Cargando…
Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol
BACKGROUND: Erythema 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 pharmac...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855495/ https://www.ncbi.nlm.nih.gov/pubmed/27142846 http://dx.doi.org/10.1186/s13643-016-0251-3 |
_version_ | 1782430374692913152 |
---|---|
author | Torbahn, Gabriel Hofmann, Heidelore Allert, Roman Freitag, Michael H. Dersch, Rick Fingerle, Volker Sommer, Harriet Motschall, Edith Meerpohl, Jörg J. Schmucker, Christine |
author_facet | Torbahn, Gabriel Hofmann, Heidelore Allert, Roman Freitag, Michael H. Dersch, Rick Fingerle, Volker Sommer, Harriet Motschall, Edith Meerpohl, Jörg J. Schmucker, Christine |
author_sort | Torbahn, Gabriel |
collection | PubMed |
description | BACKGROUND: Erythema 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. METHODS: To 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 I(2) 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. DISCUSSION: Benefits 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 REGISTRATION: PROSPERO: CRD42016037932 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13643-016-0251-3) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4855495 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-48554952016-05-05 Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol Torbahn, Gabriel Hofmann, Heidelore Allert, Roman Freitag, Michael H. Dersch, Rick Fingerle, Volker Sommer, Harriet Motschall, Edith Meerpohl, Jörg J. Schmucker, Christine Syst Rev Protocol BACKGROUND: Erythema 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. METHODS: To 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 I(2) 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. DISCUSSION: Benefits 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 REGISTRATION: PROSPERO: CRD42016037932 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13643-016-0251-3) contains supplementary material, which is available to authorized users. BioMed Central 2016-05-03 /pmc/articles/PMC4855495/ /pubmed/27142846 http://dx.doi.org/10.1186/s13643-016-0251-3 Text en © Torbahn et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Protocol Torbahn, Gabriel Hofmann, Heidelore Allert, Roman Freitag, Michael H. Dersch, Rick Fingerle, Volker Sommer, Harriet Motschall, Edith Meerpohl, Jörg J. Schmucker, Christine Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title | Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title_full | Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title_fullStr | Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title_full_unstemmed | Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title_short | Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis—systematic review protocol |
title_sort | efficacy and safety of pharmacological agents in the treatment of erythema migrans in early lyme borreliosis—systematic review protocol |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855495/ https://www.ncbi.nlm.nih.gov/pubmed/27142846 http://dx.doi.org/10.1186/s13643-016-0251-3 |
work_keys_str_mv | AT torbahngabriel efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT hofmannheidelore efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT allertroman efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT freitagmichaelh efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT derschrick efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT fingerlevolker efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT sommerharriet efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT motschalledith efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT meerpohljorgj efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol AT schmuckerchristine efficacyandsafetyofpharmacologicalagentsinthetreatmentoferythemamigransinearlylymeborreliosissystematicreviewprotocol |