Science Media Centre expert reaction to Journal of Health Psychology’s Special Issue on The PACE Tri

[A.B.]

The dutch BPS'ers abandoned the hypothesis some years ago (they already seemed to have doubts in 2001), but they created a new hypothesis without changing the treatment (much).

They're working backwards from a desired conclusion: that ME/CFS patients are theirs to treat (first) and that the condition is somatoform (second). That's what this is all about.

 

[Karen Kirke]

I'm not sure it was entirely physios delivering GET in PACE. In other studies at least they haven't been able to recruit enough of them, so they used psychologists or other therapists.

But that is amazing - so exercise therapy was given by psychotherapists? Who of course could not possibly know what CBT is or let it flavour their approach?

The PACE paper specifies that "GET was delivered by physiotherapists and one exercise physiologist" (White et al 2011 p.825).

Nothing about cardigan colour.

The webappendix (http://researchonline.lshtm.ac.uk/400/) has a table on p.1 outlining who gave what. APT was delivered by OTs, CBT by a mix of clinical psychologists, nurse therapists and counselling psychologists, and SMC by 4 GPs with a special interest in CFS, 7 physicians specialising in infectious diseases and 27 psychiatrists.

54% of those who delivered CBT had previous experience in a CFS or chronic pain service. So more than 46% had no experience with a CFS service (because some would have had only chronic pain service)?

36% of those who delivered GET had previous experience in a CFS or chronic pain service. So 64% of the therapists delivering GET in the PACE trial had no previous experience in a CFS service. I'm gobsmacked by that. Odd, given that when people report harm from GET, the usual line is that the therapist wasn't specialised in delivering GET to people with CFS.

 

[Jonathan Edwards]

I'm not in any way defending the artificial division between the CBT and GET arms in terms of beliefs. I agree it's all nonsense. However, I'm not sure you're right about patients not enrolling if they had false beliefs about not being able to exercise. (Or as we would agree, actually correct beliefs, but the PACE people wrongly call them false beliefs).

...
Not saying something honest like this to patients is seriously unethical.

Lots of good points and the last one especially.

I guess that I would argue that people would not enrol for fear of going in to the GET arm if they had beliefs that they could not exercise, not because they did not want to be told their beliefs were false. If they did actually believe they could not exercise they would say no to a trial that might involve GET. So the ones that got in would not have false beliefs so much as just being a bit timid about exercising, in which case the false believe removing CBT would be irrelevant, but the exercise could also be irrelevant because getting better (supposing the reports meant anything) might just be due to the cardigans and smiles and the positive thinking aspect.

 

[SamanthaJ]

I once saw a comment under a blog about PACE from someone claiming to have been a partcipant. I'm afraid I can't remember where, wish I could. She wasn't attacking or defending it so there was no obvious reason to doubt her. She said she got worse but didn't blame the treatment. She described 'CBT' that sounded a lot like pacing, and several other commenters pointed this out. So there's yet another known unknown - how many therapists in PACE might have used their common sense rather than the manual? I'm not sure how much it matters given there's so little difference in results between the arms. She also made it sound as though she'd chosen CBT over GET, which shouldn't have been possible. It's a shame more participants aren't willing to share their experiences, it could be very enlightening.

Edit: Obviously, this is a totally unsubstantiated anecdote!
Edit again: For the record, I remember the comments responding to hers as interested but gentle.

 

[user9876]

I once saw a comment under a blog about PACE from someone claiming to have been a partcipant. I'm afraid I can't remember where, wish I could. She wasn't critical or defending it so there was no obvious reason to doubt her. She said she got worse but didn't blame the treatment. She described 'CBT' that sounded a lot like pacing, and several other commenters pointed this out. So there's yet another known unknown - how many therapists in PACE might have used their common sense rather than the manual? I'm not sure how much it matters given there's so little difference in results between the arms. She also made it sound as though she'd chosen CBT over GET, which shouldn't have been possible. It's a shame more participants aren't willing to share their experiences, it could be very enlightening.

They did record sessions and randomly check a few for therapist compliance.

 

[TreePerson]

They're working backwards from a desired conclusion: that ME/CFS patients are theirs to treat (first) and that the condition is somatoform (second). That's what this is all about.

