Open Sweden: The role of low-grade inflammation [...] in ME/CFS, Andreasson et al - recruiting

mango

mango

Senior Member (Voting Rights)
The role of low-grade inflammation for the progress of disease in patients with myalgic encephalomyelitis/chronic fatigue syndrome ME/CFS

Anna Andreasson, Martin Jonsjö, Linda Holmström.

Original title in Swedish (as stated in the ethical approval application): Betydelsen av låggradig inflammation för symtoms förekomst, grad och utveckling i Myalgisk Encefalomyelit/Kroniskt trötthetssyndrom.

Google Translate said:
Participants Needed For Research Study

Research study on the importance of low-grade inflammation in ME/CFS is seeking participants.

Beteendemedicin/the Unit for Behavioral Medicine, Karolinska University Hospital, and Stressforskningsinstitutet/the Stress Research Institute, Stockholm University, are now conducting a study that investigates the importance of low-grade inflammation for the occurrence and intensity of symptoms, as well as for the course of symptoms over time for individuals with ME/CFS.

The purpose of the study is to identify biological markers that are related to the disease symptoms.

We are looking for adults (18 years or older) who have been diagnosed with ME/CFS at a specialist center in Stockholm (TakeCare medical record system) according to the Canadian Criteria (CCC). Participation involves submitting blood samples and filling in web forms about eg. symptoms, diet and how you are feeling a total of eight times over a two-year period. Samples can be submitted at a number of nearby laboratories in the Stockholm region.

Visits and tests in the study are free of charge. No compensation for participation is paid.
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https://www.stressforskning.su.se/om-oss/press-nyheter/nyheter/deltagare-till-forskningsstudie-sökes-1.434261
 
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I'm very dubious of this. The list of other studies listed in comment #4 does not indicate even basic understanding of ME and the reliance on psychometric questionnaire is entirely superfluous, suggests typical FND crap trying to present cherry-picked correlations as significant, because science 101 is overrated, I guess.

There is some language that seem relevant at first glance but then that's basically been the "innovation" at the center of FND: psychosomatic "medicine" that pretends it's not using the language of science but incompetently and only to "prove" predetermined conclusions. Probably best to pass and recommend against participation. Enough coddling of pointless fishing expeditions.

I'd much rather have actual competent people who don't bother wasting parts of a study on nonsense. Irrelevant questionnaires have already proven to be utterly useless and only add a bunch of noise. It's been done to death. Enough of this. It's not yet science if you can't measure things reliably. Devise competent measurements or go home.
 
I think the intention is to see whether any specific cytokines are correlated with scores of their shiny new "Sickness Behaviour" questionnaire.

Personally, I'm a bit bored of cytokine studies, as cytokines haven't been found to be useful biomarkers for any illness, except the cytokine release syndrome (sometimes known as cytokine storm). Cytokines aren't really meant to spill over into the blood (where they are mostly useless), and so much cytokine activity during infections for example, goes undetected.
Aside from the longitudinal aspect, there is little innovation. Perhaps we'll see a replication of increased TGF-Beta over several time periods though.
 
Snow Leopard said:
I think the intention is to see whether any specific cytokines are correlated with scores of their shiny new "Sickness Behaviour" questionnaire.
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I agree. I believe this is part of their efforts to try and subgroup patients by combining psychological and biological data; an intent they have previously stated in, for example, research plans submitted to the Ethical Review Authority.

In their ACT research plan (2015) it says that the aim of evaluating symptoms in relation to psychological, neuroimmunological and endocrinological factors is to define what patient groups wiil have the best effect of ACT, and that the goal is to improve mental health, physical function (including the ability to work) and quality of life for adults with CFS.
 
Their web page was apparently updated in March, a Q&A has been added. Here's one of the answers:
Stressforskningsinstitutet Google Translate said:
Why do you not take blood samples at home so that people with more severe ME can be included in the study?

There are two reasons why we do not take blood samples at home. In part, the markers we examine are sensitive. The blood samples need to be taken in the same way each time, and they need to be stored at a certain temperature and treated carefully. This means that it does not work to take the samples at home. In order to be able to collect samples from as many as 150 people, we instead collaborate with several laboratories around the Stockholm region so that you will have to travel as short as possible to the sampling.
The study includes a urine sample for metabolism. You take it at home. If given the opportunity, we will expand the study to include people with more severe ME/CFS who only have the ability to take the urine sample. Then we can certainly not examine low-grade inflammation in those people, but other questions that we have.
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https://www.stressforskning.su.se/om-oss/press-nyheter/nyheter/deltagare-till-forskningsstudie-sökes-1.434261#Frågor och svar

There's still no info about why a psychological department is doing a study like this (heavily framed as studying "the physiological causes of ME/CFS"). In the Q&A there's this wee bit at the end:
Google Translate said:
You will also have to fill in forms about your life situation, so that we can first learn more about how, for example, stress can affect the disease.
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and this:
We will not provide any treatment in this study. After the end of the study, we hope to be able to identify different groups of people with ME/CFS who could benefit from different treatments. You as a participant may be asked to participate in a treatment study after this study has been completed.
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I can't help wondering what treatments the Stress Research Institute have in mind... Their own version of "ACT" (gradually increase activity, managing irrational fears etc) or maybe CBT? I really wish they were more transparent about the models they are using...
 
