The PACE results – an analysis by science writer and broadcaster Vivienne Parry

April 15, 2011


All material on this page was contributed. The MEA did not have a hand in writing the introduction.

The Association of Young People with ME (AYME) invited respected journalist and broadcaster Vivienne Parry to write an independent article on the PACE Trial in light of the controversy that surrounds it and the use of graded exercise therapy and cognitive behavioural therapy with this condition.

Vivienne Parry is a highly respected scientific journalist, best known for her broadcasting for Radio 4 where she presents many medical science programmes. In the New Year’s Honours 2011, she was awarded the OBE for services for the public understanding of science. Below is Vivienne Parry’s analysis of the PACE trial written exclusively for the LINK publication.


ME/CFS is a disease which has far too little time and money spent on it. And whilst research on its cause, or more likely its many causes, is still in its infancy, the need for better treatments for those who are affected today by this dreadful condition is acute.

Thanks to the PACE trial, the largest ever study of ME/CFS treatments whose results were published in March, we at least now know for sure that there are two treatments – graded exercise therapy (GET) and cognitive behavioural therapy (CBT) – that are safe and moderately effective.

But the trial outcome didn’t go down well in the ME/CFS community with the result condemned as ‘disappointing and surprising’ by some organisations, although it was welcomed by AYME. I want to take a look at those comments but let me first refresh your memories on what the trial involved and why it was carried out.

Back in 2003, patient groups were concerned that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) might do more harm than good. They favoured pacing (a way of adapting available energy to daily life with the help of a diary) along with specialist medical care but this had not been subject to a large scale trial. The only way to find out for sure which was the best treatment and whether there were any safety problems was to do a large randomized trial of the various treatments. A randomised trial means that neither eligible patients nor their doctors have a choice about their treatment; a computer randomly allocates them to one of those being trialled. This trial could not be blinded (no-one knows who’s had what treatment) because the treatments are so obviously different but it was blinded as far as those who were analysing the results were concerned. This was as rigorous a study as it is possible to have.

From the outset, Action for M.E. and a number of patients were involved in the design of the trial. PACE involved 640 patients from England and Scotland. It was carried out by a team of experts and led by researchers from Queen Mary University London, King’s College London and the University of Edinburgh. The research proposals were subject to extensive review and scrutiny by independent experts and trial committees. The £5 million cost was funded by the Medical Research Council, the Department of Health, the Scottish government and also by the Department of Work & Pensions.

The trial assessed the safety and effectiveness of four separate treatments: specialist medical care alone, specialist medical care combined with cognitive behavioural therapy (CBT), or with graded exercise therapy (GET), or with adaptive pacing therapy (APT), usually just called pacing. The specialist medical care involves general advice about managing the illness plus normally prescribed medicines for symptoms such as insomnia and pain.

The 640 patients, all of whom had fatigue as their main symptom, were assigned to the four groups in roughly equal numbers of 160 individuals each. All the patients had an assessment of their fatigue and physical function at the start of the trial and a year later at the end of the trial.

The results were that average fatigue and physical function scores had improved more after CBT and GET than after either pacing or standard medical care alone. The PACE trial found that pacing has no benefit but that up to 60% of patients with CFS/ME benefited from CBT and GET. This counts as being moderately effective treatment.

This was a trial for adults so the results may not be applicable to children and it did not include those patients who were housebound. Further research is urgently needed to address the needs of these two groups.

Serious adverse reactions to treatment were recorded in two pacing patients (1%), three CBT patients (2%), two GET patients (1%) and two in the SMC-only group (1%). Let me say something about what adverse reactions mean here. Everyday things – like getting cold or flu, being in a car accident or even falling over the cat and gashing your knee – that happen to occur within a study time frame count as non-serious adverse events but not reactions to trial treatments. Serious adverse reactions were, for example, someone taking to their bed as a response to a trial treatment. Of the 10 serious adverse reactions recorded, nine were only “possibly related” to a trial treatment and only one was “probably” a reaction to a trial treatment and that was an adverse drug reaction in someone in the standard medical care alone group. All in all, this is very convincing evidence that all these treatments are safe.

So why have so many patient groups including the charity involved in the design and implementation of the trial, condemn the findings? They said that the results were at odds with numerous patient surveys, for instance one for AfME in which some 50% of patients reported harm from graded exercise therapy.

There are two problems here. One is about science. Research is about coming up with a hypothesis and then trying to knock it down. Sometimes what you believe to be the case (the hypothesis) gets overturned. Long held, cherished and utterly plausible ideas are regularly demolished by evidence. This can be incredibly disappointing but you have to move on and ask the next question, not constantly keep asking the same one in the hope that eventually you will get a different answer.

The other problem has to do with surveys which usually involve a self selected sample of the population and can produce highly biased results. For instance, responders might only be those people for whom a particular treatment hasn’t worked whereas those for whom it has worked, haven’t bothered to be involved. When respondents to one of these surveys were followed up, especially those who reported they had become much worse as a result of graded exercise therapy, it turned out that some had been sent to gyms or other inappropriate places or hadn’t had the sort of supervised, careful therapy from experts that was a feature of the trial and which should be offered to ME/CFS patients.

