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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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PACE Trial - Control & Comparison Groups. Research and Discussion

Discussion in 'Latest ME/CFS Research' started by oceanblue, Apr 5, 2012.

  1. Wildcat

    Wildcat Senior Member

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    .

    Critique of the Supremacy of CBT per se, and of CBT as the Official UK Government Sanctioned Therapy Du Jour . and evidence of the resulting Therapy Turf Wars:



    There are thousands of studies on CBT. The various medical and therapy
    Journals have been flooded with them over the years ...




    This lot are refuting the supremacy of CBT per se......

    Last Year researchers from Strathclyde, Miami universities and the Saybrooke
    Graduate Institute caused a stir re challenging the effectiveness of CBT - beware
    though - they are fighting to maintain the existence and market for all the
    other psychotherapies....

    'The group believes CBT has become pre-eminent not because it is the system
    which works best but because it is the most favoured by academics and has
    therefore become the subject of most studies'......

    the evidence was presented at the:

    Conference of the World Association for Person-Centred Psychotherapies and
    Counselling held at the University of East Anglia, UK, from 6-10 July 2008.



    .



    http://www.pctscotland.co.uk/documents/~Research/CBT_is_a_myth.htm

    CBT superiority is a myth

    The government, the public and even many health officials have been sold a
    version of the scientific evidence that is not based in fact, but is instead
    based on a logical error.

    This is how it works:

    1) More academic researchers subscribe to a CBT approach than any other.

    2) These researchers get more research grants and publish more studies on the
    effectiveness of CBT.

    3) This greater number of studies is used to imply that CBT is more effective.



    This is a classic example of the logical fallacy known as `argument from
    ignorance' ie the absence of evidence is taken as evidence of absence.


    Although CBT advocates rarely make this claim so boldly, their continual
    emphasis on the amount of evidence is misunderstood by the public, other health
    care workers, and government officials, a misunderstanding that they allow to
    stand without correction. The result is a widespread belief that no one takes
    responsibility for. In other words, a myth.

    This situation has direct negative consequences for other well-developed
    psychotherapies, such as person-centred and psychodynamic, which have smaller
    evidence bases than CBT.

    .



    http://www.uea.ac.uk/mac/comm/media/press/2008/july/CBT superiority questioned a\
    t+conference

    In the world of psychotherapy research, the finding that different therapies are
    about equal in their effectiveness is known as the 'Dodo verdict', after the
    Dodo in Alice in Wonderland who, on judging a race, declared 'everybody has won
    and all must have prizes'.






    .


    http://www.strath.ac.uk/press/newsreleases/2008/headline_144260_en.html

    Researchers urge fresh look at psychotherapy

    Widely-held assumptions about the superior effectiveness of a common form of
    psychotherapy have been challenged by academics at Strathclyde.

    They are urging government officials and colleagues who practise the method,
    Cognitive Behavioural Therapy (CBT), to offer a wider range of other types of
    treatment which have been shown to be as effective.

    The researchers are part of a team which has questioned the predominance of CBT
    in treating patients and has claimed that an undue emphasis has been placed on
    this method.

    The group believes CBT has become pre-eminent not because it is the system which
    works best but because it is the most favoured by academics and has therefore
    become the subject of most studies......






    .




    http://www.guardian.co.uk/culture/2009/oct/04/sel-help-books-boom-cadwalladr


    Positive psychology, the so-called new "science of happiness", has, in just 10 years, become a cultural orthodoxy and a burgeoning field of academic study. It's the single most popular course for undergraduates at Harvard, and in Britain it has been instrumental in persuading the government to back large-scale funding of CBT (cognitive behavioural therapy). The application of science has given self- help a rigour and respect that for years it could only dream about.






    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~




    A note re Happiness Therapy:


    The Times:
    http://www.timesonline.co.uk/tol/comment/columnists/guest_contributors/article67\
    9402.ece

    'Those running Guantanamo have apparently shown interest in studies by Martin
    Seligman, a past president of the APA, on "learned helplessness". This theory,
    dating back to the Sixties, suggests that individuals who suffer persistent
    ill-treatment eventually submit wholly to their tormentor. Professor Seligman
    has since achieved worldwide fame as a researcher in the field of happiness. The
    irony is almost too grim to bear'.

