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UK: House of Lords to debate PACE study, Weds 6 Feb 2013

Discussion in 'General ME/CFS News' started by Sasha, Jan 31, 2013.

  1. peggy-sue

    peggy-sue

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    :devil:
    A session just talking to somebody about being ill/the problems it brings etc. , rather than a session with a CBT therapist would be the best control for CBT.
    (it's not within-subject so not perfect control)
    Just make the sessions in the same settings and of the same duration. The only difference being the CBT or just chatting about the illness.
    (of course, that would put a complete kybosh on CBT, so would never be considered)

    A pill would never be considered a proper control for a behavioural intervention, such as therapy.

    To control for GET would be harder. It would be best compared to pacing, because both involve a degree of activity.

    I don't know what is involved with their version of pacing, but it's not ours, is it?
  2. alex3619

    alex3619 Senior Member

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    Hi peggy-sue, adaptive pacing therapy has you always operate above a percentage of perceived activity threshold, whereas pacing as used by patients is about always operating below such a threshold. Its the opposite, though the estimated thresholds do overlap.
  3. Sasha

    Sasha Fine, thank you

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  4. Sparrow

    Sparrow Senior Member

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    My husband brought up an excellent point, in that if rather than "CBT and GET" they were proposing a drug based on that kind of research, they would probably get ripped apart.
    Roseblossom, Min, Valentijn and 2 others like this.
  5. alex3619

    alex3619 Senior Member

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    Yes, by the regulators, government, editors of journals, reviewers, and finally by us. This is why the term psychobabble was coined - different standards apply.
    Dolphin likes this.
  6. WillowJ

    WillowJ Senior Member

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    There are some problems using SMC as control group.

    As user9876 noted, there were different expectations. Expectations is part of placebo.

    Also there were different numbers of sessions. Attention is part of placebo.

    I cannot see that there was any proper control in the trial at all. There is a reason the directors stopped calling it a controlled trial (they began by referring to it as a "randomized controlled trial" and ended by calling it a "randomized trial"; they never called it blinded or placebo-controlled as some of the wild claims to media by various persons who would normally be considered to actually know these things -and what they mean- have mentioned). My guess is this reason for this change may have to do with peer review, but this is speculation.

    They could have done better with some sort of group given the same types of assurances of cures (or by not giving assurances of cures to the CBT and GET groups, which could have been unethical anyway!) and the same number of sessions of whatever (active listening? or whatever that psych term is?).
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  7. biophile

    biophile Places I'd rather be.

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    White et al briefly discussed the issue of possible confounders in the Lancet paper but only considered participants' initial expectations before the engagement with therapy and completely ignored the possibility that conditioning occurred during the dozen or so sessions that followed. Among other things, the CBT group were also told that it was safe and powerful, etc, while the GET group were also told that they could safely gradually exercise their way back to health (despite no objective evidence ever being published to confirm that).

    It would be difficult to create an adequate placebo-control group which included the potential placebo-encouraging components to CBT and GET without becoming a quasi CBT and GET. Perhaps a start would be removing the underlying rationale and prognosis given to patients, although that may be unfair as it is integral to these therapies? It would also be impractical to adequately blind the CBT and GET groups. Merely masking the fact that what they are receiving is labelled CBT/GET would probably make little difference anyway? Therapist blinding may be more important, but again difficult if you want the therapies delivered by experienced therapists. Assessor blinding could have been better though?

    However, acknowledging the existence of these problems does not magically make them go away. Framing the PACE Trial as a rigorous study on par with well-conducted drug studies is simply misleading. These problems increase the importance of additional measures for recovery.
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  8. alex3619

    alex3619 Senior Member

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    Proposal of How Placebo Groups Could be Used in Studies That Include Psychiatric or Exercise Intervention

    I don't disagree that the PACE study does not meet appropriate standards for a controlled study, I only want to emphasize that for this kind of intervention it would be very hard to get a good control group.

    Personally I think head to head trials of all suspected treatments would be a better way to go. That means real pacing not the mock pacing they used. That means antivirals for those with viruses. It means measures to control orthostatic intolerance (for those testing positive). It means antibiotics for those who are Lyme positive. If its after the phase 3 clinical trials for Rituximab then include that too - though a case could be made to include this once the full data from the phase 2 studies is released. Now since some of these include drug therapies, half of all drug therapies could then be a sham, creating a real placebo group. In fact there would be sham antivirals, sham Rituximab, sham antibiotics - several placebo groups to use.

    Why not trial Ampligen as well?

    Indeed you could throw in functional medicine and other treatments in here. By combining these things you have some real head to head comparisons. Of course this would be expensive, require multidisciplinary teams, require years of planning and oversight, but it would generate lots of papers and a whole lot of useful data.

