The Role of Ozone Therapy in Treatment of Idiopathic Tinnitus

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1 Vol. 20 No. 2 July Elhaussiney Sherief et al., Therapy in Treatment of Idiopathic Tinnitus Elhaussiney Sherief, Essam Behairy, Ahmed Ragab, Sherief Zalat, Abd Elhamid Elsawy, Attala Afez, Mohamed Noamany. Abstract: Despite numerous and diverse treatment approaches for tinnitus, no single regimen has proven consistently or highly effective in the management of tinnitus. So the aim of the present study is to assess the role of ozone therapy in the treatment of idiopathic tinnitus. Forty patients suffering from idiopathic tinnitus were included in this study. The patients were classified randomly into two groups: study group of thirty patients who subjected to Ozone treatment and control group that included ten patients who subjected to placebo treatment. The procedure consisted of drawing 50 to 100 ml of blood from the patient, treating it immediately with a gaseous mixture of oxygen and ozone mixture (taken by syringe from the ozone generator and re-infused into the blood) and injecting it back into the patient by intravenous infusion. Tinnitus evaluation was done before and after treatment that included pitch matching, loudness matching, minimal masking level, and residual inhibition. Using Ozone in the present study the rate of failure was high in Ozone treated group (25/30) (83%) without significant difference between Ozone and placebo (8/10) (80%) (p>0.05). So in conclusion Ozone therapy is not a significant modality in treatment of idiopathic tinnitus. Introduction Tinnitus is a common complaint that affects an estimated 10% to 20% of the general population (Stidham et al., 2005). It is defined as the conscious experience of sound, in the ear or in the head, with absence of external acoustic stimulation (Martinez et al., 2007). The pathophysiologic mechanisms of idiopathic tinnitus (tinnitus that evoked from auditory structures and without distinct cause) remain unclear (Kleinjung et al., 2006). Despite numerous and diverse treatment approaches, no single regimen has proven consistently or highly effective in the management of tinnitus (Martinez et al., 2007). The lack of an efficient medical or surgical therapy led MMJ(July 2007)Vol 20 N:2:P the focus of research to alternative ways of treatment (Folmer, 2006). Ozone has been used for a long time as a therapeutic tool in different fields of medicine including vascular disorders, infectious diseases and orthopaedic pathologies. Ozonated autohaemotherapy (O3-AHT) is the most commonly used route of ozone administration (Bocci, 2007). Owing to the ability of ozone to activate a number of biological targets, ozone therapy could be proficiently used in some neurodegenerative diseases (Bocci,2007). So the application of ozone in treatment of idiopathic tinnitus may be helpful. That is due to the mechanism of action of ozone that can overcome the

