Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS... 2023 Wortman et al

[Andy]

Full title: Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care

Highlights

• We investigated the effectiveness of psychosomatic therapy for PSS.
  
  
• No improvement was established in patient's level of functioning.
  
  
• We only found effects on some secondary outcome measures.
  
  
• Especially patients with moderate PSS benefited from the psychosomatic therapy.
  
  
• Psychosomatic therapy could be an important treatment to improve PSS management.

Abstract

Objective
To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS).

Methods
We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6–12 sessions delivered by specialised exercise- and physiotherapists. Primary outcome measure: patient's level of functioning. Secondary outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts.

Results
Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference − 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference − 1.93 [95% CI -3.81 to −0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference − 0.91 [95% CI -1.78 to −0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups.

Conclusion
We only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study.

Open access, https://www.sciencedirect.com/science/article/pii/S0022399923000338

 

[Andy]

"The term Persistent Somatic Symptoms (PSS) refers to a heterogeneous group of physical symptoms such as chronic widespread pain, headache, dizziness, fibromyalgia, chronic fatigue and irritable bowel syndrome that cannot be directly attributed to detectable underlying diseases or an organic pathology"

 

[Arnie Pye]

What does psychosomatic therapy consist of? Is it GET and CBT?

 

[Andy]

From the Discussion section.

"Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach. Some patients may need more explicit attention to a shared biopsychosocial disease model, more focus on understanding and acceptance of the symptoms as well as on their personal possibilities, which might reduce patients focussing on pain or complaints [55]. In addition, psychosomatic therapy aims at behavioural change and readiness to change might influence a positive outcome [57]. Some patients may lack this readiness to change. Furthermore, for the 30% of patients who were older than 66 years it might be more difficult to obtain a real change in symptoms and functioning. This needs to be verified in future studies."

 

[Andy]

What does psychosomatic therapy consist of? Is it GET and CBT?

"The psychosomatic therapy was administered by psychosomatic therapists with special interest in PSS, registered with the Dutch Association of Exercise Therapists [14] and the Dutch Association for Psychosomatics in Physical Therapy [13], respectively. It includes the following elements: psychoeducation, relaxation therapy and mindfulness, cognitive-behavioural approaches and activating therapy. During the psychosomatic therapy sessions, the therapist explores somatic symptoms and integrates the physical, cognitive, emotional, behavioural and social dimensions of the symptoms together with the patient. The overall aim of the treatment is to improve patients' functioning by stimulating self-regulation and empowerment to regain control over own health [22]. The intervention consisted of 6 to 12 sessions of 30–45 min over a period of 4 to 5 months, depending on the number and severity of the patient's symptoms."

So, in far less words, yes, pretty much GET and CBT.

 

[Arnie Pye]

This is just wall-to-wall neglect and torture (edit : I'm referring to the suggested treatment, not the results)

 

[Trish]

The usual conclusions: the treatment didn't work.
And with a bit of cherry picking they managed to find one slightly statistically significant outcome if you ignore correction for multiple comparisons, so of course they conclude the treatment is promising and more research is warranted.
Ridiculous.

 

[Sean]

• No improvement was established in patient's level of functioning.
  
  
• Psychosomatic therapy could be an important treatment to improve PSS management.

Those two statements do not fit together.

Some patients may need more explicit attention to a shared biopsychosocial disease model, more focus on understanding and acceptance of the symptoms as well as on their personal possibilities, which might reduce patients focussing on pain or complaints [55]. In addition, psychosomatic therapy aims at behavioural change and readiness to change might influence a positive outcome [57]. Some patients may lack this readiness to change.

Not satisfied with trashing our lives with their anti-science, they want to blame us for their technical and ethical failures.

They really do, at last, have no decency.

 

[rvallee]

• No improvement was established in patient's level of functioning.

• Psychosomatic therapy could be an important treatment to improve PSS management.

It's like they're playing roulette but with an additional option where either red or black gives them back all their money, and if they fall on 0/green the casino gives them a win, even if they didn't bet on it. This literally disproves the model, and they market it as a win anyway, and will get away with it.

