Bromhexine in the treatment of otitis media with effusion.

In a double blind randomised trial of 95 children aged 3-8 years with otitis media with effusion (OME), the efficacy of the mucolytic agent bromhexine hydrochloride (Bisolvon) was compared with a placebo. Each child received two 4 week courses of either bromhexine or placebo in a random fashion. One hundred and ninety ears were available for analysis, i.e. 380 'ear treatments'. There were 198 ears in the placebo group and 182 ears in the bromhexine group. The resolution rate in the placebo treated group was 19% and in the bromhexine treated group 16%. Bromhexine does not appear to be a useful drug for the treatment of OME in children.