Response to article re PACE

[EllenGB]

Response to article in the magazine published by the UK charity MCS-Aware. Nicki is the editor.

Dear Nicki,
I'd love to know who decided to devote a whole page in the new MCS-Aware magazine to the hyped claims re CBT and GET for ME and CFS ('ME can be beaten by taking more exercise?'). Thank goodness you added a few sentences from Charles Shepherd to inform the readers that the claims re CBT are "bunkum".

Your article lacked balance. There was far too little to challenge the nonsense surrounding what you described as a "landmark" study (six lines out of about 70.) Why did you not ask a psychologist who knows more about cognitive behavioural therapies than a physician for his or her take? They would have explained to readers that the findings of the PACE trial are meaningless given the sheer number of flaws. For example, the researchers excluded people with ME who had neurological symptoms so the results may not apply to them, they didn't use motion sensing devices to confirm that people had followed the GET programme as instructed, the averages for fatigue and physical functioning were well below normal at follow-up, there were many participants still on benefits at follow-up so these people were possibly too ill to work etc etc. In which case, how useful are CBT and GET?

It's sad enough that the press ignored the flaws and devoted a lot of attention to the hype. But you didn't need to follow them.

You cited White who claimed that given the evidence, CBT and GET are the "only game in town". No they're not (e.g. Goudsmit, Ho-Yen et al, Taylor et al etc). You also noted Sharpe's views that removing negative thoughts "seemed to work". On what basis? How many participants were enjoying something close to their pre-illness lives? What I read in the Lancet Psychiatry was that two years on, there were virtually no differences between the interventions. However, the information was limited and I missed some data that might have been significant.

You informed readers that according to an expert, patients get "locked into a pattern and their life constricts around what they can do. If you live within your limits that becomes a self-fulfilling prophesy". Again, where is the evidence for that? Given that minimal exertion worsens symptoms, patients don't have a choice. If they don't live within their limits, the outcomes can be dire. What this trial tried to show was that doing what makes you worse will over time, make you feel better. Would you devote the majority of an article to the views of some doctors that MCS is a result of conditioning and that avoidance is limiting and wrong?
As a patient, I really don't want to be confronted with so much nonsense in the magazine of a support group who should be well aware of the psychologisation of ME. Cover the study by all means but provide balance.

The PACE trial was scientifically extremely poor and you wasted a lot of space to it at a time when another study published this year has (again) implicated enteroviruses as a possible cause (Chia et al) and there are lots of other findings suggestive of ongoing pathology. 99% of ME patients could have told you that. Talk to them and protect them from all the disinformation surrounding the disease.

I've cc'd this to the IndependentME online community so they are aware that someone has responded and they don't have to.

Yours sincerely,
Ellen M. Goudsmit PhD, FBPsS

 

[Sidereal]

Excellent letter, Ellen. Thanks.

 

[Mary]

@EllenGB - thank you - very well said!

 

[EllenGB]

Thanks.

Re arguments against, I'm compiling a list. If angry, I'll find refs. It's a work in progress.

