Open Letter to the Chief Executive of Action for ME about the AfME web page on Graded Exercise Therapy

Trish · Oct 20, 2019

Following discussion on this thread I have now sent the following personal letter to Sonya Chowdhury, Chief Executive of the UK charity Action for ME about their current web page of advice about Graded exercise therapy. I will post any response I get on this thread.

Sonya Chowdhury
Chief Executive
Action for M.E.

Dear Sonya,

Re: Graded Exercise Therapy

I have had ME for 30 years and am the sole carer for my daughter who has had ME for 22 years. We are both currently housebound and mostly bed bound. It is therefore of great concern to me that information provided by ME organisations such as Action for M.E. (AfME) should be scientifically accurate, and advice to patients should be grounded in the highest quality evidence available.

I am also an active member of the Science for ME forum (S4ME), and a committee member, but this letter is a personal letter, not an official one. I hope this letter will be received in the spirit in which it is intended, as a genuine effort to reach out to your organisation to help you to improve your service to patients.

As you may remember, I wrote to AfME earlier this year about my concerns about your employment related ‘Toolkit for Professionals’ document, which was subsequently withdrawn for rewriting. I look forward to reading the new version.

I watched with interest the webcast of the recent AfME conference and Annual General Meeting. There was much to commend about AfME’s activities, particularly your work on patient support, advocacy and mentoring. I was interested to see the report on the recent survey on treatments which will help inform your work, and your submission to the NICE guideline committee’s call for evidence. I also commend AfME’s support for David Tuller’s critiques of PACE and other similar trials, and your statements that you do not support the current guideline recommendation of CBT and GET.

I therefore find it puzzling, and very concerning, that the current pages on your website about treatments still recommend CBT and GET among a range of treatments for patients to consider. In this letter I focus on your recommendations about GET.

I have discussed this subject with other members of the S4ME forum, and will post it in the public area of the forum, along with any reply I receive from you or any other representative of AfME. Our discussion is taking place on this thread in the Members only area of the forum. You may find it informative to read that discussion alongside this letter.

https://www.s4me.info/threads/action-for-mes-page-on-graded-exercise-therapy-october-2019.11790/

The rest of this letter is in three parts. First I spell out the specific problems with your information page about GET; then give a short summary; and finally I have written a suggested draft for a replacement page.
____________________________________

Problems with the AfME page on GET

https://www.actionforme.org.uk/living-with-me/treatment-and-management/graded-exercise-therapy/

Patient choice

The premise on which your treatment and management pages are based is patient choice. That is, on the face of it, a commendable approach, but only if patients are given accurately evidenced information on which to base that choice.

Your current GET page is highly misleading and equivocal about the evidence, to the extent that a newly diagnosed patient is likely to be at best confused, and at worst misled into thinking GET, especially when provided by a specialist clinic, is safe and, at least for some patients, effective.

There is no evidence to support either the efficacy or the safety of GET, whoever provides it.

Specialist clinics, expert therapists and research evidence

Take this statement near the start of the page, for example:

“GET refers to a systematic programme of physical activity or exercise that aims to support you to gradually increase your overall activity levels. It should only be undertaken with the supervision of a qualified and experienced M.E./CFS-specialist physiotherapist or occupational therapist (OT) who has experience of working with people with M.E. For this reason, GET is usually offered as part of a symptom-management programme at a specialist NHS M.E./CFS clinic.”

The FINE trial and the reanalysed PACE trial both showed that GET is ineffective. The small, not clinically significant, transient, subjective improvements found on both trials were no more than would be expected in any open label trial from the placebo effect. These transient differences between treatment groups were not supported by any objective evidence of improvement in fitness, stamina or return to work, and even these small subjective improvements were shown to be no better than doing nothing at long term follow up.

AfME has supported these conclusions. You have agreed that, even under careful clinical trial conditions with expertly supervised expert therapists, GET did not work. So why suggest it still as a viable option for patients to consider?

Take this statement towards the end of the page:

“Action for M.E.’s position on GET
It is our view that, while potentially moderately helpful for a minority of people with M.E. and/or CFS, this treatment is not effective or safe for everyone.”

