Episode 116: New media about otitis media treatment

In episode 116, James and Mike take a re-look, with some new evidence, at the use of antibiotics for acute otitis media in children and come to the conclusion that antibiotics do have an effect and produce side effects. They both agree that if the child is really sick you may as well give antibiotics and if they aren't really sick then you can wait.

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Comments

otitis media

Just a short remark to the study from Pittsburgh, if I read the study protocoll correctly it appears that initially there was only one primary endpoint (AOM-SOS score of 0-1 after 7 days) which turned out to be non significantly different between placebo and antibiotics. The other two "primary" endpoints were only defined one year after the end of the study and the third one (average symptom-score over 7 days) is still defined as a secondary endpoint in the study protocoll.
In the Finnish study I am concerned that the surrogate marker of "lack of otoscopic improvement" (0.6%vs 20%) contributes significantly to the overall result.
So do I need to change my practice to only prescribe in feverish and really sick kids?
Not convinced.

otitis media

I actually felt those studies were not that exciting. I was confused why they chose augmentin first line and not amoxicillin. I also felt they were cherry picking for effectiveness when one of the studies, I can't remember which, suggested benefit when comparing 2 improvement scores in a row. They felt this was okay because otitis media has such an up and down natural history that if they were getting better, they'd be better for two days in a row. And obviously, as you pointed out, the benefit was slim, especially compared to the actual number of kids who get better with placebo and the high number of side-effects.

Finally, there was only one case of mastoiditis in both studies. No other major catastrophes occured. The other issue was that as you mentioned in the beginning of the podcast Mike, is the worry about hearing loss. I'm on an ENT rotation now and they rave about that benefit after tubes, but how much evidence is there for that? The actual prevention of hearing loss and speech delay?

Long term effects?

If we increase the prescription of antibiotics for acute otitis media, what will be the long term consequences? The trial bellow, published in 2009, randomized 168 children aged 6 months to two years to amoxicilin or placebo and then followed them prospectively. Children randomized to the amoxicilin group had a 20% increase in absolute risk for a recurrent episode of acute otitis media in the following 3 years (number needed to harm = 5). None of the new trials addresses the issue of long term effects of antibiotics in otitis media. One has to wonder if we might be trading immediate benefits for long term harms.

Bezáková N, Damoiseaux RA, Hoes AW, Schilder AG, Rovers MM. Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants. BMJ. 2009 Jun 30;338:b2525. http://www.bmj.com/content/338/bmj.b2525.full

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