1. The means for both main outcomes measures were below normal at follow-up.
2. The percentage of those on benefits was significant post-treatment and indicates many remained unwell, especially at follow-up. (Need to get %)
3. No actigraphy measures at follow-up to demonstrate fidelity to the protocol i.e. an increase in activity as required by both GET and CBT. Improvement could be due to pacing (definitions Jason and Goudsmit), as documented in American trials.
3. No stratification of samples as required by the CDC case definition e.g. comparing post-viral versus gradual onset etc.
4. No outcome measures for symptoms other than fatigue and sleep disturbance. No measure of factors described as more disabling e.g. cognitive impairment and somatic symptoms.
5. Fatigue scale used is hard to interpret as it asks about symptoms compared to previous weeks. As ME is a chronic condition that fluctuates, asking people to compare level of fatigue with two or so weeks earlier (when most were also feeling ill) is meaningless. Small differences mean little as long term follow-up e.g. Deale et al 2001 indicated (scores raised again, despite 68% having continued some form of CBT during five years.) Also reported by Sharpe following 1996 trial.
6. Some tests are inappropriate for a condition which fluctuates and abnormalities show up after exertion, so single tests like walking for a few minutes are impossible to interpret.
7. Criteria for recovery were not realistic and would not assess recovery as generally understood, e.g. ability to return to full time job etc. There is no evidence that any participant made complete recovery and was able to return to pre-morbid life.
8. No tests to show improvement in muscle strength cf. Paul et al.
9. No measure of perceived stress that might explain improvement or act as a confounder.
10. Factual error: APT is not based on the Envelope theory as this requires people to match ability and activity (source Prof. JASON). There is a 70% rule in APT which is inconsistent with the Envelope theory and difficult to justify.
11. Factual error: The researchers did not use the London criteria so it is not clear if any participant had ME as described by experts such as Dr Ramsay.
12. They did not assess the form of pacing most used by patients. Only one charity recommends APT.
13. Rationale for stopping patients from resting when they feel unwell is based on an old hypothesis linked to operant conditioning and developed in relation to another condition significantly different from ME. It is now regarded as invalid. It's also sexist.
14. CBT and GET deny documented evidence of a pathological reaction to exertion in muscle, immune function, metabolism etc. Post-exertional worsening is a key symptom, shown in objective tests, and not a faulty belief. If there is no worsening following exertion, the diagnosis of ME and CFS must be reviewed. If there is a worsening, the aim to increase that which makes patients worse is irrational.
Just add to the list. Maths and factual errors are the strongest.

 

[charles shepherd]

Hi Ellen

I haven't seen this article that your have comprehensively replied to and cannot find a link on the MCS website

Is there a copy available that we can look at?

Thanks

Charles

 

[SOC]

Hi Ellen

I haven't seen this article that your have comprehensively replied to and cannot find a link on the MCS website

Is there a copy available that we can look at?

Thanks

Charles

@EllenGB
Just tagging this so Ellen is more likely to see it.

 

[helen1]

Thanks @EllenGB. Did they respond to your letter?

 

[Snow Leopard]

Ellen, your concerns are valid and well expressed. The only part I can suggest is being more specific in what you'd like to see in response e.g. a formal correction in the magazine.

"Talk to them and protect them from all the disinformation surrounding the disease." is a worthy statement, however it is worth sharing your vision of what that would look like - so those who aren't already on board know what action to take.

 

[EllenGB]

Thanks @EllenGB. Did they respond to your letter?

No. Not yet.

 

[EllenGB]

Ellen, your concerns are valid and well expressed. The only part I can suggest is being more specific in what you'd like to see in response e.g. a formal correction in the magazine.

"Talk to them and protect them from all the disinformation surrounding the disease." is a worthy statement, however it is worth sharing your vision of what that would look like - so those who aren't already on board know what action to take.

I think we have to choose our battles and this magazine is not widely read. the response should suffice but it's a learning exercise, for me. It made me rethink what is wrong and how to tackle it. I went back t the past and have started a list of arguments against PACE.

 

[EllenGB]

Hi Ellen

I haven't seen this article that your have comprehensively replied to and cannot find a link on the MCS website

Is there a copy available that we can look at?

Thanks

Charles

No, it's online on the site for members only.

 

[EllenGB]

Looks like an article published elsewhere, given they included your response and you don't seem to know about it.

 

[EllenGB]

Ellen, your concerns are valid and well expressed. The only part I can suggest is being more specific in what you'd like to see in response e.g. a formal correction in the magazine.

"Talk to them and protect them from all the disinformation surrounding the disease." is a worthy statement, however it is worth sharing your vision of what that would look like - so those who aren't already on board know what action to take.

