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The effects of non-invasive vagus nerve stimulation on immune response and reported fatigue in patients with CFS, FM and RA, 2021, Traianos E et al

Discussion in 'BioMedical ME/CFS Research' started by Cheesus, May 25, 2021.

  1. Cheesus

    Cheesus Established Member (Voting Rights)

    Traianos E, Dibnah B, Lendrem D, et al
    Annals of the Rheumatic Diseases 2021;80:1057-1058.

    Background: Fatigue is reported as a common symptom among autoimmune and other chronic diseases such as fibromyalgia (FM), a long-term condition with uncertain pathophysiology. Previous studies from our group suggest that non-invasive vagus nerve stimulation (nVNS) may contribute to the improvement of patient reported outcome measures (PROMs) of fatigue in patients with primary Sjögren’s Syndrome (1).

    Objectives: This follow-up study uses the gammaCore device (electroCore) to assess the effect of nVNS on PROMs of fatigue and immune responses in chronic fatigue syndrome (CFS), FM and rheumatoid arthritis (RA).

    Methods: The study included thirteen CFS, fourteen FM and fifteen RA patients who used the gammaCore nVNS device twice daily over a 26-day period. Pre- and post- nVNS bloods were drawn at baseline and final visits. Whole blood samples were stimulated with 2 ng/mL lipopolysaccharide (LPS) and the IL-6 and TNF-α cytokine concentrations were quantified at 24 hours. In addition, the epidermal growth factor (EGF), IFN-γ, IL-6, IP-10, MIP-1α, and TNF-α levels were measured in ‘pre-nVNS’ serum and flow cytometric profiles of whole blood immune cells were analysed. The patient reported outcome measures (PROMs) recorded at each visit were the Visual Analogue Scale (VAS) (0-100 cm) of abnormal fatigue, Hospital Anxiety and Depression (HAD) Scale, Orthostatic Grading Scale, Epworth Sleepiness Scale (daytime sleepiness), and Profile of fatigue (PRO-F) for Physical and Mental fatigue. Paired t-tests were performed to assess for changes in PROMs, cytokine levels, and cell subset distribution and associations of cytokine response with PROMs were investigated by correlation analyses.

    Results: Eleven CFS, twelve FM and fourteen RA patients completed the study. There was a significant reduction in daytime sleepiness in CFS (p =0.0321) and FM (p =0.0294) patients between the final and baseline visits and a significant reduction in HAD depression (p =0.0413) in FM (Fig.1). Improvement in VAS for abnormal fatigue, HAD-Anxiety, HAD-Depression, PRO-F Physical and Mental fatigue was observed in all three groups over the study period with a reduction in VAS fatigue in 64% of CFS, 67% of FM and 62% of RA patients. There were no significant changes in the immune cell subsets or in cytokine response. Finally, higher baseline pre-nVNS supernatant IL-6 levels were predictive of an improvement in VAS fatigue (p =0.0006), Daytime Sleepiness (p =0.0466) and PRO-F Physical fatigue (p =0.0196) in RA, while higher baseline TNF-α levels were predictive of an improvement in VAS fatigue (p =0.0003), Daytime Sleepiness (p =0.0380), Orthostatic (p =0.0281) and PRO-F Physical fatigue (p =0.0007) in FM.

    Conclusion: Our findings suggest that nVNS may contribute to the improvement of PROMs of fatigue in CFS, FM and RA. NVNS led to significant reductions in daytime sleepiness in CFS and FM, and depression in FM. Further studies and a larger sample size are needed to investigate the potential effects of nVNS on diseases characterised by persistent fatigue.

    ljimbo423, MeSci, Barry and 4 others like this.
  2. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

    Probably trying to get an indication to be able to prescribe this device (GammaCore) for these diseases. Would have been better if they also used a placebo stimulator that maybe made a noise or something but didn’t deliver a shock. Might be something here.
  3. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    It seems a waste of time without controls. Any change may either be due to passage of time or reporting bias. It would be quite odd if there was not improvement for both reasons.

    The immunology study looks very strange - stimulating with LPS - what for?
    They do not even tell us about more obvious measures like whether the CRP level came down in RA.

    This is a meaningless study as far as I can see.
  4. Trish

    Trish Moderator Staff Member

    That looks pretty underwhelming to me. The did lots of subjective questionnaires and only a couple of them just reached statistical significance without any correction for multiple comparisons as far as I can see.

    I agree they should have had a control group treated with a sham stimulator.
  5. Simon M

    Simon M Senior Member (Voting Rights)

    yes, there's no full paper but it looks like they're clutching at straws, sadly. Never mind the lack of controls.

    I also think the device costs around £500 per month to rent (at least that's the price in the US; these devices tend to charge similar rates for the UK). It has recently been approved by NICE for treating cluster headaches.

    My interest is that it has a good track record in treating migraines (better than the other neurostimulation devices on the market). I would love to try for my chronic migraines – currently trying one other neurostimulation devices having failed with the first. (After monoclonal antibodies failed for me, my consultant said I had exhausted what he had to offer and suggested I give some of these devices).

    If there was decent evidence it helps with ME/CFS as well, maybe I could have managed to get hold of one. But this is not decent evidence, sadly.
    Last edited: May 25, 2021

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