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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 ,
E Shreef ,
E Behiry ,
S Zalat  and
M Noaman
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
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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.

Keywords

Sensorineural Hearing LossSudden Hearing LossOzone
Type
Main Articles
Information
The Journal of Laryngology & Otology , Volume 123 , Issue 1 , January 2009 , pp. 54 - 60
Copyright
Copyright © JLO (1984) Limited 2008

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References

1 Byl, FM. Sudden hearing loss: Eight years experience and suggested prognostic table. Laryngoscope 1984;94:647–61CrossRefGoogle ScholarPubMed
2 Simmons, FB. Sudden idiopathic sensorineural hearing loss: some observations. Laryngoscope 1973;83:1221–7CrossRefGoogle ScholarPubMed
3 Wilson, WR, Byl, FM, Laird, N. The efficacy of steriods in the treatment of idiopathic sudden hearing loss. Arch Otolaryngol 1980;106:772–6CrossRefGoogle Scholar
4 Wilson, WR, Veltri, RW, Laird, N, Sprinkle, PM. Viral and epidemiologic studies of idiopathic sudden hearing loss. Otolaryngol Head Neck Surg 1983;91:653–8CrossRefGoogle ScholarPubMed
5 Horn, CE, Himel, HN, Selesnick, SH. Hyperbaric oxygen therapy for sudden sensorineural hearing loss: a prospective trial of patients failing steroid and antiviral treatment. Otol Neurotol 2005;26:882–9CrossRefGoogle ScholarPubMed
6 Simmons, FB. Theory of membrane breaks in sudden hearing loss. Arch Otolaryngol 1968;88:41–8CrossRefGoogle ScholarPubMed
7 Merchant, SN, Adams, JC, Nadol, JB Jr. Pathology and pathophysiology of idiopathic sudden sensorineural hearing loss. Otol Neurotol 2005;26:151–60CrossRefGoogle ScholarPubMed
8 Schuknecht, HF. Pathology of the Ear, 2nd edn. Philadelphia: Lea & Febiger, 1993Google Scholar
9 Mattox, DE, Simmons, FB. Natural history of sudden sensorineural hearing loss. Ann Otol Rhinol Laryngol 1977;86:463–80CrossRefGoogle ScholarPubMed
10 Doyle, KJ, Bauch, C, Battista, R, Beatty, C, Hughes, GB, Mason, J et al. Intratympanic steroid treatment: a review. Otol Neurotol 2004;25:1034–9CrossRefGoogle ScholarPubMed
11 Travagli, V, Zanardi, I, Bocci, V. A realistic evaluation of the action of ozone on whole human blood. Int J Biol Macromol 2006;39:317–20CrossRefGoogle ScholarPubMed
12 Halliwell, B, Clement, MV, Long, LH. Hydrogen peroxide in the human body. FEBS Lett 2000;486:10–13CrossRefGoogle ScholarPubMed
13 Bocci, VA. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res 2006;37:425–35CrossRefGoogle ScholarPubMed
14 Madej, P, Plewka, A, Madej, JA, Nowak, M, Plewka, D, Franik, G et al. Ozonotherapy in an induced septic shock. I. Effect of ozonotherapy on rat organs in evaluation of free radical reactions and selected enzymatic systems. Inflammation 2007;30:52–8CrossRefGoogle Scholar
15 Di Paolo, N, Bocci, V, Salvo, DP, Palasciano, G, Biagioli, M, Meini, S et al. Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. Int J Artif Organs 2005;28:1039–50CrossRefGoogle ScholarPubMed
16 Di Paolo, N, Gaggiotti, E, Galli, F. Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Rep 2005;10:121–30CrossRefGoogle ScholarPubMed
17 Weng, SF, Chen, YS, Hsu, CJ, Tseng, FY. Clinical features of sudden sensorineural hearing loss in diabetic patients. Laryngoscope 2005;115:1676–80CrossRefGoogle ScholarPubMed
18 Eisenman, D, Arts, HA. Effectiveness of treatment for sudden sensorineural hearing loss. Arch Otolaryngol Head Neck Surg 2000;126:1161–4CrossRefGoogle ScholarPubMed
19 Aoki, D, Takegoshi, H, Kikuchi, S. Evaluation of super-high-dose steroid therapy for sudden sensorineural hearing loss. Otolaryngol Head Neck Surg 2006;134:783–7CrossRefGoogle ScholarPubMed
20 Choung, YH, Park, K, Shin, YR, Cho, MJ. Intratympanic dexamethasone injection for refractory sudden sensorineural hearing loss. Laryngoscope 2006;116:747–52CrossRefGoogle ScholarPubMed
21 Xenellis, J, Papadimitriou, N, Nikolopoulos, T, Maragoudakis, P, Segas, J, Tzagaroulakis, A et al. Intratympanic steroid treatment in idiopathic sudden sensorineural hearing loss: a control study. Otolaryngol Head Neck Surg 2006;134:940–5CrossRefGoogle ScholarPubMed
22 Gianoli, GJ, Li, JC. Transtympanic steroids for treatment of sudden hearing loss. Otolaryngol Head Neck Surg 2001;125:142–6CrossRefGoogle ScholarPubMed
23 Battista, RA. Intratympanic dexamethasone for profound idiopathic sudden sensorineural hearing loss. Otolaryngol Head Neck Surg 2005;132:902–5CrossRefGoogle ScholarPubMed
24 Tucci, DL, Farmer, JC Jr, Kitch, RD, Witsell, DL. Treatment of sudden sensorineural hearing loss with systemic steroids and valacyclovir. Otol Neurotol 2002;23:301–8CrossRefGoogle ScholarPubMed
25 Uri, N, Doweck, I, Cohen-Kerem, R, Greenberg, E. Acyclovir in the treatment of idiopathic sudden sensorineural hearing loss. Otolaryngol Head Neck Surg 2003;128:544–9CrossRefGoogle ScholarPubMed
26 Gordin, A, Goldenberg, D, Golz, A, Netzer, A, Joachims, HZ. Magnesium: a new therapy for idiopathic sudden sensorineural hearing loss. Otol Neurotol 2002;23:447–51CrossRefGoogle ScholarPubMed
27 Psifidis, AD, Psillas, GK, Daniilidis, JCh. Sudden sensorineural hearing loss: long-term follow-up results. Otolaryngol Head Neck Surg 2006;134:809–15CrossRefGoogle ScholarPubMed
28 Suzuki, H, Furukawa, M, Kumagai, M, Takahashi, E, Matsuura, K, Katori, Y et al. Defibrinogenation therapy for idiopathic sudden sensorineural hearing loss in comparison with high-dose steroid therapy. Acta Otolaryngol 2003;123:46–50CrossRefGoogle ScholarPubMed
29 Zadeh, MH, Storper, IS, Spitzer, JB. Diagnosis and treatment of sudden-onset sensorineural hearing loss: a study of 51 patients. Otolaryngol Head Neck Surg 2003;128:92–8CrossRefGoogle ScholarPubMed
30 Cinamon, U, Bendet, E, Kronenberg, J. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. Eur Arch Otorhinolaryngol 2001;258:477–80CrossRefGoogle ScholarPubMed
31 Slattery, WH, Fisher, LM, Iqbal, Z, Friedman, RA, Liu, N. Intratympanic steroid injection for treatment of idiopathic sudden hearing loss. Otolaryngol Head Neck Surg 2005;133:251–9CrossRefGoogle ScholarPubMed