Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial.

Abstract

OBJECTIVES:

Musculoskeletal pain and fatigue are common features in systemic lupus erythematosus (SLE). The cholinergic anti-inflammatory pathway is a physiological mechanism diminishing inflammation, engaged by stimulating the vagus nerve. We evaluated the effects of non-invasive vagus nerve stimulation in patients with SLE and with musculoskeletal pain.

METHODS:

18 patients with SLE and with musculoskeletal pain ≥4 on a 10 cm Visual Analogue Scale were randomised (2:1) in this double-blind study to receive transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (SS) for 4 consecutive days. Evaluations at baseline, day 5 and day 12 included patient assessments of pain, disease activity (PtGA) and fatigue. Tender and swollen joint counts and the Physician Global Assessment (PGA) were completed by a physician blinded to the patient's therapy. Potential biomarkers were evaluated.

RESULTS:

taVNS and SS were well tolerated. Subjects receiving taVNS had a significant decrease in pain and fatigue compared with SS and were more likely (OR=25, p=0.02) to experience a clinically significant reduction in pain. PtGA, joint counts and PGA also improved. Pain reduction and improvement of fatigue correlated with the cumulative current received. In general, responses were maintained through day 12. Plasma levels of substance P were significantly reduced at day 5 compared with baseline following taVNS but other neuropeptides, serum and whole blood-stimulated inflammatory mediators, and kynurenine metabolites showed no significant change at days 5 or 12 compared with baseline.

CONCLUSION:

taVNS resulted in significantly reduced pain, fatigue and joint scores in SLE. Additional studies evaluating this intervention and its mechanisms are warranted.

• Authors: Cynthia Aranow, Yemil Atish-Fregoso, Martin Lesser, Meggan Mackay, Erik Anderson, Sangeeta Chavan, Theodoros P Zanos, Timir Datta-Chaudhuri, Chad Bouton, Kevin J Tracey, Betty Diamond
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 80 Issue 2 Pg. 203-208 (02 2021) ISSN: 1468-2060 [Electronic] England
• PMID: 33144299 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Topics

• Adult
• Aged
• Double-Blind Method
• Fatigue (immunology, therapy)
• Female
• Humans
• Lupus Erythematosus, Systemic (complications)
• Middle Aged
• Musculoskeletal Pain (immunology, therapy)
• Pain Measurement
• Pilot Projects
• Transcutaneous Electric Nerve Stimulation (methods)
• Treatment Outcome
• Vagus Nerve Stimulation (methods)