2 Vol. 20 No. 2 July Elhaussiney Sherief et al., proposed etiological factors. Ozone could increase the oxygenation of the ischemic tissues (Bocci, 2007). Ozone as well exhibits immune modulatory effect (Halliwell et al.,2000; Bocci,2006). So, there are many meeting points that can be the base for the application of ozone in treatment of idiopathic tinnitus. From another point of view, ozone can also play a role in management of tinnitus as it can act in a similar way that some drugs act for management of idiopathic tinnitus. For example, prostaglandin E 2 via the vasodilatory effect on the blood vessels could enhance blood flow through the microvasculature of the inner ear. Ginkgo biloba and hyperbaric oxygen could increase the blood supply to the brain and therefore, improve O2 supply to the inner ear. So the aim of the present study is to assess the role of ozone therapy in the treatment of idiopathic tinnitus. Patients and Methods;- Forty patients suffering from idiopathic tinnitus who were presented to the department of Otorhinolaryngology, Menofiya University hospital were enrolled in the present study. The patients were classified randomly into two groups: 1-Study group: that included thirty patients who subjected to Ozone treatment protocol. 2-Control group: that included ten patients who subjected to placebo treatment. Table 1: Grading Of tinnitus: Idiopathic tinnitus was diagnosed after: history taking, otorhinolaryngology examination, general medical examination and audiological test battery (pure tone audiometry, speech audiometry and impedance audiometry). ABR is performed when a retrocochlear lesion (as acoustic neuroma) is suspected as in asymmetrical SNHL, decreased speech discrimination or unilateral tinnitus. Also laboratory investigations were obtained that included: complete blood count, lipid profile, serum glucose level, sedimentation rate, liver & kidney function tests and bleeding profile. All patients had tinnitus that was not associated with any other otological symptoms as SNHL or vertigo, and without apparent disease of the external or middle ear e.g. wax impaction, perforation or inflammation. Causes of pulsatile tinnitus e.g. vascular and muscular causes were also excluded. Also patients with hormonal changes (pregnancy or menopause), thyroid dysfunction, vitamin B12 deficiency, G-6PD (favism), patients being treated with ACE inhibitors, thrombocytopenia and anemia patients were also included in the exclusion criteria. Tinnitus evaluation was done that included pitch matching, loudness matching, minimal masking level, and residual inhibition. Grading of tinnitus was done as follows as shown in table 1. Mild Moderate Severe Tinnitus is audible only in quiet environments Tinnitus is audible only in ordinary acoustic environments, but masked by loud environmental sounds; it can disturb going to sleep, but not sleep in general Tinnitus is audible in all acoustic environments, disturbs going to sleep, can disturb sleep in general, and is a dominating problem that affects quality of life (Baguley et al, 2006 ).

3 Vol. 20 No. 2 July Elhaussiney Sherief et al., Treatment protocol: After fulfilling the inclusion criteria and the exclusion criteria; the patients were submitted to the ozone therapy session using the AHT (auto-haemotherapy). The treatment sessions were done in the pain therapy unit using the ozone generator. The procedure consisted of drawing 50 to 100 ml of blood from the patient, treating it immediately with a gaseous mixture of oxygen and ozone mixture (taken by syringe from the ozone generator and re-infused into the blood) in a 1:1 volume relationship, for at least five minutes and injecting it back into the patient by intravenous infusion. It is important that the exposure of blood to the gas mixture lasts at least 5 min. Because blood is very viscous, it takes 5-10 min to achieve a complete and homogenous equilibrium. In the present study, citrate was used as an anticoagulant, which may at least in part explain the lack of effects of O3-AHT on the extent of platelet aggregation. Our approach has been to perform 2 sessions weekly for 10 sessions as already done using the ischemia regimen of ozone therapy. During the treatment course, there was a reevaluation to assess the progress of recovery. The re-evaluation was done after the fifth and tenth session. The placebo group received blood auto transfusion (patient receive his own blood after withdrawal from the same patient). Recovery assessment: The tinnitus status post treatment was re-evaluated on the basis of tinnitus evaluation tests and therefore classified into: cured (disappearance of tinnitus), improved and no effect (failed). A decrease in tinnitus loudness by at least 10 db was accepted as clinically favorable progress (improvement).the improvement also included the decrease in the tinnitus frequency and tinnitus grade. The same variables that considered influencing the response to treatment were analyzed. These variables were: patient age, sex and tinnitus (duration, character, grade, intensity matching, frequency matching and the possibility of masking). Results In the present study, forty patients were included, 19 males and 21 females. The mean age was 38.6 with a range of 20 to 59 years. Thirty six patients were complaining of tinnitus in both sides and 4 in one side. The character of tinnitus was whistling character in 15 patients, roaring in 9 patients and whistling and roaring in 16 patients. The duration of tinnitus was less than 2 months in 26 patients and with 2 months or more in 14 patients. High pitched frequency tinnitus was detected in 25 patients, mid frequency in 5 patients and low pitch frequency in 10 patients. Three patients with tinnitus intensity from 20 to 29 db, 27 with tinnitus intensity from 30 to 39 db and 10 with tinnitus intensity from 40 to 49 db. According to tinnitus grade (table 1) there were 4 patients with tinnitus grade I, 23 with tinnitus grade II, 13 with tinnitus grade III; 28 patients with minimal masking pitch of high frequency, 6 with mid frequency and 6 with low frequency. Using Ozone in the present study the rate of failure was high in Ozone treated group (25/30) (83%) without significant difference between Ozone and placebo (8/10) (80%) p>0.05 (Table 1).

