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The PACE Trial – The Results

Discussion in 'General ME/CFS News' started by Bob, Aug 17, 2012.

  1. Bob

    Bob

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  2. Bob

    Bob

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    The Cost Effectiveness Paper

    The PACE Trial’s cost effectiveness analysis has recently been published (1), and it showed that CBT and GET resulted in no significant difference to the number of patients receiving welfare benefits (income-related and illness/disability-related) or private financial payments (income protection insurance and private pensions.)

    The number and proportion of participants claiming welfare benefits increased for every therapy group, and for every benefit category, across the board.

    There was also no significant change in the number of days of lost employment after treatment with CBT and GET, compared to the control group.

    So, some revealing information to take from the cost effectiveness paper is that CBT and GET resulted in no significant difference to:
    • The number of patients receiving welfare benefits (income-related and illness/disability-related) and private financial payments (income protection insurance and private pensions.)
    • The number of days of lost employment.
    References:

    (1) Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis
    Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith, Peter D. White.
    August 1, 2012
    PLoS ONE 7(8): e40808. doi:10.1371/journal.pone.0040808
    http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808
     
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  3. Bob

    Bob

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    Comment

    A flawed hypothetical cognitive behavioural model of illness

    The PACE Trial, published in the Lancet in February 2011, was a multi-million pound UK government-funded research study, researching the effects of four potential treatments for CFS/ME, involving 641 patients. The treatments investigated were Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET), Adaptive Pacing Therapy (APT), and Specialist Medical Care (SMC).

    CFS/ME is categorised by the WHO, and the UK government, as a neurological disorder. However, the versions of CBT and GET, which were investigated in the PACE Trial, were based on a controversial cognitive behavioural model of CFS/ME which hypothesises that the illness is a ‘reversible’ psychosomatic condition, ‘perpetuated’ by a (maladaptive) 'fear of exercise' and a (maladaptive) ‘avoidance of exercise’ leading to ‘deconditioning' (1)(2).

    The results of the PACE Trial demonstrated that CBT and GET cannot be used to successfully treat or cure CFS/ME. Only approximately 13% of participants responded (achieved a minimum clinically useful outcome) to treatment with CBT or GET. This demonstrated that the hypothesis that CFS/ME is a psychological or psychosomatic condition, perpetuated by a fear of exercise etc., is unfounded.

    It is not surprising that CBT and GET, as treatments for CFS/ME, remain controversial with patients while they are promoted as ‘successful’ treatments that ‘reverse’ the illness, or reverse disease progression. Such a model of disease is not supported by the evidence of the PACE Trial, in which 87% of participants were not shown to respond to treatment, and it is not supported by the anecdotal experiences of many patients, a substantial proportion of whom anecdotally report being harmed by CBT and GET in clinical settings (3).

    Interestingly, based on information in the protocol, the authors of the PACE Trial, many of whom have a background in psychiatry and in promoting CBT and GET as treatments for CFS/ME, seem to have expected the results to show a 60% benefit for CBT and GET, and only a 10% benefit for specialised medical care (the SMC control group), but in fact, it was the opposite: Roughly 60% improved in the control group, and only approximately 13% improved as a result of CBT or GET.

    Maybe the psychiatrists (the authors) had always mistakenly believed that their therapies were highly successful treatments, when in fact, the improvements seen in their patients were a result of natural improvements over time, as demonstrated by SMC control group in the PACE trial (58% and 65% improvement rates for SMC). The psychiatrists assert that CFS/ME patients have 'maladaptive' cognition and behaviour which ‘perpetuates’ the illness, but the PACE Trial gave us evidence that the psychiatrists, are in fact, mistaken about the treatments they offer and about the nature of CFS/ME.

    It should be noted that the PACE Trial’s deterioration rates for CBT and GET, as determined by an equivalent measure as the improvement rates, have not yet been released. Once the deterioration rates are released, the results for CBT and GET might confirm CFS/ME patients’ anecdotal reports of harm from CBT and GET (3).

    Harm from exposure to CBT and GET (3)(6) may be a result of ‘post exertional malaise’ or ‘postexertional neuroimmune exhaustion’, widely recognised to be a primary symptom of CFS/ME (4)(5). CFS/ME is reactive to activity or exertion (4), which is why patients often use ‘pacing’, to self-manage symptoms.

    It should be noted that Adaptive Pacing Therapy (APT) was invented specifically for the PACE Trial and thus it was a failed attempt to devise a new therapy. APT is not the same as ‘pacing’, as recognised, and used, by many CFS/ME patients. If a form of pacing, recognisable to patients, was properly tested in a medical trial, then it might also confirm patients’ anecdotal experiences, whereby a majority of CFS/ME patients anecdotally report finding ‘pacing’ beneficial for managing their symptoms (3).




