What is Action for ME's current (March 2018) position on the PACE trial?

[Barry]

open-label study combined with subjective measures

This seems to be the psychiatrists' bread and butter strategy, probably because their work is supposed to be confined to mental problems, and how people think. There really should be much greater protections built into the medical establishment, to prevent one branch of medicine barging in and presuming to dictate what happens in another branch, that they have no real understanding of at all.

 

[Solstice]

Kicked up again. @Action for M.E. , we're all eagerly awaiting an answer.

 

[Sisyphus]

This seems to be the psychiatrists' bread and butter strategy, probably because their work is supposed to be confined to mental problems, and how people think. There really should be much greater protections built into the medical establishment, to prevent one branch of medicine barging in and presuming to dictate what happens in another branch, that they have no real understanding of at all.

Perhaps they have an understanding that the other branch of medicine may be a threat to their own little castle.

 

[Allele]

This seems to be the psychiatrists' bread and butter strategy, probably because their work is supposed to be confined to mental problems, and how people think. There really should be much greater protections built into the medical establishment, to prevent one branch of medicine barging in and presuming to dictate what happens in another branch, that they have no real understanding of at all.

What really shocks me is how real medical science world has failed to laugh these people off the stage.
The willingness to accept psychogenic anything, without any satisfying evidence whatsoever, is surprising and inconsistent with their oaths.

The lack of objection by the general medical establishment to the usurpation of the real meaning of terms like "somatic", "evidence-based", "central sensitization", "medically unexplained symptoms", "treatment resistant", etc into terms that secretly or overtly communicate that the patient has supernatural powers to create and cure biologic disease is stunning and unexplainable--unexplainable unless one considers that it offers a convenient way to relieve themselves of a condition or person who challenges them.

Not to mention the long history of just about every single "psychogenic" disorder in the end being caused by a bacterium, virus, or other pathogen.

Why is not the medical establishment outraged at this, or laughing in their faces?

 

[Barry]

What really shocks me is how real medical science world has failed to laugh these people off the stage.
The willingness to accept psychogenic anything, without any satisfying evidence whatsoever, is surprising and inconsistent with their oaths.

The lack of objection by the general medical establishment to the usurpation of the real meaning of terms like "somatic", "evidence-based", "central sensitization", "medically unexplained symptoms", "treatment resistant", etc into terms that secretly or overtly communicate that the patient has supernatural powers to create and cure biologic disease is stunning and unexplainable--unexplainable unless one considers that it offers a convenient way to relieve themselves of a condition or person who challenges them.

Not to mention the long history of just about every single "psychogenic" disorder in the end being caused by a bacterium, virus, or other pathogen.

Why is not the medical establishment outraged at this, or laughing in their faces?

It's almost as if the BPS crowd has bewitched the rest of the world.

 

[Sasha]

Just a reminder that the topic of this thread is a question posed to AfME concerning their current position on PACE (though I can understand the temptation of the digressions!)...

 

[Graham]

I was a member of AfME for a very long time, and it was brilliant in the early days when we knew so little. I stuck with it through the early PACE years because I hoped that reasoning would win through, but eventually lost heart. I am perfectly able to accept their membership of this forum, providing that they realize that it is a scientific forum.

If I come up with some daft statement (well, "when" rather than "if") I get challenged. I reply. I get a thorough analysis from others - factual, not personal, but precise. And I'm all the better for it - it has made me sharpen up my ideas, and my presentation of ideas.

But to my mind, if AfME (or any other body representing people with ME) wants to be part of this forum, they must accept this open, scientific style of debate. We do not insist that everyone sings from the same songsheet, but science cannot exist without debate.

My background in maths and physics reminds me of the debate between Einstein and Bohr about the nature of the quantum state. We may not be up to that level, but this was a fierce debate, and yet one that has been highly respected for years, as have both of the participants.

If @Action for M.E. is unable to discuss or debate its position, then I do have my doubts whether it has the right to remain in a science forum. I would be very sorry to see that happen. I do appreciate though, that an organization like AfME is an unwieldy beast, and it may well take a while to "clear" any response with the system. So I will be patient. For a while.

 

[NelliePledge]

As the well known football chant goes @Action for M.E. “its all gone quiet over there”

 

[Action for M.E.]

Hello, Clare here. I appreciate your patience given that I haven’t been able to give the forum my full attention recently.

You have asked about Action for M.E.’s view on PACE's methodology and its claims that CBT and GET can improve patients' health and lead to recovery.

Our view hasn’t changed: the methodology continues to be debated and we agree that this calls the results of the trial into question. Even taken at face value (without considering any re-analysis of the data), the PACE trial shows that CBT and GET offers only moderate improvement for a minority of patients.

