Transcutaneous Vagus Nerve Stimulation in the Treatment of Long Covid-Chronic Fatigue Syndrome 2022 Natelson et al

[Sly Saint]

Preprint

Abstract
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, we decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. Fourteen patients provided evaluable data. Eight of these fulfilled our requirements for treatment success. Since our criterion for a successful study was that at least a third of patients had to show a positive response to treatment, this was a successful pilot that warrants a follow up study that is appropriately sham controlled.

https://www.medrxiv.org/content/10.1101/2022.11.08.22281807v1

 

[Sly Saint]

article on the study

Background
In one of their other recent study, the authors showed that nearly half of the long COVID patients fulfilled the 1994 case criteria for myalgic encephalomyelitis (ME)/CFS, assessed via a five-point Likert scale. On the Likert scale, zero, one, two, three, four, and five indicated no to very severe CFS, respectively. The 1994 case definition for CFS requires an individual to experience over six months of chronic fatigue that does not improve by taking rest and is not the result of ongoing exertion. Additionally, it substantially reduces one's activity in one of the following spheres: work, school, personal or social.

Long COVID shares many ME/CFS symptoms, including fatigue, problems with attention and concentration (brain fog), diffuse muscular pain, and post-exertional malaise. However, in their current work, the researchers focused primarily on CFS. Since there is no treatment for long COVID, they reviewed a Belgian paper reporting improved symptoms in long COVID patients following the application of tVNS. They further confirmed these preliminary findings about the tVNS treatment in the current study.

https://www.news-medical.net/news/2...treatment-for-long-COVID-chronic-fatigue.aspx

 

[BrightCandle]

Two fell out of the study out of 16, 12.5% loss potentially made much worse. 5 saw no improvement at all, none of the rest showed any significant improvement and one got substantially worse. This all looks well within the normal oscillation of the condition especially since they had no control. Despite the authors enthusiasm for improvement their defined criteria for success are kind of bad at a third showing any sign of improvement whatsoever, that is common in the ebbs and flows of the syndrome already. The data is presented only in text and doesn't give good indications of the effect size at all which requires you to work out that no one changed their level of function that I can tell (no one went from severe to moderate). A null result IMO, does nothing (which is precisely what happened to me when I did this, nothing).

 

[Denise]

This study does NOT apply to ME as it uses Fukuda. That Natelson says in the background that this applies to (ME)/CFS , ME/CFS is not acceptable.
Honest question - how is it that he continues to stick to Fukuda? He was on the IOM (NAM) committee.... He didn't write a dissent (that I can recall) so what's the deal?

 

[leokitten]

I think because Natelson, for better or worse, doesn’t necessarily support using more restrictive criteria. I spoke to him about the various Dx clinical criteria at an NIH ME conference years ago. He means well wants to help as many people as possible but told me he doesn’t want to exclude people because we don’t know what’s happening with them and they overlap. Trust me I don’t agree when it comes to research studies, why include more potential confounders!