That statement is highly misleading. There is no evidence from clinical trials that GET is ‘potentially moderately helpful’ for anyone.

ME is a fluctuating condition, which means some people undertaking any treatment may find it coincides with an improvement phase in their symptoms, and attribute that improvement to the treatment they were trying at the time. That is why we need clinical trials to test whether the apparent effectiveness is attributable to the treatment or not.

As shown in the open label Rituximab trials, some patients improved. But once the double blind trial was unblinded, it was found that there was no significant difference between the treatment and placebo arms. I am sure AfME would not recommend Rituximab as a treatment for patients to consider just because ‘some patients improved’ while taking it, so why recommend GET as a treatment for consideration?

Evidence of harms

Ideally we would look to well conducted clinical trials for evidence about harm, but even the still very flawed Cochrane review of Exercise therapy for CFS now admits that there is no useful evidence about harms from any of the clinical trials of GET. There is also no equivalent of the ‘yellow card’ system for reporting harms of non-drug treatments. And a recent study of UK ME/CFS clinics shows that they are not asking patients about, or keeping any records of harm.

We therefore have to turn to patient surveys for evidence about harm. Your own surveys, along with all the others carried out by other organisations, consistently show a large proportion of patients who have undertaken GET report significant harm. It is good that you mention this on your GET page, but there are serious problems with the way you report it.

It is helpful that you show survey evidence that a significant proportion of patients experience ‘worsening of symptoms’ and ‘harm’, and you say this:

“Instead of CBT and/or GET, some disease experts recommend that patients manage their activities to stay within their “energy envelope” to prevent crashes and possible long-term worsening from post-exertional malaise.”

However, there are serious problems with your comments about harm:

These mentions of harm are always given in the context of ‘some people improve’, or ‘some experts say’, but they give no indication of how any individual patient can tell whether they might be one of the patients who suffer ‘long term worsening of symptoms’. In truth there is no way anyone can tell - whether they are an ‘expert’ therapist or a patient - whether they will be one of the unlucky majority who will suffer harm, until it has already happened and is too late.

The level of harm is underplayed. What does harm mean? What does worsening of symptoms mean? How long is long term? These need to be spelled out realistically and starkly.
Harm can mean going from walking into the clinic to start GET, to needing to use a wheelchair and needing long term help with personal care by the end of treatment; from being able to work part time to being confined to your home needing help with household tasks. Worsening of symptoms can mean manageable pain becoming hard to bear; muscle fatiguability kicking in after a few metres walking instead of a few hundred metres; brain fog going from being able to work, albeit with some difficulty, to not being able to read or watch TV; new symptoms can arise, such as intense sensitivities light and sound. Worsening of symptoms can mean lying in a darkened room needing everything done for you for years.

And nobody knows who will be worst affected, or how much GET can set these effects in train until it is too late. It’s not just a matter of feeling a bit worse for a few days, it can be lifelong and devastating. No drug with these side effects would be allowed to be offered as a ‘choice’ to patients. So why GET?

Too much reliance on ‘expert’ therapists

Far from being ‘expert’ the therapists prescribing GET are doing so in the face of clear clinical trial evidence that GET is ineffective. And ‘specialist clinics’ rely on the ‘expertise’ of their therapists to ‘know’ what is best for patients. How can they know anything about either effectiveness or harm, if they do not follow up patients long term. Most ME/CFS clinics have no way for patients to report harms, or for the clinics to record harm.

No therapist, however ‘expert’ knows what level of activity is best for individual patients. All they can do is educate patients about pacing and the potential harms of overactivity, and help patients to find which way suits them to help them learn their own body’s reactions, and to try to avoid PEM. Therapists need to focus more on ‘first do no harm’, and avoid claiming a level of expertise they do not have.

I would recommend that Action for M.E. take a step back from reliance on the assurances from organisations like BACME that they have a level of expertise not supported by scientific evidence.
_______________________________

Summary

The section on the AfME website advocates patient choice, but does not provide patients with evidence based information on which to base that choice.

