Body reprogramming for fibromyalgia and central sensitivity syndrome: A preliminary evaluation, 2023, Lanario et al

This. No controls mean the results mean nothing much. Also, the usual problem of people who are skeptical of something called 'body reprogramming' won't go near this course, so you have a group of people who are mostly open to the idea of being fixed by thinking differently and expect some improvement.

Listing the authors and affiliations - mostly a Devon/Cornwall association

Joseph Lanario - Faculty of Health, University of Plymouth
Esther Hudson - Cornwall Partnership NHS Foundation Trust, Redruth, Cornwall
Cosima Locher - Faculty of Health, University of Plymouth; University Hospital Zurich
Annily Dee - University Hospitals Plymouth NHS Trust, Plymouth
Kerry Elliot - Royal Cornwall Hospital NHS Trust, Truro, Cornwall

I haven't looked at the paper yet - it will be interesting to see the number of dropouts in the followup

 

I had a quick look at the patients' guide to Body Reprogramming.
http://www.bodyreprogramming.org/guide/PatientGuide.pdf

The theoretical idea seems to be that people who are perfectionists don't listen to their bodies when the are sick, and push through the body's 'stop' signals like pain and fatigue, so the body adapts by ramping up the stop signals to get us to take notice. Then when people have recovered from the infection or whatever, the signals are still ramped up, so we go on experiencing these increased pain and fatigue as 'stop' signals when we are actually well.

The treatment is a mish mash of breaking up activities with other activities, adding relaxation and mindfulness, regular exercise, sleep hygiene, healthy eating, doing things we enjoy and happy thoughts.

The inventor of the treatment is a professor who claims he cured himself from ME/CFS presumably with these treatments.

 

Just noting the ongoing disappearance of ME/CFS. Now it seems that you can have fibromyalgia with PEM, presumably meaning that the NICE Guideline for ME/CFS can be ignored.

Just making up a conceptual model isn't the answer to this problem though.

Time to move on from CBT it seems and offer essentially the same sort of treatment with a different name. Old wine, new bottles.

A clinical service evaluation. So people whose reputations and income depend on finding a good result found a good result.

Because it was a clinical service evaluation, participants did not have to give their informed consent. And yet, the authors write: "Our study provides first evidence that the body reprogramming intervention is an effective approach" - so they were trialling an unevidenced therapy on participants. The word 'harm' does not appear in the paper. So, it seems that there was no acceptance of the possibility of this unevidenced therapy causing harm, and no monitoring of harm.

 

Dropouts
Of the 189 patients who were enrolled in the course (having accepted the CSS diagnosis), 135 filled out the end of course questionnaires and 81 (43%) of them filled out the questionnaires 3 months after the course. That's surely an enormous winnowing out of the non-believers and people who found that they were getting worse.

And, even with that, the reported average improvement in the primary outcome is very much in the 'relatively minor improvement' category that is characteristic of ineffective treatments relying on placebo effects in subjective outcomes (e.g. expectation effect, natural fluctuation in illness, being polite to the therapist).

 

I just want to emphasise the point about this being assessed as not actually being a study requiring consent from patients.

The authors claim they are trying something novel and unevidenced. They can't have things both ways. If it is novel, then participants should be asked to give consent; it should be explained that there is no evidence for the therapy they are being given. And there should be careful monitoring of harms, including beyond the 3 months, and with a substantial effort to follow up with the people who dropped out.

This isn't science and it isn't ethical. I think a complaint should be made to the ethical board that approved this study.

 

It looks like any sort of therapy can be shown to produce a similar sort of benefit.
Even 'mindfulness-based mediation' . Is that where the participant and their body have a good chat with each other in order to resolve differences?

Sorry for copying so many paragraphs, but I find the naivety displayed here amazing. Patients are upset because there is no effective care and no real understanding of what is causing their symptoms. And these people think that making up a story, a story that actually is far from new and is basically, 'you are over-sensitive, you need to get over yourself', with a few flourishes to, in their mind, make it sound all up to date and complicated ('a sophisticated computer' ) is going to fix the problem.

Derision is the easiest response to this paper. But, the authors of this paper with their weak unevidenced and harmful ideas are being let loose on people with debilitating symptoms. It's bloody awful and has to stop. Perhaps these authors have trouble hearing stop signals?

 

Further exclusion criteria included... non-acceptance of their CSS diagnosis or unwilling to take part in a group-based therapeutic intervention.

They are not even pretending anymore, are they.

How much more blatant does this corruption of methodology and ethics have to get before the rest of medicine steps in and kicks them out of the game?

Academic freedom does not extend to this toxic garbage.