A Systematic Review of Eligibility and Outcomes in Tinnitus Trials

Objective To analyze existing tinnitus treatment trials with regard to eligibility criteria, outcome measures, study quality, and external validity and to recognize the effect of patient demographics, symptom duration, severity, and otologic comorbidity on research findings to help practitioners apply them to patient encounters. Data Sources Systematic literature search conducted by an information specialist for development of the American Academy of Otolaryngology—Head and Neck Surgery Foundation’s tinnitus clinical practice guideline. Review Methods Articles were assessed for eligibility with the PRISMA protocol (Preferred Reporting Items for Systematic Reviews and Meta‐analyses) and data extracted by 2 independent investigators. Studies were assessed for methodological quality, inclusion and exclusion criteria, patient demographics, and outcome measures. Results A total of 147 randomized trials met inclusion criteria. Nearly all studies took place in a specialist setting. More than 50% did not explicitly define tinnitus, and 44% used a subjective severity threshold, such as “severely disturbing.” Fifty‐four percent required symptom duration of at least 6 months for study eligibility, and up to 33% excluded patients with “organic” hearing loss or otologic conditions. Mean age was 52.2 years, and median follow‐up was 3 months. Only 20% had a low risk of bias. Conclusion Randomized trials of tinnitus interventions are most applicable to older adults with tinnitus lasting ≥6 months who are evaluated in specialty settings. High risk of bias, short follow‐up, and outcome reporting raise concerns about the validity of findings and may influence how clinicians apply trial results to individual patients and establish treatment expectations, thus demonstrating the need for further quality research in this field.