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

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Feb 19, 2011.

  1. Dolphin

    Dolphin Senior Member

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    Well said, Mark.
    In particular, GET and CBT based on GET fall right into those philosophies you mention: "you can get better if you try hard enough" and the corollary, "you're not getting better because you're not trying hard enough".
  2. Dolphin

    Dolphin Senior Member

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    There are follow-up studies planned. I think the authors have permission to follow them for up to 5 years e.g. look at people's medical records (?).
    However, I'm not sure I can remember many/any of the details - and they may not have said what the details were. So we may only get to hear what they want us to hear.

    The independent team idea is interesting.
  3. Mark

    Mark Acting CEO

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    One thing we do know Cort, is that it only 'helps' a fairly small proportion of patients - less than half of the subset of ME/CFS they selected here - to any extent at all, and it helps those people to a very small extent. Whether the benefits will prove to be sustained, I rather doubt. And that is out of a group that has been carefully selected to contain nobody with immune abnormalities, neurological problems, etc. Was it about 40% of them that you said were already on anti-depressants and were diagnosed with psychiatric conditions? Any analysis of whether those were precisely the patients who tended to see a benefit?

    We would next need to understand exactly who it helps, who it doesn't help, and who it is harmful to - and the only way to know that would be yet more expensive psych studies (noooo!!)...carried out by people who aren't fraudulent (ain't gonna happen).

    Out of that highly selected group of people who don't have ME symptoms, still about 1% experienced serious adverse effects. That's low, but it's hardly insignificant! There's a comment on the other main discussion thread of PACE that looks at the detail of those adverse effects - and we are talking here about serious adverse effects that will often lead to the patient's death. So while the numbers of those experiencing harmful effects in this particular study are low, that would be no consolation of you were part of that 1%, and since the cohort represents less than 25% of the profile of those diagnosed with ME/CFS, and goes out of its way to exclude those genuinely ill, what would be the risk level for the wider group? Exactly who is at risk, and who is not?...

    I won't have the numbers exactly right here, but they seem to stack up something like this: "providing you're in the 25% subset of patients diagnosed with ME/CFS who we looked at, then after a year of this therapy you have a 40% chance of a 9% improvement in fatigue levels (ignoring those who dropped out of the treatment of course), and at least a 1% risk of serious harm that could cause your death" - and that doesn't sound like a great deal to me, especially when we all know these are the best results they were able to deliver.

    It seems to me absolutely critical to query exactly who the patients are who are at risk of being killed by this treatment, and to emphasise most strongly that the PACE trial provides no evidence whatsoever that these 'therapies' are safe for the types of people who were excluded from the study. By the authors' own findings, the majority of people diagnosed with ME/CFS and referred to the trial by CFS 'specialist centres' were not considered suitable for inclusion in the trial, so it's dangerous territory indeed because in reality, here in the UK, at least, these treatments are now going to be pushed on to all of those people, regardless of whether they would have been excluded from the PACE trial.

    Based on the study's own findings, we can be reasonably confident that, in the real world, some people will die as a result of these treatments. We can also be confident that any benefits they do deliver will be very small indeed.


    And note that with both CBT and GET, the therapies are delivered by human beings, according to very different assumptions and beliefs on the part of the individual therapists, and within a different cultural context in the UK compared with the US: CBT and GET are not just CBT and GET and that's it, well-defined: when we talk about those therapies we are not talking about something as homogeneous as a real medical treatment. I do not believe that the therapies are so consistent and rigorous that one psychologist is just as good as the next. I do expect that they got their most effective people involved in this study: the people who deliver good results. We already know that if you get nurses to do it, it doesn't work at all - and to me it's obvious that this helpful result can now be used to claim that these therapies must be delivered by trained psychologists, and nobody else can do it: very handy for the profession. And so I further expect that the general standard of therapy and the results of real-world CBT and GET will be even worse than what the PACE study found.

    And so I would be interested to see league tables of the results achieved by the individual therapists - if we have to have them at all.

    Most people I've spoken to who don't have ME/CFS - including my family - seem to struggle to understand why patients would be so resistant to the idea that CBT or GET might help. They figure if there's something that might help, why reject it? Some figure that if you're so resistant to the idea, maybe that implies that actually you do need such therapy. My guess is that most people in the wider world will find your line on this much more reasonable, and it will be an easier sell, politically.

