OA09.03
Purpose: Tinnitus is a common problem for which there is no universally effective treatment, and an estimated 1.2 million individuals are not able to benefit at all from current, widely used treatment strategies. Sound-based and educational therapies' (SBE) are the focus of most approaches but appear to be inadequate for those with significant non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life). Given the emergent evidence of Integrative Medicine (IM) to enhance mood, decrease distress and empower patients to cope more effectively, this NIDCD-funded R21 evaluated the possibility that an IM approach targeting treatment of the non-auditory aspects of tinnitus is more effective in alleviating tinnitus symptoms when added to current commonly applied SBE therapies, compared with SBE alone.
Methods: Participants (N=49) with debilitating tinnitus [i.e., Tinnitus Handicap Inventory (THI) score ≥38] were randomized in a 1:3 ratio to either SBE (n=15) or SBE+IM (n=34) groups followed over 9 months (i.e., pre-, immediate post-, and 3 mo post-intervention). Using intention-to-treat principles, we employed a 2-level mixed effects model to examine the effect of intervention group on intercept and THI change over time.
Results: As expected, baseline THI scores (B=62.0, SE=4.8, p≤.001) did not differ by group (p>.10), and both groups significantly improved over the course of the study (B=−2.7, SE=0.7, p≤.001). Moreover, compared to SBE alone, those in the SBE+IM group exhibited even greater improvement (B=−1.7, SE=0.8, p≤.05). In addition, the study tested the feasibility and acceptability of the IM approach, as measured by enrollment, adherence to various treatment components, and by patient report of satisfaction with each component. While enrollment targets were surpassed with excellent adherence in the experimental group, retention was problematic, particularly in the control group.
Conclusion: Although SBE alone significanlty reduces tinnitus symptoms, the addition of IM treatment to SBE results in further symptom reduction.
Contact: Ruth Wolever, ruth.wolever@duke.edu
