Efficacy and safety of patent foramen ovale closure for mitigating migraine: a systematic review and meta-analysis of randomized trials and observational studies.

IF 4.7 2区 医学 Q1 CLINICAL NEUROLOGY
Therapeutic Advances in Neurological Disorders Pub Date : 2024-09-25 eCollection Date: 2024-01-01 DOI:10.1177/17562864241271033
Todung Donald Aposan Silalahi, Timotius Ivan Hariyanto
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引用次数: 0

Abstract

Background: Although often asymptomatic, patent foramen ovale (PFO) may cause disabling migraine symptoms. Evidence regarding PFO closure for prevention of migraine is still ambiguous and conflicting.

Objectives: This study aims to analyze the efficacy and safety of PFO closure for mitigating migraine symptoms.

Design: This is a systematic review and meta-analysis of randomized clinical trials (RCTs) and observational studies.

Data sources and methods: A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until March 12, 2024. This review incorporates literature that examines the comparison between PFO closure and control with outcome data related to migraine. We employed random-effect models to analyze the standardized mean difference (SMD) and odds ratio (OR) for presentation of the outcomes.

Results: A total of five RCTs and six observational studies were incorporated. The results of our meta-analysis showed higher reduction of monthly migraine attacks from baseline (SMD -0.34; 95% CI: -0.51, -0.18, p < 0.0001, I 2 = 19%) and monthly migraine days from baseline (SMD -0.30; 95% CI: -0.53, -0.08, p = 0.009, I 2 = 0%) among PFO closure than control. However, the complete resolution of migraine (especially based on the evidence from RCTs; p = 0.24), HIT-6 score (p = 0.08), and MIDAS score (p = 0.15) did not differ significantly between two groups of intervention. The majority of adverse events reported were atrial fibrillation and access site infection/bleeding that only occurred in small proportions of patients (⩽5%).

Conclusion: This study suggests better efficacy of PFO closure in reducing monthly migraine attacks and days with similar safety profile when compared to control.

Registration: PROSPERO (CRD42023453635).

卵圆孔闭合术缓解偏头痛的疗效和安全性:随机试验和观察性研究的系统回顾和荟萃分析。
背景:卵圆孔未闭(PFO)虽然通常无症状,但可能导致致残性偏头痛症状。有关关闭 PFO 以预防偏头痛的证据仍不明确且相互矛盾:本研究旨在分析关闭 PFO 以减轻偏头痛症状的有效性和安全性:设计:这是一项对随机临床试验(RCT)和观察性研究进行系统回顾和荟萃分析的研究:在 Scopus、Medline、ClinicalTrials.gov 和 Cochrane Library 数据库中进行了全面检索,检索期截至 2024 年 3 月 12 日。本综述纳入了研究偏头痛相关结果数据的 PFO 关闭与控制比较的文献。我们采用随机效应模型分析了结果表述的标准化平均差(SMD)和几率比(OR):结果:共纳入了 5 项研究性临床试验和 6 项观察性研究。我们的荟萃分析结果显示,与对照组相比,PFO闭合患者每月偏头痛发作次数从基线减少的比例更高(SMD -0.34;95% CI:-0.51,-0.18,p I 2 = 19%),每月偏头痛天数从基线减少的比例更高(SMD -0.30;95% CI:-0.53,-0.08,p = 0.009,I 2 = 0%)。然而,两组干预者的偏头痛完全缓解率(尤其是基于 RCTs 的证据;p = 0.24)、HIT-6 评分(p = 0.08)和 MIDAS 评分(p = 0.15)并无显著差异。报告的不良事件主要是心房颤动和入路部位感染/出血,仅在小部分患者中发生(⩽5%):这项研究表明,与对照组相比,PFO闭合术在减少每月偏头痛发作次数和天数方面具有更好的疗效,且安全性相似:prospero(CRD42023453635)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
8.30
自引率
1.70%
发文量
62
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Neurological Disorders is a peer-reviewed, open access journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of neurology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in neurology, providing a forum in print and online for publishing the highest quality articles in this area.
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