Effects of a health education program on cytokines and cortisol levels in fibromyalgia patients: a randomized controlled trial, 2018, Pernambuco et al

Andy

Andy

Retired committee member
Background
Fibromyalgia (FM) is a syndrome characterized by widespread chronic pain associated to other symptoms, such as: fatigue, anxiety, depression and sleep disorders. Health education programs (HEP) have emerged as good non-pharmacological strategies to treat it. However, it is still not clear if the benefits are only subjective, or it has also objective impacts on immune and or neuroendocrine systems.

Methods
Fifty-eight fibromyalgia women were randomly allocated in experimental group (n = 27) or control group (n = 31). The experimental group was submitted to HEP treatment for 11 weeks, while control group did not receive intervention at the same period. All data were collected at zero and 11th week by a blinded researcher. The statistical analysis were made in GraphPad Prism software (version 5.0) with significant level adjusted for α = 0.05.

Results
Forty-four patients concluded the full study, 21 in the experimental group and 23 in the control group. Intragroup and intergroup analysis revealed that treatment induced significant increases of IL-4 plasma levels, anti-inflammatory cytokine/inflammatory cytokine ratio (AC/IC ratio), salivary cortisol levels, in addition to significant decreases on FIQ scores. Intergroup variation analyses revealed also significant increases of IL-10 plasma levels.

Conclusion
The results presented suggest that this kind of HEP could induce subjective and objective changes (immune and neuroendocrine), that could explain, at least in part the improvement of fibromyalgia patient’s health status.
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Open access at https://advancesinrheumatology.biomedcentral.com/articles/10.1186/s42358-018-0022-z
 
i'd like to see the data for the different levels of severity (Brazilian Fibromyalgia Impact Questionaire) - with small sample size, results can be skewed by 1 or 2 patients - do these subjects accurately represent patterns found in Fibromyalgia population (age, severity, duration of illness, etc)

also, effects of having your disease taken seriously, and given support, vs the control group (no treatment) with perception of being neglected yet again.
 
If I understand this correctly, and I sure hope I'm mistaken because this would make it lukewarm garbage, this is a "training program" in which they explain a disease that is fundamentally recognized as being a mystery and try to see if it changed anything in their cytokines and cortisol.

There is a table with the "treatment". Basically: discussion, yoga, discussion, pilates, discussion, discussion, motivation. It is established that almost nothing is known about the disease mechanism. How can there be a training course for something that is not understood you may ask?

So there are 2 objective measures, but those measures are generally ignored as something interesting but ultimately inconsequential when it comes to establishing whether the disease has a genuine physiopathology, rather than being down to perception. So what is the value in measuring cytokines, for the sake of having an objective measure, when it is generally disputed (probably incorrectly) that observing different cytokine measures in patients is not good enough evidence that it is a physiological disease?

No man was selected for the study because fibromyalgia affects up to nine women for each affected man
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This ratio seems excessive and out of line with published research.

Just most psychosocial nonsense paying some lip service to the bio part while fundamentally not caring about it.
 
Question the 11 week interval between the assays of cortisol and interleukins. Do individual subjects have the same levels of interleukins and cortisol generally throughout weeks and months?

For instance: research on the effect of exercise on cytokines in ME: the chemicals are tested just prior to the exercise and immediately after. I wonder if, within an 11 week interval, those chemicals could be affected by stresses in life, by viruses, etc.


What they are measuring is the placebo effect, of being attended to by medical professionals, of being in a group of fellow-sufferers, of having your diagnosis taken seriously. The research does admit to the Hawthorne effect--on the fibromyalgia impact questionnaire.

And aren't the cytokine and cortisol assays just completely irrelevant since neither is an indicator of the diagnosis, for which there is no biomarker as yet, except possibly fMRIs?

Conflating and misleading, null.
 
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Funny how they conclude that increased cytokines and cortisol is a good result. Such findings may simply be due to different activity patterns before and after. I really don't know why you'd design a study like this, but... meh
 
The pattern of cortisol secretion is altered in fibromyalgia. Normally it should be higher in the morning but in FMS, it's not.
Certain cytokines are pro-inflammatory; others are anti-inflammatory (ILs 4, 10, 13).
But the whole premise is sketchy.
 
During the first eleven weeks, the control group was not submitted to any intervention. Patients were kept in hold and they submitted to the HEP treatment only after the completion of the research.
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That's not a control group. This is a waiting list comparator arm, a useless trial design. A true control group would force these patients to get out of bed/house, show up to the hospital on the same schedule as the intervention group but have them play solitaire or read a newspaper instead. $100 says they would have found the same increases in cytokines and cortisol as the 'intervention'. Half wits.
 
Sid said:
That's not a control group. This is a waiting list comparator arm, a useless trial design. A true control group would force these patients to get out of bed/house, show up to the hospital on the same schedule as the intervention group but have them play solitaire or read a newspaper instead. $100 says they would have found the same increases in cytokines and cortisol as the 'intervention'. Half wits.
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I have seen far too often "waiting list" being cited as a passive form of treatment. I guess it's a thing, apparently one that makes no distinction between waiting for nothing and waiting for actual treatment. Or it probably does in most cases and as always there's just exceptions for stigmatized diseases.
 
They seem to have bought into the Burnout theory of cortisol production

"It is important to note that the hypocortisolism presented by FM patients are related to HPA axis dysfunction, also named stress response axis [3]. According to this theory, individuals expose to stress agents (physical or psychoemotional) for long periods could experience a phenomenon called burnout syndrome, characterized by lower cortisol production in response to stress agent [30]. We believe that the increasing of cortisol levels in the experimental group could indicate that the coping strategies taught in the ISF contributed in a positive way to these patients, helping them to live or face more adequately the different types of adversity."
 
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rvallee said:
I have seen far too often "waiting list" being cited as a passive form of treatment. I guess it's a thing, apparently one that makes no distinction between waiting for nothing and waiting for actual treatment. Or it probably does in most cases and as always there's just exceptions for stigmatized diseases.
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Lots of psychotherapy trials use this design because it makes it exceedingly easy to show a statistically significant result in favour of 'therapy'.
 
Sid said:
That's not a control group. This is a waiting list comparator arm, a useless trial design. A true control group would force these patients to get out of bed/house, show up to the hospital on the same schedule as the intervention group but have them play solitaire or read a newspaper instead. $100 says they would have found the same increases in cytokines and cortisol as the 'intervention'. Half wits.
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and a very small number of patients. 58 started and only 44 finished. Given that they were split into 2 groups and only 21 people finished in the "experimental" group that's not many.
 
shak8 said:
The pattern of cortisol secretion is altered in fibromyalgia. Normally it should be higher in the morning but in FMS, it's not.
Certain cytokines are pro-inflammatory; others are anti-inflammatory (ILs 4, 10, 13).
But the whole premise is sketchy.
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In many patients it is within the same range as controls and even when it is not, cortisol secretion patterns during the day is directly related to day to day metabolic demands and sleeping rhythms, which can often be quite different in a person who is not working full time versus someone who is.
 
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