Castilho Gustavo Leão, Dias Norimar Hernanes, Martins Regina Helena Garcia
Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery Department, Universidade Estadual Paulista Julio de Mesquita Filho, Botucatu Medical School, São Paulo, Brazil.
Clin Otolaryngol. 2023 Jan;48(1):50-57. doi: 10.1111/coa.13999. Epub 2022 Nov 9.
To evaluate the effectiveness of betahistine in the treatment of primary tinnitus.
To evaluate the effectiveness of betahistine in the treatment of primary tinnitus.
Universidade estadual Paulista Julio de Mesquita Filho, Botucatu Medical School, São paulo, Brazil.
Adult patients with primary tinnitus who had not undergone treatment for tinnitus in the last 6 months were included. Patients with profound sensorineural deafness, hearing aid users and patients with metabolic, neurological, psychiatric or decompensated cardiovascular diseases were excluded.
in the betahistine group, patients received betahistine 24 mg every 12 h for 90 days; in the control group, patients received placebo tablets every 12 h for 90 days.
Primary outcome measure: Tinnitus Handicap Inventory (THI).
Clinical Global Impression Improvement (CGI-I) and a question of 'Yes' or 'No' to participants about their perception of improvement in symptoms.
Of 284 participants initially identified, 62 were randomised (betahistine group n = 31; control group n = 31). Median age (IQR) 54 (48-60) years, with a balanced number of men and women. There was no difference in THI outcome between the study groups (median difference, -2 points; 95% CI, -8 to 6 points); the THI after the intervention was a median (IQR) 4 (-4 to 14) lower points in the betahistine group, and a median (IQR) 2 (-6 to 10) in the control group. There was no statistical difference in secondary outcome measures. Adverse events were mild and there was no statistical difference between groups.
Betahistine dihydrochloride was ineffective in the treatment of primary tinnitus in adults.
评估倍他司汀治疗原发性耳鸣的有效性。
评估倍他司汀治疗原发性耳鸣的有效性。
巴西圣保罗州立大学胡利奥·德梅斯基塔·菲略分校博图卡图医学院。
纳入过去6个月内未接受耳鸣治疗的成年原发性耳鸣患者。排除重度感音神经性耳聋患者、助听器使用者以及患有代谢性、神经性、精神性或失代偿性心血管疾病的患者。
在倍他司汀组，患者每12小时服用24毫克倍他司汀，持续90天；在对照组，患者每12小时服用安慰剂片，持续90天。
主要结局指标：耳鸣障碍量表（THI）。
临床总体印象改善量表（CGI-I）以及向参与者询问其对症状改善的感知（是或否）。
在最初确定的284名参与者中，62名被随机分组（倍他司汀组n = 31；对照组n = 31）。年龄中位数（四分位间距）为54（48 - 60）岁，男女数量均衡。研究组之间THI结局无差异（中位数差异为 -2分；95%置信区间为 -8至6分）；干预后倍他司汀组的THI中位数（四分位间距）降低了4（-4至14）分，对照组降低了2（-6至10）分。次要结局指标无统计学差异。不良事件轻微，组间无统计学差异。
盐酸倍他司汀治疗成人原发性耳鸣无效。
