Hoffmann 1995b.
Methods | Randomised controlled trial | |
Participants | 20 participants with ISSHL, with or without tinnitus. All participants had no improvement after 14 days of pharmacological treatment with hydroxyethyl starch, pentoxifylline and cortisone. | |
Interventions | Control (10): no treatment HBOT (10): 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 | Audiometry at 3 months, subjective tinnitus scale | |
Notes | Rank 6 for sample size: power to detect mean hearing improvement of 20 dB more in active group than control < 80% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement of sequence generation "20 patients were randomised " |
Allocation concealment (selection bias) | Unclear risk | No mention of concealment |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding for any party "...an untreated control group..." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No apparent losses to follow‐up, numbers not clearly reported |
Selective reporting (reporting bias) | Low risk | No indication of missing outcomes |
Other bias | Low risk | No obvious other sources of bias |