Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS, 60% of Patients Show No

Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS: 60% of Pa

You can view the page at http://forums.aboutmecfs.org/content.php?369-A-Hitch-in-its-Step

 

This brings up a question of British sporting etiquette. Should you congratulate a group for cheering an own goal?

:Sign Good one:

There it is in a nutshell!

And what to do when the ref wears the same colours as the team that scored the own goal, the papers report that they won the game with the own goal, the team go through to the next round, and the 'defeated' side are not interviewed in the match reports so that everybody can have a chance to calm down and play the next round?

 

Cost-saving measure

Enough of carping and criticism! I've adjusted my thinking, and this has produced a positive suggestion for improving results of the objective portion of the study -- walking for 6 minutes.

An admittedly difficult calculation of the cost per patient-meter, a solid objective measure of improvement, left me dissatisfied. Here's a suggestion which could result in real savings by the NHS.

A small-scale experiment using U.S. currency, reveals that strategic placement of a 100 lb. note could achieve comparable results at a fraction of the cost, and in far less time.

Now, all I need is someone to supply British currency for a full-scale study. There appears to be no shortage.

 

The more I read Cort - several "hitches" in their step appear. What a difference you and forum members are bringing about.

 

This is a great idea! Have them do an article on this study, which comes to the opposite conclusions as the PACE study, and uses better metric and longer follow up! Even better, before someone contacts them, lets line up links to all of the papers that re-inforce this point. It would be good to have that as a sticky post anyways.

Hi acer2000, we really need an easy sticky on this to assist fast advocacy, and we should be posting links everywhere to threads like this, good responses etc. I totally agree. Bye, Alex

 

This question has probably already been answered but... Have these or any other researchers just given their cohorts antidepressants and then record if they recovered throughly? It seems counterintuitive not to try this route. My guess is that would be too easy.

 

This question has probably already been answered but... Have these or any other researchers just given their cohorts antidepressants and then record if they recovered throughly? It seems counterintuitive not to try this route. My guess is that would be too easy.

It's a good point Revday, but the problem with that approach is one of patient cohort and the diagnostic criteria used.
The PACE trial used the Oxford Criteria, which doesn't exclude fatigue due to psychological causes.
So if some patients responded positively, it wouldn't tell us anything about ME, as defined by WHO.

Having said that, I would assume that many of the patients complaining of depression had already been prescribed antidepressants, and that they didn't help their fatigue levels.

 

I think we're all feeling a bit battered and a bit low since this study was published...
So I just want to restate the positives that have come from this study...

What the study gives us, as patients, is some solid evidence, in the form of official UK government research data, that we can use in our favour... as follows:

1. Psychological interventions (CBT and GET) do not cure ME.

2. CBT and GET are not effective treatments for ME. ('moderately effective' does not equate to 'effective', as even the authors of the study admit.)

3. Only 16% to 60% of patients (depending on which data-set you use) experience any benefit from CBT or GET.

4. Those patients who do benefit from CBT and GET are only helped in a very small way (or helped 'moderately' in the language of the authors), which is about a 10% reduction in fatigue levels. (BTW What is a 10% reduction of 'extremely fatigued'?)

5. CBT and GET do not suit everyone, and do not help everyone, and they harm some patients, and therefore should only ever be offered as a choice, or an option, for a patient to use if the patient thinks they might be helpful for their particular circumstances. CBT and GET should never be offered as a treatment or cure for ME/CFS.

6. GET, and other psychological interventions, do not provide any benefit for severely ill (bed-bound and house-bound) patients, as proved by the UK government funded 'FINE Trial', which was published a few months ago. (The failed FINE Trial was published very quietly without any fuss or promotion.)

It's too early to say yet but I'm not at all sure that this study puts us in a worse situation than we already were. It might very well put us in a stronger position than we were before, because now we have hard evidence of the failings of CBT and GET.

And of course, the success rate of the PACE trial was under the very best conditions of an expensive research trial setting, and as we all know, that doesn't translate to everyday medical settings.