4 Vol. 20 No. 2 July Elhaussiney Sherief et al., Table (2) Tinnitus improvement after treatment with ozone versus placebo in patients with State of Tinnitus condition after treatment : Total Tinnitus group treated with ozone NO % idiopathic tinnitus. Tinnitus group treated with Placebo NO % This table shows that there was no statistical significance difference regarding tinnitus improvement in patients treated with ozone versus placebo (p-value > 0.05). Tables that study the effects of different variables on tinnitus improvement with ozone versus placebo were presented in (tables (3,4,5,6,7).

5 Vol. 20 No. 2 July Elhaussiney Sherief et al., Tinnitus Table (3) Relation of age and sex differences to tinnitus improvement with ozone versus placebo in patients with idiopathic tinnitus. Ozone Placebo Studied variables ( n = 2 ) ( n = 3 ) ( n = 25 ) Improve d ( n = 8 ) Test of significance P- value Age : years years years years > 0.05 Female Total Sex: This table shows that there was no statistical significance differences in the age and sex between tinnitus treated with ozone versus tinnitus treated with placebo (p-value > 0.05). - > 0.05

6 Vol. 20 No. 2 July Elhaussiney Sherief et al., Table (4) The relation of tinnitus character to the degree of tinnitus improvement in patients with idiopathic tinnitus treated with ozone versus placebo Tinnitus Ozone Placebo Studied variables ( n = 2 ) ( n = 3 ) ( n = 25 ) ( n = 8 ) Test of significance P- value Character: Whistling Roaring Whistling and Roaring > 0.05 Total * Significant ** Highly significant This table shows that there was no statistical significance differences in the tinnitus character between tinnitus treated with ozone versus placebo (p-value > 0.05). -

7 Vol. 20 No. 2 July Elhaussiney Sherief et al., Table (5) The relation of tinnitus duration to the degree of tinnitus improvement in patients with idiopathic tinnitus treated with ozone versus placebo Tinnitus Ozone Placebo Studied variables ( n = 2 ) ( n = 3 ) ( n = 25 ) No Improve d ( n = 8 ) Test of significance P- value Duration < 2 months months > 0.05 Total * Significant ** Highly significant This table shows that there was no statistical significance differences in the tinnitus duration between tinnitus patients treated with ozone versus placebo (p-value > 0.05).

8 Vol. 20 No. 2 July Elhaussiney Sherief et al., Table (6) the relation between different tinnitus studied variables and improvement in patients with idiopathic tinnitus treated with ozone versus placebo Studied variables ( n = 2 ) Ozone Placebo Test of significance P- value ( n = 3 ) ( n = 25 ) ( n = 8 ) Pitch matching : High Mild Low Loudness matching: db > db db < 0.05* Minimal masking pitch : High Mild Low Total > 0.05 * Significant ** Highly significant This table shows that there were no statistical significance differences in the tinnitus pitch as well as minimal masking pitch between tinnitus with ozone and tinnitus with placebo (p-value > 0.05). On the other hand, there was a statistical significance differences in the tinnitus loudness between tinnitus patients treated with ozone versus placebo (p-value < 0.05).

