Otorinolaringoiatria

Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss

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Ragab, A.; E. Shreef; E. Behiry; S. Zalat & M. Noaman, Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss. Journal of Laryngology and Otology 123(1): 54-60, 2009.

 

Abstract

OBJECTIVE:
To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss.
DESIGN:
Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial.
SUBJECTS:
Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient’s blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates.
RESULTS:
Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p < 0.05). Mean hearing gains, pure tone averages, speech reception thresholds and subjective recovery rates were significantly better in ozone-treated patients compared with placebo-treated patients (p < 0.05).
CONCLUSION:
Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.