Too much credence is given to ‘expert therapists’, yet these so called experts ignore the clinical trial evidence that the treatment is ineffective, and keep no records of harm. The expertise of the therapists is no more than wishful thinking.

The survey evidence that ‘some people say they are helped’ is not evidence of efficacy, any more than it was in the open label Rituximab trials.

The likely harm is downplayed, with no explanation of what ‘worsening of symptoms’ means, or the fact that you can’t tell if you will be harmed until it is too late.
____________________________________

Suggested draft alternative version of AfME's web page on GET.

Graded Exercise Therapy - a warning

Post exertional malaise - the elephant trap

The core defining symptom of ME is post exertional malaise (PEM). This means a significant worsening of symptoms following what, to a healthy person, is seemingly trivial activity. PEM often starts a day or more after the triggering activity. As well as feeling much sicker, the person with PEM has significant lowered of ability to carry out normal activities. PEM can last for days, or weeks and may lead to long term decline in health and function. It therefore follows that people with ME are best advised to pace their activities carefully to try to avoid triggering PEM.

What is GET, and what other names does it have?

Graded exercise therapy was developed as a treatment for ME/CFS on the mistaken assumption that people with ME are just deconditioned, are afraid to exercise, and need to be encouraged to exercise more in order to recover. There is no evidence supporting this assumption.

GET is any program which involves finding your 'base level' of activity that you can maintain, and then adding a planned increase in activity at regular intervals, such as 10% each week, regardless of symptoms. This may be specific activities like walking, or an increase in normal daily activities. It is sometimes called Activity Management, Active Pacing or Pacing Up. Even some so called pacing programs may include encouragement to increase activity once the base level is found. This is not pacing.

Pacing - recommended management strategy

Action for ME advises that management of ME should be based on pacing (see Pacing section) which means staying well within the patient’s current ‘energy envelope’, with additional rests when necessary according to symptoms. The aim is to avoid post exertional malaise as much as possible.

The NICE guidelines are out of date

The current version of the NICE guidelines for ME/CFS that doctors use to decide on treatment for their patients suggests that Graded Exercise Therapy is moderately effective for patients with mild to moderate ME. This guideline is currently under review. The advice is not supported by evidence.

The evidence - GET is ineffective

GET has been shown to be ineffective in large clinical trials. For example, although the two largest trials, the PACE trial and FINE trial both showed slight, transient improvement on fatigue and physical functioning in questionnaires, this was not supported by any objective evidence of improvement in fitness, stamina or return to work. At long term (1 to 3 year) follow up after GET, the patients who had GET were still just as sick and had just as much reduced functioning as and those who had no treatment beyond standard medical care.

It is therefore clear that GET does not work.

The evidence - GET causes serious harm

There is evidence from several large surveys, involving thousands of people with ME, that more than half of patients who undertook GET were significantly harmed. This is not just a trivial or temporary worsening of symptoms. It can be a life changing, lifelong worsening of symptoms and an inability to work. Many patients report that after GET they became housebound, bedbound, and needing long term care.

It is worth noting that some people may recommend patients have a right to choose to try GET on the grounds that these same surveys show that a small proportion of patients report that they found GET helpful. But ME is a fluctuating condition, and whatever a patient happens to be doing at the time of an upturn in their health may be wrongly taken to mean that it was the treatment that led to the improvement.

The clinical trial evidence is unequivocal, GET does not work. And remember, no one knows until it is too late whether they will be seriously and permanently harmed by GET.

Our advice - a warning against undertaking GET

Action for ME therefore strongly advise patients not to undertake GET or any activity management program that involves increasing activity beyond your own personal current level that you can maintain easily and without triggering PEM.

The expert therapist and the specialist clinic - not so expert after all

There is no evidence that any therapist, however experienced, can tell which patients will be harmed by the exercise and activity based treatments. Indeed recent research has shown that specialist clinics in the UK do not even hold records of harms reported by patients, nor do they carry out long term follow up to determine whether their patients are being harmed by following their advice. Our recent patient survey showed that, far from being protected by the therapists’ claimed expertise, a higher proportion of patients who attended specialist GET were harmed.

Patient choice - don’t choose GET!

