Études cliniques

relatives au low level laser chez les patients acouphéniques

Evaluation of the customer satisfaction among users of the EarNoiseEliminator MedicLaser

IHA-GfK, Finn Andersen, Gabriele Deterville, ISO-Zertifiziert (ISO-9001), nach Normen des Swiss-Interview
The IHA-GfK is the most renowned institut of market study in Switzerland. The results given and statements made in this presentation correspond 100% to the data collected and are fully valid.

A total of 141 patients were interviewed. After the MedicLaser + EarNoiseEliminator treatment, the results were very promising. It has been shown and can be assessed that other known marketed therapies did not reach the same value.

The Soft Laser EarNoiseEliminator is used to treat tinnitus in 96% of cases. 56% do not know the cause of this complaint. The main causes of the complaint were named as illness, stress and work, as well as serving in the armed forces. 42% of the respondents had used the Soft Laser EarNoiseEliminator for 3 months. For 65% of those affected, the complaint had been reduced by up to 25%, for 20% between 25% and 49% and, for 9%, by 50%-100%. The longer the period of use, the greater the success of the treatment. On a scale of 0 to 9, satisfaction with the Soft Laser EarNoiseEliminator achieved an over average of 4.8. Satisfaction with the Soft Laser EarNoiseEliminator increased in proportion to the length of use as well as with the extent to which the complaint had been reduced. 18% also used the Soft Laser EarNoiseEliminator for other forms of treatment, such as for joints, acne, scars and arthrosis. The satisfaction of those respondents who had also used the Soft Laser EarNoiseEliminator for other forms of treatment achieved overall a good score of 6.38 on a scale of 0 to 9. Overall satisfaction with the Soft Laser EarNoiseEliminator increased with length of use. 54% of the respondents would buy the Soft Laser EarNoiseEliminator again. 67% would recommend the Soft Laser EarNoiseEliminator to others.

Thérapie laser à basse énergie pour le traitement des acouphènes avec le EarNoiseEliminator EarLaser

Dott. Domenico Cuda, Dott. Antonio R. de Caria, département ORL- Clinique de Piacenza, Italie
L'étude sans aucun doute la plus pertinente concernant le traitement par EarNoiseEliminator Earlaser a été réalisée en Italie. En 2007, dans le cadre d'une étude en double aveugle, le centre de traitement des acouphènes de la division ORL de la clinique de Piacenza a traité 46 patients (27 hommes et 19 femmes) souffrant d'acouphénie, avec le EarNoiseEliminator EarLaser. Ces lasers à lumière froide disposent d'une puissance de plus de 5mW, et présentent une longueur d'onde de 650 nm.

Les mesures ont été évaluées à l'aide du système d'évaluation standardisé THI (Tinnitus Handicap Inventory -selon Dr. Newman). L'amélioration constatée après les traitements était significative. La différence entre le groupe testé et le groupe placebo était elle aussi significative. Au total, les résultats ont montré une amélioration dans 88 % des cas. Chez 62 % des patients traités, l'amélioration était très significative (d'une catégorie selon le THI). Dans 11,6 % des cas, l'amélioration a même été tout à fait remarquable (de 2 catégories selon le THI).

Double-blind study for low-level-laser-therapy in patients with chronic cochlear dysfunction

Dr. Stefan Tauber et al., HNO-Universitätsklinik und Laser Forschungslabor, Universität München
In a double-blind placebo-controlled study low-level-laser light was applied to 175 patients with chronic tinnitus. The patients received 3 single irraditations with different diode-laser with 635-830 nm and dosages from 4 to 100 Joule/cm2.

Low-level laser therapy for chronic tinnitus has been well tolerated without side effects. In general higher dosages caused to a stronger attenuation of tinnitus.

In comparison to placebo:
- tinnitus loudness is improved by laserlight of 780 nm
- tinnitus is attenuated by laserlight between 690 and 830 nm concerning visual analogue scales of 5 different parameters.
- total tinnitus score has been improved by irradiation with laserlight of 635 up to 830 nm.
Regarding those results, tinnitus-laser offers an innovative and secure way of effective tinnitus treatment in patients with chronic tinnitus. Tinnitus-lasers are a new therapeutic system for chronic cochlear tinnitus without risk of side-effects.

