Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: analysis of an RCT and material drawn from the Swedish national database

Abstract

A randomized placebo-controlled study has demonstrated no effect of prednisolone in customary dosage on idiopathic sudden sensorineural hearing loss (ISSNHL). The aim of the present paper is to analyse a larger patient group by meta-analysis of data from the RCT together with a corresponding material drawn from the Swedish national database for ISSNHL. Data from 192 patients, 18-80 years with ISSNHL, were available. All had an acute hearing loss of at least 30 dB measured as PTA in the three most affected contiguous frequencies. All patients had been enrolled within one week after onset and evaluated by audiograms after 3 months. 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 required to demonstrate a treatment effect for prednisolone compared to placebo/no treatment. 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 at onset had an equal negative prognostic value in all groups and signs of inflammation had a positive effect. Prednisolone in customary dosage does not influence recovery after ISSNHL.

Hearing Changes After Intratympanically Applied Steroids for Primary Therapy of Sudden Hearing Loss: A Meta-analysis Using Mathematical Simulations of Drug Delivery Protocols

“…In prior studies, however, multivariable statistical analysis suggested that increasing age slightly worsened the prognosis for hearing recovery (32–34). Some authors have stated that the highest incidence for ISSHL is around an age of 50 years (35,36).…”

“…Some studies performed multivariable statistical analysis to filter out important factors influencing the prognosis. However, we think it would help advance the field to also have individual patient data available for meta-analyses (34,54–58). Even in times of continuing efforts of cost reductions for print publication, publishers need to understand the importance of providing individual patient data, at least in the form of supplementary digital materia…”

Prognostic Factors for Recovery from Sudden Sensorineural Hearing Loss: A Retrospective Study

“…Systemic steroids are the standard initial treatment for ISSNHL, although a placebo-controlled study showed that systemic steroids did not result in superior improvement [11]. IT steroid injections are effective when they are used alone or with systemic steroid administration.…”

Evaluation and Treatment of Acute and Subacute Hearing Loss: A Review of Pharmacotherapy

“…The three studies had contradictory findings and small sample sizes (N=267 total), and as such no recommendation could be made about the efficacy of steroids in the management of SSNHL . The authors of another meta‐analyses concluded that oral prednisolone in a standard dosing regimen does not influence recovery in SSNHL . In the literature currently, oral steroids are often used as a control when investigating new therapies, such as nonsteroidal pharmacological agents or intratympanic steroids.…”

“…42,43 The authors of another metaanalyses concluded that oral prednisolone in a standard dosing regimen does not influence recovery in SSNHL. 44 In the literature currently, oral steroids are often used as a control when investigating new therapies, such as nonsteroidal pharmacological agents or intratympanic steroids. The most commonly used steroids in these trials are prednisone, prednisolone, and methylprednisolone.…”