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


METHODS
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.
Bianchin
Giovanni
G
Otorhinolaryngology Unit, Santa Maria Nuova Hospital, Reggio Emilia, Italy. giovanni.bianchin@asmn.re.it
Russi
Gianpaolo
G
Romano
Nicola
N
Fioravanti
Paola
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold / Q000502:physiology; D001781:Blood Component Removal / Q000379:methods*; D008078:Cholesterol, LDL / Q000097:blood*; D005340:Fibrinogen / Q000378:metabolism*; D005500:Follow-Up Studies; D003639:Hearing Loss, Sudden / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function / Q000502:physiology; D016896:Treatment Outcome
D008078:Cholesterol, LDL; D005340:Fibrinogen