The results from this data support what many UK patient surveys have been saying for years... That CBT and GET do not provide benefits for a good proportion of ME patients.
I really hope now that CBT and GET will just be offered as tools to those who want to try them, as something that might help some patients in a small way, and not offered as any more than that.

Hopefully, now, this trial puts to bed the arguments that psychological interventions are an effective treatment or a cure-all, and we can get down to some serious biomedical research into real treatments. I'm really hoping so anyway.

Well, that's my positive take on the situation... I don't know if it helps anyone, but focusing on those findings helps me to deal with the fraud and the abuse that we are subjected to.

 

I know I've pointed this out before, but I think it bears repeating to add to your list:

This very expensive trial, paid for by UK taxpayers, did not demonstrate any improvement in functional status sufficient to enable disabled people to return to work and stop receiving public benefits.

I'm not sure exactly how this ties in with #6 about no benefit for the severely ill/homebound/bedbound. Is there, anywhere in all this mess, data about how many of the trial participants were on disability benefits? Perhaps none at all, since the severely ill could not participate?

 

I think we're all feeling a bit battered and a bit low since this study was published...
So I just want to restate the positives that have come from this study...

What the study gives us, as patients, is some solid evidence, in the form of official UK government research data, that we can use in our favour... as follows:

1. Psychological interventions (CBT and GET) do not cure ME.

2. CBT and GET are not effective treatments for ME. ('moderately effective' does not equate to 'effective', as even the authors of the study admit.)

3. Only 40% to 60% of patients (depending on which data-set you use) experience any benefit from CBT or GET.

4. Those patients who do benefit from CBT and GET are only helped in a very small way (or helped 'moderately' in the language of the authors), which is about a 10% reduction in fatigue levels. (BTW What is a 10% reduction of 'very fatigued'?)

5. CBT and GET do not suit everyone, and do not help everyone, and therefore should only ever be offered as a choice, or an option, for the patient.

6. GET, and other psychological interventions, do not provide any benefit for severely ill (bed-bound and house-bound) patients, as proved by the UK government funded 'FINE Trial', which was published a few months ago. (The failed FINE Trial was published very quietly without any fuss or promotion.)

It's too early to say yet but I'm not at all sure that this study puts us in a worse situation than we already were. It might very well put us in a stronger position than we were before, because now we have hard evidence of the failings of CBT and GET.

And of course, the success rate of the PACE trial was under the very best conditions of an expensive research trial setting, and as we all know, that doesn't translate to everyday medical settings.

The results from this data support what many UK patient surveys have been saying for years... That CBT and GET do not provide benefits for a good proportion of ME patients.
I really hope now that CBT and GET will just be offered as tools to those who want to try them, as something that might help some patients in a small way, and not offered as any more than that.

Hopefully, now, this trial puts to bed the arguments that psychological interventions are an effective treatment or a cure-all, and we can get down to some serious biomedical research into real treatments. I'm really hoping so anyway.

Well, that's my positive take on the situation... I don't know if it helps anyone, but focusing on those findings helps me to deal with the fraud and the abuse that we are subjected to.

It depends on what NICE do in the wake of it, for one thing. The cynical manipulation of words in the press (and they've come from somewhere- most likely the press release and that press conference) is already a major problem, and will adversely affect many patients dealing with more gullible doctors and relatives and community at large. They haven't let the poor results slow them down so far - in fact, they're demanding more research!

The evidence of minimal efficacy, together with the enormous methodological discrepancies at all stages of this trial, and ethical issues as well (including possible discrepancies as identified by various people over the six years of the trial), and the waste of taxpayer money on such poor results (which could have been predicted on previous CBT/GET trials!) need to be brought to the fore probably on a frequent basis in the coming years.

 

It depends on what NICE do in the wake of it, for one thing. The cynical manipulation of words in the press (and they've come from somewhere- most likely the press release and that press conference) is already a major problem, and will adversely affect many patients dealing with more gullible doctors and relatives and community at large. They haven't let the poor results slow them down so far - in fact, they're demanding more research!

