ME Association press statement about the results of the PACE study

February 18, 2011


“Results are at serious variance to patient evidence on both cognitive therapy and exercise therapy”

This is the response from The ME Association to the results of the PACE trial, which were published in The Lancet on Friday 18 February 2011

An abstract of the paper can be found here: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext

The Lancet press release can be found here: https://meassociation.org.uk/?p=4621

The MEA will be producing a more academic response to The Lancet in due course.

All of the comments below can, if preferred, be placed as quotes from Dr Charles Shepherd, Hon Medical Adviser.

___________________________________________________________________________________________________________________________________

Headline comments from Dr Charles Shepherd, Hon Medical Adviser at the MEA:

“The largest ever clinical trial into the effects of CBT, GET and adaptive pacing therapy (APT) has produced results that are clearly at serious variance from those reported by the largest ever survey of patient opinion on these forms of treatment.

We find the trial results extremely worrying because pacing, in the form that the MEA recommends, may as a result  no longer be offered as a treatment option in NHS clinics. And at the same time, NICE may well strengthen its inflexible and unhelpful recommendations regarding CBT and GET.

We also fear that the way in which the results are already being reported in media headlines – eg Got ME? Just get out and exercise, say scientists – will lead some doctors to advise inappropriate exercise regimes that will cause a serious relapse.

This is not a good day for people with ME/CFS.

They have a complex multisystem illness that requires a range of treatment options based on their individual symptoms as well as the stage and severity of their illness”

____________________________________________________________________________________________________________________________

Additional comments from The ME Association

The ME Association does not accept the over-simplistic conclusions that CBT (cognitive behaviour therapy) and GET (graded exercise therapy) are safe and moderatively effective treatments for everyone with ME/CFS.

We continue to maintain that the results from large and repeated surveys of patient reporting (see additional information below) into the possible value of these two approaches to management provide a far more informed and unbiased view of both their safety and effectiveness in what is a complex multisystem disease with a wide range of clinical presentations.

Equally, we do not accept some of the seriously flawed reasoning behind the use of CBT and GET in ME/CFS.

The use of these two treatments in the PACE trial has been based on the belief that ME/CFS is caused by a combination of abnormal illness beliefs and behaviour, where fear and inactivity can result in physiological changes.  We believe this is wrong.  Firstly because there is now considerable and compelling evidence involving neurological, muscle, hormonal and immunological abnormalities to demonstrate that ME/CFS is a complex biomedical condition which is not the result of inactivity and deconditioning.  Secondly because the vast majority of people with ME/CFS do not have abnormal illness beliefs and behaviour.

The form of adaptive pacing used in the PACE trial is not the same as the model we recommend and which is favoured by the overwhelming majority of people with ME/CFS. The form of pacing advocated by the MEA is not based on the theory that CFS is an irreversible condition and that people rigidly adapt their lives to this fact through the use of a daily diary.

The MEA accepts that CBT can sometimes be of some help to some people who are having difficulties coping with some aspects of ME/CFS. We also accept that activity management, which involves gradual and very flexible increases in both physical and mental activity, plays a key role in any management plan.

But we also feel that far too much time and money has been repeatedly spent on research into CBT and GET over the years and that the time has come to start using these financial resources to discover the underlying biomedical causes of this illness, along with really effective forms of treatment. This is why we welcome the MRC (Medical Research Council) initiative to provide £1.5 million of ring-fenced money for research into the biomedical aspects of ME/CFS.

Background information:

* Our most recent survey of patient opinion on management options, which involved over 4,000 responses, was carried out at the same time as the PACE trial was in progress. The numbers involved exceed those in the PACE trial. Full report available here: https://meassociation.org.uk/?page_id=1345
* Results for CBT: 25% improved; 55% reported no change; 20% made worse (sample size=2137)
* Results for GET : 22% improved; 21 reported no change; 57% made worse (sample size = 997)
* Results for pacing: 71% improved; 24% no change; 5% made worse (sample size=906)
* A similar study to the PACE trial, which was carried out in Spain, and published in January 2011, found no benefits from CBT and GET when compared to standard medical care. Abstract can be found here: http://www.ncbi.nlm.nih.gov/pubmed/21234629
* Physical deconditioning does not seem to be a perpetuating factor in CFS – research abstract from paper by Bazelmans et al available here http://www.ncbi.nlm.nih.gov/pubmed/11200949
* MRC announcement of ring-fenced funding for biomedical research into ME/CFS can be found here: https://meassociation.org.uk/?p=4085.
* A further MRC announcement and press release is due next week.

