Efficacy of a mechanism-based psychological intervention for persistent gastrointestinal symptoms in [UC] and [IBS]:... 2025 Löwe et al

[Andy]

Full title: Efficacy of a mechanism-based psychological intervention for persistent gastrointestinal symptoms in ulcerative colitis and irritable bowel syndrome: results of a three-arm randomised controlled trial (SOMA.GUT-RCT)

Summary​

Background​

Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC) are chronic gastrointestinal conditions with differing pathologies but overlapping symptoms and shared risk factors contributing to symptom persistence. Illness-related anxiety and dysfunctional symptom expectations constitute two empirically proven mechanisms of symptom persistence. Yet, the efficacy of a targeted psychological intervention focussing on these mechanisms remains untested. The SOMA.GUT trial tested whether such a mechanism-based intervention can reduce gastrointestinal symptom severity in individuals with IBS or UC.

Methods​

The SOMA.GUT trial was an investigator-initiated, three-arm randomised controlled trial with nationwide recruitment in Germany of adult patients with either IBS or UC and at least moderate gastrointestinal symptom severity (Irritable Bowel Syndrome—Severity Scoring System, IBS-SSS ≥175). Patients were randomly assigned (1:1:1) to one of three groups: to standard care (SC) alone; to a targeted psychological intervention addressing illness-related anxiety and dysfunctional symptom expectations (GUT.EXPECT + SC); or to a supportive intervention designed to give insights into non-specific treatment effects (GUT.SUPPORT + SC). Randomisation was stratified by gender and diagnosis. Both intervention arms comprised four therapist-guided online sessions. The primary outcome was change in IBS-SSS gastrointestinal symptom severity between baseline and three months in the intention-to-treat population. Key secondary outcomes, measured at six weeks, three, six, and 12 months, included the mechanisms targeted by the GUT.EXPECT intervention. This trial was registered (ISRCTN30800023) and has been completed.

Findings​

Between April 2022, and February 2024, 2099 patients were screened online for eligibility. Of the 240 patients included in the full analysis set (UC: 126, IBS: 114), 176 (73.3%) self-identified as female, 62 (25.8%) as male and two (0.8%) as diverse. Change in IBS-SSS gastrointestinal symptom severity at three months did not differ significantly between groups (global p = 0.83); SC: −50.4 (95% CI −70.7 to −30.1), GUT.SUPPORT + SC: −55.4 (−75.0 to −35.9) and GUT.EXPECT + SC: −59.4 (−79.4 to −39.4). However, in exploratory analyses, the GUT.EXPECT intervention group showed relevant improvements in illness-related anxiety and expectations about symptom coping at three months compared to SC only, as well as in IBS-SSS gastrointestinal symptom severity at 12 months. No differential treatment effects were observed for UC and IBS, and no intervention-related serious adverse events were reported in any group.

Interpretation​

While gastrointestinal symptom severity remained similar between the groups at three months, the targeted psychological variables improved, and the symptom improvement observed at 12 months might indicate a delayed effect of the mechanism-based intervention. These findings may support the relevance of the proposed biopsychosocial mechanisms and the potential of psychological interventions in gastrointestinal disorders. However, higher treatment intensity, and broader biopsychosocial targeting may be required to achieve more immediate and clinically meaningful symptom relief.

Open access

 

[BrightCandle]

While gastrointestinal symptom severity remained similar between the groups at three months, the targeted psychological variables improved,

We convinced people that symptoms weren't abnormal successfully and have redefined recovery to complete failure of treatment but at least the people feel better about it!

 

[Sean]

We convinced people that symptoms weren't abnormal successfully and have redefined recovery to complete failure of treatment but at least the people feel better about it!

Not even that, all we can conclude is that some patients report feeling better about it.

As is tradition they have failed to collect data that enables us to distinguish between merely modifying questionnaire response behaviour and actual improvement in the underlying condition.

Not going to read the full paper, but I will take a guess that neither the 3 nor 12 month results reached clinical significance, let alone justify the inferences/extrapolations in the last two sentences of the Interpretation section.