And they have the utter shamelessness of taking such a null result, making it about being "promising", about something that has been used onto millions of people for decades.

This is madness. Nothing matters here. Not reality, not the patients, not the outcomes. They just make stuff up on and on, for decades, always talking about the thing they sell as fully effective being "promising" and also irrefutably effective, even though the evidence is complete garbage.

All of this taken at face value, taught at medical schools as being just as valid as the number of bones in the human body. Completely absurd.

 

[Hutan]

Authors and institutions:

Margreet S.H. Wortman ab , Johannes C. van der Wouden b, Jos W.R. Twisk c, Bart Visser a, Willem J.J. Assendelft d, Henriëtte E. van der Horst b, Tim C. Olde Hartman d
a Centre of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands
b Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan, 1117 Amsterdam, the Netherlands
c Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
d Department of Primary and Community Care, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands

I think it's important to note who these people are who can write highlights that both include an acknowledgement that their treatment did not work for a set of conditions while simultaneously saying that their treatment is important for improving the conditions.

 

[Hutan]

From the Discussion section.

"Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach. Some patients may need more explicit attention to a shared biopsychosocial disease model, more focus on understanding and acceptance of the symptoms as well as on their personal possibilities, which might reduce patients focussing on pain or complaints [55]. In addition, psychosomatic therapy aims at behavioural change and readiness to change might influence a positive outcome [57]. Some patients may lack this readiness to change. Furthermore, for the 30% of patients who were older than 66 years it might be more difficult to obtain a real change in symptoms and functioning. This needs to be verified in future studies."

I can picture authors and others of their ilk mentally making note - 'must do better with screening people who enter the trials to ensure only people who will believe are included'.

As it was, one of the exclusions was 'psychosomatic therapy not suitable for the patient, according to the GP'.

Participants were recruited from 39 general practices in the Netherlands participating in the academic networks of GPs of Amsterdam University Medical Center (UMC) and Radboud UMC. Through an electronic health record search, participating GPs selected, the 10% most frequently attending patients with PSS (aged 18 to 80 years) from the past two years.

So, actually, there was some screening. GPs who don't believe in PSS or talking therapy for PSS are more likely to have patients with the symptoms that would otherwise qualify them for a PSS diagnosis who also don't believe. GPs who do believe in PSS but knows their 'PSS' patient will not appreciate being told that they just need to think better probably won't have nominated such a person for the trial. And of course, the patient has some free will, and, so long as they are aware of what the treatment is, could choose whether to participate.

It's really interesting to consider that sentence from the discussion that I bolded:
"Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach."
That suggests some serious obfuscation of what the trial was about in its promotion. The authors say that the prospective participants received a pack with extensive information - so how could the fact that this was a trial of psychosomatic therapy not have been mentioned? For patients to join a trial of psychosomatic therapy without knowing that that was what they were signing up for seems unethical to me. Which raises questions about the ethical approval process, and also about the GPs who participated in the recruitment.

 

[Hutan]

The psychosomatic therapy was administered by psychosomatic therapists with special interest in PSS, registered with the Dutch Association of Exercise Therapists [14] and the Dutch Association for Psychosomatics in Physical Therapy [13], respectively.

Good grief, there truly is a community for everybody.

Prior to starting treatment of patients included in the CORPUS study, the therapists (n = 34) completed an accredited e-learning concerning PSS

And it appears there might be 35 of them (one also provided training to the 34 who did the therapy).

 

[Hutan]

The primary outcome measure was patient's level of functioning, measured with the Patient-Specific Complaints instrument (PSC) [30], in which the patient chooses the three most important activities for which he/she perceives limitations, rated on an 11-point numeric rating scale (0 representing ‘not a problem at all’ and 10 ‘impossible‘). The PSC is similar to the Patient-Specific Functional Scale (PSFS) [31], both were developed to assess patient-specific functioning and can used interchangeably. Both instruments are thoroughly validated and responsive measurement instruments [32,33]. However, using the PSC is a deviation from our protocol where we originally proposed the use of the PSFS. We selected the PSC over the PSFS, as it is widely used in the Netherlands and recommended in the majority of Dutch physiotherapy guidelines [34].