    Outcome measures would need to be diverse, from actimeters and Stevens protocol testing, to cytokines and yes, even SF-36 and the like.

    All data would have to be grouped for analysis by every feasible group, including Ramsay and CCC. Obtaining sufficient data initially to do this would be part of the entry workup, as would objective markers that might allow future subgrouping including NK cell function and so on.

    This data would be blinded using designations to replace patient names, and made available to every team wanting to write a paper on this. It would be public data, and set up that way from the start, though of course not released till the active phase of the study was over. Thus analysis methods, time and cost would be spread over every country and research group who took an interest.

    I can't see this ever happening. I am just saying it could be done if there were funding and a will to do so. I suspect it would require a multinational study as well, with every country paying for part of it.

    This is probably a pipedream, but it is feasible.
  9. Dolphin

    Dolphin Senior Member

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    - that's info (that it was going to be published later this year) I think few would know about it (Peter White referred to that research in a letter back in 2010 but who knew when it might come out). It and other things she said make me believe PDW directly or indirectly could have communicated his thoughts to her.
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  10. Dolphin

    Dolphin Senior Member

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    BTW, this happened at least once:

    http://www.ncbi.nlm.nih.gov/pubmed/8430715

  11. Dolphin

    Dolphin Senior Member

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    FWIW, there has been research looking at the active ingredients of therapies

    e.g.
    http://www.ncbi.nlm.nih.gov/pubmed/17697477

  12. Valentijn

    Valentijn Activity Level: 3

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    The study at http://www.simonwessely.com/Downloads/Publications/CFS/139.pdf (Beale, Husain, Chalder, Wessely) compared CBT and relaxation therapy, with a similar amount of sessions.

    Basically the CBT group had big improvements compared to the relaxation group immediately after the therapy and at 6 months follow-up, but lost most of those gains after 5 years (except in self-reported CGI scores). And the relaxation group showed steady improvement at 6 months and/or 5 years, even surpassing the CBT group on a psychiatric survey. That 5 year followup study was in 2001, and it's a pity they didn't do a 10 or 15 year followup - probably too worried that the CBT declines and relaxation improvements would continue :p

    I think the most interesting outcome was that 63% of CBT patients were improved from baseline after 6 months, but only 48% were improved from baseline after 5 years. Whereas relaxation patients went from 12% being improved after 6 months to 32% being improved after 5 years. Fatigue scores showed a similar patters - big drop from 6 months to 5 years for CBT patients, and modest gains for the relaxation group.

    The huge peak at 6 months for CBT patients in that study seems a bit odd though (brainwashing effects should set in faster). I think I'll take another look at the 6 month followup study :p

    EDIT: The "relaxation therapy" is specified as using "progressive muscle relaxation", which requires repeatedly tensing muscles. Horrible control :p But in theory, real relaxation and talk therapy might be a good control.
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  13. Firestormm

    Firestormm Guest

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    Was there not some study that looked at CBT used with MS and ME? What I am trying to suggest is that CBT is as relevant for other people as it is for ME especially people with a long term disability. But is tailored for the patient group concerned unless those patients have different conditions of course. I attended a trial 8 week Mindfulness and CBT group session and that was aimed at various participants. It helped some more than others but I think we all got something from it.

    Whether or not those 'somethings' are demonstrably useful wasn't the primary objective. CBT like relaxation and indeed mindfulness or meditation come to that; all these therapies depend to a great extent on the patient taking on board what is learned and continuously applying it or adapting it to their own lives outside of any instruction programme or clinical consultation.

    Do you think we should refrain from comparing/expecting PACE to be as reliable as a drug study? I mean at the end of the day, these are therapies. PACE was a model of course based on manuals which attempted to adapt CBT/GET to what was believed to work for those in the Trial and/or reflect what was thought to be 'pacing' and 'standard medical care'.

    Having said that they did use antidepressants didn't they. I always felt PACE was overly ambitious and would need to cut corners and redesign parameters. According to the debate - from what I remember - amending the definition of recovery for example once the trial was underway, and removing the more objective measures, is perfectly acceptable. Personally, I think it weakens the whole thing. But there we go.
  14. peggy-sue

    peggy-sue

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    Nurse Chalder's little study didn't add anything to current knowledge.
    A similar study (but not on CFS) comparing all the different kinds of talking therapy, concluded that the only important factor in successful therapy is the quality of the relationship between therapist and client.