    References:

    (1) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.
    Prof PD White et al.
    The Lancet, Volume 377, Issue 9768, Pages 823 - 836, 5 March 2011
    doi:10.1016/S0140-6736(11)60096-2
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

    (2) CBT and GET treatment manuals
    PACE Trial website
    http://www.pacetrial.org/trialinfo/

    (3) ME Association patient survey 2010
    http://www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res10.pdf
    Action for ME patient survey 2010:
    http://www.actionforme.org.uk/get-i...t-and-exercise-on-prescription-survey-results
    Action for ME patient survey 2008:
    http://www.actionforme.org.uk/get-informed/about-me/treatment/which-treatments-have-other-people-found-helpful

    (4) Myalgic encephalomyelitis: International Consensus Criteria
    Carruthers et al
    doi: 10.1111/j.1365-2796.2011.02428.x
    http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/pdf

    (5) The Chronic Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study
    Keiji Fukuda et al
    Ann Intern Med. 1994;121:953-95 1994
    http://www.ncf-net.org/patents/pdf/Fukuda_Definition.pdf

    (6) Reporting of Harms Associated with Graded Exercise Therapy and Cognitive
    Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
    Tom Kindlon
    Bulletin of the IACFS/ME. 2011;19(2): 59-111
    http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk=&tabid=501
     
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  4. Bob

    Bob

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    Acknowledgements
    Much of this information, and the analysis of the PACE Trial, was a community effort, and many people have been involved, over a long period of time. There are too many people to acknowledge, but if anyone wants to see who was involved from this forum, then you only have to have a look through the main PACE Trial discussion thread:
    http://forums.phoenixrising.me/index.php?threads/pace-trial-and-pace-trial-protocol.3928/

    Having said that, this text is my own, so I’m solely responsible for any errors in it.



    For a deeper analysis of the PACE Trial paper, please see Phoenix Rising's analysis, here:
    ME Analysis - Evaluating the results of the PACE study
    http://evaluatingpace.phoenixrising.me/homepageanim.html



    This video is taken from Phoenix Rising's analysis, with an extra introduction courtesy of Graham:
     
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  5. Bob

    Bob

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    All questions, comments, feedback and corrections are very welcome, and will be gratefully received.

    Please feel free to distribute, but please include a link to this forum thread, so that people can read the most up-to-date version:
    http://forums.phoenixrising.me/index.php?threads/the-pace-trial-–-the-results.18950/

    Or use this link (not a phoenix rising link), where the most up-to-date PDF version can be viewed online, and easily downloaded:
    https://docs.google.com/open?id=0Bw9CNtVoYI7obnZERmFDY0NCbFk

    I have also attached a PDF file, to this post, which contains the text from all of the above posts.
    If I make any changes to the text, for any reason, I will update the PDF file.

    The current PDF attachment is Version 5.1, dated 5th September 2012.
     
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  6. Esther12

    Esther12 Senior Member

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    Sorry Bob - not had a chance to look at this yet, so have nothing to add, I'm just replying as a way of marking the thread for when I have more time.
     
  7. alex3619

    alex3619 Senior Member

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    Hi Bob, I agree the PACE trial excluded the severe patients (mostly bedbound), but the definition of moderate used now is "mostly housebound". I suspect it had limited numbers of moderate patients, and was heavy on mild or misdiagnosed patients.

    Very severe patients (fully dependent on others) are in a whole other category. Even light movement in bed would be problematic for them, so graded exercise would not be an even remote option.

    I will have to read this more carefully a few times. It looks like a nice summary, of potential use to advocates who are wanting something short and to the point.

    Bye, Alex
     
  8. Firestormm

    Firestormm Guest

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    GET this STICKIED :thumbsup:
     
  9. currer

    currer Senior Member

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    Fantastic work, Bob, and everyone else involved.

    Please try to get this published in a scientific journal. It looks like high quality work and deserves publication.

    PLEASE PLEASE PLEASE SEND IT FOR PUBLICATION.
     
  10. currer

    currer Senior Member

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    Can it be sent to the ME Association and Action for ME in Britain?
    And equivalent organisations on the US?
     
  11. currer

    currer Senior Member

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    Should we lobby for the release of the deterioration rates?

    Does anyone think our advocacy organisations will have the courage to do this?
     
  12. alex3619

    alex3619 Senior Member

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    Currer, I don't think its about courage. I think we do not have the power to do it. However that doesn't mean we shouldn't try. We would then have it on record that they chose not to release the data, again and again, in response to repeated requests. That has some political value too. Bye, Alex
     
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  13. Bob

    Bob

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    Thanks for the feedback everyone! :)

    Sorry it's not written more succinctly. I had only intended to write a few sentences, outlining the main results, but then I felt I needed to include some explanations, and some background info etc. etc., so it got longer and longer.

    It's not as polished as I would have liked, because my brain struggles with writing and editing.
    But I'm pretty certain that it's accurate.
     
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  14. Bob

    Bob

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    Hi Alex,

    Yes, the PACE Trial excluded 'completely' housebound and bedbound patients, and I suppose that a proportion of 'mostly' housebound patients would have felt that they could not participate.