The PACE trial

* The randomised controlled trial compared CBT, GET, adaptive pacing therapy and specialised medical care.
* The assessments took place in hospitals in Bristol, Edinburgh, Oxford and London.
* The trial was largely funded by the Medical Research Council and cost over £4million.
* The MEA has been opposed the PACE from the onset.
* NICE are currently considering whether they should review their guideline on ME/CFS to take account of the PACE trial results.

MEA contact information:

Tony Britton (press and public relations)
Tel: 01406 370293

13 thoughts on “ME Association press statement about the results of the PACE study”

  1. Thanks for this guys. I very much appreciate the prompt release.

    Will await the details hitting the press and news tomorrow.

    Might have to hide behind a cushion 🙁

  2. Thank-you very much for this prompt response, Dr. Shepherd and Tony.

    I could not agree more that enough tax-payers’ money has now been wasted on these unhelpful trials.

    It is inexcusable to persist in perpetuating the myth of ME/CFS as a biopsychosocial condition, in the face of decades of evidence to the contrary, and the consequent myth that patients with authentic, organic Myalgic Encephalomyelitis can be “treated” with CBT, GET or Adaptive Pacing.

    Who gains by perpetuating these myths? Certainly not patients.

    On the contrary, patients are literally left to suffer and die prematurely.

    The NHS should be called to account and NICE guidelines for the made-up “CFS/ME” must be scrapped.

  3. The £5 million PACE research is about to be published in the Lancet. The patients studied were chosen by the Oxford Criteria, which excludes those with neurological signs. ME/CFS is a neurological disease. Yet they will apply the subjective results of PACE to people with ME/CFS. Welcome to Newspeak, UK.

    The results were assessed purely on subjective grounds, asking the patients questions and recording responses. This method of assessing results is notoriously inaccurate, as people will put a good gloss on things to make themselves and/or the researchers feel better. It would have been simple to use actometers, as in an earlier stage of the study, to provide objective data, but for some reason that was not chosen as a method.

    We have been waiting for these results for some time. It is four years since they completed recruitment. £5 million of ME/CFS research funding has gone into this study, and yet it is clearly fit for no purpose at all.

  4. This is a robust from the MEA, which is most welcome.

    I wonder how the PACE study researchers (and their supporters) will explain their position, when CCC defined ME is found to be caused by an infectious retrovirus ?

  5. Although this response is rather long I feel it accurately demonstrates how NICE guidelines, based on these ethically questionable studies, detrimentally inform M.E. patient care.

    Firstly, with regard to the classification of M.E., this urgently needs addressing due to the confusion often experienced by sufferers when faced with G.P s and Consultants who use varying terms to describe a sufferer’s condition, and whom advocate treatments that are nearly always based in psychology rather than pathology, which means that sufferers wait many years, often reaching crisis point before they receive appropriate medication or other therapies to help relieve their chronic symptoms.

    I soon learned at the beginning of my illness that where possible it was best to avoid any contact with G.P.s and consultants with regard to M.E., I eventually received help from social services regarding care needs and financial support, but 3 years ago my illness deteriorated drastically and so I had no choice but to ask for help; it nearly destroyed me and this is an account of what happened.

    Over the last 14 years of my illness, G. P.s have primarily used the term CFS to describe my illness, which is a symptom, one of many that therefore does not accurately encompass the other symptoms (muscle spasms, neuropathic pain, loss of feeling, ligament problems, cognitive problems, etc). Where CFS does not accurately account for my symptoms, I am told that the remaining symptoms are caused by me having a continual panic attack (a diagnosis from a consultant 13 years ago who made me blow in a paper bag and said that the dizziness I felt proved I that I was having a continual panic attack!), accompanied by the newer term, ‘Widespread Pain Syndrome’. Had I not insisted on seeing a different Neurologist when I deteriorated 3 years ago I would not have been prescribed Garbapentin and an increased dose of Amitryptaline to help relieve some of the symptoms. In order to get that appointment however, I was hauled into my local surgery and put through a humiliating half hour ‘Spanish inquisition’ by a partner of my G.P. practice who asked me to justify my mental health status, asked me to explain to him what the difference between M.E. and Fibromyalgia was; he bullied me, treated me unprofessionally and with total disrespect. He eventually reluctantly referred me, but made it very clear that I was wasting people’s time.