Yes, the media has obviously allowed itself to be totally manipulated by the authors of the study, but the media shouldn't publish this stuff without analysing the study and consulting the patient community first. Especially the BBC which is supposed to be a public service. The garbage that they've published is an outrage.

There is a real danger that vulnerable patients, especially children, will be exploited by the spin put on this paper, but the results also give our community solid evidence to fight against exploitation. If only one good thing has come from this study, it's that it has proved that ME is not cured, or effectively treated, by the 'best' psychological interventions on offer from the UK's most influential psychiatrists. This may very well give us a very powerful voice against psychological treatments, and enable us to more effectively demand biomedical research and treatment. It might also, once and for all, put to bed the lies that ME is a psychological disorder. The study spectacularly failed to effectively treat ME patients.

I'm also really worried that the spin will cause our community more damage. But I'm not entirely sure that it will. It's hard to see how this will pan out over the coming months.

So, although the recent press articles have been an outrage, I think that it is too early to know how this will affect us, and it might have the opposite effect than currently seems obvious.

I don't imagine that NICE will make any changes at all for the foreseeable future.

The evidence of minimal efficacy, together with the enormous methodological discrepancies at all stages of this trial, and ethical issues as well (including possible discrepancies as identified by various people over the six years of the trial), and the waste of taxpayer money on such poor results (which could have been predicted on previous CBT/GET trials!) need to be brought to the fore probably on a frequent basis in the coming years.

Yes, we need to keep on challenging this paper very strongly. And I really hope that the patient organisations are going to represent us properly and protect the patient community. (I want to see Action for ME rebut this study in the strongest terms. But I won't hold my breath for that!)

 

addition

Home goal - just wait. Gosh how things are slow UK wise should we remind all there is no empire now.

 

I know I've pointed this out before, but I think it bears repeating to add to your list:

This very expensive trial, paid for by UK taxpayers, did not demonstrate any improvement in functional status sufficient to enable disabled people to return to work and stop receiving public benefits.

I'm not sure exactly how this ties in with #6 about no benefit for the severely ill/homebound/bedbound. Is there, anywhere in all this mess, data about how many of the trial participants were on disability benefits? Perhaps none at all, since the severely ill could not participate?

I would imagine some were on disability benefits; severely in the UK tends to me housebound/bedbound.

They did collect the data. It was of the secondary outcome measures they didn't publish:

11. The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME [31], will measure hours of employment/study, wages and benefits received, allowing another more objective measure of function.

They did give us:

The Work and Social Adjustment scale provides a more comprehensive measure of participation in occupational and domestic activities

- I'm suspicious the results of this suited them more. Cort referred to this in his piece - the first person that I've seen do so so well done to him.

The questions that make it up can be seen at page 208 in the full protocol document (11MB):
https://www.yousendit.com/download/T2pGd0VBaFI4NVh2Wmc9PQ

As Cort pointed out, the people were only in the middle (CBT: 20.5, GET: 21.0) which isn't great on a 0-40 scale with 0 being the best.

Also, two of the predictors they were to look at were:

16. Receipt of ill-health benefits or pension

17. In dispute/negotiation of benefits or pension

With these sorts of studies in the past, they have sometimes said that being in receipt of disability benefits led to poorer outcomes (the implication being that they are bad for patients).

We may still be faced with that given they say:

We plan to report relative cost-eff ectiveness of the
treatments, their moderators and mediators, whether
subgroups respond diff erently, and long-term follow-up
in future publications.

 

Bob-

My opinion is that emphasis should be on the fact that this study is a scam. All the method flaws add up to that this study is totally invalid so the results are meaningless. the results don't say that GET and the evil version of CBT are moderately beneficial; the results say that GET and evil CBT seemed moderately beneficial to this group of Idiopathically Chronically Fatigued people who had no neurological illness including no ME.

This study is invalid. period.

