OBJECTIVE: The purpose of this study was to compare the efficacy of systemic steroid alone and combined with intratympanic methylprednisolone in the treatment of patients with idiopathic sudden sensorineural hearing loss. STUDY DESIGN: Prospective, randomized controlled trial. Settings Katip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey. SUBJECT AND METHODS: Seventy-nine patients who met the inclusion criteria for idiopathic sudden sensorineural hearing loss were included in this study. Patients were randomly divided into 2 groups according to treatment: group A received combination therapy (intratympanic methylprednisolone + oral steroid) and group B received oral steroid alone. Of the 79 patients included, 6 patients missed the 1-month follow-up visit. Overall, 73 patients (37 combination group, 36 oral steroid group) who completed the 1-month follow-up and study intervention were included in the per-protocol analysis. Both the relationship between certain prognostic factors and the clinical outcome after treatment were analyzed. RESULTS: Combination therapy showed significant hearing improvement and speech discrimination scores compared with the use of systemic steroids alone (P < .05). In hearing outcomes in patients with severe hearing loss, combination therapy had statistically significant hearing improvement compared with oral steroid alone (P < .05). CONCLUSION: We recommend that combination therapy can be considered as initial treatment especially for patients with severe hearing loss.
RCT Entities:
OBJECTIVE: The purpose of this study was to compare the efficacy of systemic steroid alone and combined with intratympanic methylprednisolone in the treatment of patients with idiopathic sudden sensorineural hearing loss. STUDY DESIGN: Prospective, randomized controlled trial. Settings Katip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey. SUBJECT AND METHODS: Seventy-nine patients who met the inclusion criteria for idiopathic sudden sensorineural hearing loss were included in this study. Patients were randomly divided into 2 groups according to treatment: group A received combination therapy (intratympanic methylprednisolone + oral steroid) and group B received oral steroid alone. Of the 79 patients included, 6 patients missed the 1-month follow-up visit. Overall, 73 patients (37 combination group, 36 oral steroid group) who completed the 1-month follow-up and study intervention were included in the per-protocol analysis. Both the relationship between certain prognostic factors and the clinical outcome after treatment were analyzed. RESULTS: Combination therapy showed significant hearing improvement and speech discrimination scores compared with the use of systemic steroids alone (P < .05). In hearing outcomes in patients with severe hearing loss, combination therapy had statistically significant hearing improvement compared with oral steroid alone (P < .05). CONCLUSION: We recommend that combination therapy can be considered as initial treatment especially for patients with severe hearing loss.