PBC-HOPE: A randomized controlled trial of hypnosis and psychoeducation in women with primary biliary cholangitis and fatigue 2025 Untas et al

[Andy]

Abstract

Objectives:
Fatigue is the main symptom of primary biliary cholangitis (PBC), but has not yet been improved by any therapeutic intervention. This study evaluated the efficacy and safety of hypnosis and psychoeducation in improving fatigue associated with PBC (PBC-HOPE ClinicalTrial.gov number, NCT03630718).

Methods:
Fifty-five women with PBC and significant fatigue, defined by a PBC-40 fatigue score ≥ 33, were randomly assigned to standard care (SC) alone (n=18), SC plus hypnosis (n=18) and SC plus psychoeducation (n=19), with four weekly sessions for the intervention groups. Self-report questionnaires, including the PBC-40, were completed at inclusion (D0) and Week 12 (W12). The first eight patients in each group were interviewed at both times. The primary outcome was the difference in PBC-40 fatigue score between D0 and W12. The secondary and exploratory outcomes were the psychometric scores and interview findings.

Results:
The primary outcome was not achieved, with a median (interquartile range) difference in PBC-40 fatigue score of -3.0 (-10.0; 1.0), -6.0 (-8.0; -4.0), and -6.0 (-11.5; -4.8) for SC, SC-hypnosis, and SC-psychoeducation, respectively. The quantitative secondary outcomes were consistent with this result. The qualitative exploratory outcomes indicated that both interventions positively modified patients’ perceptions of fatigue, underlining the appropriation of the intervention. No serious adverse events occurred.

Discussions:
At 12 weeks, hypnosis and psychoeducation interventions were not associated with a significant reduction in quantitative measures of fatigue associated with PBC. However, the qualitative changes in perceived fatigue associated with these interventions suggest that maintenance sessions could be beneficial in the longer term.

Paywall

 

[Hutan]

At 12 weeks, hypnosis and psychoeducation interventions were not associated with a significant reduction in quantitative measures of fatigue associated with PBC.

Well, that's not where I thought it was going. Just to be clear, those "quantitative" measure are self-reported questionnaires of fatigue and who knows what else. So even in an unblinded trial with subjective outcomes, these researchers couldn't get a positive result.

The qualitative exploratory outcomes indicated that both interventions positively modified patients’ perceptions of fatigue, underlining the appropriation of the intervention.

So, they are pinning their hopes on the face to face interviews with small groups of participants who probably were only making polite vague murmurings of positivity.

However, the qualitative changes in perceived fatigue associated with these interventions suggest that maintenance sessions could be beneficial in the longer term.

There's an investigation here crying out to be done about researchers who keep clinging to any shred of hope when it's obvious that the treatments don't work. What can be done to help them move on with their lives?

 

[Utsikt]

They even changed the primary outcome after the trial had ended.

This was the original that got moved to secondary in June 2025:

Primary Outcome Measures

1. Multidimensional fatigue inventory (MFI) (1)
   [Time Frame: At Day 0]
2. Multidimensional fatigue inventory (MFI) (2)
   [Time Frame: At week 5]
3. Multidimensional fatigue inventory (MFI) (3)
   [Time Frame: At month 3]
4. Multidimensional fatigue inventory (MFI) (4)
   [Time Frame: At month 6]

This is the new primary that got bumped from secondary:

PBC-40 questionaire [Time Frame: At month 3]

 

[Utsikt]

What can be done to help them move on with their lives?

Maybe some hypnosis and psychoeducation?

 

[rvallee]

Well, that's not where I thought it was going. Just to be clear, those "quantitative" measure are self-reported questionnaires of fatigue and who knows what else. So even in an unblinded trial with subjective outcomes, these researchers couldn't get a positive result.

So, not quantitative, then. They're calling quantitative what is obviously and explicitly a qualitative assessment. I tried looking for the paper on the high seas but can't find it to confirm that this is indeed what they are doing, but it wouldn't be surprising. This is a discipline that has been routinely using the term RCT to hint at high quality controlled trials, when the C explicitly stands for clinical instead, so it tracks. The slippery slope is nothing but grease at a 90 degree incline at this point.

Really, though, words and their meaning, why bother?

The qualitative exploratory outcomes indicated that both interventions positively modified patients’ perceptions of fatigue, underlining the appropriation of the intervention.

It does, uh? So their intent here was to modify perception/reporting of fatigue. Why does trash like this keep getting money when they explicitly make it clear that it's entirely pointless?

This is the new primary that got bumped from secondary:

OK, so, clearly, a qualitative assessment. Literally not a single quantitative question in this questionnaire. Plus, the questions are so all over the place that it makes comparing apples to oranges sane and normal by comparison. Honestly, this is a terrible questionnaire.

No wonder nothing has ever been achieved out of this ideology. Any random person would have better chances of accidentally building a working nuclear reactor while attempting to make themselves a snack.

 

[rvallee]

There's an investigation here crying out to be done about researchers who keep clinging to any shred of hope when it's obvious that the treatments don't work. What can be done to help them move on with their lives?

It's been clear for many years that only consequences can do it, and that it's precisely impunity that is the root cause of this failure. They are clowning around instead of doing real work and it's celebrated as better than actual real work.