Some people also said that the trial was meaningless because it excluded those with a neurological disease, therefore could not have contained anyone who had ME since this is classified as a neurological disease. This is a bit silly because why would you design a trial that excluded the very patients you wanted to study? The problem arises from a line in the so called ‘Oxford criteria’ which were used to assess eligibility for the trial and says ‘those with proven organic brain disease’ should be excluded. This means those with conditions like dementia, multiple sclerosis and Parkinsons, not ME/CFS. The choice of the Oxford criteria, rather than the CDC (an American measure) or Canadian criteria was also condemned since some people say that using these allows those with fatigue from causes other than ME/CFS to be included and therefore those that got better were not people who had ‘real’ ME. However, the Oxford criteria excludes anyone who has an alternative cause for their ME/CFS symptoms. The researchers also assessed all patients to see if they met alternative definitions of ME/CFS. One definition, according to the London criteria for ME, based on Melvin Ramsay’s original description of ME from the Royal Free hospital and the other according to CDC guidelines. The results were the same in these groups. As well as using the Oxford criteria 67% of patients also met the International CFS Criteria and 51% the London ME Criteria.

What does this mean for treatment? CBT and GET are moderately effective for six out of every ten adult patients. They are likely to be effective in children but no one knows this for sure until further research is done. They are safe but only in the hands of therapists who are properly qualified. Finally, the NICE guidelines are not due for revision until 2013 and NICE have recently confirmed that they will not be altering them until then.

The nub of patient reaction to this seems to rest on an implication – which is why so many found some of the newspaper headlines so offensive – that the way they get better must say something about the cause of their illness. So, for instance, if CBT works for you, it must mean that ME/CFS has a psychological cause or if graded exercise therapy works, it must mean you are lazy. I find this completely baffling. I’ve worked a lot with cancer groups who campaign to have CBT as part of their treatment because it helps them feel better. No-one would dream of suggesting, I hope, that their cancer was a psychiatric disease.

I sit on the Council of the MRC (although I joined it after the PACE trial was approved) and I’m delighted that a further £1.5 million is going to be made available for ME/CFS research by the MRC. Contrary to what is claimed on message boards, there are strong voices, including my own, speaking up for the need for ME/CFS research within the MRC, which must include work on both causes and better treatments. I look forward to telling you the results of this research in the future.

The therapies are defined as:

• Cognitive behavioural therapy (CBT) – A clinical psychologist or specially trained nurse, helps the patient to understand how their symptoms are affected by the way that they think about and cope with them and encourages them to try out increasing their activity.

• Graded exercise therapy (GET) – A physiotherapist helps the patient to try a gradually increasing tailored exercise programme which takes into account the individual patient’s symptoms, fitness, and current level of activity.

• Adaptive pacing therapy (APT) – An occupational therapist helps the patient to match their activity level to the amount of energy they have, aiming to help the patient adapt to the illness rather than assuming they can gradually do more.

With kind permission of AYME 14/4/2011

32 thoughts on “The PACE results – an analysis by science writer and broadcaster Vivienne Parry”

  1. Leaving aside the entry criteria, which patients rightly questioned, there are two points I would like to make here.

    I. The original study design (1) had an SF36 assessment figure of 75 designated as ‘improvement’. This was changed, in the outcome report (2), so that improvement could be said to have occurred, the level chosen to represent ‘improvement’ was >60. SF36 at 60 is normal functioning for 75 – 84 year olds.

    2. The article above says only one patient had true serious adverse reaction, and that was in the SMC group. Yet we hear nothing about the almost one-third of patients who dropped out of the study cohort.

    PACE was a travesty of science and a waste of precious resources.

    References

    1) http://www.ncbi.nlm.nih.gov/pubmed/17397525
    2) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

    Jane Clout.

    1. Spot on, Jane. Moreover, if you compute the improvement on the two outcome measures had they stuck to the original criteria and cut-off points, the results aren’t even modest (p=.000). This is what happens when someone who is not an expert in the field looks at something and does not consult a relevant expert. Old fashioned medical journalists used to check, but it appears that Vivienne did not. I’m sure she meant well but she has a reputation for good articles and this shows laziness. We’ve had far too much opinion from people knowledgeable in one area who then regard themselves as able to interpret data from a completely different speciality. I recommend a reference to the opinion of someone with consultant status or equivalent before taking anything on board. Very disappointed.

  2. Darn. Foggy today. Forgot to say that to enter the study, patients had to have an SF36 of <65, so they could, by the outcome measures that were finally used in the Lancet article, be worse than when they started and still be said to have 'improved'.

  3. This ‘respected journalist’ is merely an apologist for PACE. Her tone and content is patronising in the extreme.

  4. “The PACE trial found that pacing has no benefit but that up to 60% of patients with CFS/ME benefited from CBT and GET. This counts as being moderately effective treatment.”

    This refers to the proportion of particpants who improved by a ‘clinically useful difference’ and the correct figures are:
    Pacing (APT): 42% (not 0%), SMC control 45%, CBT 59%, GET 61%. So CBT/GET results were about 15% better than for controls, which is not what Vivienne Parry writes at all.

    She also neglected to mention that on the only objective outcome measure, the 6-minute walking test, the CBT group showed NO difference with the control group while the GET group improved a small amount to 379m: the norm for people of working age is about 600m. ‘Moderately effective’ was the authors’ claim for CBT/GET, it’s a very optimisitc reading of their results.

  5. Parry’s article is an embarrassment and a very good example of the attitude AYME display in regards to those with the disease ME/CFS. Parry has not understood the research paper, the published literature on the disease ME/CFS, or the chronic fatigue that was studied in the PACE trial.

