Ni 2004.
| Methods | Double blind, randomised controlled trial | |
| Participants | 52 patients (aged 12 to 66 years), randomly assigned to 2 different treatment groups. Gender data were unavailable. | |
| Interventions | Group 1: carbogen and drug course (IV dexamethasone + vitamin B + LMW dextran + salvise miltiorrhiaze + oral intake of vitamin C + vitamin E); carbogen inhalation for 30 minutes, 30 minutes break followed by another 30 minutes of inhalation Group 2: drug course only |
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| Outcomes | 1. Complete recovery: normal hearing in 0.25 to 4 kHz frequency range
2. Significant recovery: > 30 dB in 0.25 to 4 kHz frequency range
3. Some recovery: 15 to 30 dB in 0.25 to 4 kHz frequency range The proportion of patients who had some degree of recovery was 76.9% in group 1 (treatment) and in group 2 (control) was 50 %. The difference in outcome between the 2 groups reached statistical significance (P < 0.05). |
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| Notes | Adverse effects: 5 patients in group 1 (treatment, carbogen) complained of a sensation of swelling in the area of the head, which settled spontaneously and did not interfere with their treatment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | Allocation concealment up to the point of assignment |