Saliva fatigue biomarker index as a marker for severe ME/CFS in a community based sample, 2021, Jason et al

A pity it's paywalled, I'd like to see the figures.
The results sentence is ambiguous.

Does that mean severe ME was different from both non severe ME and controls, with no difference between the latter 2 groups, or does it mean all 3 groups were different from each other.

From the title of the paper, I assume they mean only the severe ME formed a different group.

Given they only had 59 pwME in the sample, it would seem reasonable to assume about a quarter had severe ME, making the sample size very small.

I hope it's an easy test that can be done with much bigger samples and wider age range.

 

The paper has no figures, the results are ten lines split into two paragraphs.

What I don't like is that the biomarker, based on what I read in the background, has been studied previously in healthy individuals as a general marker of physical fatigue. What if the pwME is not "fatigued" when the test is performed?

 

I have been shown a copy of the full paper.

The first thing we need to understand is that they use their own idiosyncratic definition of Severe ME/CFS, which they shorten to S-ME/CFS.

People fitting just Fukuda but not IOM or ICC criteria are classed as ME/CFS. (19 people)
Those fitting more than one definition are classed as S-ME/CFS.
(40 people)

To me it looks like there was very little between group difference, the standard deviation indicating lots of between group overlaps between individual readings. So not a definitive biomarker.

 

I'm not sure what the added value of collecting data at more sites for illness studies. It is troubling enough we don't know what is "normal" in the sites we have, making it difficult to filter out what is abnormal, regardless if samples are collected from serum, plasma, any part of the digestive system or skin/hair.

 

Why on earth would Jason and Katz do that? Surely these experienced ME/CFS researchers both know better than to create confusion around what 'severe' means? Why wouldn't you make the title something like
"Saliva fatigue biomarker index as a marker for IOM-compliant ME/CFS in a community based sample"?

And I don't understand why this first sentence is included in the abstract - what relevance has the prevalence study (which does sound interesting) to the biomarker study? Sure they may have plans to operationalise a biomarker in a large sample, but that's just a wish. In terms of what goes in the abstract, it's a lot less important than the stats and/or something about the peptide fragments.

I'd be disappointed if my (hypothetical) graduate student came to me with that abstract as an initial draft. But for this to be produced by experienced ME/CFS researchers and published - well, it's .. really disappointing.

And my disappointment doesn't end there. It's actually published in Fatigue, the IACFSME journal that published Crawley's Lightning Process paper. Seriously - what is going on with that journal? Where are their editorial standards?

I think I had better go get something to eat - perhaps my irritability is a sign of low blood sugar...

 

Nope, it's not a blood sugar problem.

 

Authors:
Leonard Jason - Professor - De Paul University, Chicago
John Kalns - employee - Hyperion Biotechnology, Texas
Alicia Richarte - employee - Hyperion Biotechnologies, Texas
Ben Katz - Professor - Northwestern University
Chelsea Torres - 'psychology trainee' - De Paul, Chicago

Disclosure Statement:
No potential conflict of interest was reported by the author(s)

Hyperion Biotechnology:
Midnattsol said the test is a general fatigue one. Presumably it's this one, advertised on the Hyperion website. No scientific studies to support the test are listed: just
"Technology protected under US Patents (Kalns et. al): 9,316,651, 8,945,854, 8,738,338, 8,442,808. Other references available upon request."




I haven't read the paper yet due to the paywall, and of course it can be legitimate for private companies to collaborate with independent researchers. But it's not great that the only part accessible to most people with ME/CFS gives no stats, and the results section sounds so inadequate.

As for the Fatigue Journal - a paper supporting the commercial Lightning Process, and a paper supporting a commercial 'fatigue test'... It's looking a bit like a trend.

 

Yes, or used the actual symptoms to define the classes e.g. ME/CFS with PEM; chronic fatigue without PEM. Or at least not added the layer of assumption about severity, and just referred to something like 'Fukuda Only ME/CFS' and 'Multiple Criteria ME/CFS'.

But, if they had wanted to tell us something about the approach to sampling, they could have told us that participant selection was from a community based sample. The first sentence of the abstract as it is now doesn't tell us what the approach to sampling was.

I agree. I'm not suggesting the researchers had bad intentions. I'm just noting that two recent papers in the IACFSME's journal are of commercial products (this one and the Lightning Process), whose owners would benefit financially from having the products better known by people with ME/CFS. And that, given IACFSME is a charity aiming to work in the best interests of people with ME/CFS, you would hope that the editorial standards for such papers would be very stringent, so as to not create false impressions of product utility.