    .
  2. Wildcat

    Wildcat Senior Member

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    Pace Trial SMC involved being given a leaflet.
  3. Snow Leopard

    Snow Leopard Senior Member

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    Re CBT/Happiness for all... So instead of curing societies ills, we should instead just try to brainwash people into being happy. Interesting precedent being set there...
    Sean, Wildcat, Enid and 1 other person like this.
  4. Esther12

    Esther12 Senior Member

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    This actually reflects a lot of early criticisms of 'pragmatism' as a philosophy (I posted some stuff from Bertrand Russell a while back), which has served as the underpinning for much psychiatry, and particularly a biopsychosocial approach. These problems were widely predicted.

    I expect that all of these things can be helpful for a type of mental health, and for improving subjective questionnaire scores. I don't want hope or to feel that I am receiving treatment which my physicians and I believe will alter the course of my illness and improve quality of life. I want to be provided with information as accurately and clearly as possible, without any concern about how this will affect my feelings, positivity or hope. I'm not interested in playing at having a treatment because doing so increases one's sense of control, or help one feel a sense of support from society at large - such pragmatism serves to legitimise quackery which can lead on to far greater problems elsewhere.

    (That could sounds a bit harsh - if so, it's not aimed at you Don!)
    Sean likes this.
  5. alex3619

    alex3619 Senior Member

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    Its a brave new world indeed. Where does it end? Mass drugging the population to keep them happy? Genetic engineering to enforce happiness? Unhappiness a punishable crime - but with psychiatric institutes instead of prison? Here is a novel idea: why not make things better so that people will be naturally happy?

    Bye, Alex
    Enid likes this.
  6. Don Quichotte

    Don Quichotte Don Quichotte

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    This may be true for you, but most people do want hope and do want to feel that they have a true partner who cares about them as people and not just as hosts of diseases. They want to know that their physicians are giving them what they think is the best treatment after they have carefully weighed all possible risks and potential benefits for them specifically.
    I agree that there are people (among them physicians) who exploit this vulnerability.
    But, such physicians do not give true hope and are not true partners for their patients, even if they manage to deceive them initially.

    I agree that when physicians abuse the trust of their patients and the unique human relationship they cause double damage-not only do they cause significant harm to their patients, but they also lead to questioning of the physician-patient relationship in general .

    I agree that every patient should be given the most accurate information. I do not think this should be done in an insensitive way, without caring how this will effect that patient's feeling or hope.

    I do not think anyone is interested in that.

    Yet, saying that a more humanistic approach to medicine legitimizes quackery is like saying that putting your money in the bank and not under your mattress legitimizes bank-robberies.

    This is taken from a book about medicine at the time of Hippocrates, but I think much of it is as true today.

    " some physicians sought to profit from theatrical effects so that, by astounding the public, they might mask their incompetence"such men are in fact like the supernumeraries in tragedies. Just as they have the appearance, dress and mask of an actor without being actors, so too with physicians; many are physicians by repute, very few are such in reality."..

    "Those who devote themselves to a foolish parade of manual skill are especially delighted to find a fractured nose to bandage but such bandaging acts in every way contrary to what is proper." "Reject graceful and showy bandages as doing no good, for this sort of thing is vulgar and purely a matter of display, and will often bring harm to the person being treated: the ill person is not looking for what is decorative, but for what is beneficial."

    :" rush about on flying visits on wait to be consulted in their surgeries. This kind of doctor never gives any account of the particular illness , or is prepared to listen to one; he simply prescribes what he thinks best in the light of experience, as if he had precise knowledge, and with the self confidence of a dictator the visits of the free doctor his method is to construct an empirical case-history by consulting the invalid and his friends; in this way he himself learns something from the sick and at the same time he gives the individual patient all the instructions he can. He gives no prescription until he has gained the invalid's consent."

    "The originality of the Hippocratic manner of speaking consisted in initiating a dialogue with the patient for the purpose of collecting information about the diagnosis or prognosis of the illness, or the course of treatment to know how to question a patient was indispensable, but it was also necessary to know how to listenthe patient's response served as a guide for the physician in the course of treatment-but only on the condition that the physician knew how to interpret it. Where he did, an attentive dialogue came to be established that marked the beginning of authentic partnership between physician and patient in fighting illness."

