Oxytocin receptor antagonism in migraine: a randomized, double-blind, placebo-controlled provocation study
Abstract
BACKGROUND AND OBJECTIVES: Oxytocin has been implicated in migraine pathophysiology through its roles in pain modulation and vascular regulation. Its receptors are present in migraine-related brain regions and cerebral vessels and interact with key migraine mediators such as calcitonin gene-related peptide (CGRP). Declining oxytocin levels coincide with increased migraine frequency, but a causal role in humans remains unclear. This study examined whether acute oxytocin receptor blockade provokes migraine attacks or alters cerebrovascular function.
METHODS: In this randomized, double-blind, placebo-controlled, cross-over study, women with episodic migraine (WM), healthy women (HC), and men with episodic migraine (MM) aged 18-45 years received the oxytocin receptor antagonist atosiban (6.75 mg bolus followed by 54 mg over 3 h) or placebo on two separate visits. Women used continuous hormonal contraception to ensure stable hormone levels. The primary endpoint was the incidence of migraine-like attacks in WM within 12 h post-infusion. Secondary endpoints included the incidence and intensity of any headache and vascular responses.
RESULTS: A total of 20 WM (27.1 ± 5.6 years), 20 HC (25.7 ± 6.8 years) and 20 MM (29.3 ± 6.1 years) completed both provocations visits. During the 12-hour observation period, the incidence of migraine-like attacks in WM did not differ between atosiban and placebo (atosiban: 6 (30%) vs. placebo: 4 (20%; p = 0.75)). Headache of any kind were reported in…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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