ME Association response to PACE trial recovery paper | 15 February 2013

February 15, 2013


The following letter has been sent to Psychological Medicine in response to the paper they published on January 31 on Recovery from chronic fatigue syndrome after treatments given in the PACE trial

INTENDED FOR PUBLICATION

16 February 2013

Editor

Recovery from chronic fatigue syndrome after treatments given in the PACE trial

To most doctors and patients the term ‘recovery' has an unambiguous common sense meaning: a sustained return to symptom-free normal health with the ability to repeatedly and reliably participate in all aspects of normal life – employment, education, social activities, etc.

However, important data from the PACE trial (White et al 2011) that should have been used as objective measures of recovery was omitted from the paper describing recovery in ME/CFS (White et al 2013). This is both puzzling and disturbing – as are the reasons given for the omission.

Considering the enormous cost of the PACE trial, it should have been possible to obtain any missing information, as well as asking participants a very simple question: Have you recovered as a result of cognitive behaviour therapy (CBT), graded exercise therapy (GET) or Pacing?

There are three specific markers of recovery where data should have been reported but was not:

Firstly, receipt of a state sickness or disability benefit. Claiming a state sickness benefit is clearly incompatible with recovery and data on benefit status was included in the cost analysis study (McCrone et al 2012). This analysis reported that: Receipt of benefits due to illness or disability increased slightly from baseline to follow-up. Consequently, the recovery paper should have provided information on the individual benefit status in everyone who had recovered.

Secondly, employment or education status. The recovery paper argues unconvincingly that Return to work is not, however, an appropriate measure of recovery if the participant was not working before their illness and is influenced by other factors such as the job market. However, a sustained return to meaningful paid employment, or education, or the ability to do so, is a very robust measure of recovery. This information should have been included.

Thirdly, recovery in a condition whose cardinal clinical features relate to mobility – exercise-induced muscle fatigue and weakness – must be matched with an ability to mobilise in a normal and timely manner. The overall results for all the treatments in the PACE trial relating to changes in the six-minute walking test from baseline to 52 weeks do not represent a return to normal levels of activity. In fact, the figures for all the treatment groups at 52 weeks are below the 402m reported to be present in patients with class 3 heart failure (Lipkin et al 1986). So why were the results for those who have recovered – who should now be achieving a much higher distance – omitted? And in relation to overall physical functioning, I am unable to understand how it is possible to meet the entry criteria for the PACE trial with a short form-36 physical function subscale score of 65 yet leave the trial as recovered with a score as low as 60.

I welcome the fact that behavioural interventions such as CBT and GET can result in improvement in some people who come under the wide range of clinical phenotypes that equate to ME/CFS. However, patient evidence continues to indicate that most people with ME/CFS find CBT to be ineffective (or even harmful); around half consistently report that GET makes them feel worse; and the vast majority report that pacing is the most acceptable and effective form of activity management (Managing my ME, ME Association, 2010). This is hardly surprising given the increasing research evidence involving abnormalities in the central nervous system (Cader et al 2009, Puri et al 2011), muscle energy metabolism (Jones et al 2012) and immune system function (Lorusso et al 2009) that are not compatible with a primarily psychosocial model of causation.

There is widespread concern in the patient community about the way in which these research results relating to CBT and GET are being distorted in the media and adopted by organisations such as the National Institute for Clinical Excellence (NICE) as a ‘one size fits all' approach to management. To conclude that they are safe and effective for everyone with mild or moderate ME/CFS, as NICE currently does, is simply wrong.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

7 Apollo Office Court
Radclive Road
Gawcott
Bucks MK18 4DF

References

Cader S, O'Donovan DG, Shepherd C, Chaudhuri A (2009). Neuropathology of post-infectious fatigue syndrome. Journal of the Neurological Sciences, S60 – S61.

Jones DE, Hollingsworth KG, Jakovljevic DG, Fattakhova G, Pairman J, Blamire AM, Trenell MI, Newton JL (2012). Loss of capacity to recover from acidosis on repeat exercise in chronic fatigue syndrome: a case-control study. European Journal of Clinical Investigation, 42, 186 – 194.