I thought this was interesting - each patient identifying activities where they experience limitations, and then reporting how much limitation they experience. I don't have a problem with it, as far as subjective measures go.

Hypochondriacal beliefs were measured with the Illness Attitude Scale (IAS) [39] using the total score and the scores on two subscales [40].

Wow. These people don't seem to have a problem in saying out loud what a lot of the BPS people only say in code.

We invited patients who did not consent to randomisation to participate in a parallel cohort. Only seven patients were included in this cohort, of whom five completed all follow-up measurements. We therefore do not report the data of these patients.

That adds another element of choice. I expect if the outcomes had been great, there would have been some reporting.

 

[Hutan]

I note in the waterfall diagram that one of the people allocated to the treatment is shows as 'deceased'. That raises the issue of harm. The word 'harm' does not occur in the paper, and the methods section includes nothing about monitoring harm. and yet this sort of treatment has the potential to cause immense harm.

 

[Hutan]

I think what they have done is as fine an example of desperate cherry picking as you will see. Bear with me as I try to explain.

PSC is the primary outcome - the three activities chosen by the participant as being important to them and impacted on by their health condition.

Table 2 gives the changes in the scores, for each of the three activities (first reported as being the most important to the patient). They don't sum the scores for the three activities, which is odd. None of the activity selections ended up being significant even with various efforts to adjust how the analysis was done.

The split of the cohorts was then done, so post-hoc, based on the PHQ-15 scores. Although supposedly a measurement of psychosomaticism, PHQ-15 is actually a measure of symptom burden - although just presence and frequency, not impact.

The PHQ-15 is a whole other horrific rabbit-hole...
Standardization of a screening instrument (PHQ-15) for somatization syndromes in the general population 2013

The PHQ-15 is widely used as an open access screening instrument for somatization syndromes in different health care settings

The PHQ-15 is a self-administered somatic symptoms subscale, derived from the full Patient-Health-Questionnaire [7,24]. Relatively brief, it screens for 15 somatic symptoms that account for more than 90% of the physical complaints reported in the outpatient setting (exclusive of self-limited upper respiratory symptoms) [20].

It's a measure of somatic (physical) symptoms and then is taken to be a measure of somatisation (psychosomaticism) - because symptoms like headache and fatigue are a sign of somatisation. The lack of logic and rigor - you'd think I'd be inured by now, but I continue to be surprised by it.

Remember how PSC was the rating of change of illness impact on three activities? Well, Table 3 is just for PSC-1. Yes, it's just for the first activity out of three. It just so happened that the change in ratings for the second rated activities was actually worse for the treatment group than in the control group. So, the authors only using the data for the first activity for a post-hoc subset of their sample is an act of bias, a deliberate effort to find a positive result.

And even then, I can't understand what they have done. I have other things I need to do with my energy now, so I'll leave it there.

But I do note that if the overall effect is not significant, then if one half of a sample had a positive result, then it's likely that the other half of the sample had a negative result.

I find this a weird study, because, superficially there are bits that are quite well done. But it's like a shiny apple skin of adherence to research methodology over a rotten core of poor practice, faulty assumptions and bias.

 

[Sean]

'Promising', and always will be.

 

[DokaGirl]

I can picture authors and others of their ilk mentally making note - 'must do better with screening people who enter the trials to ensure only people who will believe are included'.

As it was, one of the exclusions was 'psychosomatic therapy not suitable for the patient, according to the GP'.

So, actually, there was some screening. GPs who don't believe in PSS or talking therapy for PSS are more likely to have patients with the symptoms that would otherwise qualify them for a PSS diagnosis who also don't believe. GPs who do believe in PSS but knows their 'PSS' patient will not appreciate being told that they just need to think better probably won't have nominated such a person for the trial. And of course, the patient has some free will, and, so long as they are aware of what the treatment is, could choose whether to participate.

