Craig Formby1, Xin Yang2, Roberta W Scherer3. 1. Emeritus, Department of Communicative Disorders, University of Alabama, Tuscaloosa. 2. The Culverhouse College of Business, University of Alabama, Tuscaloosa. 3. Retired from Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Abstract
PURPOSE: Tinnitus retraining therapy (TRT) has been widely used for 30 years, but its efficacy and the component contributions from counseling and sound therapy remain controversial. The purpose of this secondary analysis from the Tinnitus Retraining Therapy Trial (TRTT) was to compare treatment response dynamics for TRT (counseling and conventional sound generators) with partial TRT (pTRT; counseling and placebo sound generators) and standard of care (SOC; a patient-centered counseling control). METHOD: The TRTT randomized 151 participants with primary tinnitus (no significant hearing or sound tolerance problems) to TRT, pTRT, or SOC, each of which encouraged use of enriched environmental sound. The primary outcome, mean change in Tinnitus Questionnaire score assessed at baseline and follow-up across 18 months, was normalized for a common baseline and fitted with an exponential model. Time constants were estimated to quantify and compare the treatment response dynamics, which were evaluated for statistical significance using bootstrap analyses. RESULTS: The change in response to TRT took less time to achieve than that for either pTRT or SOC, as demonstrated by time for normalized Tinnitus Questionnaire scores to decline to 63% and 99% of baseline TRT values: 1.2 months (95% CI [0.2, 1.9]) and 5.7 months (95% CI [0.9, 9.0]), respectively. Corresponding SOC values were 2.7 months (95% CI [1.5, 4.1]) and 12.4 months (95% CI [6.9, 19.0]), while those for pTRT were 2.2 months (95% CI [1.2, 3.4]) and 10.1 months (95% CI [5.7, 15.9]). The differences were significant for TRT versus SOC (p = .020), borderline significant for TRT versus pTRT (p = .057), but nonsignificant for pTRT versus SOC (p = .285). The magnitude of the asymptotic treatment response did not differ significantly among groups. CONCLUSION: Sound generator use in TRT increases treatment efficiency (beyond any advantage from enriched environmental sound) without affecting treatment efficacy (determined by counseling).
PURPOSE: Tinnitus retraining therapy (TRT) has been widely used for 30 years, but its efficacy and the component contributions from counseling and sound therapy remain controversial. The purpose of this secondary analysis from the Tinnitus Retraining Therapy Trial (TRTT) was to compare treatment response dynamics for TRT (counseling and conventional sound generators) with partial TRT (pTRT; counseling and placebo sound generators) and standard of care (SOC; a patient-centered counseling control). METHOD: The TRTT randomized 151 participants with primary tinnitus (no significant hearing or sound tolerance problems) to TRT, pTRT, or SOC, each of which encouraged use of enriched environmental sound. The primary outcome, mean change in Tinnitus Questionnaire score assessed at baseline and follow-up across 18 months, was normalized for a common baseline and fitted with an exponential model. Time constants were estimated to quantify and compare the treatment response dynamics, which were evaluated for statistical significance using bootstrap analyses. RESULTS: The change in response to TRT took less time to achieve than that for either pTRT or SOC, as demonstrated by time for normalized Tinnitus Questionnaire scores to decline to 63% and 99% of baseline TRT values: 1.2 months (95% CI [0.2, 1.9]) and 5.7 months (95% CI [0.9, 9.0]), respectively. Corresponding SOC values were 2.7 months (95% CI [1.5, 4.1]) and 12.4 months (95% CI [6.9, 19.0]), while those for pTRT were 2.2 months (95% CI [1.2, 3.4]) and 10.1 months (95% CI [5.7, 15.9]). The differences were significant for TRT versus SOC (p = .020), borderline significant for TRT versus pTRT (p = .057), but nonsignificant for pTRT versus SOC (p = .285). The magnitude of the asymptotic treatment response did not differ significantly among groups. CONCLUSION: Sound generator use in TRT increases treatment efficiency (beyond any advantage from enriched environmental sound) without affecting treatment efficacy (determined by counseling).
Authors: Michael Alexander Chesnaye; Steven Lewis Bell; James Michael Harte; Lisbeth Birkelund Simonsen; Anisa Sadru Visram; Michael Anthony Stone; Kevin James Munro; David Martin Simpson Journal: Ear Hear Date: 2021 May/Jun Impact factor: 3.570
Authors: Roberta W Scherer; Craig Formby; Susan Gold; Sue Erdman; Charles Rodhe; Michele Carlson; Dave Shade; Melanie Tucker; Lee McCaffrey Sensinger; Gordon Hughes; George S Conley; Naomi Downey; Cynthia Eades; Margaret Jylkka; Ada Haber-Perez; Courtney Harper; Shoshannah Kantor Russell; Benigno Sierra-Irizarry; Mark Sullivan Journal: Trials Date: 2014-10-15 Impact factor: 2.279