 

[Utsikt]

All differences in effect on secondary outcomes had disappeared by 12 months.

So they are claiming that a temporary dip in e.g. reported anxiety scores can cause a delayed, but lasting effect on the bowel.

 

[rvallee]

Illness-related anxiety and dysfunctional symptom expectations constitute two empirically proven mechanisms of symptom persistence

OK seriously this is just fully embracing the post-truth era. And it's The Lancet, supposed to be one of the respectable ones, and they just allow total bullshit to pass as factual. What in the hell?

Yet, the efficacy of a targeted psychological intervention focussing on these mechanisms remains untested.

The first claim is literally built on this lie, out of trials that assert that CBT-or-whatever should be effective at it, which it isn't. This sentence is a lie, it has been tested many times, there are even commercial products built on this bullshit, from a failed trial no less (ACTIB?). It's why they pretend like the conclusion theu started with is anything but a delusional fantasy.

However, in exploratory analyses, the GUT.EXPECT intervention group showed relevant improvements in illness-related anxiety and expectations about symptom coping at three months compared to SC only, as well as in IBS-SSS gastrointestinal symptom severity at 12 months.

See how completely absurd this bullshit it. They assert that symptoms are perpetuated because of anxiety, mainly by asking overlapping questions, or whatever, a purely speculative claim with zero evidence for it, find that their bullshit intervention to address anxiety has slightly changed answers on questionnaires, by coaching the participants to do that, but find no benefit on the symptoms, which would actually disprove the hypothesis, showing how they are actually unrelated, if this were anything but an obvious bullshit study of no scientific value. But they actually assert the opposite. Just like every other trial of the same thing.

Pack it up, humanity is done until it addresses the fact that bullshit hasn't just crept everywhere, it's the dominant force right now.

While gastrointestinal symptom severity remained similar between the groups at three months, the targeted psychological variables improved, and the symptom improvement observed at 12 months might indicate a delayed effect of the mechanism-based intervention.

This is just so embarrassing for everyone involved. Literally "it didn't work, but you can imagine that it could have eventually worked, so in a sense, it did work".

However, higher treatment intensity, and broader biopsychosocial targeting may be required to achieve more immediate and clinically meaningful symptom relief.

The absolute most cringe-worthy "Imagine a world"-based medicine. They even frame this as "more immediate symptoms relief" while they report no symptom relief. Everyone involved in this is guilty of scientific fraud.

This is worse than having no standards, it's negative standards. This is a system that cannot regulate itself, cannot realistically perform its functions and needs to be reformed top to bottom. You can't just replace the people involved, it's not about them, it's the systems that are irreparably broken, by design, by the people who run this system.

 

[rvallee]

All differences in effect on secondary outcomes had disappeared by 12 months.

So they are claiming that a temporary dip in e.g. reported anxiety scores can cause a delayed, but lasting effect on the bowel.

While saying that doing the same thing for longer might have, somehow, all worked anyway. This would be a comically inept level of fraud if it wasn't that it represents the "best and brightest", showing how the fish is rotten from the head down.

 

[rvallee]

Their excuses for why it failed, despite somehow hinting that it was actually a success all along, is that although they expected "immediate" relief, which they define as within 1 year, they saw instead a delayed, by a year, effect, and that supports a biopsychosocial mechanism, while saying that they probably need "higher intensity", which is not even a thing here, or more targeted, which also does not make sense in the context seeing as the intervention is the same generic nonsense as always, to achieve "immediate relief", which again they somehow define as happening within 1 year.

The 'intervention' is also predictably exactly the same thing as ACTIB. Which was a failure. And still concluded it was a success. But they pretend like it didn't happen, I guess because they, yes, were all wearing baseball caps, but this time they wore them backward, and that's just not the same, or whatever.

Most cults put more effort into pretending to make sense. Really, they just do, they have to. Because no cult has ever benefited from this much infinite institutional support as this.

 

[Sean]

This is worse than having no standards, it's negative standards.

This.