Abstract
BackgroundErythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis. Recommendations regarding pharmacological agents, dose and duration of treatment are subject of intense debate. This review aims to explore differences in efficacy and safety between pharmacological treatments and control treatment.MethodsTo identify relevant studies, we will conduct a systematic literature search. We will include randomised controlled trials (RCTs) and non-RCTs. Eligible comparative studies need to (1) consider patients with a diagnosis of erythema migrans resulting from Lyme borreliosis and (2) compare different pharmacological agents against each other, against any other non-pharmacological treatment, placebo or no treatment. Two review authors will independently assess included studies for risk of bias according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions and related to specific study designs. We will address patient-relevant outcomes including clinical remission of cutaneous symptoms, any treatment-related adverse events, quality of life and progressive symptoms such as neuroborreliosis or Lyme carditis and flu-like symptoms. Provided that the identified trials are comparable in terms of clinical issues, combined estimates will be provided. Estimations of treatment effects will be calculated based on a random effects model. Heterogeneity will be evaluated based on I2 and chi-square test. In case of significant heterogeneity, a pooled estimate will not be provided, but heterogeneity will be investigated on the basis of methodological and clinical study aspects. We plan subgroup analysis to reveal potential differences in the effect estimates between patient populations and treatment specifications. We will consider risk of bias using sensitivity analyses to decide whether to rely on the pooled estimates. The quality of a body of evidence for individual outcomes will be assessed using the GRADE approach.DiscussionBenefits and harms of pharmacological treatment in erythema migrans have not yet been adequately assessed. This systematic review will evaluate and summarise available evidence addressing benefits and harms of different pharmacological treatments. In addition, this summary of clinical evidence will inform decision-making between clinicians and patients and will play an important part in patient care.Systematic review registrationPROSPERO: CRD42016037932Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0251-3) contains supplementary material, which is available to authorized users.
Highlights
Erythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis
Lyme borreliosis (Lyme disease) is an infectious disease caused by spirochetes and transmitted by tick bites
Borrelia burgdorferi s. l. complex infection is known in most northern hemisphere countries in Europe, USA and Asia according to the distribution of the respective Ixodes ticks [1,2,3,4,5,6]
Summary
Erythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis. This review aims to explore differences in efficacy and safety between pharmacological treatments and control treatment. Lyme borreliosis (Lyme disease) is an infectious disease caused by spirochetes and transmitted by tick bites. From the primary skin manifestation, Borrelia burgdorferi can disseminate to other organs. The typical clinical sign of early skin infection with B. burgdorferi is a circular, outwardly expanding red patch with central clearing called EM. EM associated with early infection is found in about 70–90 % of patients [5, 11, 12] and can have a range of appearances including the typical bull-s-eye lesion, but atypical lesions are common [7,8,9, 13, 14]. The current literature provides no standardised criteria for the diagnosis of Lyme borreliosis but case definitions for surveillance by the Centers for Disease Control and Prevention (CDC) [16] or epidemiological issues by the European concerted action on Lyme borreliosis (EUCALB) [10] were provided
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