COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Treatment with HELP-apheresis in patients suffering from sudden sensorineural hearing loss: a prospective, randomized, controlled study.

Laryngoscope 2010 April
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 >or=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.

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