9 Vol. 20 No. 2 July Elhaussiney Sherief et al., Table (7) the relation between tinnitus grades and improvement in patients with idiopathic Tinnitus Ozone Placebo Studied variables Grade : I II III Total ( n = 2 ) ( n = 3 ) ( n = 25 ) No Improve d ( n = 8 ) Test of significance 32.3 P- value < 0.05* * Significant ** Highly significant This table shows that there was statistical significance differences in the pretreatment tinnitus grade between tinnitus with ozone and tinnitus with placebo (p-value < 0.05) in which ozone therapy succeeded more in little grade of tinnitus (100% cure of tinnitus grade I) and the more increase the grade the more suspected failure of ozone therapy.

10 Vol. 20 No. 2 July Elhaussiney Sherief et al., Discussion In the present randomized placebo controlled clinical trial, we presented forty patients who were diagnosed as having idiopathic tinnitus. In order to estimate the recovery rate, we grouped the patients who were cured or improved together, so both of them are considered to have a recovery. Our treatment protocol had a recovery rate of 17% in comparison to the control group which had a recovery rate of 20%. We suggested that, the different actions exerted by ozone didn t have significant effect upon idiopathic tinnitus and didn t interfere with the pathophysiological mechanisms of idiopathic tinnitus. The hypothetical background of tinnitus generation that were not confirmed and qualified well till now may have a role in the failure of ozone therapy (Kleinjung et al.,2006). The possibility of insufficiency of the total treatment duration may be also another cause of failure. The low rate of tinnitus recovery after Ozone treatment may be due to the lack of pretreatment psychological assessment to distinguish the psychological aspect of tinnitus. Although the psychological background of tinnitus is still not clearly accepted. The psychological effects can be observed in TRT (tinnitus retraining therapy) studies that use a team of physicians, audiologists, and psychologists in a program that combines counseling and noise generators (Lockwood et al., 2002). There were a group of variables that had been studied for there relation to the recovery. These variables included: patient age, gender, duration, site, character, and grade of tinnitus, intensity matching, frequency matching and the possibility of masking. On studying these supposed prognostic factors that could affect the treatment outcome, we found that the pretreatment tinnitus loudness (by tinnitus intensity matching) and the grade of tinnitus was significantly affecting the outcome as the low tinnitus grade and loudness carried a better chance for recovery. The other studied variables didn't affect the outcome. The absence of any significant relations between most of the variables and the outcome after ozone therapy was due to the failure of our method in treating patients with idiopathic tinnitus. On the other hand, most of these variables seem not to have any prognostic effects to a significant degree with any other therapeutic modalities. (Lockwood et al., 2002) We suggest that the grade of tinnitus which is a subjective method for tinnitus assessment was in direct relation to the loudness of tinnitus that is estimated via the tinnitus intensity matching. This is accepted in our reported relation between ozone therapy and pretreatment tinnitus grade and intensity. This significant relation means that the less pretreatment tinnitus grade and intensity, the more suspected recovery with ozone therapy. We presumed that the less tinnitus grade and intensity is associated with a less pathological affection and so can be corrected and reversed, especially with the weak potentiality of ozone therapy in idiopathic tinnitus. Bocci,2006 reported that during ozone therapy many patients exhibited feeling of wellness and euphoria. He explained this feeling as a result of metabolic improvement and enhancement of neurotransmission release that in turn modify the patients mood. This effect could explain the tinnitus improvement after ozone therapy especially when the limbic system is involved in order to disrupt the associative link formed between the tinnitus-generating activity in the auditory system and the emotion-generating autonomic/limbic system of the brain (Sahley 2001).

