Audiology in the sudden hearing loss clinical trial.

Abstract

OBJECTIVE:

To report the pretreatment and posttreatment population characteristics and the overall stability of the audiologic outcomes found during the Sudden Hearing Loss Clinical Trial (ClinicalTrials.gov: Identifier NCT00097448).

STUDY DESIGN:

Multicenter, prospective randomized noninferiority trial of oral versus intratympanic (IT) steroid treatment of sudden sensorineural hearing loss (SSNHL).

SETTING:

Fifteen academically based otology practices.

PATIENTS:

Two hundred fifty patients with unilateral SSNHL presenting within 14 days of onset with 50 dBHL or greater pure tone average hearing threshold in the affected ear.

INTERVENTION:

Either 60 mg/d oral prednisone for 14 days with a 5-day taper (121 patients) or 4 IT doses for 14 days of 40 mg/ml methylprednisolone (129 patients).

MAIN OUTCOME MEASURE:

Primary end point was change in hearing [dB PTA] at 2 months after treatment. Noninferiority was defined as less than 10 dB difference in hearing outcome between treatments. In this article, pretreatment and posttreatment hearing findings will be reported in detail.

RESULTS:

A general (and stable) effect of treatment and a specific effect of greater improvement at low frequencies were found in both treatment groups.

CONCLUSION:

Hearing improvements are stable, and a significantly greater improvement occurs with lower frequency after either oral or IT steroid treatment of SSNHL.

• Authors: Chris Halpin, Helen Shi, Domenic Reda, Patrick J Antonelli, Seilesh Babu, John P Carey, Bruce J Gantz, Joel A Goebel, Paul E Hammerschlag, Jeffrey P Harris, Brandon Isaacson, Daniel Lee, Chris J Linstrom, Lorne S Parnes, William H Slattery, Steven A Telian, Jeffrey T Vrabec, Steven Rauch
• Journal: Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (Otol Neurotol) Vol. 33 Issue 6 Pg. 907-11 (Aug 2012) ISSN: 1537-4505 [Electronic] United States
• PMID: 22805100 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents
• Steroids
• Prednisone
• Methylprednisolone

Topics

• Administration, Oral
• Administration, Topical
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Audiometry, Pure-Tone (methods)
• Clinical Trials as Topic
• Hearing Loss, Sudden (diagnosis, drug therapy)
• Humans
• Methylprednisolone (administration & dosage, therapeutic use)
• Prednisone (administration & dosage, therapeutic use)
• Prospective Studies
• Recognition, Psychology
• Research Design
• Speech Perception
• Steroids (administration & dosage, therapeutic use)
• Treatment Outcome