Efficacy and safety of patent foramen ovale closure for mitigating migraine: a systematic review and meta-analysis of randomized trials and observational studies
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, I2 = 19%) and monthly migraine days from baseline (SMD −0.30; 95% CI: −0.53, −0.08, p = 0.009, I2 = 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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
Read the paper
Related studies
- Bioactive Molecules Released in Food by Lactic Acid Bacteria: Encrypted Peptides and Biogenic Amines
- A central role for amyloid fibrin microclots in long COVID/PASC: origins and therapeutic implications
- Bioaccessibility and bioavailability of phenolic compounds
- The Glutamate Hypothesis in ALS: Pathophysiology and Drug Development
- Therapeutic Approaches to Genetic Ion Channelopathies and Perspectives in Drug Discovery
- Effects of the Mediterranean Diet on the Components of Metabolic Syndrome Concerning the Cardiometabolic Risk
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.