Background: Generalized anxiety disorder (GAD), chronic pain (CP) and irritable bowel syndrome (IBS) are debilitating inflammatory disorders that are frequently seen in primary care facilities but not sufficiently addressed by classical medical treatments. Transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic tool for a wide range of conditions that showed already encouraging clinical results. However, the effects of tVNS, on these disorders, GAD, IBS and CP,were not yet explored in the context of an investigation conducted in a private healthcare center.Objective: In an uncontrolled, open label, small investigation scale study, we investigated the feasibility, safety and the effects of tVNS for patients suffering from GAD, CP and IBS in a multidisciplinary healthcare center.
Methods:The effects of tVNS on GAD, CP and IBS in 10 participants (anxiety, 40%; chronic pain, 30%; IBS, 30%) were investigated during a 4-week period and a 2-month follow-up. GAD, CP and IBS were assessed using the Generalized Anxiety Disorder GAD-7, the Brief Pain Inventory Short Form questionnaire and the Irritable Bowel Syndrome Severity Scoring System. Transcutaneous vagus nerve stimulation was performed using a transcutaneous electrical nerve stimulation device and ear clip electrodes plugged in the concha area of the ear. All participants, received a bi-weekly 30-minute stimulation for 4 weeks. The tVNS parameters, (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs), were set for each group to target different physiological effects meditated by the vagus nerve.
Results:The anxiety and the IBS group showed a non-statistically significant improvement but an improved clinical status (mean score from "severe" to "moderate") both at the end of the stimulation period (4 weeks) and at 2-month follow-up. The CP group didn't show any significant clinical improvement (mean score from "moderate" to "moderate"). Furthermore, tVNS was demonstrated to be likely safe and was well tolerated.
Conclusions:Due to low sample size, this study failed to demonstrate significant clinical effects of tVNS on GAD, IBS and CP. However, trend analysis may carefully suggest tVNS to be a noteworthy clinical alternative to be used in private healthcare center in the treatment of chronic inflammation disorders like GAD and IBS. Acute tVNS was well-tolerated and is likely safe. Powerful, double-blind controlled studies are needed to support the use of tVNS for these disorders. Clinical Trial Registration: http:/www.clinicaltrials.gov. Unique identifier: NCT03440255. Abbreviations α7nAChR, alpha7 nicotinic acetylcholine receptor; ABVN, auricular branch of the vagus nerve; CAN, central autonomic network; CAP, cholinergic anti-inflammatory pathway; CP, chronic pain; DMVN, dorsal motor nucleus of the vagus; GABA, γ-aminobutyric acid; GAD, general