Evidence map›Paper›PMID 27699586›Full record

ArticleThe journal of headache and pain2016

Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine: an open-label study.

Licia Grazzi, Gabriella Egeo, Anne H Calhoun, Candace K McClure, Eric Liebler, Piero Barbanti

Open access · goldAbstract read
In one paragraph

Article in The journal of headache and pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
6.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 68 citations in OpenAlex.

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  9. Hallmarks of primary headache: part 1 - migraine.The journal of headache and pain · 2024
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  14. Non-invasive neuromodulation of the cervical vagus nerve in rare primary headaches.Frontiers in pain research (Lausanne, Switzerland) · 2023
    Review
  15. Narrative Review of Noninvasive Brain Stimulation in Stroke Rehabilitation.Medical science monitor : international medical journal of experimental and clinical research · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Licia GrazziHeadache Center, Carlo Besta Neurological Institute and Foundation, Via Celoria 11, 20133, Milan, Italy.
Gabriella EgeoHeadache and Pain Unit, Istituto di Ricovero e Cura a Carattere Scientifico, San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy.
Anne H CalhounCarolina Headache Institute, 6114 Fayetteville Rd., Suite 109, 27713, Durham, NC, USA.
Candace K McClureNorth American Science Associates Inc., 4050 Olson Memorial Highway, Suite 450, 55422, Minneapolis, MN, USA.
Eric LieblerelectroCore, LLC, 150 Allen Road, Suite 201, 07920, Basking Ridge, NJ, USA.
Piero BarbantiHeadache and Pain Unit, Istituto di Ricovero e Cura a Carattere Scientifico, San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy. piero.barbanti@sanraffaele.it.
Carolina Headache Institute · USFondazione IRCCS Istituto Neurologico Carlo Besta · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto di Ricovero e Cura a Carattere Scientifico San Raffaele

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

MenstruationAdultAnti-Inflammatory Agents, Non-SteroidalDisability EvaluationFemaleHumansMigraine DisordersPain MeasurementTreatment OutcomeTryptaminesVagus Nerve StimulationAnti-Inflammatory Agents, Non-SteroidalTryptaminesMenstrually related migraineMenstrual migraineProphylactic treatmentVagus nerve

Identifiers

PMID27699586
PMCPMC5047863
OpenAlexW2528276612

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.