    I believe that G.P.s have prejudiced my care because of the classification of this disease and how it is always associated with psychological problems by the G.M.C., because although the neurologist prescribed new medication, he was not willing to do any further tests despite initially saying that he would; I believe that once he contacted my G.P., the G.P. gave him incorrect information about me with regard to my mental health that then dissuaded the consultant from any further action. What the neurologist did make clear however, was that CFS was NOT to be put on any sick notes since I have a supposedly ‘undiagnosed condition’. It maddens me that after all these years I still have no proper diagnosis and I am left in ‘limbo land’ despite some consultants in other areas having no problems in giving a formal diagnosis. I was then passed back and forth between neurologist and pain specialist while they decided what to do with me, and you guessed it, after the last neurology appointment, I was yet again referred to a psychologist on the premise of attending the pain clinic.

    At the pain clinic I was given a HAD test for depression and it was within normal limits. My first appointment was made for 7pm in an evening; by that time of day I am completely exhausted as it is. I was not seen until 8.30pm; by that time I was in a lot of pain as I need to sit on a completely padded and sprung chair if I am to sit for any length of time, my speech was also incoherent and I was upset because of the exhaustion and pain. The pain specialist’s report to my G.P. was a disgrace; she took my incoherence for anxiety, questioned my account of my background (apparently, I only ‘think’ that I’m a music and film technologist: was I expected to bring my degree certificate?), she queried my HAD score, said that I only ‘think’ that I can’t travel very far, said I would be resistant to any rehabilitation because of my ‘complex history’, said I did not have trigeminal neuralgia (a diagnosis from a maxillofacial specialist in the late 90’s), said that the muscle spasms were based in anxiety and so on and so forth. The only reason I was able to find this out was that the same G.P. who referred me, hauled me back into the surgery for another half hour session to tell me about the contents of the letter (he took great delight in this), and told me that I didn’t have trigeminal neuralgia. I said that I had a formal diagnosis some 13 years or more ago at the beginning of my illness from a maxillofacial specialist who was the original one who prescribed Amitryptaline for this and that I still have problems, but the G.P. said ‘no you didn’t because the pain specialist says you don’t have the it and I’ll print the letter off to prove it’; as if the letter proved anything. If he had bothered to look back in my notes he would have seen why I was initially prescribed Amitryptaline. During that appointment, I told him that NHS Direct had advised me to call an ambulance when I have massive torso spasms as the administering of anal diazipam would help me recover more quickly, but he said that I must NOT go to hospital under any circumstances as I would be wasting hospital beds. It took me up to six weeks to get over these spasms as they crush the muscles so anal diazipam would help me recover more quickly and it would be less painful for me. I was also told by NHS Direct that if I was not allowed to go to hospital I must take 10mg of diazipam not 5mg as prescribed by my G.P. which I did, but because I was so afraid of telling the G.P. about this, I would run out of diazipam before I was due to refill the prescription so I had to suffer until I could ask for more. I was still having counselling at the time via NHS and I was coming to the end of it as I had worked through my difficulties regarding my illness; I showed the letter to my counsellor and told her what was happening with my G.P. and like me she was disgusted. This is just a small example of what we are up against with regard to unprofessional attitudes, abuse and confusion as regards classification and treatments.

    The psychology used against sufferers is even worse. During the second appointment with the pain specialist last year, she said she could offer me a new service called ‘IMPACT’ they were trialling that combined physiotherapy, psychotherapy, and information about coping with pain which she thought I would really benefit from. Firstly however, she said that I would have to see the psychologist for an assessment as this was part of the process. She also told me that I had ‘Widespread Pain Syndrome’, but when I told her that her diagnosis did not explain the muscle spasms, loss of feeling, exhaustion and sensory problems, she just dismissed me out of hand. I was about to lose my work due to the new more severe symptoms and so I didn’t dare refuse the treatment because I was afraid that a refusal to engage with therapies may affect any future benefit claims.

    I returned a third time for the psychology appointment. During his ‘assessment’ he informed me that all the coping mechanisms I had used in the past (self help, professional counselling, and CBT via ‘moodgym’ online) and all the advice I had been given by various medical professionals, had been absolutely of no use to me because I still had bouts of depression and I was still in pain. I said that I had bouts of depression when my condition deteriorated, which I felt was only natural and that I always recovered, and that up until I started to have massive spasms I had learned to cope with the continual pain. He said that if I would agree to attend a 2 day a week program he thought he could help me transform my life for good. He said that at these sessions they would intentionally cause me to have spasms and I would have to go through a lot of physical pain. Immediately I said this would be impossible as I could barely spend an hour or two away from home without becoming very ill, attendance 2 days per week accompanied by the physical stress he said I would be put through could see me seriously incapacitated for months afterwards. He said that I wasn’t going to be forced to do it but then asked if I would be prepared to have 8 psychotherapy sessions at the same clinic instead as he felt I would benefit greatly from that; I reluctantly agreed. Meantime I looked up some information about the psychologist, and he and his colleagues had been developing the ‘mindfulness’ techniques which is quite new to psychology. It seemed like a good approach to illness so I decided I would fully engage with the psychologist at the next session.

