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Circulating CGRP as a diagnostic biomarker in female migraine patients: a single-center case-control study

Qinyue Huang, Nan-Xi Li, Hanyu Dou, Haiyun Han, Meijie Suo, Yuhan Wang, Jing Jin, Xi-Long Wang et al.

The Journal of Headache and Pain, 2025

184 participants · 7 citations

Abstract

Migraine constitutes the predominant cause of disability-adjusted life years (DALYs), yet remains diagnostically challenging due to lack of biomarkers. Calcitonin gene-related peptide (CGRP) has been recognized as the pathophysiological cornerstone of migraine. Despite the therapeutic breakthrough of anti-CGRP therapies, their clinical efficacy remains limited. Given higher prevalence, frequency and severity of migraine in women, this study aims to investigate the diagnostic and therapeutic value of plasma CGRP in female migraine patients. This prospective observational study enrolled 184 female migraine patients and 85 healthy controls. CGRP concentrations were quantitatively analyzed using a magnetic particle chemiluminescent immunoassay (MP-CLIA) platform. High- and low-expression subgroups were stratified according to a predefined cutoff value of serum CGRP levels. Additionally, patients who received the CGRP receptor antagonist rimegepant during the acute phase of migraine were analyzed. Circulating CGRP concentrations were significantly higher in female migraine patients than those in healthy controls. Receiver operating characteristic (ROC) curve analysis determined that 40.00 pg/mL was the optimal cutoff value for subgroup stratification of CGRP levels. Using this threshold, migraine patients were classified into a high-CGRP subgroup (n = 112) and a low-CGRP subgroup (n = 72). A comparative analysis showed that the high-CGRP group had a higher monthly migraine attack…

How strong is the evidence?

Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 184 participants or records.

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