A Randomized, Double-blind, Placebo-controlled Study of Dextran/Pentoxifylline Medication in Acute Acoustic Trauma and Sudden Hearing Loss

Abstract

The effectiveness of any therapy in acute acoustic trauma or sudden hearing loss of unknown origin has not been demonstrated convincingly. The assessment is difficult because of a relatively high rate of spontaneous recovery. Nevertheless, many different forms of treatment are recommended. We tested one form, treatment with rheoactive substances, in a prospective, randomized, double-blind trial and compared treatment with (a) infusions of dextran-40 with pentoxifylline, (b) saline infusions with pentoxifylline, and (c) saline infusions with placebo medication. Pure-tone hearing thresholds served as control parameters and were taken before treatment and at 1 and 4 weeks after the onset of therapy. Three hundred eighty-two patients were included in the trial, 331 (87%) could be analyzed, 184 patients were treated because of sudden hearing loss, 147 because of acute acoustic trauma. The three treatment groups were comparable in their basic characteristics including the amount of initial hearing loss. In patients with sudden hearing loss, no significant differences of hearing recovery were detected between the three treatment groups. Hearing recovery was also similar in patients with acute acoustic trauma. A power analysis of the study revealed that possible true treatment differences of a hearing recovery of 10 dB would have lead to significance with a probability of over 90%. It is concluded that there were, in fact, no clinically relevant differences in hearing gains of sudden hearing loss or acute acoustic trauma between treatments with saline infusions together with placebo medication and treatment with dextran-40 and/or pentoxifylline.

Corticosteroid Treatment of Idiopathic Sudden Sensorineural Hearing Loss

“…These treatments were later shown not to have better effect than placebo (6,22,23) and fell into disrepute to the benefit for corticosteroid therapy already before the trial period (15).…”

Hyperbaric Oxygen Therapy as Salvage Therapy for Sudden Sensorineural Hearing Loss

“…However, in most cases, the real cause of SSNHL remains unknown. Different therapeutic agents such as vasodilator, anticoagulant, plasma expander, steroid, and hyperbaric oxygen (HBO) therapies have been used [3][4][5][6][7] . Although limited evidence on their effects is available, clinical trials for most of these therapies are rare.…”

Comparison of intratympanic steroid treatment versus hemodilution and vasoactive treatment combination in sudden hearing loss

“…Probst ve ark. [17] ise AİK tedavisinde %40 dekstran + pentoksifilin, sodyum klorür + pentoksifilin ve sodium klorür + plasebo şeklinde uygulanan tedavi metotları arasında klinik olarak anlamlı fark olmadığını bildirmiş-lerdir.…”