Comparison of melatonin and sertraline therapies on tinnitus: A randomized clinical trial

Tinnitus is the perception of noise or ringing without external acoustic stimulants which affects almost 10% of general population. Many therapies have been recommended including diet modifcations, herbal remedies, and chemical drugs. Most common utilized drugs for tinnitus are melatonin and antidepressants such as sertraline which have been proven in different studies. In this study, we aimed to compare the effcacy of melatonin and sertraline in treating tinnitus for the frst time. Methods: In this clinical trial, 70 patients with tinnitus according to inclusion and exclusion criteria were included and randomly divided into two groups: melatonin group, taking melatonin 3 mg once daily and sertraline group taking sertraline 50 mg once daily, all treating for 3 months. Before and after treatments, every patient received Tinnitus Handicap Inventory (THI) questionnaire and severity of tinnitus was assessed, and data analysis was performed. Results: Before treatments, the mean of THI score for melatonin and sertraline groups were 45.02 ± 17.67 and 44.85 ± 20.57, respectively. There was no signifcant difference between both groups THI score (P = 0.23). After 3 months, the mean of THI scores for melatonin and sertraline groups were 30.29 ± 19.62 and 36.96 ± 25.03, respectively which the mean of THI scores in two groups was decreased signifcantly (P < 0.01, for‑both). In addition, indicated the signifcant decline in THI score of melatonin group who were under treatments with melatonin 3 mg once daily (P = 0.02). Conclusions: Here in this clinical trial, we demonstrated that both melatonin and sertraline are effcient in treating tinnitus, but the usage of melatonin 3 mg once daily is more effective.