Neural correlates of transmeatal cochlear laser (TCL)

Christian M. Siedentopf, Department of Radiology II, Division of Neuroradiology, University Hospital of Innsbruck, Austria
Transmeatal cochlear laser (TCL) treatment has recently been proposed as a therapeutic procedure for cochlear dysfunction such as chronic cochlear tinnitus or sensorineural hearing loss. The aim of this study was to investigate whether TLC has any influence on the central nervous system using functional MRI with healthy young adults. The laser stimulation device was placed on the tympanic membrane of both ears. A laser stimulation run and a placebo run were performed in random order. The participants were unable to differentiate between verum and placebo stimulation. In the comparison of verum to placebo runs, we observed significant activations within the left superior frontal gyrus, the right middle and medial frontal gyrus, the right superior parietal lobule, the left superior occipital gyrus, the precuneus and cuneus bilaterally, the right anterior and the left and right middle and posterior cingulate gyrus and the left thalamus. This network of brain areas corresponds well to results from previous PET studies of patients with tinnitus. Though TCL seems to have a clinically measurable effect on the central nervous system the neurophysiological mechanism leading to the observed activated neuronal network remains unknown.

Laserbehandlung bei Tinnitus-Patienten

Dr. Beyer, Dr. Tauber
Untersuchungen über die räumliche Verteilung des Lichts in der Gehörschnecke wurde mit unterschiedlichen Wellenlängen von der Arbeitsgruppe Dr. Beyer und Dr. Tauber des Laser- Forschungslabors des Klinikums Großhadern (Universität München) durchgeführt. Es wurde eine Leistungsdichte von 4J/cm2 an der Gehörschnecke erreicht. Mit diesem Parameter wurden 30 Patienten innerhalb von 2 Wochen behandelt, von denen 40% leichte bis signifikante Besserungen beschrieben.

Die Erfolge der Studien zeigen: Laserlicht trägt zur Verbesserung des Tinnitus bei. Die Leistung des Softlasers ist so berechnet, dass mit einer Behandlungszeit von 15-30 min die notwendige Leistungsdichte an der Gehörschnecke erreicht wird, um eine erfolgreiche Behandlung durchzuführen.

Von der Ohrmuschel reicht der äußere Gehörgang ins Innere des Ohrs hinein, daran anschließend befindet sich das Trommelfell. Über das Trommelfell werden die Schallwellen zum Innenohr geleitet, das von einer harten Knochenkapsel umgeben ist und aus einem verzweigten System von Gängen und Hohlräumen besteht, die mit Flüssigkeit gefüllt sind. In dieser knöcherne Schnecke befinden sich die Hörsinneszellen.

Akute oder chronische Überlastungen der Hörschnecke führen zu einer Überforderung der in ihr arbeitenden Hörzellen, woraus eine Schädigung der Hörzellen resultieren kann. Folgen sind z.B. Druck im Ohr, akuter Hörsturz, akuter oder beginnenden Tinnitus, Hörverzerrung, Schwerhörigkeit oder Schwindel.

Durch die natürliche Einbettung der Gehörschnecke in den Schädel ist sichergestellt, dass die Laserstrahlung des Softlasers durch das Trommelfell genau zu den Hörzellen gelangt und so die oben genannten Symptome behandelbar sind.

Low-Level Laser Terapia (LLLT) per il trattamento degli acufeni

Dott. R. Teggi, Dott. C. Bellini, Dott. M. Bussi, IRCCS San Raffaele - Università Vita e Salute - Milano
I risultati terapeutici ottenuti con LLLT sono stati confrontati con i risultati di un gruppo placebo; n definitivo sarà di 30 pazienti per gruppo, attualmente dati riferiti a n=13 per gruppo terapeutico e n=16 per gruppo controllo. Studio randomizzato, in doppio cieco; laser del gruppo placebo del tutto identico al gruppo che effettuava terapia ma non emettente luce terapeutica. Applicazione di LLLT domiciliare con EarNoiseEliminator per 20 minuti al giorno per 4 mesi. Caratteristiche del laser: 5mw, 650 nm, energia totale assorbita per applicazione 6 Joule/c.

Conclusioni: Miglioramento delle caratteristiche "fisiche" dell'acufene; Loudness diminuita. Peraltro non variazioni statistiche dei valori di THI e delle scale VAS. Nessun effetto collaterale registrato. Acufene dopo terapia è più facilmente mascherabile e diminuiscono i pazienti affetti da iperacusia. Questi ultimi dati suggeriscono il possibile impiego della LLLT associata alla TRT per migliorare i parametri che maggiormente ostacolano il successo della terapia con l'arricchimento sonoro.
(Sur demande cette publication est disponible en langue italienne.)