    I have personally encountered "leading experts" who thought that patting me on the head and telling me all will be well, was enough and there was no need for them to recognize life-threatening symptoms.
    I have also met "rising stars" who knew for sure that what I was experiencing is "impossible" and therefore there is no doubt that I am faking my illness.
    I have met those who proved to me how right Nietzsche was when he said that the most dangerous physicians are those that like born actors play born physicians. Those who have impressive bed-side manners and appear highly knowledgeable caring and compassionate, but this is all a nice custom that quite efficiently hides their total lack of reasonable clinical skills and incompetence.

    But, fortunately, I have also met others who did their best to save my life and do what they can to help me lead the best possible life.
  7. Don Quichotte

    Don Quichotte Don Quichotte

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    Placebo is not doing nothing. Placebo is the non-pharmacological treatment that a patient receives.
    The placebo arm is added in order to control for the effect of receiving treatment that the patient and the physician think will help.
    Placebo=to please.
    So, you can't compare supportive listening by a GP to placebo, because this is one of the components of placebo.
  8. Esther12

    Esther12 Senior Member

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    Hi Don.

    I think that I was not really clear enough in my last post, as I was semi-replying to you, semi-responding to how your arguments have been used to legitimise this sort of quackery with CFS. I did not mean to imply that you were arguing for these sorts of things, but others are interested in that, and this has caused problems in CFS. "it's not aimed at you Don!" was my inadequate attempt to make that clear.

    Having seen the problems which these sorts of arguments have led to, I am now much more wary of them, even in the modest way that you present them.

    It might seem like a good idea to have doctors try to behave in a humanistic and caring manner, and allow this to guide how they communicate with their patients, but this can very easily lead to paternalism and dishonesty. Doctors already have a lot of leeway in how they treat their patients, and I worry that allowing any considerations other than honesty and clarity to affect the manner in which they communicate with patients will lead to some decline in honesty and clarity, particularly when there seems to be so little effective regulation and over-sight for the claims made by doctors to patients.

    That doesn't mean that we need doctors to act like arses, and we should all to talk to one another in an understanding and respectful manner, but I'm opposed to trying to medicalise such things, and I think that such an approach leads to other problems.

    ps: Sorry for going OT people. I forgot which thread I was in!
    Wildcat likes this.
  9. Wildcat

    Wildcat Senior Member

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    Hi Don,

    in Britian we are dealing with a situation in which research funds for biomedical research on our disease has been denied in favour of granting money for CBT studies, for over two decades. However 'humanistic' doctors are, such diversion of medical research funds does not help the patients.

    The Main Researchers (Prinicipal Investigators) of the PACE Trial have blatant vested interests as Chief Medical Officers for insurance Companies that have a stated policy of denying payout to ME sufferers.

    No amount of 'humanism' would have reassured Smallpox sufferers, if all the Smallpox research funds had gone into CBT and 'helping the patient live with the disease'.

    .
  10. Wildcat

    Wildcat Senior Member

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    While Hippocrates was undoubtedly an advanced thinker, Smallpox, TB, Diptheria and Bubonic Plague (just a few examples) were not preventable/treatable before the necessary advances in biomedical science were made.
  11. Wildcat

    Wildcat Senior Member

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    Having been exposed to the 'philosophy of hope' I must say that I found it lacking.
  12. Snow Leopard

    Snow Leopard Senior Member

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    I was suggesting combining supportive listening with the placebo as a singular control group (and obviously it should be added to the pharmacological arm too).

    I should also make a key point - the improvements measured (via subjective questionnaires) in a placebo group can be due to a variety of biases apart from the hypothesised placebo effect. Basic human optimism can lead to reporting improvements on a questionnaire without an actual improvement in pain or activity or mental health.

    In fact the Cochrane review of Placebo as a treatment found that it was mostly ineffective and subject to wide variance (suggesting other systematic factors).
    Wildcat likes this.
  13. oceanblue

    oceanblue Senior Member

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    "Comparative" vs "Controlled" Studies

    particular thanks to Don Q and Snow Leopard for their comments on appropriate placebos/controls. I hope to post specific replies later but meanwhile this might be of interest.

