UNITI-RCT: single versus combined treatments for chronic tinnitus
Record details
- Authors: Schoisswohl S, Basso L, Simoes J, et al. (incl. Langguth B)
- Journal / source: Nature Communications (2025)
- Design: Multicenter RCT, 5 sites in 4 countries
- Sample: 461 (230 single / 231 combination)
- Primary endpoint: Between-group difference in THI change, baseline to week 12
- Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: Yes
What this research found
Within-group THI change: −11.7 (single treatments) vs −14.9 (combinations); the between-group difference of ≈3.2 points was statistically significant (p=0.034) but below a ~7-point clinical-meaningfulness benchmark (external literature value — the paper itself does not define this threshold). Paper verbatim: CBT and hearing aids alone had large effect sizes 'which could not be further increased by combination treatment.'
The largest trial ever to compare tinnitus treatments head-to-head. Statistically significant, clinically marginal difference between strategies — the substantive finding is which single treatments performed best.
Limitations and conflicts of interest
Open-label; no untreated arm.
Funding / conflicts: EU-funded (UNITI consortium).
Corrections to this record
- 2026-09-04: PMID filled; author styling corrected (2nd/3rd authors are Basso L and Simoes J; Langguth is a co-author, not 2nd).
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.