Let's not forget why they did this study. What they have already declared; I forget whether they declared it in the paper or the press release, but they said, paraphrased:

This definitive study shows adaptive pacing does not work and CBT and GET are modestly beneficial for "CFS" and are the only treatments ever proven beneficial. Thus NICE should make "CFS" patients not do pacing and require them to do GET and CBT.

If our main point is that it is only moderately beneficial (which it is not) then UK people will be told even more that they do not have a physical illness and they must ratchet up their exercise. This will disable and kill thousands of more people than these therapies have already.

Here is some good info from Mithriel:

There are just a few points for US readers.

Adaptive pacing is not at all like pacing. It involves keeping a diary and adhering strictly to a tight schedule. No sleep during the day, rests for a specific number of minutes at a certain time for instance. It is very difficult to do and completely ignores how a person is feeling. It is the complete opposite of the pacing that helps patients where you listen to your body. In some ways it is worse for ME than GET as you can do your daily walk when you feel up to it and pace yourself the rest of the time.

PDW hates pacing and has called this travesty pacing so as to discredit the patient experience. Doctors will now tell us not to listen to our bodies when that was never trialled at all.

They did not find that CFS and ME responded the same way. They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards. Also, PDW has his own meaning of PEM, it is the soreness you experience when you are deconditioned then exercise. This trial said nothing about neuroimmune disease.

They had great difficulty recruiting for the trial. Anyone who knew anything about it would not enter. There were complaints about the set up from all the patient organizations except AfME so all members knew of the flaws. They were forced to change the criteria for entry and started asking GPs to send along fibromyalgia patients.

It was a mess and the results dreadful despite their best efforts to get a positive result, yet they have been reported as wonderful in the UK and will be used against us. The rest of the world may see them as laughable, rightly, but our plight is enormously increased. Our present government has declared war on the disabled, every single person on benefits is to be reassessed and this paper spells disaster for those of us with ME.

Mithriel

 

Bob-

My opinion is that emphasis should be on the fact that this study is a scam. All the method flaws add up to that this study is totally invalid so the results are meaningless. the results don't say that GET and the evil version of CBT are moderately beneficial; the results say that GET and evil CBT seemed moderately beneficial to this group of Idiopathically Chronically Fatigued people who had no neurological illness including no ME.

This study is invalid. period.

Yes, I agree that it's important to take that approach as well. But I think we can rebut it coming from both angles.

I think that the problem with only taking your approach, Justin, is that experience tells us it will fall on deaf ears, especially with the UK government, the MRC and NICE.
The establishment doesn't listen to us when we talk about the complexities of the disease and the need for more appropriate and exclusive diagnostic criteria. We've been telling them that for decades.

So if they don't listen when we tell them that the study is invalid, then maybe we can play them at their own game by using the data from the study against them, which I think might give us some advantage.

I guess we have to throw everything we've got against this study, which will involve coming from it from all angles.


As Mithriel says, it's also very important to make sure that everyone knows that Adaptive Pacing Therapy, as used in the study, is not the same as pacing, and bears little resemblance to it. I think we all need to keep repeating that again and again so everyone in our community knows it.

If our main point is that it is only moderately beneficial (which it is not) then UK people will be told even more that they do not have a physical illness and they must ratchet up their exercise. This will disable and kill thousands of more people than these therapies have already.

I think we need to re-spin the results and emphasise that CBT and GET only worked for some patients, and that it had 'little' effect on those it did work for. I think we should reinterpret the results and replace the word 'moderate' with 'small' or 'little' when we talk about it. A 10% reduction in fatigue doesn't seem like a 'moderate' improvement to me. It seems like a small improvement to me. I would call a 35 to 65% improvement in fatigue levels a 'moderate' improvement. So who got to chose the word 'moderate'?

But, yes, I agree with what you say Justin... But I think there's more than one angle we can come at this from.

 

I think most people would say 10% is small not moderate, right.

The adaptive pacing thing is extremely important in my mind. they say they are studying one thing and they are clearly studying another. in the same way, i think that's just as clear that they were studying ICF not ME, so i think both points can be made. ME is a neuro disease, they studied people without neuro-disease.