Hi,

I've done that for years but it's not been taken up by any group. I was involved inn the initial challenging of the hysteria explanation in the 1980s and early 1990s and what we did worked. Then came Simon Wessely. I quickly realised that his was not a science-based view, as detailed in my article in InterAction, and a subsequent essay on the denial of evidence (parts taken up by 'M Williams' though she did not credit me as the source, which is a little odd). When advisor to MEAction (now AFME), I helped keep the psychologisation under control but then they decided to go to bed with Simon and I was fired. The rest is history. I've failed miserably in all my attempts to change course and demolish the psychologisation, but am not clear why advice was not taken and strategies that didn't work continued to be pursued. Unless we go in a different direction, or there's a miracle, we risk ten plus more years of psychological nonsense (and as a senior member of the profession, that wording says something). I stand by it. What's happened e.g. denial of evidence, group think etc, is a disgrace. but if Prof. Komaroff writes about graded activity and I alert him to the dangers of that advice and he tells me to ... off, what can you do? Some people like 'experts' who will advocate graded activity in journals which I find hard to explain. Komaroff is NOT a psychiatrist. Just because there are a lot of RCTs suggesting CBT and GET are helpful doesn't mean they are helpful. They are all flawed. It's quality we need, not quantity.

Perhaps groups unconsciously believed the total garbage written by the small group of cyberbullies from about 2004 onwards. However, there was no smoke, no fire and not even a match, as detailed in my blog on Wordpress. Perhaps they fear that the bullies will start again if they name me, refer to me or take my advice. It would be an awful shame if that was the reason. As a psychologist (perhaps the only one in Europe who was/is active re ME and has Europsy certification e.g. Wearden isn't, Knooop isn't - Europsy has ridiculously high standards), I know the weaknesses in the psychobabble and can discuss them with authority.

I am ashamed sometimes of the scientists who accept the nonsense re PACE. What negative beliefs? They can't cause some of the abnormalities seen on SPECT, in immune function and muscle metabolism. Even this psychologist can see that. Anyone who thinks things through would realise that the White/Sharpe narrative makes little sense given all the lit. I can and have explained where the CBT model came from and how unscientific it is but if no one takes any notice, people will only get info from Sharpe and White and Dr Shepherd who has to challenge everything on his own but isn't as familiar with the operant conditioning views of the fifties that underpin the CBT model for CFS as I am. The only person who realised I was on to something was Prof. Coyne. Expect him to incorporate some of the sexist views surrounding the CBT model soon. So that's denial of evidence, bias and sexism for starters. A well qualified psychologist could help any group demolish the CBT model with ease. Prof. Jason is working on it in his way. now Prof. Coyne. Hmm. Just noticed they are men. Groups aren't dismissing my views cause I'm a woman, are they? Surely not. anyway, I wasn't used in the past ten years and groups in the UK and Netherlands let the psychiatrists get away with far too much. The current issue of MEdium (ME Stichting Holland) is so depressing. they had an interview with a prof who is into medically unexplained symptoms. Why? It's really not relevant to ME and dangerous without a comment from someone with a different view.

What to do? Look at my list of flaws in the PACE trial, use it when talking to journos, and let me help with countering the psychologisation. As I noted years ago, it is my view that ME and CFS are the most psychologised conditions in recent years. I am still of that opinion. Those who gossip that I support a psychiatric explanation are ill-informed. There's no evidence of that so the gossip is not helpful. Counterproductive. Challenge it were you can.

You need good info and intel. Get it wherever you can and don't give the CBT fanclub a reason to dismiss you e.g. with general statements that CBT (as a whole) is nonsense. It's the CBT protocol for ME and CFS which is but CBT for medical conditions is not. If you have any medical disorder and you get depressed, CBT can help. But that's not what the Chalder protocol states. The devil is in the detail.

Happy to be interviewed but no longer so keen to write as that hasn't achieved much.