    However, CBT is the one being touted officially, because it's such a skimpy thing - not delving into any causes, not doing any follow-up. Simply modifying a behaviour pattern then counting the modification as a success. It thus requires fewer sessions and effectively, looks cheap.
    But it's only ever any good for things like minor phobias.
    There was a huge amount of petitioning going on a few years ago from therapists and counsellors to block the official sanctioning of CBT as the only therapy to be offered to anybody. (because it's cheap and quick.... and shoddy and only storing up more serious problems for later :devil: ).
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  15. Stukindawski

    Stukindawski

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    If it's felt that studies like PACE are used to contribute to a posited aetiology and are touted as evidence of it, I think the comparisons then hold plenty of merit.

    Honestly I feel like PACE is a waste of psychiatry in many respects. If psychiatric care was first tailored to helping patients come to terms with their illness, deal with the new set of limitations placed on them and acknowledge the bereavement suffered due to the loss of a 'normal' life, it could do an awful lot more good.

    As far as exercise goes, I think at least Klimas and Peterson address the pathology of the illness in the way they prescribe it (objective, measurable limitations seems a lot more sensible too) and Klimas herself has stated if it hurts or if you're pushing yourself, you're supposed to stop.

    CBT can be useful in so far as the elements of it which constitute what I would describe as common sense. But any form which is quite coldly delivered and doesn't allow a patient the chance to process their emotions I would find a little cruel.
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  16. Valentijn

    Valentijn Activity Level: 3

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    There has been some forays into MS, RA, and other disease by the BPSers. Basically they give them the same horribly inappropriate questionnaires they give ME patients, and draw similar conclusions. I'm not sure how they manage to deal with the disappointment of not being able to suggest those patients be denied medical care.
  17. biophile

    biophile Places I'd rather be.

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    The study also used the original PACE criteria for recovery in fatigue and physical function but just called it "improvement" (<4 CFQ bimodal score and >=85 SF-36 physical function score). ;) Although they do try and argue that recovered patients may still have higher than normal levels of fatigue.

    CBT/GET studies will never be as reliable as well-conducted double-blind placebo-controlled drug studies. We should not expect them to be, but yes, they can still be compared to see what level of evidence they deserve to be graded at, they will always remain a lower grade of evidence (barring some radical hypothetical advancements over the coming centuries). The 2008 BMJ Clinical Evidence review (co-authored by Wessely) concedes that CBT/GET research up until that point was basically all "low quality evidence", but I have not seen the 2011 version yet. It would be hypocrisy to ridicule open-label drug studies for CFS but place the PACE Trial in such high praise in comparison. It is ridiculous for the Science Media Centre to present or allude PACE as the highest quality of clinical evidence on par with well-conducted drug studies.

    Do you mean the study which was effective in reducing the average self-reported fatigue levels in the MS group to below that of the healthy controls, something which no CBT study has ever done for ME/CFS? Perhaps the healthy controls needed some CBT too to balance it out!

    peggy-sue re CBT. You may be intertested in these two papers:

    http://www.tandfonline.com/doi/pdf/10.1080/13642530903230459

    http://www.sciencedirect.com/science/article/pii/S027273581300007X
  18. peggy-sue

    peggy-sue

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    I can't see the first link, Biophile, my pc won't let me, but the second one says pretty much the same as the one I was thinking about - but that came out several years ago - maybe 7 or 8?
    I got a bit involved with supporting the anti-CBT brigade.

    The really huge problem with CBT is the lack of follow-up.
    Success is reported. Subsequent fall-out is ignored.
    As I've said before, CBT did me a massive amount of harm although my case was published as a resounding success story.

    I am very, very anti-CBT.
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  19. biophile

    biophile Places I'd rather be.

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    This URL should work better : http://www.tandfonline.com/doi/full/10.1080/13642530903230459 .

    I think it is important for outside observers to know that many of the critics of CBT/GET did not suddenly become that way overnight for no reason beyond ideology. It appears to me that many patients had negative experiences with it and this prompted them to doubt the "evidence base", and after examining it closely, discovered it is flawed.
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  20. Firestormm

    Firestormm Guest

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    Yes one of the speakers in the debate, a former psychiatrist I seem to recall, said he himself had reservations about the promotion of CBT. Or at least he wasn't as keen on it and to the extent that some others were. But he also acknowledged that the results of PACE indicated, well here's what he said:

    If you read NICE blind as it were you could be forgiven for thinking that CBT was the only thing being offered for a disease that is compared to rheumatoid arthritis and MS in terms of potential levels of disability. Two diseases that were mentioned - as per NICE - in the debate.

    Yet for other diseases (admittedly that we know more about) CBT and GET are in addition to other forms of treatment. I have always said that NICE could do more to promote the use of drugs to help us manage our symptoms. I think that this is at least one addition to NICE that would have provided some balance and highlighted the lack of knowledge of the disease or diseases themselves.

    If they had done that then at least CBT and GET would gain some perspective i.e. as complements to xxxx and that they might be helpful for some people. If you see what I mean. I'm afraid I am struggling rather a bit today.

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