Evidence map›Paper›PMID 37738465›Full record

ArticleJournal of Crohn's & colitis2023

Neuroimmune Modulation Through Vagus Nerve Stimulation Reduces Inflammatory Activity in Crohn's Disease Patients: A Prospective Open-label Study.

Geert D'Haens, Michael Eberhardson, Zeljko Cabrijan, Silvio Danese, Remco van den Berg, Mark Löwenberg, Gionata Fiorino, P Richard Schuurman, Göran Lind, Per Almqvist and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
6.3field-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

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 5 countries.

Geert D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Michael EberhardsonDepartment of Medicine, Karolinska Institutet, Solna, Sweden.
Zeljko CabrijanDivision of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, Zagreb, Croatia.
Silvio DaneseDepartment of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Italy.ORCID 0000-0001-7341-1351
Remco van den BergDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Mark LöwenbergDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Gionata FiorinoDepartment of Gastroenterology and Digestive Endoscopy, VIta-Salute San Raffaele Hospital, Milan, Italy.ORCID 0000-0001-5623-2968
P Richard SchuurmanDepartment of Neurosurgery, Amsterdam UMC, Amsterdam, The Netherlands.
Göran LindDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Per AlmqvistDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Peder S OlofssonDepartment of Medicine, Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Kevin J TraceyFeinstein Institutes for Medical Research, Manhasset, New York.
Stephen B HanauerDivision of Gastroenterology and Hepatology, Northwestern University-Feinberg School of Medicine, Chicago, Illinois, USA.
Ralph ZitnikSetPoint Medical, Valencia, California, USA.
David ChernoffSetPoint Medical, Valencia, California, USA.
Yaakov A LevineDepartment of Medicine, Karolinska Institutet, Solna, Sweden.ORCID 0000-0002-3313-6858
Amsterdam University Medical Centers · NLAlta Bates Summit Medical Center · USFeinstein Institute for Medical Research · USKarolinska University Hospital · SEVita-Salute San Raffaele University · ITKarolinska Institutet · SELinköping University · SENorthwestern University · USUniversity Hospital Dubrava · HR

Funding

SetPoint Medical, Inc
6 · The paper itself

Abstract

BACKGROUND AND

aimsCrohn's disease [CD] is a debilitating, inflammatory condition affecting the gastrointestinal tract. There is no cure and sustained clinical and endoscopic remission is achieved by fewer than half of patients with current therapies. The immunoregulatory function of the vagus nerve, the 'inflammatory reflex', has been established in patients with rheumatoid arthritis and biologic-naive CD. The aim of this study was to explore the safety and efficacy of vagus nerve stimulation in patients with treatment-refractory CD, in a 16-week, open-label, multicentre, clinical trial.

methodsA vagus nerve stimulator was implanted in 17 biologic drug-refractory patients with moderately to severely active CD. One patient exited the study pre-treatment, and 16 patients were treated with vagus nerve stimulation [4/16 receiving concomitant biologics] during 16 weeks of induction and 24 months of maintenance treatment. Endpoints included clinical improvement, patient-reported outcomes, objective measures of inflammation [endoscopic/molecular], and safety.

resultsThere was a statistically significant and clinically meaningful decrease in CD Activity Index at Week 16 [mean ± SD: -86.2 ± 92.8, p = 0.003], a significant decrease in faecal calprotectin [-2923 ± 4104, p = 0.015], a decrease in mucosal inflammation in 11/15 patients with paired endoscopies [-2.1 ± 1.7, p = 0.23], and a decrease in serum tumour necrosis factor and interferon-γ [46-52%]. Two quality-of-life indices improved in 7/11 patients treated without biologics. There was one study-related severe adverse event: a postoperative infection requiring device explantation.

conclusionsNeuroimmune modulation via vagus nerve stimulation was generally safe and well tolerated, with a clinically meaningful reduction in clinical disease activity associated with endoscopic improvement, reduced levels of faecal calprotectin and serum cytokines, and improved quality of life.

Indexed as

Biological ProductsCrohn DiseaseVagus Nerve StimulationHumansInflammationLeukocyte L1 Antigen ComplexProspective StudiesQuality of LifeRemission InductionBiological ProductsLeukocyte L1 Antigen ComplexCrohn’s diseaseneuroimmune modulationvagus nerve

Identifiers

PMID37738465
PMCPMC10798868
OpenAlexW4386946746

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.