 

[nasim marie jafry]

You informed readers that according to an expert, patients get "locked into a pattern and their life constricts around what they can do. If you live within your limits that becomes a self-fulfilling prophesy". Again, where is the evidence for that? Given that minimal exertion worsens symptoms, patients don't have a choice. If they don't live within their limits, the outcomes can be dire. What this trial tried to show was that doing what makes you worse will over time, make you feel better.

@EllenGB This is crucial - living within one's limitations/pacing is not a choice, it is simply essential to surviving and coping with ME.

 

[EllenGB]

Which is why I can't understand that groups are not promoting it, complete with scientific lit so readers know it's not a lay invention based on fear but a carefully thought our strategy (that works). There are different versions e.g. with and without diaries, but the principle is the same. You respond to your body as opposed to GET, where there is no such link and your rest periods are scheduled days before. (No link because they see fatigue as conditioned so they don't want to perpetuate/reinforce the rest leads to fatigue connection).The connection is the other way around, of course, but if you are OCD about deconditioning etc, you won't respond to such suggestions. Group think rules and we must deal with that sooner rather than later. It's science. But if the Annals of Internal Medicine don't care about errors, and so far they don't, then it's hard to be an old fashioned scientist who demands accuracy.

 

[nasim marie jafry]

@EllenGB Indeed, Ellen, pacing should be promoted by all groups if they wish to truly support people with ME. But I don't myself view pacing so much as a formalised concept - it is more spontaneous, reactive than that - it is simply how we respond to our daily lives and symptoms, though I could probably do with a stricter approach myself as I have pretty much constant PEM, and it is a case of minimising the severity. Your thread above is brilliant, would you be okay with my linking to it on Twitter, if not, I won't do so! I know this is public forum but I would not link to anyone's comments without first asking. No probs if you prefer I don't, I understand. NASIM

 

[EllenGB]

Pacing should be spontaneous. It does not require 16 one hour session to learn. But they do need to define it properly and explain the science behind it. And supporting it. In that sense, it has to be formalised. Just writing about pacing and leaving people to guess how you pace isn't enough.

Don't think people are that interested in my ideas for a link on twitter, though I myself did post one.

 

[Valentijn]

But they do need to define it properly and explain the science behind it. And supporting it. In that sense, it has to be formalised. Just writing about pacing and leaving people to guess how you pace isn't enough.

That also might help in preventing the BPS brigade from redefining pacing to act more like GET.

It needs to be very clear that symptoms (maybe with help from heart rate monitoring) are the primary indication of limitations, and that those limitations cannot be exceeded. While pacing might result in being a bit more functional due to not being in a constant state of PEM exacerbation, there is no inherent goal to increase functional capacity or any sort of physical conditioning.

 

[EllenGB]

Heart monitoring? NO!!!!! Your body will tell you when you've gone too far (your brain might not so you need a kitchen timer for computer work). Heart monitoring is for those who don't realise they feel sick, ill, weak, yuk, tired. Your heart can work well while you feel like death. (I had 24 hour monitoring).

Who are the BPS brigade?

 

[Old Bones]

Heart monitoring? NO!!!!! Your body will tell you when you've gone too far (your brain might not so you need a kitchen timer for computer work). Heart monitoring is for those who don't realise they feel sick, ill, weak, yuk, tired. Your heart can work well while you feel like death. (I had 24 hour monitoring).

Can you please explain why you are so vehemently opposed to heart rate monitoring. The problem for many of us is the delayed effect of too much physical activity. We often don't know the extent to which we've exceeded our limitations until 24 hours after the fact, or even longer. Although my body tells me when I've "gone too far", in the moment I'm not always aware that I'm "going too far". In fact, when I first purchased my monitor a few years ago on the advice of a doctor, I believed it would be a waste of money -- thinking it would demonstrate my heart rate was normal. Instead, it measured heart rates into the 160's doing simple tasks like getting dressed or brushing my teeth.

I definitely agree with your advice to use a kitchen timer for cognitive tasks. If I don't, my heart rate is significantly elevated the following day according to -- you guessed it -- my monitor.