Yes it reminds me of Tony Blair and the weapons of mass destruction.

 

[Kalliope]

They did record sessions and randomly check a few for therapist compliance.

Weren't some of them stolen? They were kept in a desk behind an unlocked door and at least some of the recordings got lost in a robbery as far as I remember. So the PACE-researchers concerns about protecting their patients and thus not even reveal data from the trial can't have been that extensive..

 

[user9876]

Weren't some of them stolen? They were kept in a desk behind an unlocked door and at least some of the recordings got lost in a robbery as far as I remember. So the PACE-researchers concerns about protecting their patients and thus not even reveal data from the trial can't have been that extensive..

Yes that was reported in the Information tribunal as they tried to use it as an excuse. I think that for another trial Wessely reported a computer was stolen so errors in a paper couldn't be checked. So perhaps Kings have a high crime rate.

 

[Barry53]

Sound familiar? Isn't this what they call CBT? Or at least that sort of CBT that ME/CFS patients get. So the arms in PACE are really Standard care; pacing ; CBT; CBT plus GET. The last two showed no real difference in outcome so there is no reason to attribute any improvement to exercise therapy.

Sounds very sensible to me. I would just be slightly more pedantic re the trial arms:-

• SMC
• SMC + "pacing"
• SMC + CBT
• SMC + CBT + GET

I agree, what are the chances really, that GET was administered without any accompanying CBT? I suspect that GET embraces CBT as part of its implementation anyway. i.e. GET = CBT + something.

 

[TiredSam]

Yes that was reported in the Information tribunal as they tried to use it as an excuse. I think that for another trial Wessely reported a computer was stolen so errors in a paper couldn't be checked. So perhaps Kings have a high crime rate.

I'm sure Wessely said they had a problem with gremlins too.

 

[NelliePledge]

I imagine gremlins can be very vexatious

 

[Snow Leopard]

But from what I hear on PR I cannot work out why anyone should think deconditioning would explain sensitivity to noise, pain, PEM, etc. etc. And it cannot possibly explain 'crashes' - that would be a physiological impossibility.

Yeah, these people simply don't listen to patients, I mean how can the fatigue of our face muscles be due to deconditioning!?! (FYI: smiling can be tiring!)

All of the studies of VO2Max shows that patients typically have low-normal VO2Max that heavily overlaps (often no significant difference) with sedentary controls. The evidence also shows some patients have VO2Max that is above age norms too. I've been ill for well, a long time (15+ years) and I too had above average VO2Max when tested last year (above average on the first day, but not the second day of the CPET).

The GET studies that tested VO2Max (late 90s) found that VO2Max was not associated with changes on questionnaires. Curiously, one GET study found the GET group had a ~10% improvement from baseline, but the GET group after the intervention still had a VO2Max lower than the control group at baseline. Notably, the PACE trial found no change on the step test, which is the only measure of fitness in the trial.

I just don't understand why a medical professional would choose to put forth a strong opinion about this without bothering to check the literature first.

I agree, what are the chances really, that GET was administered without any accompanying CBT? I suspect that GET embraces CBT as part of its implementation anyway. i.e. GET = CBT + something.

If you read the literature, manuals etc, you'll discover that GET is also a psychological therapy, only the "directionality" between behaviour and cognitions is reversed. Their model of CBT focuses on changing cognitions first and increasing activity second, whereas GET focuses on activity first and expect that this will change cognitions (eg the idea that activity is going to increase symptoms). In previous studies, they speculate that the effect of GET is due to a change in cognitions related to activity. (So the effect is still based on changing cognitions, which changes questionnaire answering behaviour, without necessarily reducing functional disability).

 

[Dolphin]

I'm not sure it was entirely physios delivering GET in PACE. In other studies at least they haven't been able to recruit enough of them, so they used psychologists or other therapists.

With the notable exception of Jessica Bavinton, and probably a few others similarly lacking in any sort of sense, physiotherapists generally know too much about the human body to buy into the principals and application of GET.

PACE:

10 physiotherapists
1 exercise physiologist

Web Appendix Table A: Characteristics of therapists and doctors

 

[user9876]

Yeah, these people simply don't listen to patients, I mean how can the fatigue of our face muscles be due to deconditioning!?! (FYI: smiling can be tiring!)

