It seems that certain research environments are mucking about without anyone checking what they’re actually doing. What they produce is not useful either for patients, clinicians or the health authorities. Those who do benefit from this are the researchers themselves, by building their own and their peers’ prestige – and the insurance companies who fund them.

I have previously written about the poor quality of ME research; how research is misused and how poor quality studies lead to stigma and harmful treatment.

Recently, the results of a Danish study were published. The researchers had measured cortisol and self-perceived stress in adolescents with what the researchers call «multisystem functional somatic disorders», FSS. I have taken a closer look at the study and found that it belongs to the same category.

The study is part of a larger project. According to the study protocol from 2016, 120 adolescents with psychosomatic disorders were to be treated with acceptance and commitment therapy. The scientists were to measure the effect of the treatment using questionnaires (main outcome measure) and objective tests (changes in cortisol, heart rate, biomarkers for inflammatory and oxidative stress and level of physical activity) as secondary outcome measures at inclusion and at 12 months.

Neither the feasibility study (2020) nor the main study (2021) mention the results of the objective tests. But let’s look at the main study first.

The main study

The main study ran from 2015 to 2019 and the results were published in 2021.

The study had 91 participants; between 15 and 19 years of age. 47 participants received standard treatment (EUC); «a 1½-hour manualised psychiatric consultation with a physician providing further psychoeducation regarding multiple FSS and introducing general health promoting strategies for sleep, eating habits, physical and social activities, and engagement in positive activities».

44 participants were treated with 30 hours of acceptance and commitment therapy (AHEAD).

Compared to standard treatment, the therapy had no additional benefit in improving physical health.

Nevertheless, the scientists claim that “the AHEAD intervention resulted in a clinically relevant improvement” and that the results “underpin the importance of an organised and systematic treatment offer for the most severely affected youth.».

Misleading graphs

The results of the changes are illustrated with graphs. The graphs are truncated.

If you shorten the vertical y-axis in a graph too much, it can give the impression of changes much larger than the reality.

The graphs in Figure 2 of the article give the impression of large changes where there are only clinically modest effects.

Example: The graph on the left, which shows the total score for physical health, SF-36, is presented in a truncated y-axis from 25 to 50. In the figure on the right, the results are entered on the entire scale; from 1-100.

The modest changes may just as well be due to the Hawthorne effect; when people, who are the subjects of an experimental study, change or improve their behavior because it is being studied.

The results of the objective outcome measures are not mentioned.

Approved delay?

I contacted one of the scientists; Karen H. Kallesøe and asked about the results of the objective outcome measures. She replied that they have recently published the results of cortisol and that the rest of the results are still being analyzed.

The study took place between 2015 and 2019. All the results of the questionnaires; the subjective outcome measures have been analyzed and published.

Kallesøe says that they expect to publish the other objective results during this year or next year. The reason for the delay is the lack of control group data and lack of funding for the analyses. She confirms that «yes – it has been approved by the ethical committee as these were secondary measures with the psychological intervention being the primary one.».

When I sent a freedom of information (FOI) request to the committee which approved this delay, they replied that it is not a document they are in possession of, «as the committee does not process such applications.».

Cortisol

Anyway; the results of the cortisol measurement were published in February 2024. That is to say; not quite.

According to the protocol, cortisol was to be measured before and after the therapy; at baseline and at 12 months. Instead of comparing the results before and after the therapy, the scientists compared the cortisol level of the participants before the therapy with data from a general child cohort study; Copenhagen Child Cohort 2000.

The researchers found that cortisol did not differ significantly between different primary symptom presentations, and was not significantly associated with self-perceived stress.

Nevertheless, they believe that the results may indicate that the participants in the main study “did indeed experience overall higher subjective stress levels than those seen in the general population; a finding that also provides support for the involvement of stress in FSD.

But; the researchers have not answered their own questions and therefore we don’t get to know how the therapy actually affected the cortisol levels.

Why is this important?