Action for M.E. supports patient choice in determining which treatment they undergo. In the case of GET, we unequivocally warn patients against choosing any therapy that encourages them to ‘push the envelope’ by increasing activity according to any plan or schedule. If GET were a drug treatment it would have been withdrawn as both ineffective and seriously harmful.

So what do I do?

There is no effective treatment for ME. We therefore can only recommend a management strategy that minimises harm, namely pacing.

Will I ever be able to increase my activity?

ME is a fluctuating condition. An unknown proportion of patients find their symptoms gradually improve over time while they are pacing, and this is accompanied by a gradually increasing ‘energy envelope’. If that happens to you, you are likely to find that you naturally increase your activity to follow that increasing ability to undertake activities without triggering PEM. Even then we advise continuing to pace carefully listening to your body, and staying well within that expanded envelope.

Do not try to ‘push the envelope’ or be tempted to try GET with a planned schedule of increasing activity, even if you feel a little better. Some patients report taking advantage of an apparent improvement to catch up on things they have not been able to do for a long time, and crashing badly as a result.

Take care. Pace, pace, pace.

______________________________________

I hope this is helpful. I look forward to your response.

With good wishes,

Trish Davis
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Barry · Oct 20, 2019

Excellent Trish ... you're a star .

Starlight · Oct 20, 2019

Thank you Trish. Your letter is so good and explains so clearly the harm caused by GET and the reality of life with ME. It must have taken an enormous amount of your time and energy to put it all together. I really appreciate it. Thank you for this and for all that you do.

Adam pwme · Oct 20, 2019

Excellent Thankyou.

Trish · Oct 20, 2019

Starlight said: ↑

It must have taken an enormous amount of your time and energy to put it all together.
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Once I start something like this I have to finish it and send it or I don't sleep much. Now it's done I'll probably need to hibernate for a bit.

Ravn · Oct 21, 2019

Starlight said: ↑

Thank you Trish. Your letter is so good and explains so clearly the harm caused by GET and the reality of life with ME. It must have taken an enormous amount of your time and energy to put it all together. I really appreciate it. Thank you for this and for all that you do.
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I second that unreservedly. And add that it is an excellent example of constructive criticism. I hope it will be received in an equally constructive manner.

ProudActivist · Oct 21, 2019

This is an amazing job! I hope they use your text.

Amw66 · Oct 21, 2019

Trish said: ↑

Once I start something like this I have to finish it and send it or I don't sleep much. Now it's done I'll probably need to hibernate for a bit.
Click to expand...

Thank you Trish.
Succinct, easily understood and non ambiguous.
That it should be necessary is both concerning and sad. Let's hope that the constructive criticism is received in the spirit in which it is intended and changes are made asap.

ETA spelling

Daisymay · Oct 21, 2019

Really excellent Trish, thanks very much for doing this, now rest and pace!

wigglethemouse · Oct 21, 2019

Well done. It's the perfect letter. You are polite, recognise the good things they do, explain what concerns you, and offer a draft to replace the current text.

ScottTriGuy · Oct 29, 2019

I guess you've not received a response from Chowdhury yet @Trish?

I'm now eager to see how / if she replies.

Trish · Oct 29, 2019

All I've had so far is the automated email reply saying she would be out of the office for a few days.

Trish · Oct 29, 2019

Reply from Sonya:

Dear Trish

Many thanks for your email and apologies for my delay in replying; I have been working in Scotland and London (twice) over the last couple of weeks and am very behind on emails.

I am delighted to hear that you were able to watch our AGM and conference online, and appreciate your positive feedback about our work, and position on CBT and GET. Thank you for taking the time, effort and energy to make suggestions intended to help us improve the information, services and support we offer to people with M.E.

Our intention is not to recommend any treatment or management approach for M.E., as we state on all our treatment and management website pages, and share information based on the best available scientific evidence as well as patient experience. Your email suggests that we need to do this in a much clearer way, and I have shared your valid concerns with my team, along with your suggested draft alternative, which the team have found valuable. We take on board your feedback.

