Superiority trialsBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d2981 (Published 18 May 2011) Cite this as: BMJ 2011;342:d2981
- Philip Sedgwick, senior lecturer in medical statistics
- 1Section of Medical and Healthcare Education, St George’s, University of London, Tooting, London, UK
Researchers investigated the effectiveness in primary care of topical intranasal corticosteroids in children aged 4 to 11 years with bilateral otitis media with effusion. A randomised double blind, placebo controlled superiority trial was performed.1
The primary end point was the proportion of children cured of bilateral otitis media with effusion in one or both ears at one month. The proposed smallest effect of clinical interest was a difference of 15%. A total of 105 children were allocated to receive nasal mometasone furoate 50 µg, given once daily into each nostril for three months, and 112 were allocated to placebo spray.
At one month 40.6% of the children in the topical steroid group and 44.9% in the placebo group were cured. The difference between the steroid and placebo groups in the percentage cured was not significant (difference favouring placebo 4.3% (95% confidence interval −9.3% to 18.1%; P=0.55)). …