INTRODUCTION: Up to 80% of children have been affected by otitis media with effusion (OME) by the age of 4 years, but prevalence declines beyond 6 years of age. Non-purulent middle-ear infections can occur in children or adults after upper respiratory tract infection or acute otitis media. Half or more of cases resolve within 3 months and 95% within a year, but complications such as tympanic membrane perforation, tympanosclerosis, otorrhoea, and cholesteatoma can occur. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent otitis media with effusion in children; and of pharmacological, mechanical, and surgical interventions to treat otitis media with effusion in children? We searched: Medline, Embase, The Cochrane Library and other important databases up to March 2006. (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 22 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: