Effectiveness of amoxicillin alone in the treatment of uncomplicated acute otitis media: a systematic review protocol.

INTRODUCTION: Amoxicillin is the first-line antibiotic recommended by most scientific societies for the treatment of uncomplicated acute otitis media (AOM) in children and adults. In low-income and middle-income countries however, absence of setting-specific recommendations and antibiotic resistance, promoted by higher population density and over-the-counter antibiotic availability, could hamper the effectiveness of amoxicillin. We aim to provide updated information to enable evidence-based decisions for first-line therapy of uncomplicated AOM in our setting.

METHODS AND ANALYSIS: We will conduct a systematic review of all randomised controlled trials on the clinical effectiveness of amoxicillin for the treatment of uncomplicated AOM in children above 6 months and adults. The search will include studies published from the generation of the included databases to 31 December 2017. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and study quality will be assessed by the Risk of Bias Assessment Tool from the Cochrane Handbook for randomised trials. A meta-analysis will be conducted for homogeneous studies, eventually, using the fixed-effect model. Subgroup analysis will include age groups, amoxicillin dosage, treatment duration, effectiveness criteria, time of trial realisation, study quality and region of the world involved.

ETHICS AND DISSEMINATION: Formal ethical approval is not required, as primary data will not be collected. The results will be disseminated through a peer-reviewed publication and presented at scientific meetings.

PROSPERO REGISTRATION NUMBER: CRD42017080029.