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February 18, 2011 / zzirf

Flawed PACE Trial causes band wagon news reports – the public are being duped

News Reports are flooding in all over the world about the results of the flawed PACE trials findings.  They are reporting that the PACE trial therapies of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) are the most successful treatments for Chronic Fatigue Syndrome which is known more accurately as Myalgic Encephalomyelitis (ME) in the UK.  Headlines such as “Chronic Fatigue Syndrome, also known as ME, should be treated with a form of behavioural therapy or exercise, say British scientists” are being vigorously circulated this month.  However, what is NOT being publicised enough are the politics and the unscientific research underpinning the PACE trials.

Unscientific research Method

The Unscientific Research Methodology

Consider some of the following:

  • The MRC PACE Trial used the Oxford criteria which do not define patients with ME/CFS. If used correctly, they exclude people with neurological disorders yet ME is a classified neurological disorder (WHO ICD-10 G93.3).
  • The Trial’s “operationalised Oxford research diagnostic criteria for CFS” (Trial Protocol version 5, 2006, Section 7.2) were partly financed by the Chief Principal Investigator’s (Professor Peter White) own money (JRSM 1991:84:118-121).
  • Professor White sought Ethics Committee approval to advertise his PACE Trial to GPs, asking them to refer anyone “whose main complaint is fatigue (or a synonym)”. The MRC PACE Trial entry criteria had an “open door” policy and did not identify people with ME/CFS (those supposedly under study in the PACE Trial), hence the reported results cannot be claimed to refer to ME/CFS patients.
  • The MRC PACE Trial excluded children and those who are severely affected. The results of any trial that excluded those who are severely affected cannot be taken seriously.
  • The MRC PACE Trial used no objective measures of outcome (ie. actigraphy) to show improvement or non-improvement and relies upon participants’ subjective answers to questionnaires. This is an unscientific way to gather evidence.
  • The only research supporting CBT/GET as treatment for ME/CFS patients has been generated by those who stand to gain most in professional and financial terms from its promotion. Similar independent corroboration should be required before experimental psychological interventions are applied nationally.
  • Professor White and his co-Principal Investigators all have financial links with the health insurance industry, a matter of grave concern tothe former Chairman of a House of Commons Science and Technology Select Committee and former Dean of Biology (Dr Ian Gibson MP); a member of the Home Affairs Select Committee (Ann Cryer MP); a Minister of State for the Environment (The Rt Hon Michael Meacher MP); a former President of the Royal College of Physicians (Lord Turnberg); the Deputy Speaker of the House of Lords (the Countess of Mar), and a former Health Minister and Honorary Fellow of the Royal College of Physicians (Baroness Julia Cumberledge) (Gibson Inquiry Parliamentarians’ Report, 2006). In an obvious reference to Professor White, this Report stated: “There have been numerous cases where advisors to the DWP have also had consultancy roles in medical insurance companies, particularly the company UNUMProvident. Given the vested interest that private medical insurance companies have in ensuring CFS/ME remains classified as a psychosocial illness, there is a blatant conflictof interest here. The Group finds this to be an area for serious concern…”. In Professor White’s case, this blatant conflict of interest remains unresolved, as he is Chief Medical Officer for the insurance giant Swiss Re, and another of the PACE Trial Principal Investigators, Professor Michael Sharpe, is associated with UNUMProvident.
  • Professor Simon Wessely, who directed the PACE Clinical Trial Unit, is on record stating that CBT provides no effective treatment: in his past Editorial (JAMA 19th September 2001:286:11) he stated that CBT and GET are only “modestly effective” and that neither is “remotely curative”. Wessely is also on record as stating: “It should be kept in mind that evidence from randomised trials bears no guarantee for treatment success in routine practice.  In fact, many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions” (The act of diagnosis: pros and cons of labelling chronic fatigue syndrome. Marcus JH Huibers and Simon Wessely.  Psychological Medicine 2006:36: (7): 895-900).
  • The Adaptive Pacing Therapy (APT) used in the PACE Trial is not the same as pacing, a common sense approach that patients find helpful.  The CEO of the “Action For ME”, Sir Peter Spencer, said: “The findings contradict the considerable evidence of our own surveys.  Of the 2,763 people with ME who took part in our 2008 survey, 82% found pacing helpful, compared with 50% for cognitive behavioural therapy and 45% for graded exercise therapy.” And “worryingly, 34% reported that graded exercise therapy made them worse.”
  • The MRC FINE Trial (sibling of the PACE Trial) failed spectacularly. It found that “pragmatic rehabilitation” (PR, based on CBT/GET) was minimally effective in reducing fatigue and improving sleep only whilst participants were engaged in the programme and that there was no statistically significant effect at follow-up. Furthermore, pragmatic rehabilitation had no statistically significant effect on physical functioning; equally, its effect on depression had diminished at follow-up. Moreover the other intervention being tested (“supportive listening” or SL) had no effect in reducing fatigue, improving physical functioning, sleep or depression.
  • The results of the MRC PACE Trial were anticipated to be in favour of the interventions being studied because the Trial is but one prong of a UK Blair Government three-pronged “integrated plan” to roll out CBT and GET across the nation for those with ME/CFS (Department of Health, 2004, Statement of Information released via the Welsh Assembly Disclosure Log 2296), the other two prongs being the NICE Clinical Guideline 53 published in August 2007 and the national “Fatigue” Clinics that cost taxpayers £8.5 million to deliver an intervention known to be ineffective and to have made at least 50% of those who have undertaken it actively worse.  The “integrated plan” was designed to ensure compliance, so it was never in doubt that the PACE Trial results would conform to the “integrated plan”, as indeed is the case (ie. CBT and GET are said to be safe and moderately effective treatments for everyone with ME/CFS and to be better than APT).

