This well done open label randomized published in the NEJM comes to us from the Netherlands. Parts of Europe and Scandinavia have long had a more enlightened & conservative approach to acute otitis media. But this condition is a little different. I think we have all had the young child with tubes (grommets) in their ears who now has fluid (or pus) discharging from the ear. Should we put them on oral antibiotics, topical drops or adopt a wait and watch approach? This is a useful question to answer.
This study randomized children in a 1:1:1 fashion to hydrocortisone-bacitracin-colistin ear drops, or augmentin (think diarrhea) or initial observation. The primary outcome measure was the presence of otorrhea at 2 weeks as determined by otoscopy by a study investigator.
There were 230 patients enrolled. The results showed a fantastic treatment effect of the topical drops. At 2 weeks only 5% of the children randomized to drops had otorrhea as compared to 44% in the Augmentin group and 55% in initial observation.
There are perhaps a few issues of external validity when interpreting this paper. The specific ear drops studied are only available in the Netherlands and France. Nevertheless, there likely are similar drops around the world that do not contain ototoxic aminoglycosides. The study protocol involved quite a lot of home visits which may have provided extra insensitive for medication compliance.
The primary outcome is interesting and of dubious importance. The reason for placement of typmanostomy tubes is to allow for the drainage of the middle ear. Therefore drainage could be considered a normal and perhaps desirable process in the setting of otitis media. Of course one might be concerned about prolonged otorrhea and inflammation. But it is hard to know if this is a meaningful outcome.
I think the biggest issue of concern is the general caution that should come when looking at small studies showing dramatic treatment effects. These are almost always shown to be less impressive on subsequent study.
What are the take home points? Despite some of the above concerns, this is a compelling study. I doubt that the drops really work as well as this small study suggests. But now I find myself searching for the appropriate drops the next time I see that kid with tympanostomy tubes and pus flowing from ear.
M.A. va Dongen T, J.M.G. van der Heijden G, Vanekamp RP, et al. A Trial of Treatment for Acute Otorrhea in Children with Tympanostomy Tubes. N Eng J Med 2014;270:723-33.