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Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.
JAMA Otolaryngol Head Neck Surg. 2019 07 01; 145(7):597-608.JO

Abstract

Importance

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.

Objective

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.

Interventions

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).

Results

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.

Trial Registration

ClinicalTrials.gov identifier: NCT01177137.

Authors+Show Affiliations

No affiliation info availableCenter for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.Department of Communicative Disorders, University of Alabama, Tuscaloosa.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

31120533

Citation

Tinnitus Retraining Therapy Trial Research Group, et al. "Effect of Tinnitus Retraining Therapy Vs Standard of Care On Tinnitus-Related Quality of Life: a Randomized Clinical Trial." JAMA Otolaryngology-- Head & Neck Surgery, vol. 145, no. 7, 2019, pp. 597-608.
Tinnitus Retraining Therapy Trial Research Group, Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019;145(7):597-608.
Scherer, R. W., & Formby, C. (2019). Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngology-- Head & Neck Surgery, 145(7), 597-608. https://doi.org/10.1001/jamaoto.2019.0821
Tinnitus Retraining Therapy Trial Research Group, Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy Vs Standard of Care On Tinnitus-Related Quality of Life: a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 07 1;145(7):597-608. PubMed PMID: 31120533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. AU - ,, AU - Scherer,Roberta W, AU - Formby,Craig, PY - 2019/5/24/pubmed PY - 2020/6/13/medline PY - 2019/5/24/entrez SP - 597 EP - 608 JF - JAMA otolaryngology-- head & neck surgery JO - JAMA Otolaryngol Head Neck Surg VL - 145 IS - 7 N2 - Importance: 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. Objective: 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. Interventions: 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). Results: 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. Trial Registration: ClinicalTrials.gov identifier: NCT01177137. SN - 2168-619X UR - https://www.unboundmedicine.com/medline/citation/31120533/Effect_of_Tinnitus_Retraining_Therapy_vs_Standard_of_Care_on_Tinnitus_Related_Quality_of_Life:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/10.1001/jamaoto.2019.0821 DB - PRIME DP - Unbound Medicine ER -