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A Randomised, Doubl...
A Randomised, Double Blind Trial of N-Acetylcysteine for Hearing Protection during Stapes Surgery
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- Bagger-Sjöbäck, Dan (author)
- Karolinska Institute, Sweden; Karolinska University Hospital, Sweden
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- Strömbäck, Karin (author)
- Uppsala universitet,Öron-, näs- och halssjukdomar,Academic Hospital, Sweden
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- Hakizimana, Pierre (author)
- Linköpings universitet,Avdelningen för cellbiologi,Hälsouniversitetet,Karolinska Institute, Sweden
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- Plue, Jan (author)
- Stockholms universitet,Institutionen för naturgeografi,Stockholm University, Sweden
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- Larsson, Christina (author)
- Karolinska University Hospital, Sweden
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- Hultcrantz, Malou (author)
- Karolinska Institutet,Karolinska Institute, Sweden; Karolinska University Hospital, Sweden
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- Papatziamos, Georgios (author)
- Karolinska University Hospital, Sweden
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- Smeds, Henrik (author)
- Karolinska Institutet,Karolinska Institute, Sweden; Karolinska University Hospital, Sweden
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- Danckwardt-Lillieström, Niklas (author)
- Department of Otolaryngology, Academic Hospital, Uppsala, Sweden
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- Hellström, Sten (author)
- Karolinska Institutet,Karolinska Institute, Sweden; Karolinska University Hospital, Sweden
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- Johansson, Ann (author)
- Karolinska University Hospital, Sweden
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- Tideholm, Bo (author)
- Karolinska Institutet,Karolinska University Hospital, Sweden
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- Fridberger, Anders (author)
- Linköpings universitet,Avdelningen för cellbiologi,Hälsouniversitetet,Karolinska Institute, Sweden
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(creator_code:org_t)
- 2015-03-12
- 2015
- English.
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In: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 10:3
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
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- ref (subject category)
- art (subject category)
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Bagger-Sjöbäck, ...
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Strömbäck, Karin
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Hakizimana, Pier ...
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Plue, Jan
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Larsson, Christi ...
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Hultcrantz, Malo ...
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Papatziamos, Geo ...
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Smeds, Henrik
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Danckwardt-Lilli ...
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Hellström, Sten
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Johansson, Ann
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Tideholm, Bo
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Fridberger, Ande ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Other Medical an ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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PLOS ONE
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Stockholm University
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Uppsala University
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Karolinska Institutet
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Linköping University