I think patents disappear when GET doesn't work or makes them worse and they simply assume they are cured rather than too ill to come back. Not follow up of drop outs and no recording of deterioration allows a false view to form.

 

[snowathlete]

OMG not the pale blue cardigans? Surely you need a dark blue one for exercise therapy. Sorry, stick to the point.

But that is amazing - so exercise therapy was given by psychotherapists? Who of course could not possibly know what CBT is or let it flavour their approach?

That seems pretty serious. CBT is pretty much defined as what a psychotherapist does in this context since we have no real idea what goes on. The pale blue cardigan is the closest we have to a chemical formula. At least I thought the therapy would come from girls with big quads and ... sorry, I am in a slightly mischievous mood.

The GET I was given was delivered by an occupational therapist.

 

[snowathlete]

I think patents disappear when GET doesn't work or makes them worse and they simply assume they are cured rather than too ill to come back. Not follow up of drop outs and no recording of deterioration allows a false view to form.

I've seen some information that shows CFS clinics are not following up patients properly. There's no appropriate method of catching whether patients are made worse, or why they stop attending. The primary reason for this is that those running the services do not believe the treatments can make patients worse. From my own personal experience, I can tell you that I did report GET making me worse, but the service I went to has kept no record of this.

So even though there are other patients like me who have reported being made worse by these treatments in these clinics, the clinics will always claim there is no evidence that the treatments they provide make any patients worse.

 

[Daisymay]

Yeah, these people simply don't listen to patients, I mean how can the fatigue of our face muscles be due to deconditioning!?! (FYI: smiling can be tiring!)

I quite agree my face muscles ache with smiling and also if I whistle my face muscles get really painful.

I have wondered if others get this pain with whistling and if it could even point to people having ME/CFS.

Similarly small but repeated rapid movements with hands causes mine to ache, could that also point to people having ME/CFS?

Mind you when I was first ill with glandular fever in 1980, it did affect my face, my mouth went a bit squint and the doc thought I had Bell's Palsy but it was just glandular fever somehow affecting my face that way. And my perception of the size of my face and touch was all to pot plus tingling, actually my whole body was affected that way.

So perhaps the whistling is just a peculiarity of me and no one else has a problem!

 

[Sean]

Apart from any other reasons, like the increasing lab evidence for PEM, I know for a cold hard fact that deconditioning is not a primary factor for me, because I managed to keep up enough physical activity to avoid it for the first 2-3 years.

But it not only didn't help at the time, knowing what we now know it almost certainly contributed to a much poorer long term outcome.

And they wonder why we are skeptical of conventional medical advice about deconditioning and treating it with exercise.

 

[Sean]

On its own, deconditioning is simply not an issue.

Agreed. It offers no primary explanatory or therapeutic power.

But what really shits me about the deconditioning claim is that they did not test for the presence of deconditioning when they first proposed it, let alone whether it is primary or secondary, and have not done so to this day, despite long standing and well accepted methods for doing so being available all that time.

They have never done even minimal due diligence on this core assumption. It would have been the very first thing I would have empirically tested (along with its relationship to PEM, and separately the existence and nature of PEM itself).

This willful failure alone condemns them, scientifically and ethically, and speaks unflattering volumes about the UK medical establishment for letting them get away with it for so long.

 

[MeSci]

I quite agree my face muscles ache with smiling and also if I whistle my face muscles get really painful.

I have wondered if others get this pain with whistling and if it could even point to people having ME/CFS.

Similarly small but repeated rapid movements with hands causes mine to ache, could that also point to people having ME/CFS?

Mind you when I was first ill with glandular fever in 1980, it did affect my face, my mouth went a bit squint and the doc thought I had Bell's Palsy but it was just glandular fever somehow affecting my face that way. And my perception of the size of my face and touch was all to pot plus tingling, actually my whole body was affected that way.

So perhaps the whistling is just a peculiarity of me and no one else has a problem!

I was diagnosed with Bell's Palsy at age 5, and it left me with a crooked face - much of it did not recover. I was taught to whistle as part of therapy, and became quite good at it (still am!). I don't think I get painful facial muscles. My hands, arms and legs ache from not much activity though, which varies over time.

ME did not develop until mid-adulthood.