This is reflected by the fact that we consistently hear from some people for whom GET and CBT have been helpful – but also from many who have had the opposite experience.

We are currently revising the information we share about on our website about both CBT and GET, using feedback from S4ME forum users on this thread (further feedback always welcome), to more accurately reflect user experience, including the potential harms associated with, and limitations of, these behavioural approaches.

Our position on recommending treatments and symptom-management will remain the same: We do not recommend any individual treatments or management approaches for people with M.E. but instead offer key information to allow people with M.E. to make informed decisions.

Clare Ogden
Head of Communications and Engagement
Action for M.E.

 

[Amw66]

Hello, Clare here. I appreciate your patience given that I haven’t been able to give the forum my full attention recently.

You have asked about Action for M.E.’s view on PACE's methodology and its claims that CBT and GET can improve patients' health and lead to recovery.

Our view hasn’t changed: the methodology continues to be debated and we agree that this calls the results of the trial into question. Even taken at face value (without considering any re-analysis of the data), the PACE trial shows that CBT and GET offers only moderate improvement for a minority of patients.

This is reflected by the fact that we consistently hear from some people for whom GET and CBT have been helpful – but also from many who have had the opposite experience.

We are currently revising the information we share about on our website about both CBT and GET, using feedback from S4ME forum users on this thread (further feedback always welcome), to more accurately reflect user experience, including the potential harms associated with, and limitations of, these behavioural approaches.

Our position on recommending treatments and symptom-management will remain the same: We do not recommend any individual treatments or management approaches for people with M.E. but instead offer key information to allow people with M.E. to make informed decisions.

Clare Ogden
Head of Communications and Engagement
Action for M.E.

Clare, the reanalysis was per the original protocol.
This shows that CBT/ GET are not effective for any group, not even controls.
CBT is concerning for many as there is little robust evidence that it is an effective treatment for anything.
GET is contraindicative for ME- effectiveness of this treatment may be a marker for misdiagnosis, which is high .

 

[Hoopoe]

GET is contraindicative for ME- effectiveness of this treatment may be a marker for misdiagnosis, which is high .

The PACE trial used the Oxford criteria for diagnosis which suggests GET is generally ineffective even when broad criteria centering around unexplained significant chronic fatigue are used.

 

[Sasha]

Hello, Clare here. I appreciate your patience given that I haven’t been able to give the forum my full attention recently.

Thank you for replying.

You have asked about Action for M.E.’s view on PACE's methodology and its claims that CBT and GET can improve patients' health and lead to recovery.

Our view hasn’t changed: the methodology continues to be debated and we agree that this calls the results of the trial into question.

Any meaningful debate about the methodology is long over, and the results of the trial have been more than 'called into question'. They have been debunked, to such an extent that any reasonable interpretation of the trial's results is that they show that CBT and GET do not work for ME/CFS. The arguments are so overwhelming that anyone now claiming that PACE's results should be taken at face value now carries the burden of making a case, if they can.

So what exactly what do AfME think still remains in question?

Even taken at face value (without considering any re-analysis of the data), the PACE trial shows that CBT and GET offers only moderate improvement for a minority of patients.

But why take it at face value? Can AfME genuinely not see that the trial can't be taken at face value? Why peddle the idea that CBT and GET work at all?

This is reflected by the fact that we consistently hear from some people for whom GET and CBT have been helpful – but also from many who have had the opposite experience.

Anecdotes are well established as the least valuable form of medical evidence. A medical charity should know that. PACE was a £5 million trial with over 600 patients and used a randomised (and poorly) controlled design. If there had been a genuine positive effect, PACE would have found it, because all its methodological biases were acting in favour of CBT and GET - but it didn't.

Why is AfME giving anecdotes equal weight to a clinical trial?

We are currently revising the information we share about on our website about both CBT and GET

I'm sorry but I see no evidence that AfME are competent to do so.

Our position on recommending treatments and symptom-management will remain the same: We do not recommend any individual treatments or management approaches for people with M.E. but instead offer key information to allow people with M.E. to make informed decisions.

And again, I see no evidence that AfME are competent to even frame the information correctly. In fact, quite the reverse.

I'm so very disappointed by your response, Clare. I had hoped that AfME was moving in a good direction but my impression is that as an organisation, there's just no understanding of the science at all. And in the current situation, that makes your organisation a liability, not an asset.

 

[Sasha]

Calling @Jonathan Edwards's attention to this.

 

[Trish]

Thank you, Clare, for clarifying the position of @Action for M.E. on the PACE trial.

I think I understand you to be saying that, on the basis of the fact that you have 'heard from some people' that they find CBT and GET helpful, you are still going to recommend these as options for people to try.

