The Journal of Laryngology & Otology

Main Articles

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

A Ragaba1 c1, E Shreefa1, E Behirya1, S Zalata2 and M Noamana1

a1 Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt

a2 Department of Anesthesiology, Menofia University Hospital, Egypt

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.

(Accepted July 24 2008)

(Online publication October 17 2008)

Correspondence:

c1 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

Footnotes

Professor A Ragab takes responsibility for the integrity of the content of the paper.

Competing interests: None declared