Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Irritable Bowel Syndrome: A Pilot, Open-Label Study

Abstract

Aim: Irritable bowel syndrome (IBS) is a frequent disease, associating chronic abdominal pain and abnormal bowel habits. The sympatho-vagal balance may be altered in IBS. We tested the effect of transcutaneous auricular stimulation of the left vagus nerve (taVNS) on symptoms and physiological and biological variables. Patients & methods: Twelve IBS women agreed to apply taVNS for 6 months. Evaluation was based on feasibility, symptoms, psychological questionnaires, fecal caprotectin, blood cytokines and bowel transit times. Results: Nine patients completed the trial: there was a significant improvement of symptoms at 3 and 6 months although none of the measured variables were modified by taVNS. Conclusion: The results suggest taVNS is feasible and may improve IBS symptoms. Randomized controlled studies are needed to confirm these preliminary results. ClinicalTrials.gov: NCT02420158.

Keywords::

• inflammation
• irritable bowel syndrome
• non invasive
• psychology
• vagus nerve stimulation

Author contributions

F Mion was responsible for study conception and design, acquisition of data, data analysis and drafting and revision of the manuscript. S Pellissier and B Bonaz were responsible for data analysis, drafting and revision of the manuscript. H Damon, A Garros and S Roman were responsible acquisition of data, and data analysis.

Financial & competing interests disclosure

This work was made possible by a research grant from APICIL Fondation, and a FARE research grant from the French Society of Gastroenterology (SNFGE). Schwa Medico France provided graciously Urostim stimulators and ear plugs for the study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that the research described was approved by the Agence Nationale de Sécurité du Médicament (ANSM), and an independent ethics committee (CPP Sud-Est III), as requested by the French law on biomedical research (Jardé law, 2016). Patients gave their written informed consent before any procedure requested by the protocol.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data, NCT 02420158. All individual participant data that underlies the results reported in the article, after de-identification will be available along with the study protocol. The data will be available for any purpose immediately following article publication with no end date. Proposals to access data should be directed to the corresponding author.

Additional information

Funding

This work was made possible by a research grant from APICIL Fondation, and a FARE research grant from the French Society of Gastroenterology (SNFGE). Schwa Medico France provided graciously Urostim stimulators and ear plugs for the study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.