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A Randomised, Double Blind Trial of N-Acetylcysteine for Hearing Protection during Stapes Surgery
Stockholm University, Faculty of Science, Department of Physical Geography.
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2015 (English)In: PLoS ONE, ISSN 1932-6203, Vol. 10, no 3, e0115657Article in journal (Refereed) Published
Abstract [en]

Background Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies. Methods We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo. Findings One year after surgery, high-frequency hearing had improved 2.7 +/- 3.8 dB in the placebo group (67 patients analysed) and 2.4 +/- 3.7 dB in the treated group (72 patients; means +/- 95% confidence interval, p = 0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting. Conclusions N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy.

Place, publisher, year, edition, pages
2015. Vol. 10, no 3, e0115657
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Other Medical Sciences
URN: urn:nbn:se:su:diva-116616DOI: 10.1371/journal.pone.0115657ISI: 000351276300003PubMedID: 25763866OAI: diva2:808257


Available from: 2015-04-27 Created: 2015-04-22 Last updated: 2015-04-28Bibliographically approved

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Plue, Jan
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