Hoffmann 1995a.
Methods | Randomised controlled trial | |
Participants | 44 participants with ISSHL for more than 6 months | |
Interventions | Control (22): air breathing at 1.5 ATA for 45 minutes daily, 5 days each week for 3 weeks HBOT (22): 100% oxygen breathing at 1.5 ATA on the same schedule as controls |
|
Outcomes | Improved hearing and tinnitus | |
Notes | Rank 2 for sample size (chronic hearing loss): 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 | Method of randomisation not clear "forty‐five patients....were randomised into a HBO group and a control group" |
Allocation concealment (selection bias) | Unclear risk | No mention of any attempt to conceal allocation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Patients and outcome assessors blind "In order to exclude uncontrolled placebo effects, the control group were dealt completely in the same manner as the HBO group ...in the chamber." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One patient lost, no explanation |
Selective reporting (reporting bias) | Low risk | No indication of missing outcomes |
Other bias | Low risk | No obvious other sources of bias |