    I’m sure in the coming months we will see several beautifully constructed responses in the Lancet regarding the PACE trial which will explain further the reasons why the trial failed and why Parry has failed to grasp the details of this issue. For now here a few points about her article.

    Parry argues that a hypothesis is created and then scientists attempt to knock it down. Yet, the hypothesis tested by the PACE trial was not the one Parry portrays. The trial was not studying the neurological disease ME/CFS, but people with the symptom chronic fatigue in the absence of neurological signs, or “CFS/ME”. As confirmed by one of the authors of the Oxford criteria; “British investigators have put forward an alternative, less strict, operational definition which is essentially chronic…fatigue in the absence of neurological signs, (with) psychiatric symptoms…as common associated features” (Professor Anthony David; BMB 1991:47:4:966‐988)”(1) Consequently, it is unscientific to then assume, as Parry has done, that ME patients must have been present in the study when this criteria was used in the first round of selection. If the Oxford criteria had been applied correctly there would be no people present with ME. Therefore, use of the London and Fukuda criteria in subgrouping cannot then have magically have found neurological signs in that cohort. The London criteria are also problematic, but I won’t repeat that issue here, as it is basically irrelevant once the Oxford criteria has selected out those with ME.

    They also never tested pacing, but the authors’ creation, which is called “adaptive pacing”. Instead of “listening to your body” and staying within your limits, patients were required to pace to a timetable and set targets. As Professor Hooper has highlighted, the authors of the PACE trial have a very different view of what pacing is and is not. “…the therapists’ Manuals (though not the participants’ Manuals) state that SSMC, CBT and GET may nevertheless all be considered to be forms of pacing.”(1)

    It is also a distortion of the truth to suggest that CBT that is offered to cancer patients is comparable to that in the PACE trial. The CBT used in the PACE trial does indeed argue that ME is a psychological disease, perpetuated by incorrect thoughts feelings and emotions.

    “CBT was done on the basis of the fear avoidance theory of chronic fatigue syndrome. This theory regards chronic fatigue syndrome as being reversible and that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue. The aim of treatment was to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability. Therapeutic strategies guided participants to address unhelpful cognitions, including fears about symptoms or activity by testing them in behavioural experiments.“ (PACE trial, page 3)
    If a cancer study were created on that basis, then yes the authors would be claiming that cancer was psychological.

    Finally, people should now be aware that the results were not clinically significant, and there remains little evidence to support the use of CBT and GET in the management of ME/CFS.

    I hope that next time Parry does a modicum of research into the next disease she wishes to involve herself in. As an OBE I would have expected better. What she should have written about is that patients and advocacy groups generally did not wish to see money wasted on a trial of these therapies, but would have preferred investment into biomedical research. An area that at least has a chance to produce effective treatments or a cure for this severe neurological disease.

    1) Magical Medicine, http://www.meactionuk.org.uk/Response-to-David-Jameson.htm

  6. @JT: ‘It is also a distortion of the truth to suggest that CBT that is offered to cancer patients is comparable to that in the PACE trial. The CBT used in the PACE trial does indeed argue that ME is a psychological disease, perpetuated by incorrect thoughts feelings and emotions.’

    Exactly!

    Can you imagine if cancer patients were offered CBT as firstline treatment and chemotherapy – to treat the physical devastation of the illness – was withheld?

    Vivienne Parry has failed utterly to understand what ME is and also why patients and enlightened scientists are appalled by PACE. Her arguments are empty, unreconstructed Wesselyite claptrap.

  7. Here’s a letter from the Irish Medical Times can deals with some of the issues:
    —————-
    Caution is still required on GET and ME

    April 7, 2011

    Dear Editor,

    According to your recent article (‘Cognitive behavioural therapy not harmful in chronic fatigue’, Irish Medical Times, March 18, 2011, http://www.imt.ie/clinical/2011/03/cognitive-behavioural-therapy-not-harmful-in-chronic-fatigue.html), “patient groups’ concerns that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) could be harmful for the treatment of chronic fatigue syndrome (CFS) can be allayed” due to the PACE trial’s results, published recently in The Lancet (Lancet 2011 doi:10.1016/S0140-6736(11)60096-2).

    It is true that the results contrast sharply with patient surveys — so much so that we have wondered what exactly was tested.

    The stated aim of both CBT and GET is to increase activity levels in CFS. If PACE trial participants did not increase activity levels as planned, we would not get good information on the safety of programmes that do involve increased activity levels.

    A review of three Dutch studies using actometers to investigate CBT for CFS found only minimal increases in total daily activity levels, and that there were no differences compared to the control groups (Wiborg et al., 2010). A similar result was previously reported by a US team (Friedberg and Sohl, 2009), which found, using detailed analysis of patient diaries along with objective measurements, that patients had simply substituted the activity component of the programme (regular walks) in place of other activities they had been doing, resulting in no overall activity increase.

    In the PACE Trial, actometers were not used. The only objective outcome measure was the six-minute walk test, which only increased for CBT participants by 21m to 354m, a change that was actually slightly smaller than that of the control group. The GET group increased by a bit more, to 379m after 12 months.

    However, this still is a very low absolute walking distance for a group with a mean age of 40. By comparison, a group of older adults (mean age: 65) covered an average distance of 631m (Troosters et al., 1999). In addition, data was unavailable for 31 per cent of GET participants and 24 per cent of those who undertook CBT; it may be the case that sicker patients were less likely to try the test.