I find this horrifying and completely incomprehensible.

It has now been established beyond doubt that the reanalysis of the PACE trial according to its own researchers' approved protocol demonstrated it to be a null trial, that the researchers own report on long term follow up showed it to be a null trial, and that the FINE trial on home-bound patients was a null trial.

Add to this evidence that the treatments have caused serious harm, with many patients undergoing GET relapsing from ambulant to bed bound, and the 2day CPET evidence of delayed recovery from aerobic exercise, and it is clear that GET and directive CBT should never be recommended.

What more evidence do you need to show that you should remove all reference to directive CBT, GET and activity management that includes incremental increases in activity? They do not work and they are harmful.

I have read your page on GET that you link to above. While it does point out the findings of the PACE reanalysis, and the survey results showing many patients report harm, the clear suggestion on that page is that GET works if carried out by a properly trained therapist.

That is wrong.

By definition, ME has PEM as its core symptom. Activity beyond our anaerobic/aerobic threshold makes us sicker. A responsible charity would make that clear. By definition, if a person can keep increasing their activity in incremental steps without triggering PEM and/or relapse, they don't have ME.

I have just read your organisation's 2016 to 2021 Strategy document that you linked from another thread and found this:
https://www.actionforme.org.uk/uploads/pdfs/2016-2021-strategy.pdf

The impact of our work so far

In July 2015 we sponsored Webinars for GPs to run a pilot webinar on M.E., led by Dr Hazel O’Dowd, Clinical Champion for CFS/M.E. Services for Avon, Gloucester, Wiltshire and Somerset. This attracted more than 150 GPs and had its running time extended by an hour to accommodate the many questions they asked. All those who shared feedback rated the webinar as good, very good or excellent.
As a result of the training they received, GPs said they would be: • more aware of M.E. and how to support patients better • more proactive in management of symptoms • more comprehensive when carrying out examinations and tests • more confident in diagnosis and referral.

I do not know the content of this GP training, but, given that I understand that Hazel O'Dowd promotes the GET/CBT approach, I am very concerned.

I would be grateful if you would make the content of the GP training available for us to see, so we can decide for ourselves whether we think it is appropriate and, I hope, influence your future work in this field of medical education.

 

[Diluted-biscuit]

Hello, Clare here. I appreciate your patience given that I haven’t been able to give the forum my full attention recently.

You have asked about Action for M.E.’s view on PACE's methodology and its claims that CBT and GET can improve patients' health and lead to recovery.

Our view hasn’t changed: the methodology continues to be debated and we agree that this calls the results of the trial into question. Even taken at face value (without considering any re-analysis of the data), the PACE trial shows that CBT and GET offers only moderate improvement for a minority of patients.

This is reflected by the fact that we consistently hear from some people for whom GET and CBT have been helpful – but also from many who have had the opposite experience.

We are currently revising the information we share about on our website about both CBT and GET, using feedback from S4ME forum users on this thread (further feedback always welcome), to more accurately reflect user experience, including the potential harms associated with, and limitations of, these behavioural approaches.

Our position on recommending treatments and symptom-management will remain the same: We do not recommend any individual treatments or management approaches for people with M.E. but instead offer key information to allow people with M.E. to make informed decisions.

Clare Ogden
Head of Communications and Engagement
Action for M.E.

I’ve heard from ME/CFS patients that claim to have been helped by many debunked things such as homeopathy and kinesiology, this to me shows why people can’t be trusted to self report improvments in this way. Big trials are the way we find out what helps and the PACE trial actually did that perfectly. CBT and GET don’t help with ME/CFS symptoms.

You need to stop trying to back both sides and follow the science.

 

[dangermouse]

Oh dear, Clare @Action for M.E.

Our position on recommending treatments and symptom-management will remain the same: We do not recommend any individual treatments or management approaches for people with M.E. but instead offer key information to allow people with M.E. to make informed decisions.

New patients (and vulnerable patients who are not aware of the issues with GET and CBT) will rely on you (as a charity for this patient group) to look out for them. They may well skim read (as they are energy deficient, very unwell and desperately wanting help) and trust that anything you list is safe to try....being as you are supposed to be a safe place to access this information.

I don’t understand. I am greatly disappointed. I thought, and hoped that you (@Action for M.E.) may have turned a corner, been brave enough to stand up for people with ME.

In my opinion GET and CBT (the fear and avoidance kind) have no place on an M.E. patient website.

If I was a newly diagnosed patient I’d be wanting help and I’d think (if I saw GET/CBT as an option on your website) that it was something that wasn’t so bad to try, because if it was it wouldn’t be included on your pages.

