A REVIEW OF CLINICAL-TRIALS REGARDING TREATMENT OF ACUTE OTITIS-MEDIA

A survey was made of the English language literature on clinical trials of therapy in acute otitis media. The articles were analysed systematically for 24 parameters related to study design. We retrieved 50 studies published between 1965 and 1989. Surprisingly, the combination of a double-blind method, clearly defined inclusion criteria, and criteria for outcome was found in only 13 studies. Most of these 13 compared different antibiotic regimens and only 4 were placebo-controlled. A recommendation based on the conclusions reached can, even in these 13 studies, hardly be obtained due to failure to show an overall difference in favour of a specific treatment regimen. Our study shows that many trials are methodologically flawed which makes it difficult to accept their results. In view of current controversy on management of acute otitis media, well conducted placebo-controlled clinical trials are still needed.