    These data could be explained by only a small fraction of the participants actually engaging in increased activity or exercise; the only reported measure of treatment adequacy was the number of appointments attended, not the type, intensity, or duration of activity/exercise performed each week.

    Lack of objective outcome measures, the possible biasing effects of missing data and the uncertainty regarding whether trial subjects actually implemented CBT/GET as planned severely limit conclusions about efficacy and safety that can be drawn from PACE. Thus the results may not be truly inconsistent with the high rates of adverse effects from graded activity/exercise programmes repor-ted by CFS patients in surveys across the world.

    Given the numerous biological abnormalities that have been associated with exercise in CFS (reviewed in Twisk and Maes, 2009), we will continue to recommend caution regarding graded exercise and activity programmes for the condition.

    1. Who wrote this one Tomk?

      The comments above from Vivienne Parry also to not make reference to the limitations of GET and CBT in respect to those sufferers in the ‘Severe’ category.

      One has to be ‘well enough’ to take part in any therapy – as was made clear in the trial itself, but not differentiated in the Headlines or by Ms. Parry.

  8. I will let Vivienne know that the flaws were not just a matter of patients misunderstading concepts etc. Re LC, Wessely noted in his podcast that anyone with neurological symptoms is not diagnosed with CFS. That means that I would not have been included in the trial and would not have been in the ‘ME’ group. There is no way that anyone with ME could have completed GET successsfully, unless well on the way to recovery. GET is diagnostic. If you improve with GET, you can’t have ME.

    1. Ellen this is the murky issue though surely? Until research (which has not supported the view to date) proves Encephalopmyelitis then studies such as this will ‘get away with it’.

      Even Encephalopathy needs to be better researched and proven to affect sufferers diagnosed with CFS/ME or become a diagnostic marker in some shape or form.

      We are not there yet (if ever we will be). I can’t see arguing this point about PACE excluding patients with ‘real’ ME will get anywhere.

      In fact Ms Parry is right in what she says in this respect. The exclusion of KNOWN sufferers of neurological illness (by which is implied proven, i.e. MS, Parkinson’s etc.) if in fact there were any in the patient cohort, would leave the remainder as being those who satisfied the criterea of CFS/ME in terms that are presently accepted in this country.

      To obtain a diagnosis of CFS/ME we fulfill criteria. We don’t have diagnostic tests as a rule. Nothing is done to prove a neurological illness. Things are done to try and rule other illnesses out.

      Until research satisfactorily demonstrates that ‘something’ is physically wrong neurologically, and can better reflect those of us presently in the same big ‘pot’, I am afraid that trials like this (and biomedical trials for that matter), will continue to be seen as valid, when cohorts are chosen in this way.

      Of course, one might argue that an adoption of the Canadian Criteria would better reflect true sufferers, but would even this be sufficient to find physical abnormalities that are shared across the board? I doubt it.

      It is very frustrated and I do get annoyed with the state of play, but even subjecting all suspected sufferers of CFS/ME at the time of diagnosis to some form of scan, would show what? Research has yet (after all this time) to prove anything substantive that, for example, can be used to better reflect what is ‘wrong with us’, unlike in, say, Multiple Sclerosis, and yet, for example, in Parkinson’s, observable physical damage remains elusive.

      I just thing that arguing ‘real’ ME sufferers were by definition excluded from the PACE trial is not going to get anyone anywhere. ‘ME’ is not (yet) recognised as an ‘organic brain disease’ is it? Neurological in origin, yes, but not specific and not quantifiable in that regard.

      1. Actually it is on the basis of neurological signs. ME patients have neurological signs. The Oxford criteria requires that a person have no signs of this kind and it is tested for. It is not true that the published research has not shown inflammation of the brain and spinal cord or other consistent abnormalities when using strict entry criteria. This has been validated in several studies. Sophia Mirza and Lynn Guilderdale were both found to have evidence of this after they died. Therefore you cannot decide that the criteria is irrelevant based on subject feelings and Parry is wrong. At least the CCC is a diagnosis of inclusion, unlike these catch all metaphors. Sorry you are also incorrect about saying ME is not recognised as an ‘organic brain disease’. It is. ICD-10 places it at G93.3. Other diseases of the brain, under Other disorders of the nervous system. ME is quantifiable and specific when using appropriate criteria.

        1. Yes JT ‘Benign Myalgic Encephalomyelitis’ is in the WHO along with PVFS.

          Proving ‘we’ have this specific disease is what has failed over the years.

          Hence, Encephalopathy has become a preferred alternative for some, but Chronic Fatigue Syndrome THE preferred alternative for most, in the medical profession and those advising Governments.

          If there was proof that you and I suffered Encephalomyelitis there would be no ambiguity. Research has not proven conclusively that this is the case. Not to the extent that would satisfy those who determine classification and treatment.

          I said that the PACE trial excluded ‘Organic Brain Disease’ and as ‘we’ are not considered to have such a thing wrong with us (at the moment in time), the patient cohort did not (in the eyes of researchers in this and other, even biomedical trials) exclude those labelled ‘CFS/ME’ or, indeed, if it were a trial in the US ‘CFS or CFIDS’.

          My point being really that there was enough ‘wrong’ with the PACE trial that any criticism need not, in my opinion, even attempt to tackle this area of contention.

