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

Published online by Cambridge University Press:  17 October 2008

A Ragab*
Affiliation:
Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt
E Shreef
Affiliation:
Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt
E Behiry
Affiliation:
Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt
S Zalat
Affiliation:
Department of Anesthesiology, Menofia University Hospital, Egypt
M Noaman
Affiliation:
Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt
*
Address for correspondence: Professor Ahmed Ragab, Lecturer and Consultant, ORL Head and Neck Surgery Department, Menofia University Hospital, 73 Sayed St, Tanta, Egypt. Fax: 00 20 40 3315000 E-mail: ahmedragab2000@hotmail.com

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.

Type
Main Articles
Copyright
Copyright © JLO (1984) Limited 2008

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