Abstract
BackgroundMenstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine.MethodsFifty-six enrolled subjects (menstrual migraine, 9 %; menstrually related migraine, 91 %), 33 (59 %) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61 %) or as monotherapy (20/51; 39 %) on day −3 before estimated onset of menses through day +3 after the end of menses.ResultsThe number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7 days) to the end of treatment (mean ± standard error, 4.7 ± 0.5 days; P < 0.001) (primary end point). Of all subjects, 39 % (95 % confidence interval: 26 %, 54 %) (20/51) had a ≥ 50 % reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns.ConclusionsThese findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.
Highlights
Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks
Menstrual migraine (MM) without aura is defined as the exclusive occurrence of attacks on days −2 to +3 of menstruation in at least 2 of 3 consecutive menstrual cycles according to the International Classification of Headache Disorders, 3rd edition (ICHD-III beta) appendix, and menstrually related migraine (MRM) without aura is characterized by the occurrence of attacks on other days of the cycle [1]
Based on the treatment benefits observed in previous studies and the potential for reducing medication overuse and medication-associated Adverse event (AE) [16], we evaluated Non-invasive vagus nerve stimulation (nVNS) used as mini-prophylaxis for MM/MRM in this 24-week study of 56 subjects
Summary
Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. More than 90 % of women with migraine attacks during menstruation have MRM [2]; the estimated prevalence among migraineurs has varied from 0.85 to 14.1 % for MM and from 3 to 71.4 % for MRM [3]. These conditions are believed to be a result of fluctuating oestrogen levels; steady or elevating levels are associated with a protective effect, whereas abrupt oestrogen withdrawals are associated with precipitation of migraine attacks [2, 4]. Clinical studies of triptans represent the strongest evidence to date for acute and preventive MM/MRM treatment, which supports almotriptan, naratriptan, sumatriptan, and zolmitriptan as acute therapies and frovatriptan, naratriptan, and zolmitriptan as preventive therapies [6]
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