          The trial was weak. It did not produce results significant enough to justify the expense – neither did the FINE trial for that matter. Over £6 million spent on therapies that achieve what exactly? Ms. Parry cited the MRCs £1.5 million into biomedical research – well compared to over £6 million on therapeutic rehabilitation, it seems rather miniscule doesn’t it?

          Then again, the MRC Biomedical Grants are not looking for treatments are they? So 250,000 sufferers (if that figure is correct – it’s based on US population prevalence estimates) in the meantime have to have something to help them adapt to their lives with chronic illness and disability.

          So attack PACE for being a rubbish study that is full of holes. £5 million to ‘prove’ GET is safe?! Even if you accept the conclusions of the trial (which I don’t by the way), it only applies to 60% of the patient population. In fact less than that as it only applied to adults. So 40% plus children have no approved and/or ‘safe’ therapeutic means to help them make necessary adjustments to their lives.

          And what about those in the adult population whose NHS provision does not offer said ‘safe’ therapies?

          For me the biggest concern about the PACE trial (aside from it being ill-conceived and flawed), was the lack of attention given to the Specialist Medical Care. I mean ‘we’ are all dependent to a greater or lesser extent on our NHS GP’s and Consultants (whatever their discipline). These professionals do more (or they should do), than provide information about our illness – they prescribe medications for goodness sake that allow us to better manage our symptoms. Yet PACE did not reveal anything about this and as a result the trial seemed to imply that such important interventions, when compared to CBT and GET, were irrelevant.

          THAT is where I personally have been focusing my efforts. Without medications to ‘take the edge off’ some of our symptoms, where would we be then? Would CBT and GET (both of which I have tried – the former over my 14 years quite concurrently and have found of benefit in terms of coping with this rather unique illness; and the latter I found to be unnecessary for me as I tend to adopt my own version – as many others probably do as well), be as ‘effective’ without Specialist Medical Care? No of course they wouldn’t.

          But PACE gave little, or almost no, consequence to this form of vital medical intervention – nobody has to date. They is no structure or particular guidance for GPs or Consultants concerning appropriate medications. The best thing I have ever found has been the MEA Clinical Issues publication – I and my GP for that matter. You don’t find the relevant information in NICE or the Map of Medicine; and sufferers do not (as a general rule), all get assigned a neurologist, and are thus likely to be denied medications that might help with management of some symptoms, that are not specifically designed for CFS/ME sufferers – such as epileptic medications.

          So, PACE (even though I agree in principle with the need for rehabilitation along similar lines to other sufferers of different diseases and so, do not and have never, considered some from of CBT and GET to be inappropriate), I do believe has many flaws and inconsistencies. Including the use of Adaptive Pacing, which is nothing like that prescribed for me by most recent Consultant (of Immunology) or by the MEA (of which I am a member).

          Aside from the flagrant breaches of initial objectives and controls within the PACE trial (much, if not all, of which has been disseminated by various more knowledgeable and academic individuals than I, together with representative patient bodies), was published in such a way as to cause great harm to sufferers. The role of the Science Media Centre in this has yet to be addressed to any satisfaction. Once again the media headlines did nothing to help sufferers address the overwhelming feeling that there disease (whatever inappropriate label is applied to it), has validity.

          CBT will be needed more as a result of the headlines and all this ongoing controversy, and not less. If you think that psychology does not have a role to play in the management of this disease, then I am afraid you are mistaken.

          How that CBT is delivered (when there remains evidence that FINE manuals are still being used by practitioners), is one of my biggest concerns. Without facts and feedback from those who are discriminated against during such sessions, including GET sessions, ‘we’ cannot hope to overcome this injustice (if it exists on anything like the scale some suspect). Y

          You have heard the stories, as have I (though personally, and in 14 years, I have never encountered such discrimination or ‘brainwashing’, though you will probably say, I was ‘lucky’, and therefore unrepresentative), but they remain just that – stories, or tales of practitioner bias and disbelief that our illness is anything other than ‘pschological’ in origin. Until these occurences can be properly investigated – prosecuted even – then we will not address this concern among patients.

          Oh dear I seem to have spouted sufficient drivel now to send anyone to sleep. I had better leave it there.

          1. Don’t believe those who wish to deceive you. ME is recognised as neurological, and there is plenty of evidence that is irrefutable.

            Here is a section from Margaret Williams latest article:

            In 1978 (33 years ago), the BMJ published a summary of the symposium on ME held that year at The Royal Society of Medicine:
             
            “ there was clear agreement that myalgic encephalomyelitis is a distinct nosological entity. Other terms used to describe the disease were rejected as unsatisfactory for various reasons: the cardinal, clinical features show that the disorder is an encephalomyelitis….Some authors have attempted to dismiss this disease as hysterical, but the evidence now makes such a tenet unacceptable….The organic basis is clear – from the finding that the putative agent can be transferred to monkeys, the detection of an increased urinary output of creatine, the persistent findings of abnormal lymphocytes in the peripheral blood of some patients, the presence of lymphocytes and increased protein concentration in the cerebrospinal fluid of occasional patients, and the neurological findings” (BMJ 3rd June 1978).

      2. Firestorm,

        If you read the list of references on the discussion bit of the FB page, you’ll note immunological and other pathological abnormalities related to minimal exertion. Dr Lane is a neurologist. His study on muscle fucntion is most interesting. Especially the bit linking some cases to, erm, enteroviral infection. Shhh. Don’t tell the Lancet. They can’t handle such complexites. And then there is Paul et al 1999.