Lipkin DP, Scriven AJ, Crake T and Poole-Wilson PA (1986). Six-minute walking test for assessing exercise capacity in chronic heart failure. British Medical Journal (Clinical Research Edition) 292, 653

Lorusso L, Mikhaylova SV, Capelli E, Ferrari D, Ngonga GK, Ricevuti G (2009). Immunological aspects of chronic fatigue syndrome. Autoimmunity Reviews, 8, 287 – 291.

Managing my M.E. What people with ME/CFS and their carers want from the UK's health and social services (2010)
www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res4.pdf Accessed 10 February 2013

McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD (2012). Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One, 2012, 7, e408084

Puri BK, Jakeman PM, Agour M, Gunatilake KDR, Fernando KAC, Gurusinghe AI, Treasaden IH, Waldman AD, Gishen P (2011). Regional grey and white matter volumetric changes in myalgic encephalomyelitis (chronic fatigue syndrome): a voxel-based morphometry 3-T MRI study. British Journal of Radiology, 85, e270 – 273.

White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M (2011). Comparison of adaptive pacing, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized controlled trial. Lancet, 377, 823 – 836.

White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M (2013). Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine, 2013, January 31, 2013: 1-9 Epub ahead of print.

ENDS

13 thoughts on “ME Association response to PACE trial recovery paper | 15 February 2013”

  1. Thank-you so much for this clear and simple outline showing some very valid criticisms of PACE, Dr. Shepherd.

    On the matter of obtaining benefits;
    I was under the impression that the (bio)psychosocial model uses “being on benefits” as an indicator of poor prognosis for future recovery- so surely, this really IS something that they should have taken into consideration; the information collected and reported on.

    1. Have we both read the same letter? I must strongly disagree with you and highlight the support for CBT and GET.

      “I welcome the fact that behavioural interventions such as CBT and GET can result in improvement in some people who come under the wide range of clinical phenotypes that equate to ME/CFS.”

      Despite this, there is no objective benefit from CBT and no clinically significant or practically important gains objectively or subjectively for GET. There is no justification for using CBT and GET. They have no scientific evidence base.

  2. The one thing that consistently gets missed out of most discussion of CBT/GET, as far as I can see, is the fact that they are therapies and not treatments.

    They are useful when used as therapies, to help make people’s life easier/more balanced, or to help people adjust to their changed life circumstances. In that context, CBT/GET are rightly used for and by people with ME just as they are for many other serious illnesses like cancer, MS, broken legs, depression, etc.

    What is unhelpful, is NICE’s obsession with calling them a treatment and providing them to patients as such, with all the attached implications of curative properties (not to mention the unspoken implication that you aren’t trying hard enough if you don’t get better, which has uncomfortable echoes of quacks and faith healers as far as I’m concerned). And doing so in the context of them being, not a part of the treatment of the illness, but the ONLY treatment.

    That’s not only an inappropriate use of language and clinical context, but for any other physical illness, would surely be considered malpractice…Can you imagine the kerfuffle if someone with a broken leg wasn’t given so much as a splint to fix the broken bones in place, and was instead just told to go through a course of GET to improve their mobility because “it doesn’t mean we think it’s psychosomatic – we use this for all sorts of physical illnesses!”? Or if someone with cancer was told to go through CBT instead of a course of chemotherapy?

  3. Watching toddlers repeatedly trying to bash square pegs into round holes might be endearing up to a point, but watching professional adults doing exactly the same thing, and year after year is, quite frankly, ludicrous.
    Thank you Dr Shepherd for an excellent letter clarifying what has been patently obvious to patients, ME charities and many international researchers for the longest time: the Emperor has no clothes – and never did.

  4. Dr Charles Shepherd

    Helva2260 – your observations hit the nail right on the head!

    Supportive CBT can sometimes be helpful in a range of medical conditions, including even cancer, when it is used to help people cope with some of very practical issues and mental health problems that may be linked to living with a long term illness.

    What makes me so annoyed is when it is put forward by NICE as a ‘one size fits all’ TREATMENT for everyone with mild to moderate ME/CFS on the basis that there isn’t any underlying disease process present and that the illness is perpetuated by abnormal illness beliefs/behaviours and inactivity/deconditioning.

