Abstract
Non interventional post registration study dealing with the treatment of otitis media with effusion (OME). Erdosteine (brand name Erdomed) was administered during 2 months in the group of 42 children aged 3-18 years, 11 with cleft palate, 7 with the chronic form of OME.
Evaluation was subjective - ear fullness and objective - oto microscopy, audiometry and tympanometry. Clinical effectiveness - subjective evaluation - ear fullness improved in 83 %.
Improvement in objective evaluation - middle ear fluid presence in oto microscopy decreased in 81 % of cases, tympanometry - identification of A curve increased in 34 %, B curve decreased in 68 % of patients. Audiometry - finding of normal hearing increased in 22%, and of air - bone gap of 30 or more dB decreased in 13% of patients.
Total treatment effectiveness assessed by physicians was very good in 57 %, and sufficient in 22 % of subjects. Safety and tolerance of Erdomed was declared excellent.