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用于预防前庭性偏头痛的药物干预。

Pharmacological interventions for prophylaxis of vestibular migraine.

机构信息

Cochrane ENT, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.

Wadham College, University of Oxford, Oxford, UK.

出版信息

Cochrane Database Syst Rev. 2023 Apr 12;2023(4):CD015187. doi: 10.1002/14651858.CD015187.pub2.

Abstract

BACKGROUND

Vestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. These unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used or proposed to be used as prophylaxis for this condition, to help reduce the frequency of the attacks. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar.

OBJECTIVES

To assess the benefits and harms of pharmacological treatments used for prophylaxis of vestibular migraine.

SEARCH METHODS

The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing beta-blockers, calcium channel blockers, antiepileptics, antidepressants, diuretics, monoclonal antibodies against calcitonin gene-related peptide (or its receptor), botulinum toxin or hormonal modification with either placebo or no treatment. We excluded studies with a cross-over design, unless data from the first phase of the study could be identified.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 3 months, 3 to < 6 months, > 6 to 12 months. We used GRADE to assess the certainty of evidence for each outcome.

MAIN RESULTS

We included three studies with a total of 209 participants. One evaluated beta-blockers and the other two evaluated calcium channel blockers. We did not identify any evidence for the remaining interventions of interest. Beta-blockers versus placebo One study (including 130 participants, 61% female) evaluated the use of 95 mg metoprolol once daily for six months, compared to placebo. The proportion of people who reported improvement in vertigo was not assessed in this study. Some data were reported on the frequency of vertigo attacks at six months and the occurrence of serious adverse effects. However, this is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results. Calcium channel blockers versus no treatment Two studies, which included a total of 79 participants (72% female), assessed the use of 10 mg flunarizine once daily for three months, compared to no intervention. All of the evidence for this comparison was of very low certainty. Most of our outcomes were only reported by a single study, therefore we were unable to conduct any meta-analysis. Some data were reported on improvement in vertigo and change in vertigo, but no information was available regarding serious adverse events. We are unable to draw meaningful conclusions from the numerical results, as these data come from single, small studies and the certainty of the evidence was very low.

AUTHORS CONCLUSIONS

There is very limited evidence from placebo-controlled randomised trials regarding the efficacy and potential harms of pharmacological interventions for prophylaxis of vestibular migraine. We only identified evidence for two of our interventions of interest (beta-blockers and calcium channel blockers) and all evidence was of low or very low certainty. Further research is necessary to identify whether these treatments are effective at improving symptoms and whether there are any harms associated with their use.

摘要

背景

前庭性偏头痛是偏头痛的一种形式,其主要特征之一是反复发作的眩晕。这些发作通常伴有偏头痛的其他特征,包括头痛和对光或声音敏感。这些不可预测且严重的眩晕发作可能会导致生活质量显著下降。据估计,这种疾病影响了不到 1%的人口,尽管许多人仍未被诊断出来。已经使用或提议使用许多药物干预措施作为这种疾病的预防措施,以帮助减少发作的频率。这些主要基于用于头痛偏头痛的治疗方法,因为人们相信这些疾病的潜在病理生理学是相似的。

目的

评估用于前庭性偏头痛预防的药物治疗的益处和危害。

检索方法

Cochrane 耳鼻喉科信息专家检索了 Cochrane 耳鼻喉科登记册;中央对照试验注册库(CENTRAL);Ovid MEDLINE;Ovid Embase;Web of Science;ClinicalTrials.gov;ICTRP 和其他未发表试验的来源。检索日期为 2022 年 9 月 23 日。

选择标准

我们纳入了在成人中进行的比较β受体阻滞剂、钙通道阻滞剂、抗癫痫药、抗抑郁药、利尿剂、降钙素基因相关肽(或其受体)单克隆抗体、肉毒杆菌毒素或激素改变与安慰剂或不治疗的明确或可能的前庭性偏头痛的随机对照试验(RCTs)和准 RCTs。我们排除了交叉设计的研究,除非可以确定研究的第一阶段的数据。

数据收集和分析

我们使用了标准的 Cochrane 方法。我们的主要结局是:1)眩晕改善(评估为二分类结局-改善或未改善),2)眩晕变化(评估为连续结局,用数字量表上的评分表示)和 3)严重不良事件。我们的次要结局是:4)疾病特异性健康相关生活质量,5)头痛改善,6)其他偏头痛症状改善和 7)其他不良反应。我们考虑了在<3 个月、3 至<6 个月和>6 至 12 个月三个时间点报告的结局。我们使用 GRADE 评估每个结局的证据确定性。

主要结果

我们纳入了三项研究,共 209 名参与者。一项评估了β受体阻滞剂,另外两项评估了钙通道阻滞剂。我们没有发现任何其他感兴趣的干预措施的证据。β受体阻滞剂与安慰剂:一项研究(包括 130 名参与者,61%为女性)评估了 95 毫克美托洛尔每天一次,持续六个月,与安慰剂相比。这项研究没有评估报告眩晕改善的比例。一些数据报告了六个月时眩晕发作的频率和严重不良事件的发生情况。然而,这是一项单一的小型研究,对于所有结局,证据的确定性都很低或非常低。我们无法从数值结果中得出有意义的结论。钙通道阻滞剂与无治疗:两项研究(共 79 名参与者,72%为女性)评估了每天一次服用 10 毫克氟桂利嗪,持续三个月,与无干预相比。与这一比较有关的所有证据都是非常低的确定性。我们的大部分结果仅由一项研究报告,因此我们无法进行任何荟萃分析。一些数据报告了眩晕改善和眩晕变化,但没有关于严重不良事件的信息。我们无法从数值结果中得出有意义的结论,因为这些数据来自于单一的小型研究,证据的确定性非常低。

作者结论

关于预防前庭性偏头痛的药物干预的疗效和潜在危害,仅有来自安慰剂对照随机试验的有限证据。我们只确定了两种干预措施(β受体阻滞剂和钙通道阻滞剂)的证据,而且所有证据的确定性都很低或非常低。有必要进行进一步的研究,以确定这些治疗方法是否能有效改善症状,以及它们的使用是否存在任何危害。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5aa7/10093999/e6e5788635a0/tCD015187-FIG-01.jpg

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