Treatment with HELP-apheresis in patients suffering from sudden sensorineural hearing loss: A prospective, randomized, controlled study

Authors


  • This study was sponsored by Santa Maria Nuova Hospital of Reggio Emilia, Italy. The authors did not have any financial relationship at the time of submission with the companies producing apheretic devices over the past 3 years. The authors declare that they have participated as speakers in scientific meetings or symposia organized by B. Braun Avitum Italy, but without receiving grants or honoraria. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

Objectives/Hypothesis:

This study's aim was to verify whether, in patients affected by sudden sensorineural hearing loss (SSHL) with high plasmatic levels of low-density–lipoprotein (LDL) cholesterol and/or fibrinogen, the therapeutic approach with a single selective plasmapheresis (HELP-apheresis) followed by 10 days of standard treatment (glycerol and dexamethazone) is more effective than 10 days of standard treatment.

Study Design:

Randomized, superiority study (difference ≥30%).

Methods:

One hundred thirty-two patients were admitted to the trial and randomly allocated to two different arms; 60 were given standard treatment and 72 were treated with HELP-apheresis plus standard treatment. Patients showed a value of LDL cholesterol >120 mg/dL and/or fibrinogen >320 mg/dL.

Results:

In the HELP-apheresis plus standard therapy group, we observed a hearing recovery in 75% of the patients 24 hours after treatment and in 76.4% of the patients 10 days after treatment. Only 25% of the patients after 24 hours and 23.6% of the patients after 10 days showed no change. In the standard therapy group, the percentage of patients with hearing recovery was 41.7% after 24 hours and 45% after 10 days, whereas 58.3% after 24 hours and 55% after 10 days had no change.

Conclusions:

The analysis enabled us to consider HELP-apheresis as the element that makes a difference in hearing recovery. In a specific group of patients, with alterations in cholesterol and/or fibrinogen, the HELP-apheresis treatment is a further option available in SSHL therapy. Laryngoscope, 2010

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