Growth hormone treatment does not affect incidences of middle ear disease or hearing loss in infants and toddlers with Turner syndrome

Abstract

Context: No randomized, controlled, prospective study has evaluated the effect of growth hormone (GH) on the rates of middle ear (ME) disease and hearing loss in girls with Turner syndrome (TS).

Design: A 2-year, prospective, randomized, controlled, open-label, multicenter, clinical trial ('Toddler Turner Study'; August 1999 to August 2003) was carried out.

Setting: The study was conducted at 11 US pediatric endocrine centers.

Subjects: Eighty-eight girls with TS, aged 9 months to 4 years, were enrolled.

Intervention: The interventions comprised recombinant GH (50 microg/kg/day, n = 45) or no treatment (n = 43) for 2 years.

Main outcome measures: The outcome measures included occurrence rates of ear-related problems, otitis media (OM) and associated antibiotic treatments, tympanometric assessment of ME function and hearing assessment by audiology.

Results: At baseline, 57% of the girls (mean age = 1.98 +/- 1.00 years) had a history of recurrent OM, 33% had undergone tympanostomy tube (t-tube) insertion and 27% had abnormal hearing. There was no significant difference between the treatment groups for annual incidence of OM episodes (untreated control: 1.9 +/- 1.4; GH-treated: 1.5 +/- 1.6, p = 0.17). A quarter of the subjects underwent ear surgeries (mainly t-tube insertions) during the study. Recurrent or persistent abnormality of ME function on tympanometry was present in 28-45% of the girls without t-tubes at the 6 postbaseline visits. Hearing deficits were found in 19-32% of the girls at the annual postbaseline visits. Most of these were conductive deficits, however, 2 girls had findings consistent with sensorineural hearing loss, which was evident before 3 years of age.

Conclusions: Ear and hearing problems are common in infants and toddlers with TS and are not significantly influenced by GH treatment. Girls with TS need early, regular and thorough ME monitoring by their primary care provider and/or otolaryngologist, and at least annual hearing evaluations by a pediatric audiologist.

Fig. 1

Frequency distribution of annual number of episodes of OM per subject. The distribution is shifted to the left somewhat (fewer episodes) for the GH group compared with the control group (p = 0.08).

Fig. 2

Percentage of subjects in the control (a) and GH (b) group at each visit who had evidence of ME dysfunction by tympanometry (1 or both ears); t-tube(s) in 1 or both ears and total percentage of subjects with abnormal tympanometry. There were no significant between-group differences at any study visit for rates of abnormal tympanometry or presence of tympanostomy tubes.