        More neurology: severely affected ME patients may have UBOs on mRI scans, especially in the white matter. See for example, Posner’s paper in Hyde’s book. As King’s etc don’t usually do a MRI, they don’t know who has neurological abnormalities, but symptoms indicative of neuro problems, also found in ME, would exclude them from entry. so those left would be ME patients without neuro symptoms. Not exactly typical in my view.

        1. Thanks Ellen I shall take a look.

          It is the disease ‘benign Myalgic Encephalomyelitis’ that I have issue with really.

          No one has to date proven that that is what ‘we’ suffer from in strictly diagnostic terms. Not enough to validate that as a causal factor at any rate.

          Even the MEA now refer to the ‘E’ in ‘ME’ as Encephalopathy (check the Home page etc. and the reasons for this can be found in their Clinical Issues booklet).

          I think what has happened is that becacuse Encephalomyelitis is the only description afforded by WHO (along with PVFS) as a distinct neurological illness, some are being driven by this fact alone. When in fact CFS and both ‘ME’s’ are recognised as being ‘neurological in origin’ by NICE.

          What needs amending, if anything, is WHO. Amending and updating. However, it will not happen until research proves a link in sufficient number of sufferers labelled with one or all of the cognomens currently in use.

          I just think that in relation to the PACE trial especially, trying to pursue this line of argument, that Myalgic Encephalomyelitis is a definite disease of the nervous system as recognised by WHO, is not the best way to seek redress.

          Maybe part of the MRC £1.5m will be used to more fully investigate whether or not the neurological symptoms are the result of specific and identifiable damage to the nervous system. Part of me hopes it will, but the other part is saying, that this has been tried many times before and failed.

          Is it not therefore time to move on and try to prove Encephalopathy, and in addition call for the WHO to finally, after all this time and effort, recognise our disease for what it might actually be?

          Of course if, as a sufferer, it was proven that I indeed had, Encephalomyelitis (the inflammation of the brain stem and spinal cord), then I would be pushing for, perhaps, recognition of that fact.

          Unfortunately, I (and a great many others – if not the vast majority), have never been investigated to that degree. Even those that have received the necessary scans and inflammation has been observed, is it sufficient to warrant a definite diagnosis and more appropriate treatment of Encephalomyelitis? If so, what specific treatment would they/are they, receiving?

          If the MEA have changed from Encephalomyelitis to Encephalopathy, along with many, many doctors (although acknowledging that many, many more prefer CFS or CFIDS), then who am I to argue? What research is there that has been overlooked or shoved under the carpet, which proves that you or I may indeed have this inflammation?

          Are the observations you have quoted sufficient to validate a diagnosis of Encephalomyelitis? Or is Encephalopathy a far more pertinent description – if a little more general?

          It is a good debate to have, and one I have had many times. Personally, and as I have repeatedly said over the years, the label doesn’t matter to me – the treatment is more important. My current label is ‘CFS/ME’ (that is what, when I was last asked (funny that hey?), by Consultant and GP, I thought best to have on my medical report).

          In terms of PACE what difference does it make? In terms of treatment, what difference does it make? And in terms of my suffering (and the suffering of others), what difference does it make what this illness is called?

          It is highly unlikely, that every one of the 250,000 of us will be all subjected to scans, even if research proves satisfactorily, that there is some identifiable cause to our incapacity. It is more likely, that if some evidence surfaces across a sufficiently large patient cohort (which you might say will depend on the Criteria used for selection :)), Encephalopathy will be even more relevant and will become the parvenu of choice.

          What the treatment will be as a result, who knows? Will it be any different than that we currently receive? As for CBT and GET, both are used for neurological illnesses like Parkinsons and MS etc. and termed ‘rehabilitation’. They are necessary, when and if appropriate, and are embraced by sufferers keen to better manage their illnesses in a structured and supportive environment.

          Hey ho… sorry I do have a tendency to waffle especially when suffering a bad dose of PEM (if that is indeed what it is :)). At least with doing all this I am able to pause and rest between publishing this drivel. We should have a record of how long it takes to post! That would be cool – something to include along with other evidence for the DWP methinks.

          Have a restful day.

          1. Firestorm,

            I see that you and I seem to have very different ideas on ME, CBT etc. There is evidence of ongoing infection so to recommend an increase in activity, even if tired, is potentially unsafe and as appropriate as recommending this to a person with meningitis. You’re clearly not aware of the evidence of ongoing infection. If exertion triggers symptoms, then GET is as appropriate as advising a smoker with lung cancer to increase the number of cigarettes smoked (gradually, ofcourse). From a scientific perspective, GET will be inappropriate for a considerable number of patients (see evidence in list of refs). As for CBT for CFS (there is no protocol for ME- itis or opathy), that too encourages increases in activity on the basis of the behavioural-avoidance model. Research has shown that outcomes tend to be mediated by factors such as increases in self-efficacy, and there are cheaper ways to achieve that then CBT as currently described in the lit. (Which is very different to CBT for Parkinson’s etc, where it is aimed at distress only, not changing the cause). If a ME patient has no psychiatric co-morbidity and their coping strategies are sound, I can see no reason to spend tax payers’ money on CBT based on the avoidance model, let alone GET. We don’t know the cause of breast cancer either, but we know enough to advise tailor-made interventions to try and cure/manage. Same with ME. A multi-disciplinary team seems to me to be best practice.

