more complete picture of LB epidemiology in the EU/EEA. The other scenarios have less value as a basis for EU-level surveillance, but can be considered periodically and locally, as they could supply complementary insights.

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

Cited by 214 publications

References 22 publications

Lyme borreliosis

Lyme borreliosis

Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial

Surveillance perspective on Lyme borreliosis across the European Union and European Economic Area

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