  5. helva2260, that may be so, but if an intervention brings about “recovery”, then perhaps some people would say that then “treatment” becomes a suitable word.

    The point with this study is that the definition of “recovery” is rubbish. I would encourage those that are able to try to write a letter if you have problems with this study.

  6. Thank you, Dr Shepherd. I hope your letter will be published.

    In this paper on ‘recovery’ the authors agree with a quote which says: ‘Objective measures of physical activity have been found previously to correlate poorly with self-reported outcomes…’ Yet, all the reported improvement outcomes rely solely on self-report. Remarkably, the authors do not attempt to correlate the results of the 6 Minute Walking Test quoted above by Dr Shepherd with the self-reported measures used in the rest of the study. These participants were supposed to be merely ‘deconditioned’.

    These results hardly indicate ‘reversal’ of the condition (whatever that was supposed to be)more or less predicted by the authors. The authors never refer to these poor results in any of their writing, especially press releases.

    The appearance is that they steer clear of any data which might endanger the appearance of a slim benefit to a few of their participants.

  7. No one in the PACE trial was helped using CBT or GET. There clearly is no scientific validity to the NICE guidelines or the beliefs in CBT and GET.

    Firstly, lead author of the PACE trial Peter White has publicly admitted that there were no patients with ME/cfs in the study and the study clearly states that 47% of participants had primary psychiatric conditions. Secondly, CBT provided NO objective improvement in 6 min walking distance. Thirdly, GET provided a clinically INsignificant increase in 6 min walking distance of only an extra 5 meters per minute, or about 7 steps per minute for a whopping £5 million pounds.

    Recovery is defined as being healthy, not “a sustained return to symptom-free normal health”. Recovery in fact is a return to the average level of health normal to a persons age and sex.

    Asking for a subjective opinion in an open label study is just asking for an answer powered by demand characteristics and nothing to do with a real life situation. That data would be even more prone to cognitive biases than the data already is. There are papers and books galore emphasing the total unreliability of self reports resulting from such questioning. Self report data is virtually meaningless. Studies need to use objective measures of disability and must ensure that patients history is blinded from trialists, and that the purpose of the study /treatment is hidden from patients. Otherwise all data is just a product of cognitive bias and has nothing to do with objective fact.

    Finally, it would not be a mark of recovery to show who was no longer in receipt of benefits or back in work/ education. These are Government statistics and defined politically by what the Government wishes to pay for. They bear no relationship to the recovery or effectiveness of proposed “treatments”, which in this instance did not help anyone in the PACE trial, which as publically admitted by Peter White contained no ME patients.

  8. The authors and friends of PACE show an alarming level of certainty about benefits of CGT and GET. Here, all scientific caution has been thrown out the window.

    This is in spite of the poor results of the PACE trial; the wobbly, untestable assumptions about thoughts leading to deconditioning which underpin PACE; the serious concerns expressed by patients; the adverse effects of GET experienced by patients; the obliviousness to underlying physical abnormalities of ME and CFS patients; the dismissal of the scientific biomedical evidence showing that GET is contraindicated.

  9. These Researchers use Misleading Word Definitions

    These researchers wrote in the summary section (abstract) of their paper that: “this study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery .”

    However, this statement is very misleading, because the authors are not using the normal dictionary meaning of the word “recovery” (namely “a return to a normal state of health, mind, or strength “), but are rather employing their own special redefinition for this word.

    Yet no indication is given in this summary that the redefined term “recovery” does not have its normal English meaning.

    Thus busy individuals such as general practitioner doctors, who may merely scan the summary of a study without always delving into its methodological complexities, will get the impression that GET and CBT are able to return CFS patients to a normal state of health, mind, and strength, which is not the case at all.

    A study which redefines the meanings of the words it uses must make sure that precise definitions of the redefined terms are clearly given, so that there can be no misinterpretations.

  10. Dr Charles Shepherd

    Could I remind everyone that while constructive criticism is an essential part of the medical and scientific debate, attacks on named individuals, including people who contribute to the website discussions, and comments that are or could be regarded as being defamatory, are not permitted

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