Honestly, I’d hope you’d rethink this and address it as a matter of urgency. I’ve been harmed by this approach/treatment and I wouldn’t want others to suffer.

 

[Sunshine3]

@Action for M.E

Clare, you do realize that people are dying from M.E....Merryn Crofts, Ian Rudds were recent deaths. M.E can be life threatening and fatal. Biomedical research is needed not exercise or cbt. Lives are at stake, what does it take to get through??? I just can't understand where you are coming from.

 

[Skycloud]

Thank you Clare, for engaging with the forum and responding in this thread.

Can I ask what Action for ME would consider to be sufficient reason to not list GET/CBT as treatments that might be 'helpful to some people' on their website?

Is AfME waiting for retraction of PACE, a change to the NICE guidelines or something else?

I'm trying to understand where the problem is.

Thanks.

edit - grammar

 

[Londinium]

This is reflected by the fact that we consistently hear from some people for whom GET and CBT have been helpful – but also from many who have had the opposite experience.

Firstly, thank you for engaging. It is welcome, even if we may disagree about some things. And despite some of the criticism (including from me ) that you receive I hope you continue to engage in this way.

However, the statement above worries me greatly - people with various medical conditions will swear blind that all manner of things helped them. Homeopathy or LP comes to mind, as does a slightly odd acquaintance of my mother's who swore blind her migraines went away after she arranged a local priest to perform an exorcism on her house. There are all manner of crackpot treatments that prey on people with long-term conditions whose advocates can point to a handful of patients who believe they were cured by them. Irrespective of one's views on CBT/GET and the scientific rigour thereof, the bar has to be set higher than that.

We are currently revising the information we share about on our website about both CBT and GET, using feedback from S4ME forum users on this thread (further feedback always welcome), to more accurately reflect user experience, including the potential harms associated with, and limitations of, these behavioural approaches.

I hope this information will reflect that whilst you may have some anecdotal data this is helpful, there is little evidence for efficacy beyond a transitory placebo effect and no evidence of sustained long-term benefits. (You don't even need to get into the PACE 'debate' to state that - AFAIK every long-term follow-up study has shown no significant effect in the long term). I feel the lack of any long-term effect is a key piece of information for any patient considering any treatment/intervention*.


---

*As we're using anecdote: it was this piece of information that led my GP and I to agree that I wouldn't be referred to a secondary service for GET or CBT. There are a hell of a lot of horror stories on the internet about negative consequences of GET in particular. However, when I was making this decision I couldn't find much in the literature demonstrating adverse effects (I know now there is heavy criticism of some of the study methods used to demonstrate safety, but that is a separate issue). Had there been good evidence of sustained response to GET I'd have probably ignored the internet horror stories and taken the risk, for the chance to recover. It was the lack of evidence for CBT/GET having a good, objective, long-term outcome that heavily depleted the benefit side of the cost-benefit analysis and led my doctor and I to decide not to take this further. IMHO, it is absolutely key for any statement that (wrongly, IMHO) discusses 'moderate improvement' from GET to also reflect that this effect was not sustained (at least, in any trial I can think of).

 

[MEMarge]

Hello Clare

Thank you again for your participation in this forum.

People above have made good comments about PACE showing that PACE-style GET and CBT do NOT lead to significant improvements in ME. Also that either can result in significant harms and deterioration.

However there are several reasons why people may say that they have improved from these "therapies":

• Some ME/CFS services are run by therapists who understand that ME is a disease which results in physiological abnormalities such as exercise intolerance (aka PEM). They assist patients in helpful ways, such as counselling, to help adjust to a sudden onset disabling illness, the reality of which is often disbelieved by doctors, media and therefore the public at large.
• They may also provide letters supporting people in applying for welfare benefits; help them with pacing or accessing aids, such as wheelchairs. They may have to SAY they are providing GET or CBT, so that their service obtains funding from the CCGs.
• However they are not using "CBT" to change "false illness beliefs", they know that these people are physically ill.
• They are NOT promoting GET as: "Oh just find a baseline, then increase your exercise by 10 or 20% every week or fortnight, even if it makes you "feel worse" and you'll be fine.
• They are more likely to be suggesting some gentle stretching to keep up range of movement where possible, and the importance of adequate rest between any activities such as getting dressed...

Another huge source of confusion is that people who do not have ME, were included in the PACE trial; and others with conditions such as primary depression may well have improved with GET and Counselling.

It seems that several of E Crawley's studies have included teenagers , who are tired, according to their parents, or other groups for whom the diagnosis of ME is fairly vague and may not even include PEM.

I suspect that the above explain many of your members who say they have improved with CBT or GET.