Kirtane M V, Biswas Anirban
Consultant ENT Surgeon, Hinduja Hospital, Mumbai, Maharashtra.
Consultant Neurotologist, Vertigo Clinic, Kolkata, West Bengal.
J Assoc Physicians India. 2017 Apr;65(4):18-24.
Patients with vestibular vertigo suffer from disabling symptoms which affect their quality of life. This article presents the efficacy and safety profile of betahistine hydrochloride in Indian patients suffering from vestibular vertigo (OSVaLD study).
Study included patients suffering from vertigo, who were prescribed betahistine (48 mg/day) according to local label. Safety and efficacy populations of this study included 80 and 75 subjects respectively. The study included three visits: an initial baseline visit, and two follow-up visits (one month and three months [final visit] post-commencement of betahistine therapy). Efficacy was assessed by administering three patient-reported outcomes (PROs) namely, Dizziness Handicap Inventory (DHI), Hospital Anxiety and Depression Scale (HADS), and Medical Outcome Study Short Form-36 version2 (SF-36®v2). Safety assessment was made by reports of Suspected Adverse Drug Reactions (SADRs) which began during the study.
Mean changes in total DHI score for Indian efficacy population at follow-up and final visits were 31 and 44 points respectively. These changes indicated significant improvements in self-perceived impairment associated with vertigo. Similar improvements in quality of life were observed by HADS subscales (HADS-A and HADS-D) and SF-36®v2 summary scores (PCS [physical component summary] and MCS [mental component summary]). There was only one report of SADR in this study in a female subject receiving betahistine 16 mg t.i.d. This SADR was gastritis of mild severity and was probably not related to betahistine.
A significant number of vestibular vertigo patients reported fair degree of spontaneous recovery. Betahistine treatment improved quality of life, was safe and well-tolerated by Indian patients suffering from vertigo.
前庭性眩晕患者会出现致残症状，影响其生活质量。本文介绍了盐酸倍他司汀在印度前庭性眩晕患者中的疗效和安全性概况（OSVaLD研究）。
研究纳入了眩晕患者，根据当地标签规定给予倍他司汀（48毫克/天）治疗。本研究的安全性和有效性人群分别包括80名和75名受试者。研究包括三次访视：一次初始基线访视，以及两次随访访视（倍他司汀治疗开始后1个月和3个月[末次访视]）。通过使用三种患者报告结局（PRO）进行疗效评估，即头晕残障量表（DHI）、医院焦虑抑郁量表（HADS）和医学结局研究简明健康调查36项第2版（SF-36®v2）。通过研究期间开始的疑似药物不良反应（SADR）报告进行安全性评估。
印度有效性人群在随访和末次访视时DHI总分的平均变化分别为31分和44分。这些变化表明与眩晕相关的自我感知损伤有显著改善。HADS子量表（HADS-A和HADS-D）和SF-36®v2总结得分（PCS[身体成分总结]和MCS[心理成分总结]）也观察到生活质量有类似改善。本研究中仅有一例SADR报告，发生在一名接受倍他司汀16毫克每日三次治疗的女性受试者中。该SADR为轻度胃炎，可能与倍他司汀无关。
大量前庭性眩晕患者报告有相当程度的自发恢复。倍他司汀治疗改善了生活质量，对印度眩晕患者安全且耐受性良好。
