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

Wyva

Wyva

Senior Member (Voting Rights)
ABSTRACT

Objective
The prevalence of pediatric Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) has been estimated from an ethnically and sociodemographically diverse community-based random sample of 10,119 youth aged 5–17. We assessed whether a salivary biomarker of fatigue could identify youth with ME/CFS.

Study design
We examined the ratio of the concentrations of 2 peptide fragments in saliva, referred to as the Fatigue Biomarker Index (FBI), in participants from our study diagnosed with ME/CFS (n = 59) and matched controls (n = 39).

Results
Significant overall differences were found in the FBI between those participants with severe ME/CFS and those with ME/CFS and the controls.

Conclusions
If confirmed in other populations, the FBI could serve as an objective test to aid in the diagnosis of severe ME/CFS.


Paywall: https://www.tandfonline.com/doi/abs/10.1080/21641846.2021.1994222
 
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A pity it's paywalled, I'd like to see the figures.
The results sentence is ambiguous.

Significant overall differences were found in the FBI between those participants with severe ME/CFS and those with ME/CFS and the controls.
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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.
 
Trish said:
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.
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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)
Using ANOVA, significant overall differences were found in the salivary FBI [F(2,95) = 3.25, p < .05] between the three groups, those participants with S-ME/CFS, those with ME/CFS and the controls. There were also no significant gender, race/ethnicity, or age differences between the S-ME/CFS, ME/CFS and Control groups. Using Tukey planned comparisons, the control group (M = −1.39, SD = .46) was significantly different at the p < .05 level from the S-ME/CFS group (M = −1.62, SD = .34). The Control group was not directionally significantly different from the ME/CFS group (M = −1.53, SD = .42), and there were no significant differences between the ME/CFS and the S-ME/CFS groups.
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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.
 
dreampop said:
I'd love to see a thorough multi-omics study of the oral microbiome. This is just 2 peptides afaict. The eyes as well. We need to start looking at reservoirs that aren't just the serum and microbiome.
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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.
 
Trish said:
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)
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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"?

Wyva said:
Objective
The prevalence of pediatric Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) has been estimated from an ethnically and sociodemographically diverse community-based random sample of 10,119 youth aged 5–17. We assessed whether a salivary biomarker of fatigue could identify youth with ME/CFS.
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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...
 
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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."

Screen Shot 2021-11-01 at 8.57.44 PM.png


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.
 
Hutan said:
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?
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Agree although I think they have used this method in previous studies before. It hampers the comparison because there were only 19 patients in the Fukuda-only group. In my view, they should have simply used the entire ME/CFS sample and compared it to controls with a graph of the actual data points.

If they wanted to study the link with ME/CFS severity they could have done a regression with a symptom questionnaire within the ME/CFS group instead of splitting it in two.

Hutan said:
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?
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I think it's simply to highlight that the sample was representative, selected randomly in a community-based study. That's probably seen as an asset but don't think this was necessary in this preliminary study (while it is necessary in some many other studies that don't take a representative sample).

Hutan said:
a paper supporting a commercial 'fatigue test'
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I don't think the group by Jason intended to promote something but are simply interested in ideas that might lead to an objective test of fatigue in ME/CFS, so also those proposed by commercial companies. Not necessarily a problem, in my view. What does look problematic is that this isn't mentioned under conflicts of interest.
 
Michiel Tack said:
Agree although I think they have used this method in previous studies before. It hampers the comparison because there were only 19 patients in the Fukuda-only group. In my view, they should have simply used the entire ME/CFS sample and compared it to controls with a graph of the actual data points.
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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'.

Michiel Tack said:
I think it's simply to highlight that the sample was representative, selected randomly in a community-based study. That's probably seen as an asset but don't think this was necessary in this preliminary study (while it is necessary in some many other studies that don't take a representative sample).
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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.

Michiel Tack said:
I don't think the group by Jason intended to promote something but are simply interested in ideas that might lead to an objective test of fatigue in ME/CFS, so also those proposed by commercial companies. Not necessarily a problem, in my view. What does look problematic is that this isn't mentioned under conflicts of interest.
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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.
 
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