Pilgramm 1985.
Methods | Randomised controlled trial | |
Participants | 1. Acute hearing loss (< 14 days since onset). 37 patients with hearing loss and/or tinnitus, 18 allocated to HBOT group and 19 to control. 2. Chronic hearing loss (14 days to 1 year since onset). 51 patients with hearing loss and/or tinnitus; 26 allocated to HBOT, 25 to control. |
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Interventions | Control: vasodilator therapy: 500 ml of 10% dextran‐40 and sorbitol 5% daily for 14 days, plus daily naphtidrofuryl hydogenaxalate 600 mg and vitamin B orally HBOT: as above, plus 60 minutes daily breathing 100% oxygen at 2.5 ATA for 10 days |
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Outcomes | Improvement in average hearing threshold by audiometry and improvement in tinnitus. Both assessed at 4 weeks from presentation. | |
Notes | Translated in detail by MP Rank 5 for sample size (acute hearing loss): 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) | Low risk | Computer‐generated sequence "All patients were randomized into a specific treatment group by computer and were maintained in these groups." |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment |
Blinding (performance bias and detection bias) All outcomes | High risk | No description of blinding for any party |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6 individuals withdrew from treatment but it is not clear if they contributed to the analysis |
Selective reporting (reporting bias) | Low risk | No indication of missed outcomes |
Other bias | Low risk | No other obvious source of bias |