            I think that using criteria for ME, as opposed to CFS, encephalopathy has been proven. However, we are now also getting evidence of myelitis. And a difference between ME and CFS as currently defined. But as a senior scientist, I think encephalopathy is justified. It’s the myelitis that needs more data.

            There’s 30 plus years of studying for you. You see the complexities, like CBt for cancer is not the same as CBT for ME or CFS as tested in trials. Actually, you don’t need a degree to notice that. Just to take the information from those with the relevant expertise. good, honest scientists. And there are still a few of us around.

  9. The web contains many examples of this woman’s scientific breath as a ‘science’ writer, but an OBE is not exactly equivalent in all respects to an FRS and most of those recipients have the humility to claim expertise in a narrow field. However, being shallow certainly cuts the mustard when vapouring about an area of non-science posing as medicine since it prevents the exposure of a scam to fleece resources for medical science being syphoned off by the psychiatric ‘profession’.

  10. And the MEA’s response – let alone AFME’s (who were quoted as being involved from the outset) – is….?

      1. Thanks JT. I actually meant the MEA’s response to this diatribe (sorry enlightening piece of prose), from Ms. Parry, which was evidently commissioned by Ayme to help pacifcy some rather infuriated members and non-members of their charity, who were less than pleased with the wholesale support they showed in light of the publication.

        I wonder if Ayme would have been so quick to circulate Ms. Parry’s comments if she had determined the Trial to be ‘unfit for purpose’? Hmmm…

        1. Yes, I would like to see that. Does the MEA intend on responding to this article from Parry the suppossed science writer?

          1. Ms. Parry is patron for an ME Charity (ANOTHER ME Charity no less):

            http://www.mesolutions.org.uk/who-we-are/

            Is it any wonder that progress is so slow when so many charities are working independent to one another?

            I mean if someone wants to donate money, the plethora of charities makes a decision difficult, no?

            All these charities with begging bowls… Little wonder that there is such confusion in the media let alone among sufferers…

  11. My sense is that AYME are wheeling in their OBE friends to defend the indefensible. ‘A scientist by training and an enthusiast to her bones’ her website says. Really, who cares what Vivienne Parry thinks?!

  12. An “independent” report from someone who sits on the MRC AND the Science Media Centre panel? Oh come ON! It’s not worth dicussing because it’s so predictable.

  13. Dear Vivienne Parry you seem to be a very opinionated person with a lot to say in defense of CBT and GET .
    CBT and GET are moderately effective for six out of every ten adult patients? Moderatly improved doesn’t sound convincing to me. If I was treating a horse and said he was moderately improved but would the farmer be satisfied or would he get out his gun to put the horse out of his misery?.They are safe but only in the hands of therapists who are properly qualified?
    I would think if you read Kay Guilderdales book about the abuse her daughter suffered at the hands of so called health professionals practicing CBT AND GET there so called safe therapies might make anyone question your deluded ideas.
    I also I feel that your use of cancer to promote your theory’s is very offensive and hurtful.
    I feel you are using cancer as a crude tool blackmailing people emotionally to have your prejudiced unpalatable therapies forced onto them.
    As someone who has had several people in there own family die of cancer my Aunt who tragically died in the 1970s. I find this abhorrent and you should be ashamed.
    My brother has MS diagnosed by experts in a hospital .Maybe you should tell him to stop taking the drugs and run around in the garden waving his arms as a cure.
    .. HIV was also written about by psychiatrists as epidemic hysteria back in 1985 .Why should I think you know what’s right when the psychiatrist and experts got HIV wrong and tried to mislead the public about the danger they were in, they got MS wrong to, They damaged Kay guilderdales daughter’s life and got so much else wrong. Psychiatrist Casper Schmidt died of HIV several years after publication of The Group-Fantasy Origins of AIDS. So what do the you experts know anyway?
    I am disappointed and irritated with your shallow optimistic self centered ideas and using cancer as an emotional weapon is low grade scientific journalism of the worst kind.
    The five million used in the Pace trial was wasted money .It would have done more good burning it in a field .Cancer has nothing to do with multiple sclerosis , so why should cancer be used against ME CFS. I am very upset.

  14. Firestorrm, despite thousands of published studies showing the neurological basis of Myalgic Encephalomyelitis, and despite the (rare) autopsies showing Dorsal Root Ganglionitis, an inflammation of the spinal chord, specifically the sensory nerve endings (Sophia Mirza, Lynn Gilderdale), the strength of the power of the Wessely school is such that we can still read statements like yours. Yes ME is inflammation of the brain and spinal chord, and ergo is an ‘itis’.

    Margaret Williams has just posted another of her quite brilliant pieces, on the PACE study and the unbelievable intransigence of the Wessely school here http://www.meactionuk.org.uk/The-Media-and-ME.htm I quote from that article:
    ‘Ms Parry says: “There are two problems here. One is about science. Research is about coming up with a hypothesis and then trying to knock it down”. This is precisely why the PACE Trial cannot be considered “scientific”. Although the Investigators’ hypothesis that “CFS/ME” is exactly the same as ME/CFS and that it is a behavioural disorder reversible by CBT and GET was indeed knocked down by the results, the Investigators refuse to accept that the trial failed’

    1. As you are aware, I do ‘get it’ Jace. My point is (and the one made above to Ellen), is that nobody as yet can say with certainty who among the huge ‘pot’ of sufferers labelled with CFS, ME x2, CFIDS etc. is actually suffering a neurological illness with proven damage such as you outline above.

