Treatment with HELP‐apheresis in patients suffering from sudden sensorineural hearing loss: A prospective, randomized, controlled study[Note *. * χ2 test. ...]

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