Money

Most Danes have private health insurance. Danish insurance companies can refuse compensation claims relating to psychological and psychosomatic disorders. Compensation and disability benefits are also not granted until the health situation has been clarified, and as long as there are treatment options, the health is not considered clarified. With a psychosomatic diagnosis, it can be very difficult to get financial support.

One of the authors who developed the study protocol is psychiatrist Per Fink. He is head of the Research Unit for Functional Disorders and Psychosomatics at Aarhus University Hospital in Denmark. He has been researching functional disorders for a lifetime. Functional disorders are the same as psychosomatic disorders. The insurance companies TrygFonden and LundbeckFonden have funded Fink’s research with many millions.

Read more about Per Fink here: ME, the insurance industry and psychiatry

Trygfonden and Lundbeckfonden have also financed this project.

In this project, the term «functional disorders», (FSS) also includes fibromyalgia (which is a chronic, rheumatic condition) and chronic fatigue syndrome, CFS (also called Myalgic Encephalomyelitis, ME which is a chronic, multisystemic disease classified under neurology).

By claiming that stress is a disease factor despite the fact that they didn’t find that, the researchers strengthen the perception of psychosomatics as a cause. Insurance companies can then refer to these research articles when they reject claims for compensation.

Read also: Unpublished research results harm us (Norwegian text).

Fink co-authored the study protocol from 2016. He is not a co-author of the following articles; (the feasibility study from 2020, the main study from 2021 or the cortisol study from 2024). For some reason, Norwegian Prof. Vegard B.B. Wyller is listed as co-author of the cortisol study. Wyller’s study from 2010 is the reference list’s no. 23.

Wyller is known for his hypothesis that ME is a sustained arousal stress response. He is often presented as an ME expert even though he doesn’t research ME. He has received most of the Norwegian research funding in the field. Wyller has collaborated with project manager Charlotte U. Rask on several occasions. By listing Wyller as a co-author and citing his research, she helps to increase his prestige and influence.

In 2022, Rask was the first opponent when Wyller’s pupil Tarjei Tørre Asprusten defended his thesis. Wyller was the Principal Supervisor. Asprusten’s dissertation casts doubt on ME and embezzles that Post Exertional Malaise, PEM – the cardinal symptom of ME is objectively measurable. Rask, Fink, Asprusten and Wyller are all members of the infamous Oslo consortium, which clings to outdated hypotheses, lousy research and harmful treatment methods.

We, the ME patients still have to fight against misconceptions about the disease, harmful treatment and accusations of harassment and activism when we criticize their research. At the same time, insurance companies can increase their profits.

Written by

Nina E. Steinkopf

Former HSEQ Chief Executive

Now; ME patient and writer

References:

2016: Kallesøe KH, Schröder A, Wicksell RK, Fink P, Ørnbøl E, Rask CU. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial. BMJ Open. 2016 Sep 15;6(9):e012743. doi: 10.1136/bmjopen-2016-012743. https://pubmed.ncbi.nlm.nih.gov/27633643/

2020: Kallesøe, K. H. , der Schrö, A. , Wicksell, R. K. , Preuss, T. , Jensen, J. S. , & Rask, C. U. (2020). Feasibility of group‐based acceptance and commitment therapy for adolescents (AHEAD) with severe functional somatic syndromes: A pilot study. In review. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507241/  

2021: Kallesøe KH, Schröder A, Jensen JS, Wicksell RK, Rask CU. Group-based Acceptance and Commitment Therapy (AHEAD) for adolescents with multiple functional somatic syndromes: A randomised trial. JCPP Adv. 2021 Dec 8;1(4):e12047. doi: 10.1002/jcv2.12047. https://acamh.onlinelibrary.wiley.com/doi/10.1002/jcv2.12047

2024: Nyengaard, R., Kallesøe, K.H., Rimvall, M.K. et al. Hair cortisol and self-perceived stress in adolescents with multi-system functional somatic disorders. BMC Psychiatry 24, 101 (2024). https://doi.org/10.1186/s12888-024-05518-4