      That Myalgic Encephalomyelitis is a ‘real’ disease is not in question. What is (as far as I am concerned), is whether I or you for that matter, actually suffers from it.

      As a label is sounds good. It refers to a ‘real’ illness. It is in the ‘right’ part of WHO. It makes no mention of an illness that might be ‘psychosomatic’.

      I mean if you had a choice (which some sufferers seem to make without evidence), of CFS or MEncephalomyelitis, odds are that those who could be bothered, would choose MEncephalomyelitis.

      MEncephalopathy is probably not as well recognised among the majority of sufferers let alone society, who are more likely to know ‘ME’, i.e. two letters and not what they stand for or actually mean.

      How many people (let alone sufferers), actually know the illness that they have been labelled with suffering from, is neurological in origin? How many really care? Who even gets to see a neurologist or has actual proof of there being a neurological cause to their incapacity?

      When it comes to the advocacy of GET and CBT (and to save effort I am addressing Ellen’s reply above – the system won’t allow me to do it up there 🙁 though it is relevant here as well I think), I do not understand why the two approaches should be any different for sufferers like myself labelled under the umbrella terms of ME x 2 and/or CFS, as they are for other long-term neurological conditions.

      In point of fact, I have found that they aren’t different. Then apparently, I am ‘lucky’ in that these therapies I have received on and off (more on with CBT and more off with GET), were delivered as they should have been.

      I think I raised this point before. I have heard the stories about how CBT especially is administered in a some ‘brain washing’ way, trying to convince the sufferer their illness is not real. But that has not been my experience.

      Similarly GET. However, Ellen points out that it is wrong for GET to be administered on someone suffering Encephalomyelitis. Now I do not understand the reasons for this being the case. With any other neurological condition for which exercise is recommended to enhance the sufferers wellbeing, it is only recommended and delivered in a way that the sufferer can manage.

      PACE did not include severe sufferers did it? There is much wrong with the PACE trial in terms of it being valid and ‘scientific’, however, those that did take part in GET were able to do so, yes?

      My illness fluctuates, it relapses and remits in the short, medium and long term. When in the past I have felt well enough, I have engaged in rehabilitation through exercise either through a structured program or, as has been more condusive to me, on my own and at my own pace. Either way I used exercise – mental and physical – to retrain my body and mind after months or even years of illness and enforced bed-rest.

      Even when in ‘remission’ I am never ‘well’, but (and to use the MEA’s own Disability scale), I am functioning at 40-30% (100% being totally bed-bound). It is a viral infection every time that leads to a severe relapse – just like the one I am ‘recovering’ from now. What I fail to see is how exercise is ‘bad’ for me just because I have a disease that is labelled ‘MEncephalomyelitis’.

      Even for people whose neurological condition is degenerative, exercise and psychological counselling is of benefit. I have (as you know Jace), been going through the neurological review of service provision for Cornwall, and these two therapies are of demonstrable benefit.

      If I am not able to participate in GET or CBT then I don’t. Simple. No self-respecting physiotherapist is going to prescribe a method of exercise that is unsuitable, are they? Patients have rights. My illness requires that when in severe relapse I rest to allow it time to do its worst. When I am like that ‘exercise’ is the last thing I am capable of doing. Even if I was to remain in this 100-90% state, nobody is going to throw GET at me or a method of CBT that tries to convince me that my physical state is the result of my mental state. I would like to see them try!

      Those too ill to are not recommended an inappropriate means of therapy. This sort of practice is legislated against. Fear of it happening is not the same as it actually happening. The PACE trial did not result in any change to NICE Guidelines. A patient has a choice. And that patient, should he or she decide that GET or CBT (or a recommended medication for that matter), is not ‘right’ for them at that time, then they say ‘No thanks’. It does not affect their care or the level of service they can receieve from the NHS. If it does then they have rights to ensure it doesn’t.

      I would like to read any practitioners’ manual that happens to be ‘out there’, if anyone has access. It is perfectly possible that I am living in cloud cuckoo land (as you know Jace it is where I usually can be found).

  15. This feels almost like propaganda. I find it very distasteful that she is introduced as an ‘independent’ when she is not at all. Apart from the associations already mentioned she has/is involved with something called PRiME. Don’t know much about it but TheOneClick group have some very interesting stuff about it and Ms Parry on their site. She’s entitled to her opinions but AYME shouldn’t ship her in like a neutral expressing a considered view.

    It’s almost funny that she can be so patronising ‘this is a bit silly’, when she is missing the point repeatedly. A shocking piece. Both in content and standard.

  16. Jace, encephalomyelitis refers to inflammation of the peripheral nerves and before the two autopsies (quite recent), there was no evidence of myelitis. I confirmed that with Dr Ramsay, who knew the illness very well. There is plenty of evidence of pathology in the brain and of persistent infection, but too little yet to support the myelitis. The term encephalitis usually refers to something else.

    There have been few studies on ME in the past few years (the focus has been on CFS, a broader construct), so some references cited online to support a neurological basis of ME actually apply to CFS or are not specific and also seen in other disorders. One can generalise to ME, but it needs testing at some time. You can’t keep on assuming for ten years. Given the inconsistencies in the lit on CFS, you understand why so many doctors are stull unsure of a neurological basis. In my view, ME presents neurologically, but most cases of CFS do not. Especially when diagnosed using the CDC criteria. It’s not simple.

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