OBJECTIVE: To investigate the therapeutic efficacy of intratympanic dexamethasone combined with systemic prednisolone in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). STUDY DESIGN: Prospective, quasirandomized, multicenter clinical trial. SETTING:One university hospital and 2 affiliated hospitals. PATIENTS: A total of 92 eligible patients with ISSNHL were allocated into 2 groups. Patients in the control group were treated with systemic prednisolone alone. Patients of the combined treatment group received additionally 3 intratympanic dexamethasone injections within 5 days. MAIN OUTCOME MEASURES: The main outcome measures used were the differences between pretreatment and posttreatment pure-tone audiometry averages (PTAs) and speech discrimination scores (SDSs). Successful treatment was defined as a greater than 10 dB improvement in PTA and 15% in SDS. The final assessment of hearing was performed 3 months after completion of treatment. RESULTS:Significant hearing recovery was observed in 31 (67.39%) of 46 cases, and in 24 (52.17%) of 46 control patients. Patients receiving combination therapy had a median improvement in PTA of 23.12 dB and a median increase in SDS of 32%. In the control group, the median hearing gain was 16.87 dB and 18%, respectively. The differences between the 2 groups were not statistically significant (p = 0.10 and p = 0.13). However, after performing a post hoc analysis by excluding individuals with profound hearing loss (PTA, >90 dB), the combined treatment group showed significant improvement compared with the control group (p = 0.04). No serious complications or adverse reactions were reported. CONCLUSION: The addition of intratympanic steroids to the conventional systemic steroid therapy may provide a safe and potentially effective therapeutic option in patients with mild-to-severe ISSNHL.
RCT Entities:
OBJECTIVE: To investigate the therapeutic efficacy of intratympanic dexamethasone combined with systemic prednisolone in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). STUDY DESIGN: Prospective, quasirandomized, multicenter clinical trial. SETTING: One university hospital and 2 affiliated hospitals. PATIENTS: A total of 92 eligible patients with ISSNHL were allocated into 2 groups. Patients in the control group were treated with systemic prednisolone alone. Patients of the combined treatment group received additionally 3 intratympanic dexamethasone injections within 5 days. MAIN OUTCOME MEASURES: The main outcome measures used were the differences between pretreatment and posttreatment pure-tone audiometry averages (PTAs) and speech discrimination scores (SDSs). Successful treatment was defined as a greater than 10 dB improvement in PTA and 15% in SDS. The final assessment of hearing was performed 3 months after completion of treatment. RESULTS: Significant hearing recovery was observed in 31 (67.39%) of 46 cases, and in 24 (52.17%) of 46 control patients. Patients receiving combination therapy had a median improvement in PTA of 23.12 dB and a median increase in SDS of 32%. In the control group, the median hearing gain was 16.87 dB and 18%, respectively. The differences between the 2 groups were not statistically significant (p = 0.10 and p = 0.13). However, after performing a post hoc analysis by excluding individuals with profound hearing loss (PTA, >90 dB), the combined treatment group showed significant improvement compared with the control group (p = 0.04). No serious complications or adverse reactions were reported. CONCLUSION: The addition of intratympanic steroids to the conventional systemic steroid therapy may provide a safe and potentially effective therapeutic option in patients with mild-to-severe ISSNHL.
Authors: Stefan K Plontke; Christoph Meisner; Sumit Agrawal; Per Cayé-Thomasen; Kevin Galbraith; Anthony A Mikulec; Lorne Parnes; Yaamini Premakumar; Julia Reiber; Anne Gm Schilder; Arne Liebau Journal: Cochrane Database Syst Rev Date: 2022-07-22
Authors: L Sutton; V Schartinger; C Url; J Schmutzhard; D Lechner; C Kavasogullari; J S Sandhu; A Shaida; R Laszig; J Loehler; S Plontke; H Riechelmann; M Lechner Journal: Eur Arch Otorhinolaryngol Date: 2018-03-31 Impact factor: 2.503