    So it could have excluded a proportion of 'moderately effected' patients, who were mostly housebound.
    But some patients would have attended the clinic with assistance.
    And, some 'mildly affected' patients might have been excluded because the recruitment criteria was a score of 65, or less, on the SF-36 physical function scale. I'm not sure what range of scores would cover 'mildly affected' patients, but maybe it would go above 65 for SF-36 physical function, in which case, some mildly affected patient might have been excluded.

    Also, patients who knew that CBT and GET would have been no benefit to them, might also have declined to participate.

    What we know for certain, is that the results cannot be extrapoloted to housebound or bedbound patients.

    So my main point was that the results cannot be extrapolated to severely affected patients because they were excluded. On the PACE Trial website, the authors acknowledge that the results cannot be extrapolated to severely affected patients. I have included a reference for this.

    The little-publicised (UK-government funded) 'FINE Trial', published in 2010, studied a CBT-based therapy with GET components, and included severly affected patients. The FINE Trial found that a CBT-based therapy, with GET components, was of no benefit to severely affected CFS/ME patients. I should have included this in my main text:

    The Fine Trial.
    Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.
    Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group.
    BMJ. 2010 Apr 23;340:c1777.
    doi: 10.1136/bmj.c1777.
    http://www.bmj.com/content/340/bmj.c1777
    http://www.ncbi.nlm.nih.gov/pubmed/20418251


    Thanks Alex. I hope it's helpful for some.
     
  15. Bob

    Bob

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    Thanks currer. :)

    There is currently a FOI request for the deterioration rates being considered by the Information Commissioner's office.

    I wouldn't know how to go about getting anything published. And it would need a considerable amount of polishing before submitting it anywhere for publication. I might spend some time polishing this up, and creating a revised version, so it can be used more widely. But it will have to wait until September. This was just intended for the forum, to inform patients and patient advocates of the primary results.

    If anyone wants to make any patient organisations aware of the results, then please feel free to use any of this.
     
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  16. Sean

    Sean Senior Member

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    Excellent stuff, Bob. Lot of work in it.

    Very useful summary.

    Much thanks. :thumbsup:
     
    Bob likes this.
  17. SilverbladeTE

    SilverbladeTE Senior Member

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    Very well done, thank you! :)


    the UK government will not listen unless they get caught with their pants down and their hands/members/tentacles/other organs in the cookie jar :p
    or a catastrophy occurs, sorry folks.
    Sometimes, rarely it can happen otherwise (break free into public consciosuness) after lot of build up hits a "flash point" etc and finally, the penny drops.
    What, you think they'll let us expose this crap and then have populace angry and asking questiosn, investigating where money went, who got party campaign funding from UNUM etc?
    get real. They've doen a very good job keeping the lid on innocent plumbers getting their heads blown off on tube trains by imbecilically led police officers, decades of Murdoch buying lapdogs, waging illegal wars etc, we are small potatoes by comparison.
    Doesn't mean ya shouldn't kep trying, but expecting those scumbags to be honest, helpful...haha!!
    it is not in their perceived interests, quite the damn reverse!
     
  18. Bob

    Bob

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    Something that I forgot to include in my first post, was that at the same time as the PACE Trial was being carried out, another medical trial was being carried out in the UK, on 296 primary care patients, including housebound CFS/ME patients. (Housebound patients were excluded from the PACE Trial).

    Originally known as the 'FINE Trial', (FINE = Fatigue Intervention by Nurses Evaluation), it tested a CBT-based therapy, with GET components, known as 'pragmatic rehabilitation'. I haven't studied the FINE Trial as closely as the PACE Trial, but the therapy seems to be at least partly based on reversing deconditioning.

    Like the PACE Trial, the FINE Trial was also funded by the UK government's main research funding body, the MRC (Medical Research Council).

    The results were that CFS/ME patients did not respond to CBT-based therapy or GET (when assessed at one year follow-up.)

    Unlike the PACE Trial, there was very little fanfare or media attention when the paper was published. In fact, there was hardly a squeak about it. It's almost as if it never existed.

    The Fine Trial.
    Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.
    Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group.
    BMJ. 2010 Apr 23;340:c1777.
    doi: 10.1136/bmj.c1777.
    http://www.bmj.com/content/340/bmj.c1777
    http://www.ncbi.nlm.nih.gov/pubmed/20418251
     
  19. Mula

    Mula Senior Member

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    It does appear that it will be impossible for them to withhold these statistics indefinitely as it is a requirement for them to publish the information that was registered in the protocol. Political this may be the best way to exert pressure on the MRC.
     
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  20. Bob

    Bob

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    Thanks Silverblade.

    Yes, I'm sure that the UK authorities don't want to know about the facts, but the PACE Trial is strong evidence against the psychosomatic model of illness.
    We should at least make sure that all of this info is widely known.
     

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