Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial.

نویسندگان

  • Steven D Rauch
  • Christopher F Halpin
  • Patrick J Antonelli
  • Seilesh Babu
  • John P Carey
  • Bruce J Gantz
  • Joel A Goebel
  • Paul E Hammerschlag
  • Jeffrey P Harris
  • Brandon Isaacson
  • Daniel Lee
  • Christopher J Linstrom
  • Lorne S Parnes
  • Helen Shi
  • William H Slattery
  • Steven A Telian
  • Jeffrey T Vrabec
  • Domenic J Reda
چکیده

CONTEXT Idiopathic sudden sensorineural hearing loss has been treated with oral corticosteroids for more than 30 years. Recently, many patients' symptoms have been managed with intratympanic steroid therapy. No satisfactory comparative effectiveness study to support this practice exists. OBJECTIVE To compare the effectiveness of oral vs intratympanic steroid to treat sudden sensorineural hearing loss. DESIGN, SETTING, AND PATIENTS Prospective, randomized, noninferiority trial involving 250 patients with unilateral sensorineural hearing loss presenting within 14 days of onset of 50 dB or higher of pure tone average (PTA) hearing threshold. The study was conducted from December 2004 through October 2009 at 16 academic community-based otology practices. Participants were followed up for 6 months. INTERVENTION One hundred twenty-one patients received either 60 mg/d of oral prednisone for 14 days with a 5-day taper and 129 patients received 4 doses over 14 days of 40 mg/mL of methylprednisolone injected into the middle ear. MAIN OUTCOME MEASURES Primary end point was change in hearing at 2 months after treatment. Noninferiority was defined as less than a 10-dB difference in hearing outcome between treatments. RESULTS In the oral prednisone group, PTA improved by 30.7 dB compared with a 28.7-dB improvement in the intratympanic treatment group. Mean pure tone average at 2 months was 56.0 for the oral steroid treatment group and 57.6 dB for the intratympanic treatment group. Recovery of hearing on oral treatment at 2 months by intention-to-treat analysis was 2.0 dB greater than intratympanic treatment (95.21% upper confidence interval, 6.6 dB). Per-protocol analysis confirmed the intention-to-treat result. Thus, the hypothesis of inferiority of intratympanic methylprednisolone to oral prednisone for primary treatment of sudden sensorineural hearing loss was rejected. CONCLUSION Among patients with idiopathic sudden sensorineural hearing loss, hearing level 2 months after treatment showed that intratympanic treatment was not inferior to oral prednisone treatment. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00097448.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Combined Intratympanic and Systemic Steroid Therapy for Poor-Prognosis Sudden Sensorineural Hearing Loss

Introduction: The aim of this study was to evaluate the efficacy of combined intratympanic and systemic steroid therapy compared with systemic steroid therapy alone in idiopathic sudden sensorineural hearing loss (ISSNHL) patients with poor prognostic factors.     Materials and Methods: Seventy-seven patients with sudden sensorineural hearing loss (SSNHL) who had at least one poor prognostic fa...

متن کامل

The Effect of Intratympanic Dexamethasone with Oral Prednisolone as a Primary Treatment in Idiopathic Sudden Sensorineural Hearing Loss

Introduction: Sudden sensorineural hearing loss (SSNHL) is a true emergency that must be diagnosed and treated immediately. The purpose of this study is to compare the efficacy of treatment with intratympanic dexamethasone plus oral prednisolone daily or every other day with that of treatment with oral prednisolone alone. Materials and Methods: Sixty-three patients with SSNHL that had been p...

متن کامل

Hyperbaric Oxygen Therapy for Sudden Sensorineural Hearing Loss after Failure from Oral and Intratympanic Corticosteroid

Systemic and intratympanic steroids are most widely used for treating idiopathic sudden sensorineural hearing loss. Other treatments include vasodilator, immunosuppressant and antiviral medication. However, only 61% of patients achieve full recovery, and controversies about the standard treatment still exist. In this case report, we present a patient with idiopathic sudden sensorineural hearing...

متن کامل

Intratympanic methylprednisolone as rescue therapy in sudden sensorineural hearing loss.

UNLABELLED Treatment in sudden sensorineural hearing loss is a contentious issue, today, oral steroids are the most common choice and considered the best treatment option, but the use of intratympanic steroids has become an attractive alternative, especially in cases when systemic therapy fails, or to avoid the side effects of the systemic use of steroids. AIM To describe the results of intra...

متن کامل

The Role of High Dose Intratympanic Dexamethasone as Salvage Therapy for Idiopathic Sudden Sensorineural Hearing Loss.

OBJECTIVE The aim of this study was to assess the efficacy of a single high dose intratympanic (IT) dexamethasone (DEX) as salvage therapy for idiopathic sudden sensorineural hearing loss (ISSNHL) after unsuccessful treatment with oral corticosteroid (CS). MATERIALS AND METHODS This was a prospective open-label study of 59 patients treated with IT DEX after systemic CS therapy has failed. All...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • JAMA

دوره 305 20  شماره 

صفحات  -

تاریخ انتشار 2011