It's really interesting to consider that sentence from the discussion that I bolded:
"Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach."
That suggests some serious obfuscation of what the trial was about in its promotion. The authors say that the prospective participants received a pack with extensive information - so how could the fact that this was a trial of psychosomatic therapy not have been mentioned? For patients to join a trial of psychosomatic therapy without knowing that that was what they were signing up for seems unethical to me. Which raises questions about the ethical approval process, and also about the GPs who participated in the recruitment.

Excellent point about ethics @Hutan.

We have all heard of psych studies that mispresented what they were really about. I don't know if this was the case here, but participants should be completely informed.

 

[bobbler]

"The psychosomatic therapy was administered by psychosomatic therapists with special interest in PSS, registered with the Dutch Association of Exercise Therapists [14] and the Dutch Association for Psychosomatics in Physical Therapy [13], respectively. It includes the following elements: psychoeducation, relaxation therapy and mindfulness, cognitive-behavioural approaches and activating therapy. During the psychosomatic therapy sessions, the therapist explores somatic symptoms and integrates the physical, cognitive, emotional, behavioural and social dimensions of the symptoms together with the patient. The overall aim of the treatment is to improve patients' functioning by stimulating self-regulation and empowerment to regain control over own health [22]. The intervention consisted of 6 to 12 sessions of 30–45 min over a period of 4 to 5 months, depending on the number and severity of the patient's symptoms."

So, in far less words, yes, pretty much GET and CBT.

But more honest in its title and more appropriate in its description as far as informed consent due to calling it psychosomatic therapy.

shsme about the methods testing whether it helps instead of whether their chosen ‘measures’ are just ‘coached into people’ gif said effects

 

[dave30th]

Well, Table 3 is just for PSC-1.

I'm trying to write a post about this paper but am very confused by Table 3. The right side of it (under "Difference") seems to show the difference between all the moderates and all the severes, whether or not they got the intervention. The left side splits them up into the intervention and non-intervention people. But the data cited in the abstract for the claim of an effect on the more moderate people seems to be reporting a change regardless of whether or not they received the intervention. In other words, the data seem to suggest that the moderates were more likely to do marginally better than the severes but it seems to have nothing to do with the intervention.

Can anyone clarify if I seem to be reading this table correctly? (This is apart from Hutan's concerns as well.)

 

[Joan Crawford]

• No improvement was established in patient's level of functioning.
  
  
• Psychosomatic therapy could be an important treatment to improve PSS management.

I was just about to post to highlight the ridiculousness of these two statements, when you beat me to it.

Unethical to continue. It does not work. Give it a rest. The END.

==

From the discussion section:
"Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach."
OK so how was that managed ethically?

"Some patients may need more explicit attention to a shared biopsychosocial disease model, more focus on understanding and acceptance of the symptoms as well as on their personal possibilities, which might reduce patients focussing on pain or complaints [55]." Symptoms are a signal to help the human to identify that there might be an issue, and that they need to attend to something, and it it can't be fixed to take care and look after themselves. How might reducing focusing on this help - as in ignore / avoid it - all that does is increase anxiety.....

"In addition, psychosomatic therapy aims at behavioural change and readiness to change might influence a positive outcome [57]." Ahhhhh, so if the so-called changes do not occur: it is therefore all the patients fault for not being ready... or something like that..... Big emphasis on the "might". Alternatively, it might be 'cos the therapy is twaddle and it's unlikely, as they have shown in this very study, to not improve patient functioning. Which is surely, kinda the point of doing anything really. (sarcasm off)

"Some patients may lack this readiness to change." Some therapists and doctors might lack the readiness to admit what they are doing and thinking is whoooooooooo.

"Furthermore, for the 30% of patients who were older than 66 years it might be more difficult to obtain a real change in symptoms and functioning. This needs to be verified in future studies." OK, so the oldies are not in to changing - so ageist as well as twaddle. Lovely.

What a total pile of junk. Please no more "future studies" Just stop.