    This paper sheds some light on the difference between a 'controlled' experiment, which PACE originally claimed to be, and the 'comparison' one in the final Lancet paper - though it turns out that PACE is actually bit of both.

    Scientific and Practical Advantages of Comparative Design in Psychotherapy Outcome Research
    Basham 1986 J Consulting & Clinical Psychology

    Essentially a comparitive study simply looks at the difference between 2 active treatments, which overcomes the problems of trying to use a 'placebo' type therapy in what is inevitably an unblinded treatment.


    Abstract highlights

    Although the use of control groups has a strong precedent in psychotherapy outcome research, control group designs have been increasingly criticized on both ethical and practical grounds. Comparative Designs, which compare two or more treatments without including a formal control group, have been offered as an alternative that avoids some of the problems inherent in use of control groups.

    Examination of the scientific basis of both control group designs and comparative designs in outcome research reveals that Comparitive Designs generally have fewer threats to validity and provide a more efficient means of control for nonspecific treatment factors...these scientific advantages indicate that Comparitive Design studies warrant a larger role in the study of psychotherapy, particularly in evaluative research.

    -----------------------

    note: any references to PACE or response bias are my own since the 1986 paper mentions neither of these.

    No Treatment controls (cf PACE)
    The study starts by looking at 'No Treatment' controls where the control group receives no active treatment or placebo. In some ways this is analgous with PACE in that the 'reference' SMC-group receives no active treatment beyond SMC which is also given to all the 'active' therapy groups too.

    The 'no treatment' group does have some benefits, in that it's a matched group of patients and will pick up any natural recovery - making it superior to simply comparing post-treatment to baseline results for a given therapy.

    However, the 'no treatment' group is likely to have different expectations to the active treatment group which could affect outcomes [either by a real 'expectation'/placebo effect or by response bias in the active treatment group]:

    Placebo/non-specific controls
    The problems of expectations can be handled in drug trials by using placebo pills with blinding of particpants but shuch an approach is hard to replicate with psychological therapies. Instead, studies sometimes use what is referred to (though not in this paper) as attentional placebos e.g non-directred counselling or relaxation therapy. These primarily aim to account for non-specific aspects of any therapy eg attention (no. of sessions), human interaction (eg empathy) and, to some extent, patient expectations as discussed in the first paper (see post #3).

    Note that PACE didn't set out to use this approach (which may be why they dropped the term 'controlled' from their trial) though there are some issues that could be relevant in the use of APT - more on this later.

    Essentially, Basham argues that such placebo/non-specific controls cannot be implemented effectively and so are rather meaningless. The main criticism is that the 'placebo' group is unlikely to be presented in an equivalent way (or with equivalent enthusiasm) leading to expectation bias against the placebo - and the Mohr paper points out that the researchers are unlikely to have access to therapists with expertise and experience in placebo treatments. Consequently Basham argues instead for use of comparative rather than controlled designs.

    Comparative Designs

    The rationale for this approach is that factors like attention and expectation will be similar in both treatments giving a 'perfect' control of these factors, "and thus are more likely to give accurate findings". The main downside is that both treatments might be effective so much larger sample sizes are needed to distinguish any real effects of a vs b.

    Similarly, any specific factors common to all treatments will also be accounted for, e.g. in PACE the approach of first establishing a 'baseline' level of activity that patients can reliably manage was used in APT (pacing), CBT and GET. Only the differences between the therapies will, in theory, account for any difference in outcomes.

    There are, however, caveats relating to comparative studies:
    more to follow on the relevance of this to PACE when I have the energy (I bet you can't wait).
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  14. oceanblue

    oceanblue Senior Member

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    PACE Control & Comparison groups - and APT

    "No treatment" Control group

    The SMC-only group is broadly a 'no treatment' group since all the other groups received SMC plus a therapy. 'No treatment' is the lowest form of control since it does nothing to compensate for expectation bias (which can lead to response bias) or placebo effect.

