The effectiveness of transmeatal low-power laser stimulation in treating tinnitus

Abstract

The aim of this study is to examine the effectiveness of transmeatal low-power laser stimulation (TLLS) in treating tinnitus. This is a prospective, double-blinded, randomized, placebo-controlled trial. Patients with persistent subjective tinnitus as their main symptom were recruited into the study from the outpatient clinics. The recruited patients were randomized into the experimental group or TLLS+ group (patients in this group were prescribed to use TLLS at 5 mW at 650 nM wavelength for 20 min daily and oral betahistine 24 mg twice per day for a total of 10 weeks) and the control group or TLLS- group (patients in this group were prescribed with a placebo device to use and oral betahistine 24 mg twice per day for 10 weeks). All patients were required to answer two sets of questionnaires: the Tinnitus handicap inventory (THI) and visual analogue scales (VAS) symptoms rating scales, before starting the treatment and at the end of the 10-week treatment period. The total score of the THI questionnaire was further graded into five grades, grade 1 being mild and grade 5 being catastrophic. Wilcoxon-signed ranks test and Mann-Whitney test were used to compare and analyze the THI and VAS scores before and after treatment for each group. Changes with p value of<0.05 were considered as statistically significant. Chi square test was used to analyze the change of parameters in categorical forms (to compare between TLLS+ and TLLS-). Changes with p value of <0.05 were considered as statistically significant. Forty-three patients successfully and diligently completed their treatment. It was noted that using any condition of the device, TLLS+ or TLLS-, patient's tinnitus symptoms improved in terms of THI scores (TLLS+, p value = 0.038; TLLS-, p value = 0.001) or VAS scores with a change of at least one grade (TLLS+, p value = 0.007; TLLS-, p value = 0.002) at p value <0.05 significant level. In contrast when TLLS+ group was compared with TLLS- group, no statistically significant result was obtained. In term of VAS scores, there seems to be no statistically significant improvement in patients' annoyance, sleep disruption, depression, concentration and tinnitus loudness and pitch heard between the two groups. Transmeatal low-power laser stimulation did not demonstrate significant efficacy as a therapeutic measure in treating tinnitus.

Evidence and evidence gaps in tinnitus therapy

“…Between both groups there were not significant differences. In the active group, 41% observed an improvement, in the placebo group even 59% of the patients [88]. …”

O uso do laser de baixa intensidade em indivíduos com zumbido e sem perda auditiva

“…As pesquisas sobre o efeito desse tipo de laser em tecidos biológicos iniciaram nos anos 80, apesar de seu 1 Introdução 22 desenvolvimento datar de antes dos anos 60. Desta forma, são encontrados na literatura artigos internacionais sobre este assunto (ROCHKIND et al, 1988;SHIOMI et al, 1997;SCHAFFER et al, 2000;NGAO et al, 2013), porém, com divergências quanto ao protocolo de aplicação e a eficácia desse tratamento.…”

“…Assim, segundo Ngao et. (2013), existe uma atenção especial da indústria pelo uso da terapia com laser de baixa intensidade como uma abordagem para o tratamento do zumbido crônico.…”

“…Porém, devido ao escasso número de estudos e as divergências metodológicas e de resultados quanto a aplicação desse tratamento para combater o sintoma do zumbido, o presente estudo se propôs a verificar o efeito do laser de baixa intensidade em indivíduos com o sintoma de zumbido. (SHIOMI et al, 1997;MIRZ et al, 1999;TAUBER et al, 2000;HAHN et al, 2001;NAKASHIMA, 2002;TAUBER et al, 2003;GUNGOR et al, 2007;CUDA;CARIA, 2008;TEGGI et al, 2009;OKHOVAT et al, 2011;YĐLDĐRĐM et al, 2011;MOLLASADEGHI et al, 2013;NGAO et al, 2013;MIRVAKILI et al, 2014;TAMURA et al, 2015;LEE et al, 2016b). Contudo, outros estudos (SHIOMI et al, 1997;HAHN et al, 2001;TAUBER et al, 2003;GUNGOR et al, 2007;CUDA;CARIA, 2008;OKHOVAT et al, 2011;YĐLDĐRĐM et al, 2011;MOLLASADEGHI et al, 2013;MIRVAKILI et al, 2014;PROCHÁZKOVÁ et al, 2015) MOLLASADEGHI et al, 2013;MIRVAKILI et al, 2014), nos níveis de incomodo com uso de escalas (GUNGOR et al, 2007;OKHOVAT et al, 2011;MOLLASADEGHI et al, 2013;MIRVAKILI et al, 2014;PROCHÁZKOVÁ et al, 2015), na acufenometria (TAUBER et al, 2003;GUNGOR et al, 2007;MOLLASADEG...…”

“…Um estudo realizado por Salahaldin et al (2012) Quando fala-se de zumbido e fotobiomodulação aplicado aos seres humanos, diversos resultados, tanto positivos (TAUBER et al, 2003;OKHOVAT et al, 2011;MOLLASADEGHI et al, 2013;DEMIRKOL et al, 2017), quanto negativos (TEGGI et al, 2009;GOODMAN et al, 2013;NGAO et al, 2013;DEHKORDI et al, 2015) são encontrados na literatura internacional. Padronizar medidas melhora a comparabilidade dos resultados do tratamento entre os diferentes tipos intervenções e centros de tratamento, facilita a integralidade das alternativas de intervenção…”