Study Objective: Tinnitus is a common disorder characterized by sound in the ear in the absence of external or internal stimuli. Low-level laser therapy (LLLT) was discovered enhancing tissue repair via increasing the blood microcirculation and cell proliferation in 1960s. In the last two decades, LLLT delivered to the cochlea has frequently been used to reduce the severity of tinnitus. However, whether LLLT effectively attenuates the severity of tinnitus remains controversial. We aimed to evaluate the efficacy of low-level laser therapy on adult patients with complaints of tinnitus. Design: Systematic review and meta-analysis with trial sequential analysis. Interventions: Low-level laser therapy (LLLT). Measurements: Tinnitus Handicap Inventory (THI) score; improvement rates of the visual analog scale (VAS), verbal rating scale (VRS) and numeric rating scale (NRS) scores. Methods: We searched PubMed, Embase, Scopus, Web of Science, and the Cochrane Library from inception through 17 September 2020. Randomized control trials that involved adult patients with complaints of tinnitus, compared LLLT to a placebo and provided sufficient information for meta-analysis were considered eligible. Main Results: Overall, 11 studies involving 670 patients were included. No significant difference in the overall effect according to the THI score (mean difference (MD), −2.85; 95% CI, −8.99 to 3.28; p
= 0.362; I2
= 0%) and the rating scale score improvement rate (risk ratio (RR), 1.35; 95% CI, 0.81 to 2.27; p
= 0.250; I2
= 67%) was demonstrated between patients receiving LLLT and those receiving a placebo. None of the subgroup analyses showed significant differences, regardless of underlying sensorineural hearing loss, the number of irradiation sessions or the wavelength used. Conclusions: Our meta-analysis suggests that the value of LLLT in controlling the severity of tinnitus remains unclear, in part due to the relatively small number of patients and underlying heterogeneity. More large-scale investigations of LLLT for tinnitus related to inner ear disease are required to further elucidate the therapeutic effects.
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