    It would be an easier way out, and a line that people would find more reasonable. I really would like to take that line if I could. I do actually believe there is an important place for talk therapies, meditation, mind/body, and really above that just the personal support of somebody who at least gives the appearance of caring, in all illnesses. I can accept that there's a place for CBT for some people - the problem is that we don't know which ones - but in any case I don't believe that CBT is remotely the best of all the options in terms of these non-medical techniques. Actually, I very much suspect they are all broadly speaking as good as each other, in practice, and that in every case the quality of the therapy depends most critically on the quality of the therapist themselves and their own personal beliefs.

    And I see my friend with MS already being offered CBT as part of a CBT expansion programme I had warned him about, and I see CBT being rolled out ever more widely, and as someone who has been interested in counselling for a long time, who has friends who are counsellors, and who has tried a lot of different counselling modalities, CBT is not my favourite model at all, nor the model favoured by the compassionate people I know and respect in this field.

    In general, I prefer the person-centred approach, personally: so how does that compare, as a treatment? Unknown of course: "there is no evidence and we are determined that there never will be, so STFU" - but there's 1.5m of our money sitting waiting for them to submit proposals, and god help us that's where I fear the money will go: on more and different psych-based studies to try and increase that pathetic percentage of theirs.

    They delivered the warning shot: somewhere this weekend I read them musing about getting those 25% of patients who are bedbound involved in the study. They will try to get that studied too, make no mistake. The fact that those patients are the most likely to die from the treatment is not the sort of thing that appears to concern these people, but I don't personally consider that to be an acceptable risk.
  4. Sean

    Sean Senior Member

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    Yes, this is important to nail down.

    Certainly doesn't. If he did say it in the formal paper, then did peer review actually work (to some degree) and require him to seriously qualify and limit his therapeutic claim?
  5. Dolphin

    Dolphin Senior Member

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    This should be <=65 (i.e. less than or equal to 65)
  6. Michelle

    Michelle Decennial ME/CFS patient

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    Acer2000 said:
    YES! This was my thought too (see comment #8). Their analysis of the study was helpful, but had NO EFFECT ON HOW THE STORY WAS TOLD! That is what their job is (or maybe it isn't; they do seem to have completely abdicated any public relations activity and that may be just as well given their effectiveness at it). Cort is certainly welcome to write a letter to the NY Times, but that's closing the door after the proverbial horse has left the barn. It's too late. Every doctor in the English-speaking world and beyond has been told that exercise will cure ME/CFS and as patients, we have very little ability to change their minds.

    CAA needed to have made sure to have sent their press release to all the media outlets the White et al group sent theirs to and laid out exactly what Cort and many of the commenters have said here about how flawed this study was. They need to give the journalists the headline. The quotes. The main narrative. Journalists, whether because they have no time or are just lazy (or both), are not going to read the study. They are not going to do much beyond read the press release, maybe call two quotes, and then write it up in their own words in the space of maybe an hour TOPS before moving on to their next assignment(s) for the day.

    PR is not an arena for "inside voices." It's the loudest and most manipulative voice that wins. Always.
  7. pugi

    pugi

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    There is a Spanish study on GET and CBT for MECFS patients based on the Fukuda criteria: "Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up."

    http://www.ncbi.nlm.nih.gov/pubmed/21234629

    Unfortunately, it has no press-release that journalists can copy/paste into their articles. Anyone can send this to David Tuller or Amy Dockser Markus?
    Can someone get hold of the complete article?
  8. Impish

    Impish Senior Member

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    Response

    I also think this part of Cort's comments is key:


    The fact that the treatments were not particularly effective for anyone suggested they were generic treatments that might have produced the same results for anyone with a chronic illness and thus may have said little about the differences between the definitions.


