Is Acute Otitis Media a Treatable Disease? Yes, and this is a paradigm shift according to NEJM
This is the NEJM editorial and the two supporting articles:
Since the physician cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly when they are treated with an appropriate antimicrobial agent (amoxicillin–clavulanate, Augmentin).
Is Acute Otitis Media a Treatable Disease? — NEJM
Treatment of Acute Otitis Media in Children under 2 Years of Age — NEJM
A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media — NEJM
There is an excellent critique of this paper in the bonus section of the most recent SMART EM podcast: http://smartem.org/smartem.org/Podcast/Entries/2011/1/23_Pediatric_UTI__Its_About_the_Future.html
ReplyDeleteBased on the analysis of the papers protocol published on ClinicalTrials.gov the authors have changed their published protocol about 70 times - 60 during the trial. The study had 4 primary outcome measures (how can you have more than one?). 3 out of 4 had a benefit. The one that didn't - time to resolution of pain - was the only one that was initially listed as the primary outcome. It is impossible not to suspect that 3 positive secondary outcomes were converted to primary outcomes after the fact (there are over 20 secondary outcomes - some were bound to be positive). Very fishy...
Also 3 times as many children will get diarrhoea/thrush/nappy rash than will have improved resolution of pain (so is this a positive or negative study?). Also, the Finnish population doesn't have pneumococcal vaccine. Also, one of the authors has a conflict of interest with the makers of Augmentin...
Conclusion: THIS IS NOT A PARADIGM SHIFTER!
The protocol can be found here: http://clinicaltrials.gov/ct2/show/NCT00377260?term=pittsburgh+otitis+media&rank=3
Chris