 

Yes, I agree that it's important to take that approach as well. But I think we can rebut it coming from both angles.

I think that the problem with only taking your approach, Justin, is that experience tells us it will fall on deaf ears, especially with the UK government, the MRC and NICE.
The establishment doesn't listen to us when we talk about the complexities of the disease and the need for more appropriate and exclusive diagnostic criteria. We've been telling them that for decades.

So if they don't listen when we tell them that the study is invalid, then we can play them at their own game by using the data from the study against them, which I think might give us some advantage.

I guess we have to throw everything we've got against this study, which will involve coming from it from all angles.

Yes, I agree. In the past, they were using Oxford-criteria-only studies and claiming we should listen to them.

They can claim they used ME and Fukuda-like (Reeves et al., 2003) criteria this time and the results were the same. People can focus on the criteria issue if they like but I think there is other stuff there that can be used.

 

I'm not normally the belaboring sort as I have neither the strength nor the inclination. However, I'm willing to risk a mini-crash because this is crucial.

Dolphin stated:

Unfortunately, White et al. had an advantage as they had the data. The CAA did not and indeed very few people in the UK seemed to have the paper before the midnight deadline. In such circumstances, it's not easy to do a press release that is there for the first round of coverage. Indeed, people were having to deal with journalists "blind" on Thursday, where journalists had the embargoed press release.

Why on earth would the CAA NOT have the embargoed press release?! Any basic PR person should be getting the same press releases journalists are getting (indeed one could argue that a PR person is a sort of specialized journalist). Not to mention, part of Suzanne Vernon's job is to be aware of what research findings on ME/CFS are coming down the pipeline (which, lord knows, is not bloody much).

Now, I am not part of the "CFIDS Association is Evil" group. I think CAA does a remarkable job finding and funding remarkable research with remarkably little money. The Pacific Fatigue Lab's work, for instance, has completely transformed the field, and am I truly grateful that the CFIDS Association had the foresight to fund their work, among others.

However, this PACE study has been an absolute PR catastrophe for ME/CFS patients. CAA let the UK group control the message, tell the story, and -- albeit inadvertently* -- gave journalists the quotes they needed to round out that story. Cort and the commenters here - who have little or no professional PR background, have quickly and amply demonstrated what the even more compelling story is: CBT and GET provide little to no improvement in patients with ME/CFS.

It may be that on some level we are to blame for not giving CAA enough money to hire a competent PR professional(s) -- god knows, they don't come cheap. Or perhaps CAA has not had the inclination to do so thinking they can manage it themselves (uh, NO THEY CAN'T!). Whatever the reason, many of us are going to suffer because of this disaster and about the only thing I can think of that has the potential to turn this around anytime soon is a decisive, positive finding with regard to XMRV.

I was thinking about starting a thread in the advocacy section about either starting/funding some sort of -- I dunno -- "endowed" (?) PR position at CAA or pooling money/setting up a PR organization (or maybe MCWPA?) hiring some bad ass PR people (say I, Miss I-live-on-SSI-which-is-40%-below-the-poverty-level!) but typing this reply has worn me out (heart pounding, face flushing, arms are killing me - and I'm actually in bed!) so I'll just have leave it there and return to radio silence again. However, in case I haven't been clear enough , let me just say we must do something about the lack of professionalism with regard to telling the ME/CFS story! This fiasco has gone on long enough.

Right. I'm gone.

*It's clear that Kim fell victim to selective quoting in the CNN and NPR stories. However, a journalist's job is to decide what the story is and then tell it. There's no doubt from the PACE press release and press conference what story they told. While it's true that a journalist shouldn't simply take that story at face value, the plain fact of the matter is that most of the time that is exactly what they do unless there is some blatant reason to believe they are not being told the truth (say, a press release from the Iranian government saying how they want to let the Israelis inspect their nuclear facilities) or there's another -- often already well-established -- narrative that differs markedly from that story. Especially when it comes to health stories, media outlets simply haven't the staff anymore to properly research a story. They simply take the dominant narrative, plug in quotes that fit that narrative -- which Kim so tidily provided -- and write it up before going on to their next assignment(s) for the day.

