Clinical trials for tinnitus: study populations, designs, measurement variables, and data analysis.

We review a few issues related to clinical trials for treating patients with tinnitus, including the study population, design, choice of measurement variables, and some new approaches to data analysis. We emphasize the importance of being aware of different subgroups of tinnitus patients, and that patients who have had tinnitus for less than 6 months could be more amenable to treatment than patients who have had their tinnitus for a longer period. We distinguish the tinnitus itself, from the reactions to the tinnitus. When the treatment is intended to reduce the tinnitus, we recommend measuring the magnitude of the tinnitus. We provide arguments and data to support the use of the Tinnitus Handicap Questionnaire as a measure of the reaction to the tinnitus. We suggest that the current quality of life measures are not valid for measuring lifestyle effects of alleviating tinnitus. Because tinnitus likely has different subgroups, and because tinnitus affects people differently, we believe data analysis should emphasize individuals, not groups. A clinically meaningful effect should represent a valid and reliable statistical change for an individual.