Corticosteroid treatment of Idiopathic Sudden Sensorineural Hearing Loss. Part 2: a meta-analysis of a RCT and the Swedish national database
(English)Manuscript (preprint) (Other academic)
Objective: A randomized placebo-controlled study (paper ON-11-66) has demonstrated no effect of Prednisolone in customary dosage on Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). The aim of the present paper is to analyze a larger patient group by meta-analysis of data from the RCT together with corresponding material drawn from the Swedish national database for ISSNHL.
Study design: Meta-analysis of data from a RCT and a Swedish national database for ISSNHL.
Patients: Data from 192 patients, 18–80 years, with ISSNHL was available. All had a hearing loss of at least 30 dB measured as PTA in the three most affected contiguous frequencies. Patients had been enrolled within one week after onset and evaluated by audiograms after three months.
Intervention: 45/99 (RCT) and 54/99 (the database) had been treated with Prednisolone in tapering doses from 60 mg daily and 42/93 with placebo (RCT) or 51/93 with no treatment (the database). Primary outcome was the mean hearing improvement on day 90 for the different groups. A mean difference of >10 dB improvement was needed to demonstrate treatment effect of Prednisolone compared to placebo/no treatment.
Results: No significant difference was seen between the Prednisolone group and placebo/no treatment (p=0.06). Total recovery was 38% in Prednisolone group, 40% in the placebo and 14% in the no treatment group. Vertigo at the onset of hearing loss and age had a negative prognostic value equally in all groups and signs of inflammation had a positive.
Conclusion: Prednisolone in customary dosage does not influence recovery after ISSNHL.
Idiopathic Sudden Sensorineural Hearing Loss, Sudden Deafness, Prednisolone, Effect of treatment, Placebo, Vertigo
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-67608OAI: oai:DiVA.org:liu-67608DiVA: diva2:411773