Τίτλος:
Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Introduction: Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. Methods: This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6–8 hours apart). Results: Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) (p = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common. Conclusions: Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The “sham” device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844. © International Headache Society 2019.
Συγγραφείς:
Diener, H.-C.
Goadsby, P.J.
Ashina, M.
Al-Karagholi, M.A.-M.
Sinclair, A.
Mitsikostas, D.
Magis, D.
Pozo-Rosich, P.
Irimia Sieira, P.
Làinez, M.J.A.
Gaul, C.
Silver, N.
Hoffmann, J.
Marin, J.
Liebler, E.
Ferrari, M.D.
Εκδότης:
SAGE Publications Ltd
Λέξεις-κλειδιά:
adult; aged; application site discomfort; application site erythema; application site pain; application site rash; Article; controlled study; dizziness; double blind procedure; episodic migraine; female; human; influenza; intention to treat analysis; major clinical study; male; multicenter study; non invasive procedure; open study; oropharynx pain; parallel design; patient compliance; patient safety; prospective study; randomized controlled trial; rhinopharyngitis; therapy effect; treatment duration; treatment outcome; vagus nerve stimulation; clinical trial; middle aged; migraine; phase 3 clinical trial; procedures; vagus nerve stimulation, Adult; Double-Blind Method; Female; Humans; Male; Middle Aged; Migraine Disorders; Treatment Outcome; Vagus Nerve Stimulation
DOI:
10.1177/0333102419876920
