Evidence map›Paper›PMID 30795781›Full record

Trial reportJournal of translational medicine2019

Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study.

Azize Boström, Dirk Scheele, Birgit Stoffel-Wagner, Frigga Hönig, Shafqat R Chaudhry, Sajjad Muhammad, Rene Hurlemann, Joachim K Krauss, Ilana S Lendvai, Krishnan V Chakravarthy and 1 more

Open access · goldAbstract readClinical TrialObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

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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

11 authors at 5 institutions in 3 countries.

Azize BoströmDepartment of Neurosurgery, University Hospital Bonn, Bonn, Germany.
Dirk ScheeleDepartment of Psychiatry, University Hospital Bonn, Bonn, Germany.
Birgit Stoffel-WagnerDepartment of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.
Frigga HönigDepartment of Neurosurgery, University Hospital Bonn, Bonn, Germany.
Shafqat R ChaudhryDepartment of Neurosurgery, University Hospital Bonn, Bonn, Germany.
Sajjad MuhammadDepartment of Neurosurgery, Helsinki University Hospital, Helsinki, Finland.
Rene HurlemannDepartment of Psychiatry, University Hospital Bonn, Bonn, Germany.
Joachim K KraussDepartment of Neurosurgery, Medical School Hannover, Hannover, Germany.
Ilana S LendvaiDepartment of Psychiatry, University Hospital Bonn, Bonn, Germany.
Krishnan V ChakravarthyDepartment of Anesthesiology and Pain Medicine, University of California San Diego, San Diego, CA, USA.
Thomas M KinfeDepartment of Psychiatry, University Hospital Bonn, Bonn, Germany. thomas.kinfe@ukb.uni-bonn.de.
University Hospital Bonn · DEUniversity of Bonn · DEHelsinki University Hospital · FIMedizinische Hochschule Hannover · DEUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRising evidence indicate that oxytocin and IL-1β impact trigemino-nociceptive signaling. Current perspectives on migraine physiopathology emphasize a cytokine bias towards a pro-inflammatory status. The anti-nociceptive impact of oxytocin has been reported in preclinical and human trials. Cervical non-invasive vagus nerve stimulation (nVNS) emerges as an add-on treatment for the preventive and abortive use in migraine. Less is known about its potential to modulate saliva inflammatory signaling in migraine patients. The rationale was to perform inter-ictal saliva measures of oxytocin and IL-1ß along with headache assessment in migraine patients with 10 weeks adjunctive nVNS compared to healthy controls.

methods12 migraineurs and 12 suitably matched healthy control were studied with inter-ictal saliva assay of pro- and anti-neuroinflammatory cytokines using enzyme-linked immuno assay techniques along with assessment of headache severity/frequency and associated functional capacity at baseline and after 10 weeks adjunctive cervical nVNS.

resultsnVNS significantly reduced headache severity (VAS), frequency (headache days and total number of attacks) and significantly improved sleep quality compared to baseline (p < 0.01). Inter-ictal saliva oxytocin and IL-1β were significantly elevated pre- as well as post-nVNS compared to healthy controls (p < 0.01) and similarly showed changes that may reflect the observed clinical effects.

conclusionsOur results add to accumulating evidence for a therapeutic efficacy of adjunct cervical non-invasive vagus nerve stimulation in migraine patients. This study failed to provide an evidence-derived conclusion addressed to the predictive value and usefulness of saliva assays due to its uncontrolled study design. However, saliva screening of mediators associated with trigemino-nociceptive traffic represents a novel approach, thus deserve future targeted headache research. Trial registration This study was indexed at the German Register for Clinical Trials (DRKS No. 00011089) registered on 21.09.2016.

Indexed as

Vagus Nerve StimulationAdultAgedCervical VertebraeDepressionFemaleHumansInflammationInterleukin-1betaMiddle AgedMigraine DisordersOxytocinPainQuality of LifeSalivaSleepIL1B protein, humanInterleukin-1betaOxytocinCervical non-invasive vagus nerve stimulationMigraineMOXY pilot studySaliva oxytocin/IL-1βTrigemino-nociceptive signaling

Identifiers

PMID30795781
PMCPMC6387501
OpenAlexW2940607116

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.