 

Is this true??

It was written by someone posting in the comment section of an article about the Pace Trial.

"as it is part funded by DEPARTMENT OF WORK AND PENSIONS. They would definitely have a biased opinion prior to research that the results of the research will SAVE THEM MONEY. "


Is it normal for this department to partially fund a study?

 

There's just such an abundance of material that we have an embarrassment of riches! Which parts to attack most strongly?! Never had it so good...

Of course we should do all of it.

Stuff like the actometer-removal stands out for me: the moving of the goalposts: that blatantly points towards manipulation of data and hence possible fraud. Also, the actometer data from the Dutch study suggests that all the self-reported measures were illusory which undermines the whole thing and undermines all questionnaire-based results - and pulling out clear referenced facts on all that, including dates, timelines, comparison with timelines for the UK decision to pull them, is a crucial job that I haven't seen done here yet (Dolphin I guess you have that to hand?). Emphasis on that issue would achieve multiple goals.

Then there's the question of who was studied, and that's crucial as well, because it points to the question of who we are and how different patient groups have been mixed up together, which is a key historical point.

Then there's the question of the size of the effect: "moderate", "small", "tiny"...I would say: small enough to be explained by methodological flaws: the actometer point supports that also, suggesting that when people say they have improved, that doesn't mean they really have. The improvements are small enough that they could be entirely explained by self-delusion: that should be the message.

It's also crucial to emphasise that APT isn't pacing, because ultimately all the damage and danger comes from the idea that you should try to push through rather than learning to listen to your body. We can't afford to allow that message to go unchallenged, because that is causing overt harm, all over the world, right now: people are making themselves sicker because they are being told to exercise and push through, and you can do that for years even though you feel it's making you worse, because the trust in doctors and the desire to get well again is just so strong.

I don't think we should accept anything or give ground at all. I don't think we need to, and I don't think we ought to ethically. We shouldn't be prepared to sacrifice truth for the sake of being believed. We should just tell it like it is.

The biggest argument we are going to have is in deciding what level of acceptance of any value in CBT we are prepared to make. The form of words we use will be crucial, whether to accept it helps some (a la Klimas) or reject it entirely. That will be an argument between me and Cort as well I think ;-) although maybe not, because as I have just written here...
http://forums.aboutmecfs.org/showth...d-Nancy-Klimas&p=159023&viewfull=1#post159023
..., the key point is that CBT is helpful to people with depressive and anxiety-related issues: those are the people who GPs would normally refer for CBT anyway, and that's what it helps with, so maybe it's that simple. With the addition that not taking patients symptoms seriously and not giving them any hope that they will ever be dealt with can be a cause of anxiety and depression in itself...

Final point: Can we have a Phoenix Rising response to The Lancet? Created, agreed and voted on by members? We could put together some text on the wiki together, and reference our threads here in our submission (using tiny URLs perhaps so as not to eat into the word limit).

 

The biggest argument we are going to have is in deciding what level of acceptance of any value in CBT we are prepared to make. The form of words we use will be crucial, whether to accept it helps some (a la Klimas) or reject it entirely. That will be an argument between me and Cort as well I think ;-) although maybe not, because as I have just written here...
http://forums.aboutmecfs.org/showth...d-Nancy-Klimas&p=159023&viewfull=1#post159023

I realise that the angle I was coming from might be perceived as giving validation to the study, and we have to be careful not to do that...

Hope said something very helpful...

...
Tell her you do not fit the Oxford criteria (which is not used by the majority of ME/CFS researchers and stresses fatigue without the specific inclusion of other symptoms), you have more symptoms than just fatigue, and therefore, the PACE results do not apply to you.
...
http://forums.aboutmecfs.org/showth...d-Nancy-Klimas&p=159012&viewfull=1#post159012