Trial Report Comparison of Digitally Delivered Gut-Directed Hypnotherapy Program With an Active Control for Irritable Bowel Syndrome, 2024, Anderson et al

[rvallee]

Comparison of Digitally Delivered Gut-Directed Hypnotherapy Program With an Active Control for Irritable Bowel Syndrome

Comparison of Digitally Delivered Gut-Directed Hypnotherapy Program With an Active Control for Irritable Bowel Syndrome - PubMed

A digitally delivered GDH Program provided to patients with IBS was superior to the active control, with greater improvement in both gastrointestinal symptoms and quality of life and provides an equitable alternative to face-to-face behavioral strategies.

pubmed.ncbi.nlm.nih.gov

Ellen J Anderson, Simone L Peters, Peter R Gibson, Emma P Halmos


Abstract

Introduction: Gut-directed hypnotherapy (GDH) treats irritable bowel syndrome (IBS), but its accessibility is limited. This problem may be overcome by digital delivery. The aim of this study was to perform a randomized control trial comparing the efficacy of a digitally delivered program with and without GDH in IBS.

Methods: Adults with IBS were randomized to a 42-session daily digital program with the GDH Program (Nerva) or without (Active Control). Questionnaires were completed to assess gastrointestinal symptoms through IBS Symptom Severity Scale (IBS-SSS), quality of life, and psychological symptoms (Depression Anxiety and Stress Scale-21) at regular intervals during the program and 6 months following the conclusion on the intervention. The primary end point was the proportion of participants with ≥50-point decrease in IBS-SSS between the interventions at the end of the program.

Results: Of 240/244 randomized participants, 121 received GDH Program-the median age 38 (range 20-65) years, 90% female, IBS-SSS 321 (interquartile range 273-367)-and 119 Active Control-36 (21-65), 91% female, IBS-SSS 303 (255-360). At program completion, 81% met the primary end point with GDH Program vs 63% Active Control ( P = 0.002). IBS-SSS was median 208 (interquartile range 154-265) with GDH and 244 (190-308) with control ( P = 0.004), 30% reduction in pain was reported by 71% compared with 35% ( P < 0.001), and IBS quality of life improved by 14 (6-25) compared with 7 (1-15), respectively ( P < 0.001). Psychological status improved similarly in both groups.

Discussion: A digitally delivered GDH Program provided to patients with IBS was superior to the active control, with greater improvement in both gastrointestinal symptoms and quality of life and provides an equitable alternative to face-to-face behavioral strategies.

 

[rvallee]

Gut-directed hypnotherapy (GDH) treats irritable bowel syndrome (IBS)

I have no idea how assertions like this pass peer review. This is the kind of stuff that makes a complete mockery of a core process of academia.

 

[Utsikt]

The primary end point was the proportion of participants with ≥50-point decrease in IBS-SSS between the interventions at the end of the program.

What’s the point of using a control group when you don’t compare the values directly between the groups?

At program completion, 81% met the primary end point with GDH Program vs 63% Active Control ( P = 0.002). IBS-SSS was median 208 (interquartile range 154-265) with GDH and 244 (190-308) with control ( P = 0.004)

The median IBS-SSS difference between the groups was 36, well below the 50 point threshold that they defined as clinically meaningful.

Therefore the intervention didn’t provide any added value beyond the control group. So the intervention wasn’t effective.

 

[Trish]

gut directed hypnotherapy...

The mind boggles. I'm imagining a mini hypnotherapist climbing down a gastroscope or up a colonoscope talking soothingly to my gut, telling it to count slowly backwards from ten while relaxing...

 

[bobbler]

I have no idea how assertions like this pass peer review. This is the kind of stuff that makes a complete mockery of a core process of academia.

Yes

We are allowed to say it’s a lie based on the facts of their own paper because that’s a fact.

And yet the industry and those running the supposed system that keeps the science in check by peer review etc won’t

It seems to come down to advertising standards each time

And I think the next campaign needs to blatantly be that journalism papers now need to come under their remit because they are being abused as propaganda vehicles certainly in all professions anywhere near to medicine and psychology

And the lies are blatant by taking a result and inverting it in the abstract then locking the results section (if anyone reads it anyway) under a paywall. At which point it is not just an advert that it’s being used as but given so many are just manifestos as there is often no research or methods do poor it’s worse than if there were no research because it’s been done to mislead that there is veracity not just opinion but political advertising and misinformation being used to influence directly those who will be buyers of services, goods etc. That’s why they do it.

 

[rvallee]

What’s the point of using a control group when you don’t compare the values directly between the groups?

The median IBS-SSS difference between the groups was 36, well below the 50 point threshold that they defined as clinically meaningful.

Therefore the intervention didn’t provide any added value beyond the control group. So the intervention wasn’t effective.

It's pretty notable how their conclusion doesn't even bother with it, they just say "heh, guess it helped, just mumble something about equity or whatever". This trial is the evidence used by a company called Nerva Health, which acquired Mahana, the company that built a similar IBS app based on research featuring some of our BPS overlords (and which was similarly a bust).

On the company website, they simply mention that 81% of participants benefited from it, which they take from this study:

At program completion, 81% met the primary end point with GDH Program vs 63% Active Control ( P = 0.002)

So, entirely ignoring the primary outcome and just going with a highly misleading distortion instead. Which is something very common in psychosomatic academia, so it's actually hard to police any of this when they can simply link to published research by influential researchers saying all the same things. What the PACE authors did was far more egregious than this and they had most of the UK medical establishment and the editor-in-chief of The Lancet to shill for them.

It really feels like totally madness how all of this is so obviously fraudulent but medical professionals basically seem addicted to it and refuse to face reality.

 

[Utsikt]

So, entirely ignoring the primary outcome and just going with a highly misleading distortion instead.

That was their primary outcome. They just chose a very bad one that will favour the intervention in most cases.

If you have a threshold X=10 for clinical improvement, and intervention A has a mean of X+1 and intervention B has a mean of X-1, you will find that participants in A reaches X in more instances than in B, even though the difference between the means between A and B = 2, well below the threshold X = 10.

Therefore choosing that outcome is a way to guarantee that you trial will be a success (A>X more often than B>X).

This kind of outcome (reaching a threshold in-group) really only measures if there is a separation between the groups, and tells you nothing about if A actually adds anything meaningful to what B already does, which is what we really care about, especially when the control is to do nothing!