Considerations for the design of clinical trials for tinnitus.

Conclusion: There are many possible control conditions to consider in designing research on tinnitus treatments. Some of the counseling procedures involve more than simply 'talking' or providing information, and it is important to make this distinction. Several good handicap scales are available, but we believe that 100-point interval scales have some superior attributes. Both primary and secondary measures of benefit should be used. Open trials have some merit, but should only be used cautiously. Several recent guidelines have been suggested for improving the design and reporting of clinical trials.
Objectives: This paper reviews some basic considerations in the design of research to evaluate tinnitus treatments, particularly counseling and sound therapies.
Methods: We have reviewed some of the basic issues, referenced some relevant work, and provided some data supporting some of our assertions.
Results: We provide some recommendations for consideration for the design of clinical trials.