Using data from our Big Survey, we are undertaking a review of our GET page and other key information pages, and hope to have our treatment and management section updates completed, as a priority, within two weeks. I’d be happy to get back to you with a more detailed response to the suggestions you make in your draft alternative, which the team will consider as part of this planned review.

Many thanks and best wishes

Sonya Chowdhury, Chief Executive, Action for M.E.
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ScottTriGuy · Oct 30, 2019

Seems like your letter is a success @Trish - congrats on job well done.

Trish · Oct 30, 2019

ScottTriGuy said: ↑

Seems like your letter is a success @Trish - congrats on job well done.
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I am concerned about this bit:

Our intention is not to recommend any treatment or management approach for M.E., as we state on all our treatment and management website pages, and share information based on the best available scientific evidence as well as patient experience.
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This seems to imply they won't come out clearly in favour of pacing.

I shall reserve judgement until the new management and treatment pages are published on their website.

Sly Saint · Oct 30, 2019

ScottTriGuy said: ↑

Seems like your letter is a success @Trish - congrats on job well done.
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yes, good work @Trish

But it should not be up to individuals to point out glaringly obvious misinformation to the largest UK ME charity.

Our intention is not to recommend any treatment or management approach for M.E., as we state on all our treatment and management website pages, and share information based on the best available scientific evidence as well as patient experience.
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that has always been their argument for putting out information on things like LP, Gupta etc as well as CBT and GET in the past.
One of the problems with this is what they consider is the 'best available scientific evidence'(?)

JemPD · Oct 30, 2019

Sly Saint said: ↑

One of the problems with this is what they consider is the 'best available scientific evidence'(?)
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indeed.

But I still think this was really worth doing @Trish , and done very well too. Thank you!
At least the reply takes what you've said seriously, and isn't a patronising dismissal. I don't hold out a great deal of hope for AfME tbh, but even if it only makes them consider your points as they update, it was well worth doing.

Sly Saint · Oct 31, 2019

I had forgotten that before their last statement on CBT,GET and the PACE trial last year, AfME made a previous statement in May 2017

Our Board of Trustees on CBT, GET and PACE
May 16, 2017

What Action for M.E. is doing

We will support the ongoing scientific debate around the PACE trial by:

actively disseminating updates relating to this on our website and social media

revising our information on GET, CBT and pacing to reflect these.

Click to expand...

https://www.actionforme.org.uk/news/board-of-trustees-on-cbt-get-and-pace/

so that's over two years ago.

Trish · Nov 9, 2019

New reply from Sonya, and the new version of the AfME page is now live.
https://www.actionforme.org.uk/living-with-me/treatment-and-management/graded-exercise-therapy/

From Sonya:

Further to my email below, please find attached a summary of the changes made as a result of your email; these went live on our website yesterday but due to meetings, I didn’t have a chance to let you know straight away.

Thank you, once again, for taking valuable time and energy to highlight improvements to the information we put out and I hope that you feel that we have listened, and responded, to your comments.

Warmest wishes
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My reply:

Dear Sonya,

Thank you for taking the time to spell out to me the changes you have made as a result of my suggestions. I appreciate that, especially as I know you are very busy.

I have had a quick look through the new page, and it is definitely an improvement. There are still some points of concern, but I am very pleased that you give much more emphasis to the likelihood of harm from undertaking GET and make it very clear it is not a recommendation.

I will share your reply and a link to the new page with members of S4ME forum. No doubt it will generate further discussion which you or members of your team are welcome to join.

All the best,

Trish
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Amw66 · Nov 9, 2019

Thank you @Trish , and @Action for M.E. it is encouraging that changes have been made.

As you say there are still concerns, but this is a welcome step that has been addressed relatively quickly.
I hope an ongoing dialogue can inform future input.

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Open Letter to the Chief Executive of Action for ME about the AfME web page on Graded Exercise Therapy

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Open Letter to the Chief Executive of Action for ME about the AfME web page on Graded Exercise Therapy

Trish Moderator Staff Member

Barry Senior Member (Voting Rights)

Starlight Established Member (Voting Rights)

Adam pwme Senior Member (Voting Rights)

Trish Moderator Staff Member

Ravn Senior Member (Voting Rights)

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