Skip to main content
. 2009 Oct 7;2009(4):CD003422. doi: 10.1002/14651858.CD003422.pub4

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
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).
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