    However, it's not quite simple as that. There were a minimum of 3 SMC sessions but, unlike with the therapies, more SMC sessions could be offered 'if clinically indicated'. All the therapy groups averaged 3 SMC sessions, while the SMC-only group had an average of 5 sessions. So it would be more accurate to say the SMC control group had an average of 2 extra SMC sessions vs an average of 13 therapy sessions in each therapy group.

    Comparative approach: CBT & GET vs APT
    While the SMC-only group makes for a (poorly) controlled study, the comparison of CBT & GET with APT is the comparative part of the study i.e. comparing different 'active' treatments. In theory, as Basham shows, this makes for more robust findings and CBT/GET did emerge from PACE as superiour to APT as well as to SMC alone. The study also showed that 'APT+SMC was not better than SMC alone'.

    So for me the key question is: to what extent is APT either a valid 'active' treatment or, alternatively, a valid attention-placebo control (given the high patient confidence in and subsequent satisfaction with APT).

    I've put some thoughts on this in the next post.
  15. oceanblue

    oceanblue Senior Member

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    The meaning of results for APT, Adaptive Pacing Therapy, in the PACE Trial

    APT as an 'active' therapy

    Pacing is widely endorsed by patients and their organisations but there is little trial data on it's effectiveness. The PACE trial created its own version of pacing, APT, which was based on a previous study of the 'envelope' theory by Lenny Jason and co-workers, and Action for ME (AfME) guidelines. The manual was piloted and modified after feedback from patients and therapists.
    The most controversial part of APT is the '70% Rule', where patients are advised not to use more than 70% of their available energy (it's not clear from the manual if this is per activity or across a whole day). The rule is based on the '75% rule' advocated by AfME, though was not used by Jason et al. in their work.

    All the APT therapists were experienced Occupational Therapists and it's not clear how much experience of pacing they had though I have a feeling that OTs generally tend to have experience of some sort of pacing (though not APT) as it's used for other illnesses too, notably chronic pain.

    So far what this tells us is that APT as implemented is effectively a novel treatment with no published evidence on it's effectiveness and a counter-intuitive '70% rule' that is likely to hold patients back in making progress. The fact that APT was not superior to SMC alone on physical function is hardly surprising (in fact it was slightly worse than SMC-only, though this wasn't statistically significant.)

    Note the Basham comment in my earlier post:
    and it seems on these criteria APT falls well short of an equivalent active treatment.

    It's tempting at this stage to dimiss APT as an irrelevance that tells us nothing, but that's perhaps too simplistic. The poor fatigue results, of no difference relative to SMC-only, is in my opinion much harder to explain.

    Why didn't APT (+SMC) improve fatigue relative to SMC alone?
    While I think there's a good reason APT had no effect on physical function, I'm a little surprised by the lack of impact on fatigue, particularly as it was a primary goal of treatment:
    All suggestions as to why APT didn't improve fatigue are welcome.


    APT as a surrogate placebo group
    Another reason I expected APT to improve fatigue, in addition to having it as an key aim of the therapy, is that its well set up for a placebo effect/response bias. APT received the highest ratings for confidence in/seems logical before treatment began (84%/72% respectively for APT vs 49%/41% for SMC) and high satisfaction levels afterwards (85% APT vs 50% SMC). So even if APT had no direct therapeutic effect I would have expected some improvement in self-reported fatigue.

    Note this comment in the PACE Lancet paper:
    also:
    However, the expectation of improvement in the APT group might be less than CBT or GET for 2 reasons:
    1. CBT & GET are promoted as leading to recovery, while APT more passively says it "provides the best conditions for natural recovery".
    2. The OT therapists may have lower expectations for APT than the GET (manily physios) and CBT (mainly psychologists) have for their therapies, particularly as the OTs won't have used APT specifically in the past. Therapist expectations can affect patient-reported outcomes (see Mohr study, above). Similarly it's not clear of the OT's allegiance to APT (wheras I don't think there's much doubt about the psychologists' allegiance to CBT). Allegiance could affect both effectiveness of implementation and patient expectations.

    Nonetheless, I would still have expected some placebo effect/response bias in APT relative to SMC. Again, alternative explanations are welcome.

    edit: this comment from WillowJ on the main PACE thread is highly relevant (and informed my own post here) though I don't think it's a complete explanation of the lack of impact of APT on fatigue:
    WillowJ likes this.

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