A Cochrane review included 3 studies. The first study was a six-week parallel-group trial (n=25, mean age 3.8 years, mean apnea hypopnea index, AHI 10.8/h) of intranasal fluticasone versus placebo and showed a statistically significant effect of the drug on improving the AHI; the AHI in the treatment group fell from 10.7/h to 5.8/h, while the AHI increased from 11.0/h to 13.1/h in the placebo group (P = 0.04 for between-group difference). The second study compared intranasal budesonide with placebo in a six-week cross-over trial (n=62, mean age 8.2 years, mean AHI 3.7/h); the post-treatment AHI was lower in the intervention group compared to placebo (1.3/h versus 4.0/h). However, the patients were not analyzed as randomized. No valid group comparisons were reported for the third trial (n=30, oral montelukast versus placebo in a 12-week parallel-group trial), which has so far only been published as an abstract.
Comment: The quality of evidence is downgraded by study quality (premature termination of the study), by indirectness (lack of long-term safety and efficacy data), and by imprecise results (limited study size for each comparison).