Mr. Miroslav Prochazka, M. D.
Ms. Renata Tejnska, B. Sc.
Private Rehabilitation Clinic "Jarov", Prague 3, CZ

This study had been inspired by the European Medical Laser Association, and was conducted in cooperation with the ENT Department of the Jarov Policlinic and with the ENT Clinic of the Faculty Hospital FNKV Prague headed by associated professor A. Hahn, M. D.

Definition of tinnitus records that it is an auditory perception for which there is no objective sonic source from the outer environment. Tinnitus can be distinguished between Subjective Tinnitus, heard only by the patient, and Objective Tinnitus which can be - and sometimes even without hearing aids - heard also by the therapist. It is interesting that Objective Tinnitus (most frequently caused by vascular or muscular reasons) is much more rare that Subjective Tinnitus. However, it is connected with significantly better prognostic outlooks for the patient due to the fact that the causation is known to us. 

In our study, we have been dealing with patients suffering from Subjective Tinnitus only. In no case we can call it a banality. As to its occurrence, it is quite a frequent and common affection - according to a Norwegian study dated of 1996, fifteen per cent of entire population have experienced a tinitus episode some time. Its incidence rises with age significantly, according to Sejna and Marik (1990) 85 per cent of population in more than their 6th decade of age meet tinnitus, at least as an episode. We are of the opinion that ratio of subjective suffering of patients with tinnitus can be best demonstrated by their anxiety for treatment, which may sometimes be found quite desperate, including tendencies to apparently absurd techniques, or even by the frequency of their suicidiae in more dramatic cases…

Success of therapy of any disease always depends on the level of its causal impact on a particular disease or symptom. Here we can regard to tinnitus as to very unrewarding problem for its aetiology can relate either to pathology of all levels of the auditory apparatus (external ear, middle ear, inner ear, appropriate structures of the central neural syste m), or to metabolic deseases (dislipoproteinemia, diabetes), or to abuse of ototoxic matters (more than 400 matters, esp. antibiotics, total anaesthetics), or last but not least to organic or functional pathology of neck vertebra in a reflexive way (a significant connection to age as well).

As well as there is no joint cause for tinnitus, there is no universal therapy of this disease either. We can stress a significant role of prophylaxis (struggle against noise, severe use of protective aids by workers working in noisy environment, prevention regarding abuse of potentially ototoxic matters …). For years, medicamentous therapy has been based upon vasoactive medication, and antihistaminics and psychopharmacologics, too. Obviously, surgical therapy has not come across too much so far. Masking tinnitus with special suppressing aids has also been widely considered. Physiotherapy has been gaining much importance recently, aimed either at pathology of axial skeleton and muscular and skin reflexive changes being quite frequent in old age, or at the initial auditory apparatus with the help of a non-invasive laser. Patients´ anticipations have not been fulfilled by acupuncture, as some very optimistic studies comming from the Far East appear to be quite unauthentic, and clinical experience rank possible effects of such a therapy among placebo effects… However, the main benefit for patients seems to consist of combination of techniques, hitting every possible part of eaetiology of tinnitus. Such a combination must always be duly individualized and goal-directed. 

Our study was conducted in the period between July 1998 to January 1999. The study comprised 37 patients, aged 18 to 86 years (average age 60 years). With regard to sex, the group consisted of 21 females (average age 62 years) and 16 males (average age 57 years). All the patients had been examined and followed by an ENT specialist as well as by rehabilitation and physiotherapy doctor specialists. Apart from basic routine checkups all patients passed auxilliary audiograms and their cervical vertebrae were x-rayed.

With regard to the level of subjectivity of tinnitus (mind that the diagnosis itself is based upon a subjective indication of a patient - an analogy to angina pectoris suggests itself) we tried to objectify this subjectivity to maximum possible extent. We set up three scales: (i) Percentage scale (patients had evaluated their complaints 100 per cent at the beginning of therapy, adjusting this figure with regard to further development), (ii) Our own scale, analogous to five-grade pain scale utilized in our specialization, and (iii) Graphic 1 - 100 scale combined with schematic figure of face mimics on which the patient marked his/her feeling. 

