Based on the Chinese exploratory multicenter MOST trial, which was published in the journal eClinicalMedicine, long-term sound therapy can yield sustained symptom relief from chronic subjective tinnitus. Tang et al reported that individualized, frequency-targeted interventions provide greater benefit than unmodified music or conventional noise-based methods.
“Collectively, the available evidence supports digital frequency-customized relieving sound as a promising, noninvasive, and scalable therapy for managing chronic subjective tinnitus, while also highlighting methodological considerations that must be addressed to strengthen causal inference and optimize personalized treatment strategies,” the investigators commented.
Study Details
A total of 440 patients from three academic hospitals in China who were aged 18 and 80 years and had chronic subjective tinnitus were randomly assigned in a 1:1:1:1 ratio to receive 1 of 4 daily 2-hour interventions: unmodified music (n = 111); unmodified music plus pitch-centered narrowband noise (n = 110); high-frequency–enhanced music (n = 108); or digital frequency-customized relieving sound (n = 111).
The primary outcome was tinnitus severity, measured using the Tinnitus Handicap Inventory (THI). Patients were evaluated at baseline and then at 1, 2, 3, 6, and 9 months, with a 3-month posttreatment follow-up assessment. The investigators established two prespecified primary endpoints: complete remission—defined as a THI score of 0 at any follow-up visit within the 9-month period, at which point patients were considered clinically cured and sound therapy was discontinued—or, for those who did not achieve remission, the magnitude of improvement measured by the change in THI score from baseline to the 9-month endpoint.
Key Findings
Only one patient in the high-frequency–enhanced music group achieved complete remission, according to the investigators, with a THI score of 0 at 6 months. A significant reduction in THI scores was seen over time in all groups, decreasing from a baseline median of 50.00 (interquartile range [IQR] = 36.00–62.00) to 35.00 after 9 months (IQR = 24.00–48.00; P < .0001), with sustained effects observed after treatment. Based on an analysis of treatment-specific effects, there were significant group–time interactions for THI scores in all arms (unmodified music: F(5, 618) = 11.45; unmodified music plus pitch-centered narrowband noise: F(5, 605) = 7.17; high-frequency–enhanced music: F(5, 599) = 8.30; digital frequency-customized relieving sound: F(5, 619) = 12.65; all P < .0001). Compared with unmodified music, digital frequency-customized relieving sound was found to demonstrate superior efficacy (parameter estimate = −4.37, 95% confidence interval = −6.25 to −2.48; P < .0001). No adverse events were observed in any group.
The investigators concluded, “All sound therapies produced clinically meaningful improvement in tinnitus severity, but digital frequency-customized relieving sound achieved the greatest and most durable reductions in THI scores, as well as improvements in anxiety, sleep, and tinnitus loudness. Importantly, patient characteristics—such as age, tinnitus duration, location (bilateral vs unilateral), and type (intermittent vs persistent)—were identified as predictors of treatment response. By providing parameter estimates, subgroup analyses, and detailed statistical reporting, this study addresses several methodological shortcomings of prior research, thereby strengthening the clinical evidence for sound therapy in tinnitus.”
Jianning Zhang, MD, PhD, of Shanghai University of Traditional Chinese Medicine; Xinsheng Huang, MD; Yunfeng Wang, MD, PhD; Shan Sun, PhD; and Huawei Li, MD, PhD; all of Fudan University, Shanghai, are the corresponding authors of the article in eClinicalMedicine.
Disclosure: The study was funded by the Ministry of Science and Technology, the Shanghai Shenkang Development Centre, the Shanghai Science and Technology Committee, and the National Natural Science Foundation of China. The study authors reported no conflicts of interest.
Source: eClinicalMedicine
