Frew I J, Menon G N
Postgrad Med J. 1976 Aug;52(610):501-3. doi: 10.1136/pgmj.52.610.501.
A double-blind, placebo-controlled, cross-over clinical trial was performed to assess the effect of betahistine hydrochloride (Serc) in Ménière's disease. The diagnosis was based on paroxysmal attacks of rotational vertigo, with tinnitus, and a fluctuating sensori-neural deafness, together with the results of auditory and vestigular tests. Twenty-eight patients were admitted to the trial over 3 years. Twenty-two patients completed the trial. In total, they received betahistine 32 mg daily, for a period of 16 weeks, and placebo also for the same length of time, preceded in every case by a 4-week pre-treatment period. Daily symptom score cards were kept. There was a statistically significant improvement in favour of the drug with regard to vertigo, tinnitus and deafness. Vertigo was the most responsive symptom. No adverse reactions were observed.
进行了一项双盲、安慰剂对照、交叉临床试验,以评估盐酸倍他司汀(敏使朗)对梅尼埃病的疗效。诊断基于旋转性眩晕的阵发性发作、耳鸣、波动性感音神经性耳聋,以及听觉和前庭测试结果。3年中有28名患者纳入试验。22名患者完成试验。他们总共接受了为期16周的每日32毫克倍他司汀治疗,同时也接受了相同时长的安慰剂治疗,每种治疗之前均有为期4周的预处理期。患者每天记录症状评分卡。在眩晕、耳鸣和耳聋方面,药物治疗组有统计学意义的显著改善。眩晕是最易缓解的症状。未观察到不良反应。