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The webpage was updated in May 2021.

The name of the study has apparently been changed to "the role of low-grade inflammation in long-term complicated fatigue".

Post-COVID and utmattningssyndrom (burnout, work/stress related exhaustion syndrome; has a separate diagnostic code in Sweden, is not the same as CFS) have been added to the inclusion criteria.

They are still looking for participants. (Not a recommendation.)
 
Wow, so now they just lump ME/CFS, post-covid and burn-out together?
What looked really bad to begin with now looks even worse.

Or is it perhaps better for us that the studie refers to 'long-term complicated fatigue' instead of ME? (although ME is seemingly (mis)placed under that very MUS-sounding umbrella term.
 
The researchers submitted an application regarding a number of changes to the study protocol in June 2021. It was approved by the Ethical Review Authority on 27 July 2021.

The following info has been copied from the application and auto-translated.

Some of the amendments in brief:
  • Addition of up to 150 individuals responding to questionnaires only
  • Asking participants to take part in an experiment
  • Advertising for study participants also via patient organisations and social media
  • Validate a questionnaire for acute fatigue
  • Adding a questionnaire on prevalence of neuropsychiatric symptoms
  • Broaden inclusion to patients with long-term complex fatigue [ME/CFS, burnout syndrome, post-covid-19]
  • Add a healthy control group
  • Add a comparison group of patients with rheumatic disease
  • Add a comparison group of patients with IBS
  • Add questionnaires
  • Add question if participant has had Covid-19
Their hypothesis is still the same:

"Our underlying hypothesis is that there are many common biopsychosocial vulnerability and perpetuating factors for fatigue, regardless of the main diagnosis of the patients. We also believe that there are subgroups that differ in terms of these factors and that are also likely to overlap between the different diagnosis groups."

Under the heading "psychological factors", the following examples are given:

"Mental illness (anxiety and depression), prolonged stress prior to onset, symptoms consistent with underlying undiagnosed neuropsychiatric problems, perfectionism, psychological flexibility and ability to emotionally regulate."

Project summary, updated version
Auto-translate said:
Summary
Prolonged complex fatigue is fatigue that does not go away with rest. The number of patients affected is expected to increase. Fatigue is associated with impaired health and significantly reduced quality of life and function. During the current pandemic, many have reported persistent fatigue despite mild COVID-19.

For better personalised interventions in long-term complex fatigue, there is a need to explore similarities and differences in biopsychosocial vulnerability and perpetuating factors and consequences for work capacity and sick leave in chronic fatigue syndrome (ME/CFS), exhaustion syndrome (UMS) and post-covid fatigue.

This study investigates inflammatory markers, nutritional status, long-term stress, neuropsychiatric conditions, and work capacity and sick leave in a longitudinal study of patients with different diagnoses, all suffering from long-term complicated fatigue.

Our hypothesis is that there are common biopsychosocial vulnerability factors for developing and perpetuating fatigue, regardless of main diagnosis, but also that there are subgroups that differ with respect to these factors.

Participating patients with ME/CFS, UMS and post-covid fatigue complete an online questionnaire at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months. There is no upper limit to the number of participants in the web questionnaire.

150 participants are asked to provide blood samples at a local laboratory in at the time of the survey and urine samples at one time.

The longitudinal design allows to examine how variations in symptoms affect work capacity and sick leave.

Two control groups are used for comparison, healthy people and patients with rheumatic disease.

The project team consists of a multidisciplinary team from Stockholm and Linköping University and clinicians from clinics in both regions who frequently encounter patients with long-term complex fatigue.
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mango said:
  • Advertising for study participants also via patient organisations and social media
  • ...
  • Broaden inclusion to patients with long-term complex fatigue [ME/CFS, burnout syndrome, post-covid-19]
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Are the patient charities (including the Long Covid charities) able to do anything to warn people to avoid this study? It sounds like a disaster in waiting.
 
It does seem like the cytokine stuff is included to make it look like a biological study. And the diet data looks like it will be too limited to be useful. The intent is clearly to further their psychological theories. The glaring hole in this is any objective measure of activity levels or of cognitive function. For a longitudinal ME study that omission is ridiculous.
 
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