    From people's other comments I think we can dig up trials that show that CBT has a similar effect on people who have cancer, hiv, etc. That actually suggests that it doesn't touch the underlying cause at all just like in these diseases.
  9. Enid

    Enid Senior Member

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    Is there a little hope ? The Lancet Early online publication 18/2/2011 available on the ME Association org uk site - click news (top) item then full text Lancet at base. The study clearly states CFS only (OK so we all know it's the same thing - just degree). The Interpretation stands out - CBT and GET can safely be added to SMC (Specialist Medical Care) to MODERATELY improve outcomes for chronic fatigue syndrome ...... Added to seems to place both in a secondary "role" to medicine - one assumes it is in place before add ons. And doesn't gel with wild Press assumptions. In the UK there is no proper medical care - they do not understand nor know how to treat (and no will whatsoever) and GET/CBT are pressured on all as "medical". The psycho researchers appear as the tail trying to wag the dog of real medicine.
  10. Dolphin

    Dolphin Senior Member

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    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.
  11. Dolphin

    Dolphin Senior Member

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    These predictors are mentioned in the trial protocol http://www.biomedcentral.com/1471-2377/7/6 :
    Here's what the main paper says:
    What data that will see the light of day may only be data that suits the authors given their willingness to not use the prespecified primary outcome measures along with some secondary ones.
  12. Dolphin

    Dolphin Senior Member

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    There is this study which also has a subgroup analysis for CFS. Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313894/pdf/11271868.pdf

    Releated study:
    Free full text:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313893/pdf/11271867.pdf
  13. Dolphin

    Dolphin Senior Member

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    The FINE Trial was supposed to cover this group. Based on their prespecified endpoint and outcome measure, they didn't find any difference!

    Free full text: http://www.bmj.com/content/340/bmj.c1777.long
  14. alex3619

    alex3619 Senior Member

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    Hi Dolphin, I am not a huge fan of the CAA but you raised a very good point. Kim McCleary was probably ambushed by reporters who had more information than she did. We have to be careful about jumping to conclusions without the facts. It would really help if she posted a personal press release detailing the issues, and explaining what happened. Bye, Alex
  15. Bob

    Bob

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    Yes, I noticed that all the press articles were published on Friday, before the public had access to the paper. And then the media, and patient organisations shut down for the weekend, so the biased press articles could not be easily challenged all weekend.

    But apart from that, it's going to take everyone quite some time to analyse all the data in the study. It's an $8m study, which was prepared and carried out over a number of years with vast resources. The patient community can't analyse that data, interpret it, and work out what it all means over night. But I'm really hoping that all the patient organisations are going to come down hard on this study, and rebut it strongly.
  16. Bob

    Bob

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    Yes, it's important for our community to remember that the PACE Trial is just part of the UK's government-funded study into CBT and GET. The FINE Trial (Fatigue Intervention by Nurses Evaluation) investigated severely ill, house-bound and bed-bound, patients and was published a few months ago. The result of the study was a complete failure to improve the functioning of severely ill patients. Of course the failed FINE Trial was published without any accompanying fanfare or media coverage. The study used GET, which they conveniently renamed as "pragmatic rehabilitation" (conveniently renamed because it didn't work), and a form of counselling. 'Pragmatic rehabilitation' is described as "a programme of gradually increasing activity designed collaboratively by the patient and the therapist", so in other words it's GET.

    But it is a very important study for us to be aware of, because it's a UK government-funded study that proves that psychological therapies do not work for severely ill patients.

  17. Bob

    Bob

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    That would be a very interesting thing to do... I wonder if there's any data available for CBT success rates with other diseases... It's worth looking into.
  18. urbantravels

    urbantravels disjecta membra

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    Wouldn't such comparisons be meaningless unless you were looking at CBT designed to convince the patient that they are not ill and they need to overcome their fear of taking actions which will worsen their symptoms?

    Let's see, how about a study of CBT for Lupus patients designed to convince the patient they really don't have fatigue and aches and pains, and need to overcome their fear of sitting out in the sunshine?
  19. Dolphin

    Dolphin Senior Member

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    Yes, I'm inclined to agree. CBT to encourage diabetics to stick to a regime that is good for their diabetes (say) is a bit different from CBT for CFS which may be about encouraging "bad" habits/be based on incorrect information about CFS.

    The manuals used in this trial can be downloaded:
    CBT treatment manual
    http://www.pacetrial.org/docs/cbt-therapist-manual.pdf

    CBT participant manual
    http://www.pacetrial.org/docs/cbt-participant-manual.pdf
  20. Cort

    Cort Phoenix Rising Founder

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    I was thinking about the cohort and added this:

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