Wednesday, May 25, 2016

Efficacy and safety of pharmacological agents in the treatment of early Lyme disease

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.


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.

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 

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.

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.

*Free, full text (pdf file, 437 KB)*:
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