Abstract
To study the effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chronic otitis media with effusion, we randomly assigned 578 4- to 8-year-old children to receive one of the following: bilateral myringotomy and no additional treatment (group 1), tympanostomy tubes (group 2), adenoidectomy and myringotomy (group 3), or adenoidectomy and tympanostomy tubes (group 4). The 491 who accepted surgical treatment were evaluated at 6-week intervals for up to 2 years. Treatment effect was assessed by four main outcomes: time with effusion, time with hearing loss, time to first recurrence of effusion, and number of surgical re-treatments. For the groups (in order), the mean percent of time with any effusion in either ear was 49, 35, 30, 26 (p less than .0001); the mean percent of time with hearing thresholds 20 dB or greater was 19, 10, 8, and 7 (p less than .0001) in the better ear; and 38, 30, 22 and 22 in the worse ear (p less than .0001); the median number of days to first recurrence was 54, 222, 92, and 240 (p less than .0001); and the number of surgical re-treatments was 66, 36, 17, and 17 (p less than .0001). The most notable adverse sequela, purulent otorrhea, occurred in 22%, 29%, 11%, and 24% of the patients...Continue Reading
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