RESUMO
BACKGROUND: Otitis media with effusion (OME) is the most common cause of paediatric hearing loss. No single treatment has proved its effectiveness. There is a lack of evidence-based medicine studies in the area of homeopathy. METHOD: A prospective randomized, double blinded interventional placebo control study was conducted. Patients, from 2 months to 12 years, with OME diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group (EG) received homeopathy (Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum), and the placebo group (PG) placebo, both of them for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days. RESULTS: 97 patients were enrolled. In the EG, 61.9% of individuals were cured (PNO went from negative in the 1st visit to positive in the 3rd visit) compared with 56.8% of patients treated with placebo. 4.8% of patients in the EG suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit) while 11.4% did in the PG. No significant difference was found. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in EG (3 vs. 13, p: 0.009). CONCLUSION: The homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME. TRIAL REGISTRATION: EUDRACT number: 2011-006086-17, PROTOCOL code: 55005646.