Silalahi Todung Donald Aposan, Hariyanto Timotius Ivan
Division of Cardiovascular, Department of Internal Medicine, Jakarta Heart Center, Matraman Raya street, East Jakarta, DKI Jakarta 13140, Indonesia.
Faculty of Medicine, Pelita Harapan University, Tangerang, Indonesia.
Ther Adv Neurol Disord. 2024 Sep 25;17:17562864241271033. doi: 10.1177/17562864241271033. eCollection 2024.
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.
This study aims to analyze the efficacy and safety of PFO closure for mitigating migraine symptoms.
This is a systematic review and meta-analysis of randomized clinical trials (RCTs) and observational studies.
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.
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, < 0.0001, = 19%) and monthly migraine days from baseline (SMD -0.30; 95% CI: -0.53, -0.08, = 0.009, = 0%) among PFO closure than control. However, the complete resolution of migraine (especially based on the evidence from RCTs; = 0.24), HIT-6 score ( = 0.08), and MIDAS score ( = 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%).
This study suggests better efficacy of PFO closure in reducing monthly migraine attacks and days with similar safety profile when compared to control.
PROSPERO (CRD42023453635).
卵圆孔未闭（PFO）通常无症状，但可能导致致残性偏头痛症状。关于PFO封堵预防偏头痛的证据仍不明确且相互矛盾。
本研究旨在分析PFO封堵减轻偏头痛症状的疗效和安全性。
这是一项对随机临床试验（RCT）和观察性研究的系统评价和荟萃分析。
截至2024年3月12日，对Scopus、Medline、ClinicalTrials.gov和Cochrane图书馆数据库进行了全面检索。本综述纳入了研究PFO封堵与对照比较以及与偏头痛相关结局数据的文献。我们采用随机效应模型分析结局的标准化均数差（SMD）和比值比（OR）。
共纳入5项RCT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封堵组从基线开始每月偏头痛发作次数减少更多（SMD -0.34；95%CI：-0.51，-0.18，<0.0001，I² = 19%），每月偏头痛天数减少更多（SMD -0.30；95%CI：-0.53，-0.08，P = 0.009，I² = 0%）。然而，两组干预在偏头痛完全缓解（尤其是基于RCT的证据；P = 0.24）、HIT-6评分（P = 0.08）和MIDAS评分（P = 0.15）方面差异不显著。报告的大多数不良事件是心房颤动和穿刺部位感染/出血，仅在小部分患者中发生（≤5%）。
本研究表明，与对照组相比，PFO封堵在减少每月偏头痛发作次数和天数方面疗效更好，且安全性相似。
PROSPERO（CRD42023453635）
