Schwab 1998.
Methods | Randomised controlled trial | |
Participants | 75 participants with sudden hearing loss with at least 20 dB loss in 1 or more frequencies and/or tinnitus, seen within 2 weeks and without any prior therapy | |
Interventions | Control (38): no treatment HBOT (37): 100% oxygen at 1.5 ATA for 45 minutes daily, 5 days each week for 2 to 4 weeks (10 to 20 sessions) |
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Outcomes | Audiometric hearing and tinnitus improvement | |
Notes | Rank 1 for sample size: power > 80% to detect an increase in proportion of participants with significant return of hearing | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of allocation sequence "75 patients were randomly assigned to one of two treatment groups" |
Allocation concealment (selection bias) | Unclear risk | No mention of attempt to conceal allocation |
Blinding (performance bias and detection bias) All outcomes | High risk | No attempt to blind any party |
Incomplete outcome data (attrition bias) All outcomes | High risk | This trial did not report results for seven participants with ISSHL and 11 with tinnitus. No strategy for dealing with this was identified |
Selective reporting (reporting bias) | Low risk | No indication of missed outcomes |
Other bias | Low risk | No other obvious source of bias |