Unfortunately, for people like me, the results of the PACE Trial may mean that patients who have genuine ME as opposed to chronic “fatigue” will continue to be denied appropriate investigation and treatment; they may be deprived of State benefits necessary for survival; their insurance claims may be rejected, and they will be condemned to an even lower quality of life. It would surely have been better if the (more than) £5 million spent on investigating what was already known had been spent on biomedical research into this complex disorder and in helping the severely affected (for instance, by providing domestic and personal assistance) and on effective pain relief for those afflicted.

My personal opinion is that most patients with ME/CFS have initially tried very hard to follow their doctors’  misguided advice about graded aerobic exercise only to find themselves in what is known in patient circles as the push-crash cycle but when they have followed the advice of  our American counterparts, who promote the “energy envelope” management strategy (The impact of energy modulation on physical function and fatigue severity among patients with ME/CFS. Leonard Jason et al; Patient Educ Couns 2009:77:237-241), their quality of life has improved by way of a more stable and predictible pattern of health.

Dr. Bruce Campbell has published a book called The CFIDS & Fibromyalgia Self-Help Book which explains to people with CFS/ME how to manage their energy resources in order to avoid relapse.  More Information

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7 Comments

Leave a Comment
  1. Clairmont / Feb 18 2011 9:44 PM

    CBT helped me develop a “can do” attitude, which no doubt contributed to my ignoring my failing health, particularly in an environment where my illness was conveniently (for insurers and governments) purported to be a mental/emotional illness. No doubt the skills I learned when engaged in CBT have assisted in my not being depressed (despite the stereotype) while having this devastating illness.

  2. Clairmont / Feb 18 2011 9:45 PM

    So… some benefit? Yes? A cure for ME/CFS? No.

  3. zzirf / Feb 19 2011 7:35 AM

    No CBT and GET are not cures Clairmont. In fact G.E.T. can be down right dangerous if the patients has the usually undetected form of diastolic cardiomyopathy. Refer Dr. Cheney for details.

  4. Claire / Feb 19 2011 11:01 PM

    As I understand it, CBT can used for coping and adjustment to the illness. Using it to “cure” M.E. makes roughly as much sense as using it to cure cancer.

    Great post, I’ll be linking it from my own.

  5. Jan Laverick / Feb 20 2011 1:50 AM

    So they gave a poorly defined group of people CBT that reprogrammed them to ignore any physical illness and symptoms that they had and GET which encouraged them to do more, then they asked them whether they were doing more and feeling better. Sound like a robust scientific study?? No I thought not.

    Thanks for the blog post, PACE can kiss my *rse! The WPI and others are working hard for us now and there can be no disputing we have a serious and deadly neuroimmune disease when you actually take the time to read the real research. Best wishes to all who suffer from this disease and those who are coming to terms with their XMRV positive status x

    • zzirf / Feb 24 2011 12:31 AM

      Touché

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  1. The PACE Trial: “This is not a good day for people with ME/CFS” « Scríbhneoir páirt-aimseartha

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