11 Vol. 20 No. 2 July Elhaussiney Sherief et al., Conclusion Ozone therapy is not a significant modality in treatment of idiopathic tinnitus. The pretreatment tinnitus intensity and grade were shown to be significantly related to outcome in idiopathic tinnitus as they have shown good prognosis in less tinnitus intensity and grade. References 1. Baguley DM, Humphriss RL, Axon PR, Moffat DA. The Clinical Characteristics of Tinnitus in Patients with Vestibular Schwannoma. Skull Base Journal May; 16(2): Bocci V. Scientific and medical aspects of ozone therapy. State of the art, Arch Med Res 37, 2006, pp Bocci V. Tropospheric Ozone Toxicity vs. Usefulness of Ozone Therapy. Archives of Medical Research: Volume 38, Issue 2, February 2007, Pages Folmer RL, Carroll JR. Long- Term Effectiveness of Ear-Level Devices for Tinnitus. American Academy of Otolaryngology Head and Neck Surgery Foundation Inc. January 2006: Volume 134, Issue 1, Page Halliwell B, Clement MV, Long LH. Hydrogen peroxide in the human body, FEBS Lett 486; 2000, pp Kleinjung T, Steffens T, Strutz J, Eichhammer P, Hajak G, Langguth B [Transcranial magnetic stimulation for the treatment of tinnitus]hno Sep;54(9): Review. 7. Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. N Engl J Med Sep 19;347(12): Martinez Devesa P, Waddell A, Perera R, Theodoulou M., Cognitive behavioural therapy for tinnitus. Cochrane Database Syst Rev Jan 24;(1). 9.Sahley T.L and Nodar R.H. Tinnitus: present and future. Lippincott Williams & Wilkins, Inc. Volume 9(5), October 2001, pp Stidham KR, Solomon PH, Roberson JB. Evaluation of botulinum toxin A in treatment of tinnitus. Otolaryngol Head Neck Surg Jun;132(6):883-9.

12 Vol. 20 No. 2 July Elhaussiney Sherief et al., الملخص العربي يعتبر طنين الا ذن مجهول السبب من التحديات التي تواجه العديد من الا طباء وذلك حيث أن القصور ف ي إدراك آيفية حدوث الخلل يقف عاي قا أمام تحديد علاج مح دد وفع ال لطن ين الا ذن فيع رف با ن ه إدراك لا ص وات متع ددة الصور تنبعث من الرأس مع غياب مو ثر سمعي حقيقي وهذا بالطبع يختلف عن م ا يع رف ب الهلاوس ال سمعية. أما أسباب هذا الطنين فقد يمكن تحديد مصدرها س واء آان ت ب سبب اض طرابات دموي ة أو ع ضلية ولك ن الغال ب هو عدم إمكانية معرفة سبب هذا الطن ين وعلي ه يع رف ب الطنين مجه ول ال سبب وه ذا الن وع ه و مح ل الدراس ة والبح ث. ف ى ه ذه الدراس ة ي تم تقي يم الع لاج ب الا وزون ف ي طن ين الا ذن مجه ول ال سبب ودراس ة م دي فاعليت ه ونجاحه في العلاج فى ٤٠ مريضا وذلك بعد تشخيص المرض من خلال التاريخ المرضى الكشف الا آلينيكي فحوصات السمع والتحاليل الطبية آم ا ت م تق يم الطن ين م ن خ لال المقارن ة ب ين درج ة وت ردد الطن ين وإمكاني ة الا خفاء والا ثر المترسب وتحديد درجة الطنين (طفيف متوسط قوى) ولقد تم اختيار ٣٠ مريض عشواي يا للعلاج بالا وزون والباقون (١٠ مرضي) تم تطبيق العلاج الارضاي ى لهم. نتاي ج البحث: ان نسبة نجاح الا وزون لعلاج الطنين مجهول السبب لم تتجاوز % ١٧ مقارن ة ب ٢٠ % للع لاج الارضاي ي. ان درجة الطنين و شدتة من العوامل التي تو ثر علي نتيجة العلاج. وب دلك ت ستنتج ه ذه الدراس ة أن العلاج بالا وزون يحقق نجاحا بسيطا.

Preface. system has put emphasis on neuroscience, both in studies and in the treatment of tinnitus.

Preface. system has put emphasis on neuroscience, both in studies and in the treatment of tinnitus. Tinnitus (ringing in the ears) has many forms, and the severity of tinnitus ranges widely from being a slight nuisance to affecting a person s daily life. How loud the tinnitus is perceived does not directly