Document Type : Original Article


1 Department of Neurology, School of Medicine, Neurosciences Research Center, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran

2 School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

3 Head and Neck Surgery, Department of Otolaryngology, School of Medicine, Amin Hospital, Isfahan University of Medical Sciences, Isfahan, Iran



Background: Tinnitus is described as the perception of sounds occurring in one or both ears or inside the human head without external auditory stimuli.
Objectives: This study aimed to compare the efficacy of amitriptyline and melatonin in the treatment of tinnitus.
Methods: This study was a randomized double-blind clinical trial of 60 patients referred to the neurology clinics of Kashani and Al-Zahra hospitals in Isfahan, Iran in 2020. Each patient was randomly assigned 1 code. Patients first filled in the THI and VAS questionnaires and were given either one of the two drugs (melatonin and amitriptyline) for 6 weeks. After collecting the desired information using an independent t test and paired t test in SPSS 26 software and error level of 0.05 the results were analyzed.
Results: Thirty patients were in the amitriptyline group and 30 patients were in the melatonin group, of which 25 were men (41.7%) and 35 were women (58.3%) with a minimum age of 18 years and a maximum of 65 years. There was no significant difference between the reduction of tinnitus before and after taking the drugs based on VAS scale in amitriptyline and melatonin groups (P=0.234), however there was a significant difference between the effect of two amitriptyline and melatonin drugs on the reduction of tinnitus based on the THI questionnaire (P=0.018).
Conclusion: The rate of tinnitus in patients decreased for 6 weeks with the use of amitriptyline and melatonin, but amitriptyline had a better effect on reducing the complications and pain of tinnitus.