Action for ME: The PACE trial and behavioural treatments for M.E. [position statement]

Its those dysfunctional cognitions and maladaptive behaviour. What else could it be?

 

I’m not familiar with the history or the inner working of British patient organizations, so I will formulate my remarks carefully.

According to my interpretation the wording used by Action for ME still leaves some forms of graded exercise therapy undisputed. The influential Cochrane review for example not only mentions deconditioning as rationale for GET, but also central sensitization. This theory has recently become the more popular justification for GET. It claims ME/CFS patients do experience symptom exacerbation after exercise, yet only because their central nervous system is sensitized to the feeling of pain and fatigue. So this theory claims to account for “legitimate concerns about the consequences of exercise”.

To “stabilise symptoms before any appropriate increase in activity levels is attempted” is an approach already used in some forms of GET. This is based on the (unproven) assumption that ME/CFS patients have a boom & bust' cycle of activity, which needs to be taken care of, before starting graded exercise. The approach used by the Belgian Pain in Motion research group (Nijs/Meeus) - confusingly called activity pacing self-management - uses for example a stabilizing phase of pacing as a stepping stone to graded exercise therapy. As far as I can see, the explanation of Action for ME does not provide arguments to suggest they disagree with this adapted form of graded exercise therapy.

The idea that the person with M.E./CFS should be in charge of the aims and goals of the overall management plan, is also not a game-changer. GET-proponents will claim that the patient can decide when to start the graded phase and at which baseline level etc.

Of course it is possible that Action for ME does question this form of GET and that they simply failed to articulate this position more explicitly (let’s hope so). But the fact that they refused to use the term GET, suggests there is more to it. I don’t want to be a pessimist. The fact that Action for ME has joined the opposition to the PACE-trial and explicitly says they should have invested in biomedical instead of behavioral research is definitely a positive development which I do not want to trivialize. But I hope someone with more esteem/leverage than me might ask Action for ME about their position on forms of graded exercise therapy that use central sensitization as a rationale and pacing as a stepping stone in a preceding stabilization phase.

 

Much like "aim to reduce and stabilise symptoms before any appropriate increase in activity levels is attempted" they are having to cede ground on playing both sides and they don't want to.

 

I know ... feels a bit weird doesn't it. Be nice to think S4ME might have had a bit of influence.

 

A positive step in the right direction. As I started reading I thought "they're not going to get everything perfect, don't be churlish now". I was even prepared to overlook

"Feel" my arse. This is an extremely late apology, and for how many years now has SC been drawing 60 grand a year, and for what exactly, and from what exactly, while the harm continued? Anyway, mustn't be churlish. But then this heart-sinking garbage:

So still some way to go, and unfortunately no reason to stop "harumphing" yet. Still, a step in the right direction I suppose.

 

AFAIK, 2-day cpet show that on day 1 most patients have a normal function. Of course, that doesn't include more severe patients who can't undergo cpet, who would be deconditioned. So the patients with less sever ME/CFS aren't even deconditioned at all! I think it's important to say that.

Re worwell: Yes, they claim that they can increase physical function a little bit, but it will definitely be misunderstood by most physiologists and therefore this statement is premature, IMO.

What progression? There is no need to agree to any pace of progression, because there is none. If you get better, you do more. The last thing a patient needs is pressure due to some agreement with their doctor, especially with a fluctuating condition like ME/CFS.

 

This is exactly the approach that was taken with me at a UK NHS ME/CFS centre. I was instructed to establish a stable baseline and then grade my activity up from there. It proved impossible to establish a stable baseline. There was no limit to how low I could drop my activity and yet still feel like shit. I was told I was just too ill to benefit from treatment.

It worries me to see this language turning up in AfME's statement, even though there are many things in the statement that I welcome.

 

In my view this is simply repositioning themselves, now that so many people, even outside of the ME world, now know PACE was a truly terrible trial, from concept to design to handling the data.

They will continue to try to play both sides, but they need to put a little distance between themselves and their PACE pals to keep membership numbers up.

@Action for M.E., If you're listening, it's easy to denounce something (you helped happen) when everyone else has already done all the hard work proving it's bad. If you really are interested in the well being of patients and your members, prove it.

Condemn BACME, Crawley, the Lightening Process, SMILE, etc..

Otherwise, it's all too little too late.

 

I thought that the statement from Sonya was pretty good, but everything else was pretty bad.

It seems like Action for ME have realised they've made mistakes, but they don't really understand why. I think that there are entrenched problems at Action for ME which mean that it is not capable of commenting competently on research and treatment issues.

I think that it's a mistake to focus on the underlying models of CBT/GET as a problem - if therapists claimed they had different underlying models, would that suddenly make the treatments any better?

They did use a fitness test, 6mwt and employment data.

Only for SF36-PF and CFQ. That was all the was needed for the 'recovery' criteria used in the 2011 Lancet commentary, but the 2013 Psych Med also had additional requirements of a self-rated CGI score of 1 or 2, and a requirement that participant not fulfil every aspect of the trial entry criteria.

The full sentence from the Wilshire abstract: "Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’." Why didn't they get this statement checked by someone like Wilshire?

The embrace of BACME is ridiculous.

BACME say "NHS M.E./CFS services should advocate collaborative work, patient-led goals". Apparently Action for ME "fully support this approach".

How can that approach be applied when patients are being misled about treatment efficacy by poorly designed trials with spun results?

This was BACME's statement on PACE:

https://web.archive.org/web/20120830075256/http://www.bacme.info/aboutbacme/pace_trial.html

This is how the PACE team described their work with BACME under 'engagement activities':

https://gtr.ukri.org/projects?ref=G0200434

Has BACME ever spoken out about the way results from PACE were spun? Or apologised for their own promotion of these results? From what I've seen, it's the opposite.

Using terms like 'collaborative' and 'patient-led' might sound nice, but they depend upon ensuring that claims made by medical professionals to patients are reasonable and founded upon a careful and critical examination of the available evidence. Misleading information about treatment efficacy destroy the ability to have a genuinely collaborative and petient-led approach to treatment, but no-one at BACME seems concerned about this.

It wouldn't amaze me if this was part of a move by BAMCE to re-position themselves, distance themselves from PACE and change the way that they use language, while making fairly minimal changes to how they treat patients, maintaining their positions and careers.

 

I'd be interested to know who drafted this. Did they get advice from BACME? AfME seems to be tied to a lot of dodgy clinicians.

 

Is that tied to, used by, or influenced by?

If they are being influenced by BACME, then that is a serious concern. The implication of a patient charity being used, or allowing themselves to be used as a fake shop front.

I have tried to give them the benefit of the doubt and assumed they allowed popularity (rather than efficacy) of alternative treatments by members to inform their recommendations. With some bad advice by their medical advisors thrown in.

Edited - spelling

 

I don't know exactly what is going on in there - I'd love to find out.