Silviu Albu1, Felician Chirtes2. 1. II-nd Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania. Electronic address: silviualbu63@gmail.com. 2. Otolaryngology Department, Military Hospital Cluj-Napoca, Cluj-Napoca, Romania.
Abstract
PURPOSE: The aim of our study was to determine whether the combination of intratympanic (IT) corticosteroid with melatonin could be associated with decreased tinnitus in patients with unilateral acute idiopathic tinnitus developed within 3months. MATERIALS AND METHODS: We evaluated this hypothesis through a prospective, randomized, controlled, double-blinded trial. Patients included in the study were randomly allocated into two groups: Group A - comprising 30 patients, received melatonin and IT dexamethazone, and Group B - including 30 patients receiving melatonin alone. After 3 months, improvement in tinnitus was assessed using different outcome measures: tinnitus loudness score, tinnitus awareness score, Tinnitus Handicap Inventory (THI), Pittsburgh Sleep Quality Index (PSQI) and Beck Depression Inventory (BDI). RESULTS: We have demonstrated significant improvements in each of the above mentioned outcomes subsequent to treatment in both groups. However, patients in the IT dexamathazone and melatonin group attained statistically significant better outcomes. Besides, the differences in improvement rate and cure rate were highly significant between the two groups, favoring the IT dexamethazone and melatonin group. CONCLUSIONS: Our preliminary study demonstrated that IT dexamethazone plus melatonin is efficient in improvement of idiopathic unilateral tinnitus developed within 3 months.
RCT Entities:
PURPOSE: The aim of our study was to determine whether the combination of intratympanic (IT) corticosteroid with melatonin could be associated with decreased tinnitus in patients with unilateral acute idiopathic tinnitus developed within 3months. MATERIALS AND METHODS: We evaluated this hypothesis through a prospective, randomized, controlled, double-blinded trial. Patients included in the study were randomly allocated into two groups: Group A - comprising 30 patients, received melatonin and IT dexamethazone, and Group B - including 30 patients receiving melatonin alone. After 3 months, improvement in tinnitus was assessed using different outcome measures: tinnitus loudness score, tinnitus awareness score, Tinnitus Handicap Inventory (THI), Pittsburgh Sleep Quality Index (PSQI) and Beck Depression Inventory (BDI). RESULTS: We have demonstrated significant improvements in each of the above mentioned outcomes subsequent to treatment in both groups. However, patients in the IT dexamathazone and melatonin group attained statistically significant better outcomes. Besides, the differences in improvement rate and cure rate were highly significant between the two groups, favoring the IT dexamethazone and melatonin group. CONCLUSIONS: Our preliminary study demonstrated that IT dexamethazone plus melatonin is efficient in improvement of idiopathic unilateral tinnitus developed within 3 months.
Authors: Karolina Müller; Niklas K Edvall; Esma Idrizbegovic; Robert Huhn; Rilana Cima; Viktor Persson; Constanze Leineweber; Hugo Westerlund; Berthold Langguth; Winfried Schlee; Barbara Canlon; Christopher R Cederroth Journal: Front Aging Neurosci Date: 2016-11-22 Impact factor: 5.750