Abtahi Seyed Hamidreza, Hashemi Seyed Mostafa, Mahmoodi Mahdi, Nilforoush Mohammad Hossein
Department of Otorhinolaryngology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Audiology Department, Communication Disorders Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Int J Prev Med. 2017 Aug 31;8:61. doi: 10.4103/ijpvm.IJPVM_229_17. eCollection 2017.
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 modifications, 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 efficacy of melatonin and sertraline in treating tinnitus for the first time.
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.
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 significant difference between both groups THI score ( = 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 significantly ( < 0.01, for-both). In addition, indicated the significant decline in THI score of melatonin group who were under treatments with melatonin 3 mg once daily ( = 0.02).
Here in this clinical trial, we demonstrated that both melatonin and sertraline are efficient in treating tinnitus, but the usage of melatonin 3 mg once daily is more effective.
耳鸣是指在没有外部声音刺激时,个体感知到噪音或耳鸣声,这一现象影响了近10%的普通人群。人们推荐了许多治疗方法,包括饮食调整、草药疗法和化学药物。治疗耳鸣最常用的药物是褪黑素和抗抑郁药,如舍曲林,这些药物在不同研究中已得到证实。在本研究中,我们旨在首次比较褪黑素和舍曲林治疗耳鸣的疗效。
在这项临床试验中,70例符合纳入和排除标准的耳鸣患者被纳入研究,并随机分为两组:褪黑素组,每天服用一次3毫克褪黑素;舍曲林组,每天服用一次50毫克舍曲林,两组均治疗3个月。治疗前后,每位患者接受耳鸣障碍量表(THI)问卷调查,评估耳鸣严重程度,并进行数据分析。
治疗前,褪黑素组和舍曲林组的THI评分平均值分别为45.02±17.67和44.85±20.57。两组的THI评分之间无显著差异(P=0.23)。3个月后,褪黑素组和舍曲林组的THI评分平均值分别为30.29±19.62和36.96±25.03,两组的THI评分平均值均显著下降(两组均P<0.01)。此外,每天服用一次3毫克褪黑素进行治疗的褪黑素组,其THI评分有显著下降(P=0.02)。
在本临床试验中,我们证明褪黑素和舍曲林在治疗耳鸣方面均有效,但每天服用一次3毫克褪黑素的效果更佳。