Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis-systematic review protocol
Thu May 19, 2016 5:14 am (PDT) . Posted by:
"Rick Laferriere" ri_lymeinfo
*Efficacy and safety of pharmacological agents in the treatment of
erythema migrans in early Lyme borreliosis-systematic review protocol *
Torbahn G, Hofmann H, Allert R, Freitag MH, Dersch R, Fingerle V, Sommer
H, Motschall E, Meerpohl JJ, Schmucker C.
/Systematic Reviews/. 2016 May 3; 5(1):73.
http://dx.doi.org/10.1186/s13643-016-0251-3
Abstract
*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.
http://dx.doi.org/10.1186/s13643-016-0251-3
*Free, full text (pdf file, 437 KB)*:
http://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-016-0251-3?site=systematicreviewsjournal.biomedcentral.com
or http://tinyurl.com/hchng68
erythema migrans in early Lyme borreliosis-systematic review protocol *
Torbahn G, Hofmann H, Allert R, Freitag MH, Dersch R, Fingerle V, Sommer
H, Motschall E, Meerpohl JJ, Schmucker C.
/Systematic Reviews/. 2016 May 3; 5(1):73.
http://dx.doi.org/10.1186/s13643-016-0251-3
Abstract
*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.
http://dx.doi.org/10.1186/s13643-016-0251-3
*Free, full text (pdf file, 437 KB)*:
http://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-016-0251-3?site=systematicreviewsjournal.biomedcentral.com
or http://tinyurl.com/hchng68
===
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