Effects of combination therapy in reduction of tinnitus functional index score for tinnitus patients in a Tertiary Hospital in Malaysia: A randomized pilot trial

Abstract

Background: This trial aimed to study the effect of combination therapy and compare it with tinnitus counseling alone in the reduction of tinnitus functional index (TFI) score. Materials and Methods: This work is a two-arm pilot-controlled trial where Muslims aged more than 18 years and with primary chronic bothersome tinnitus and a TFI score of more than 24 were recruited. The exclusion criteria were subjects with pulsatile or objective tinnitus or those with poor cognitive functions and Meniere's disease. They were randomized into two groups by using block randomization. The first treatment group received a combination of Al Quran sound therapy and tinnitus counseling, and the second treatment group received tinnitus counseling only. The results of the TFI score before intervention and 1-month postintervention were recorded and analyzed. Results: A total of 25 patients were recruited and randomized. Among them, 10 received combination therapy and 15 received counseling treatment. Overall, 68% of the patients (17/25) had reduced global TFI scores. The mean decline in total TFI score in the combination group was higher (12.4, standard deviation [SD]: 18.5) than that in the counseling group (4.9, SD: 18.8). Clinically relevant improvement was also higher in the combination group (40%) than in the counseling group (26.7%). Both comparisons were not statistically significant. Among the TFI subscales, the mean scores of intrusiveness, sense of control, and emotion decreased significantly after the intervention within the combination group, with values of P = 0.036, 0.026, and 0.036, respectively. Conclusion: This study was unable to determine if combination therapy is better than counseling due to the small sample size. However, combination therapy improved the emotion, sense of control, and degree of intrusiveness of tinnitus.