    During the first psychology session the psychologist really upset me, bringing up past matters and intimate details about my life that I had really moved on from, but he said it was necessary to bring it all up so I trusted him to do the right thing. I told him I was afraid that after he had brought up all these things he would then abandon me just at the point that I would probably need more therapy, but he reassured me that he was committed to helping me cope with my illness and would see me beyond the 8 weeks if necessary. He gave me a few things to work on for the following week, which I duly followed and I felt really positive about the next session. The psychologist came across to me as a caring individual who really wanted to help me.

    The following week at the second session everything changed. After asking me how I had been and talking generally for 10 minutes his attitude suddenly changed, he pushed my file away from him on the desk and told me he could no long help me unless I was willing to attend the 2 full days per week originally offered (I am aware that psychologists use this method of suddenly changing tack to elicit certain actions from their patients). I reiterated that this was impossible, but I asked him what happened at these sessions. I was told that mornings were spent in the gym exercising and afternoons in lectures concerning pain management and the psychology behind pain. I asked him if he would accept me coming and then going home as soon as I became ill; he said no. I told him that research shows that exercise can be detrimental to sufferers with my condition, but he said that HIS research superseded ALL other research and only HE could help me: NOTHING else would work for me he said. He told me his research was proven to make people less disabled and could even cure a condition. I told him I was too ill to attend such a clinic and people who were as ill as me just wouldn’t be able to do the course, so it followed that his research was skewed. He said people in wheelchairs were even attending, but I repeated that they couldn’t suffer the same symptoms as me because they would be very ill by the end of the first morning. He then said that if I wouldn’t attend he would cancel the rest of my psychotherapy sessions and any contact with the pain clinic; I said no and so he cancelled them.

    I was totally shocked at how he had firstly ‘messed me up’, and then tried to manipulate me into attending by denying me any further appointments at the pain clinic. I worry now that should my pain medication need further attention, I will not be allowed to access a pain specialist. I was also disgusted that this man and his colleagues, who are connected to a well known university that supposedly specialises in the care of M.E. and Fibromyalgia sufferers, are literally running pain specialist clinics and working up a model that will likely be adopted by the NHS. If you thought GET was bad, then this is a whole lot worse as it is based on ‘research’ that states that ALL other research and treatments are now invalid.

    Meanwhile, on top of all this, the G.P. hauled me into the surgery again to demand to know why I had applied for funding for the transport costs involved with attending this clinic when I could easily catch the bus. I told him it was impossible for me to use public transport as it was a two-bus hour-and-a-half trip and that I couldn’t even use buses for short trips now. He said that I wasn’t disabled as I only walked with a stick and that I am expected to catch the bus. I told him that over the last 13 years, whether at work or periods when I have studied at university, I have always been granted transport letters from G.P.s, that I use a wheelchair for anything further than walking from his reception to his office and that I have 28 hours care per week from the local authority so I am in fact chronically disabled. He said he was totally shocked by what I had just said, but he would have to have a long hard think about it as I did not fulfil the criteria. So he made me sit in silence for 5 minutes while he looked into space to think. He finally agreed but said he was very unhappy about it. It was the ‘straw that broke the camel’s back’ for me.

    It took me 6 months to recover from the psychologist’s manipulations and the abuse from this G.P. I had to use the anxiety and CBT therapy packages again via ‘moodgym’, and used self help sites for many months afterwards. It was enough to push me completely over the edge. I had self harmed as a youngster and after a particularly nasty session with my G.P. when he was refusing a referral, after nearly 30 years, I had started to self harm again and it was becoming out of control as my wounds were regularly becoming infected. I also turned to alcohol for relief, drinking myself into oblivion every night and I put on 3 stones in weight because of it, which exacerbated my illness as it was harder to walk with the extra weight. I was determined to find a balance however and worked really hard to combat this mental deterioration. Recently, I plucked up courage to move to a different G.P. (I had not dared whilst the contact with consultants was ongoing) and I’m happy to say that for the first time for a very long time, I feel like I’m developing a good relationship with a doctor who is objective and caring, but I am very concerned that the previous G.P.s attitude toward me has prejudiced any further help from any consultants. He is a partner in my practice, so funding matters will now go through him with all the NHS changes, so I know he will block access to any further treatment. I looked into making a formal complaint, but I know other people who have done so at my surgery and the surgery have just removed these people from their lists. Other surgeries are too far away, and from all accounts are even worse than the one I already attend. I still self harm but it is under control so I have not had to dress any wounds for some time now; I have also lost some of the weight as I have gone back to drinking on just two nights per week. I dare not even tell the new G.P. about the mental distress I have been in case it goes onto my records providing further so called proof that my illness is anxiety based.