Therapy was divided in three phases. With regard to our intention to qualify the importance of non invasive laser, we also decided to arrange a simple placebo trial with a device emitting no laser beam despite of audible and visible indication of proper action. All patients took medication of Egb 761 (extractum Gingko bilobae - Tanakan pills, a very considerate nootropical and vasoactive medicament significantly improving reological characteristics). This medication has been chosen on the basis of experience of our German colleagues who mention potentiation of effect of non invasive laser by parallel medication of Egb 761.

In the first phase we applied only rehabilitative therapy aimed at the axial skeleton, especially at C-vertebra. It was interesting to find functional or organic pathology on segments C5 and C6 quite frequently with the patients. Thus we got a group of patients whose tinnitus was conditioned purely by vertebral causation, and whose complaints peaked out after serious treatment of vertebral problems. The therapies used in the first phase were mobilization and manipulation techniques, and physiotherapy aimed at vertebral problems, together with activities of therapeutic physical exercise, treating particular pathologies of a certain patient as well as re-education of his/her sterotypes. 36 patients had finished this phase.

The second phase comprised, apart from medication with Egb 761 and rehabilitative therapy, also a placebo laser. Real efficacy of laser beam is always being infirmed by some medical leaders. That was why we asked MediCom Laser company to manufacture a probe without real laser beam, but with functional audible and visible controls. Due to the fact that for therapy of tinnitus we utilized an infrared laser, which was not visible with human eye, we could call this a simple blind study as neither the patients, nor the therapists could know whether the laser emitted a real working beam or not. This phase was finished by 33 patients, and in detailed statistical evaluation the success factor was higher by 3.7 per cent in comparison with phase one, this being in accordance with expected placebo effect up to 5 per cent.

In phase three we used, besides of medication and rehabilitative treatment, also a functional non invasive laser beam. We would like to stress the point of suitable wavelength and sufficient power output (i. e. emitted dosage of energy) of the laser as absolutely crucial. We are well aware that there is no universal non invasive therapy laser. For treatment of tinnitus it is necessary to have a device emitting infrared beam with a sufficient power (in the order of hundreds of miliwatts), so that we can deliver energy in the order of tens of Joules per square centimeter within a reasonable time interval. It is important to bear in mind that we attempt to go through skeleton, which is the worst possible "biological lightguide". 

Laser beam was applied at the procesus mastoideus (in the direction of counter-lateral orbit) with emitted energy dosage of 90 J/cm2 , continuous mode, followed by 45 J/cm2 with 5 Hz frequency modulation, and further on at meatus acousticus externus (in the direction of acoustic duct) with energy dosage 50 J/cm2 in continuous mode, followed by 25 J/cm2 in 5 Hz frequency, in one session on one affected ear. Unlike our colleagues from Germany and Japan, we did not apply the technique every day but mostly twice a week, with effect evaluation after 8 to 10 sessions.

Our results are given in attached table. In general, a significant move towards the level of relief after non invasive laser application in comparison with other techniques can be seen. 

From the point of view of a discussion it is interesting that, in statistically significant ratio, the rate of therapeutic success was not dependent on the time duration of tinnitus, nor on its intensity correlated with masking audiograms.

However, anamnestic data on incidention of tinnitus in connection with acoustic trauma, no matter whether long-lasting or caused by a single shock, appear as the only significant prognostic indicator. Having in mind the main effect of non invasive laser therapy - its stimulative effect - our clinical observation is quite logical: damaged structures regenerate thanks to stimulative effect of a laser beam. However, no such effect can obviously be noticed on de-vitalized structures. Furthermore, we strongly support the importance of prophylaxis of tinnitus with regard to prophylaxis of noise burden.

Results: we have quite unambiguously proven the significance of therapy with non invasive laser beam in therapy of tinnitus. In combination with comprehensive care for patients, therapy with non invasive laser is a priority from the point of view of the rate of expectation of therapeutic results. With the use of a placebo laser we have also quite convincingly came to the conclusion that our results could never be reached with a device emitting no laser light.

COMPARISON OF RESULTS

 

This study was dedicated to our tutors: Dr. O. Shonova, Dr. J. Koutny, and Dr. L. Wilden. On their shoulders we stand, and only then can we set our eyes to farthest distances of discovery…