Kombinierte Low-Level-Lasertherapie und Ginkgo-Biloba-Extrakt als Blindversuch zur Behandlung von Tinnitus

Olivier J., Plath P., Laser Therapy, 5:137-139, 1993, John Wiley & Sons, Ltd.
Tinnitus ist eine lästige und oft schwächende Beschwerde neuro-otologischen Ursprungs, aber unbestimmter Ursache. Viele Behandlungsmethoden wurden erprobt, aber bisher war keine wirklich erfolgreich. Die vorliegende vorläufige Studie berichtet über einen Blindversuch mit 40 Patienten, je 20 in einer Versuchs- und in einer Kontrollgruppe, die mit der Lasertherapie in Kombination mit der Einnahme eines Ginkgo-Biloba-Extraktes behandelt wurden.

Alle 40 Patienten erhielten eine Biloba-Extrakt-Injektion, aber nur die 20 Versuchspatienten bekamen tatsächlich Laserbestrahlungen, acht Tage lang täglich acht Minuten.

Die Kontrollgruppe erhielt nur eine vorgetäuschte Bestrahlung. Von der Versuchsgruppe gaben 50 % an, dass sich ihr Tinnitus um mehr als 10 dB reduziert habe, verglichen mit 5 % in der Kontrollgruppe sowohl bei der Selbsteinschätzung als auch bei den audiometrischen Ergebnissen.

Obgleich es sich nur um einen vorläufigen Bericht handelt, sind die Ergebnisse sehr ermutigend, und die Autoren empfehlen diese kombinierte Fotochemotherapie als vielversprechende Behandlung des Tinnitus.

Effectiveness of transmeatal low power laser irradiation for chronic tinnitus

Gungor A, Dogru S, Cincik H, Erkul E, Poyrazoglu E.; Department of Otolaryngology, Haydarpasa Military Hospital, Istanbul, Turkey.
Objective: To evaluate effectiveness of 5 mW laser irradiation in the treatment of chronic tinnitus. Study design: Prospective, randomised, double-blind study. Methods: This investigation included 66 ears in 45 patients with chronic unilateral or bilateral tinnitus. A 5mW laser with a wavelength of 650 nm, or placebo laser, was applied transmeatally for 15 minutes, once daily for a week. A questionnaire was administered which asked patients to score their symptoms on a five-point scale, before and two weeks after laser irradiation. A decrease of one scale point, regarding the loudness, duration and degree of annoyance of tinnitus, was accepted to represent an improvement.
Results: The loudness, duration and degree of annoyance of tinnitus were improved, respectively, in up to 48.8, 57.7 and 55.5 per cent of the patients in the active laser group. No significant improvement was observed in the placebo laser group.
Conclusion: Transmeatal, low power (5 mW) laser irradiation was found to be useful for the treatment of chronic tinnitus.

Infrared laser applied into the meatus acousticus

Prof. Shiomi
has investigated the effect of infrared laser applied directly into the meatus acousticus, 21 J, once a week for 10 weeks. The result of this non-controlled study is as follows: 26% of the patients reported improved duration, 58% reduced loudness and 55% reported a general reduction in annoyance.
The same author [687] has also examined the effect of light on the cochlea using guinea pigs. Direct laser irradiation was administered to the cochlea through the round window. The amplitude of CAP was reduced to 53-83% immediately after the onset of irradiation. The amplitude then returned to the original level. The results of this investigation suggest that laser therapy might lessen tinnitus by suppressing the abnormal excitation of the eighth nerve of the organ of Corti.

Average duration of tinnitus of 10 years

Dr. Hahn
examined 120 patients with an average duration of tinnitus of 10 years. The patients underwent pure-tone audiometry, speech audiometry and objective audiometry tests. The intensity and frequency of tinnitus was also determined. EGb 761 was administered 3 weeks before the start of laser therapy. The patients underwent 10 sessions of laser therapy, each lasting 10 minutes. An improvement in tinnitus was audiometrically confirmed in 50.8% of the patients; 10 dB in 18, 20 dB in 22, 30 dB in 10, 40 dB in 6 and 50 dB in 5 patients.
 
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