Among patients with subjective debilitating tinnitus and audiometric normal to mild hearing loss, does treatment with tinnitus retraining therapy with conventional sound generators result in better outcomes than tinnitus retraining therapy with placebo sound generators or standard of care?
In this randomized clinical trial of 151 participants with 18 months of follow-up, average tinnitus distress decreased in all 3 groups. There was no clinically meaningful difference in extent of reduction in tinnitus distress or other important end points among patients in the 3 intervention groups.
Tinnitus retraining therapy with conventional sound generators is no better than tinnitus retraining therapy with placebo generators or standard of care.
Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient’s tinnitus-evoked negative reaction to, and awareness of, tinnitus.
To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life.
Design, Setting, and Participants
A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs’ office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat.
Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.
Main Outcomes and Measures
The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS).
Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, −1.32; 95% CI, −1.78 to −0.85), partial TRT (effect size, −1.16; 95% CI, −1.56 to −0.76), and SoC (effect size, −1.01; 95% CI, −1.41 to −0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%).
Conclusions and Relevance
There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus.
ClinicalTrials.gov identifier: NCT01177137
The Tinnitus Retraining Therapy Trial Research Group. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online May 23, 2019. doi:10.1001/jamaoto.2019.0821
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