    Finally, I know I have gone into quite a lot of detail here about my treatment (and this only covers the last 3 years not the other 12 when I was also subjected to many humiliations), but I hope it demonstrates how utterly distressing it is for sufferers to not only cope with their ever deteriorating health, but to cope with supposedly professional people who use every opportunity to psychologically batter them into submission. Nevertheless, these professionals are informed by the guidelines provided to them by NICE, so it is hardly surprising that these abuses occur: it will not change unless the G.M.C. takes affirmative action to adjust these guidelines based on available medical research so that the next generation of G. P.s can be educated appropriately, and not as at present whereby they are provided with subjective and dangerous theories from psychologists that informs current medical care for M.E. sufferers.

    It is nothing less than a disgrace that progressive governments have failed to influence such change despite WHO’s classification of the disease.

  6. Kermit Frogsquire

    PACE trial fraud – One of the biggest problems with the PACE trial is that they used the Chalder fatigue scale. Supposedly baseline average for patients was 28 in the trial, near maximum scores – this is utter nonsense as only severely affected ME patients should score such levels. This of course meant that no one could score higher no matter how ill they were made by CBT and GET. The scale was designed to record only the benefits.

    As we can see from the MEA survey, some patients feel they do benefit from CBT and GET, however many more are either not helped or feel much much worse. Given that the standard deviation for final follow up at 52 weeks is so large, it is clear that the benefits were the result of a minority of the patients.

    The Chalder fatigue scale is not suitable to adequately rate the effectiveness of any therapy. Had we forced the patients to run marathons and they had all been hospitalised the result would have still been 28. Are we to conclude from this that running marathons is not harmful for ME patients??

    Of course not – the conclusion is that the Chalder fatigue scale is utter garbage and it is that which has been used to base most of the conclusion of the paper. The Chalder scale uses questions such as “do you feel drowsy” and “do you feel like doing something.” Most of these emotional questions result in the variance seen in studies as ME patients routinely reach top marks on pain and other such physical measures.

    The best way to assess the effectiveness of a therapy is to start everybody regardless of level at 5 on a scale and ask them how they generally feel compared to baseline – 1 for terrible – 10 for cured.

    For further reading on the Chalder scale please see –
    http://www.iacfsme.org/BULLETINFALL2008/Fall08GoudsmitFatigueinMyalgicEnceph/tabid/292/Default.aspx

  7. Kermit Frogsquire

    From the above article :

    “A more detailed analysis revealed that 86.8% of the items on the physical fatigue subscale received near maximal scores using both Likert and bimodal methods… revealed a low ceiling effect (24, 25)….. This may present a problem in clinical trials, since those with a maximum score at baseline will not be able to record an increase in fatigue during or following treatment.”

  8. The PACE trial is bogus science, nicely timed to dovetail in with the coming Incapacity Benefit review.
    It provides the “evidence based science” to show that sufferers should not listen to their bodies (pacing) but can safely be expected to return to normal activities.

    On this pretext benefit can be denied.

    What an egregious abuse of the scientific method in the interests of political expediency.

  9. Thank you, Charles and Tony, for continuing to fight for those of us who have little or no fight left in us.

  10. What strikes me this morning is the similarities between the way this PACE study and the way the Dec. 20th Retrovirology “Contamination” papers have been reported in the media.

    In both cases, the dramatic headlines (Exercise is the Best Treatment for ME : XMRV is “Contamination” say Scientists) were in no way backed by the papers they were reporting.

    Which brings us to the Science Media Centre and its control of the press. Does Dr Shepherd have anything to say about the media bias the SMC create?

    In the end, both of these spin campaigns may be own goals. They are both easily refutable, and may well help people in a position of power to realize just what we have been dealing with all these years. Conclusions in the headlines that are not backed up by the facts.

  11. The press have failed to mention that the PACE trial was partially funded by the DWP.

    The government want people off sickness benefits and the use of this particular type of CBT which denies people have a specific disease and can get well by increasing their actvity and exercising is being used for political means.

    Funny that 7 countries won’t accept our blood donations within a year or so of the link with CFS and a retrovirus even if a person says they’ve recovered.

    I have the link to the statement in the House of Commons which proves they changed their position for the press statement ahead just before the blood ban implementation on Nov 1st 2010.

    It wasn’t just for our own health, it was as a precautionary measure to protect the blood recipients. Thank you to the MEA for posting the emails from the DoH confirming this too.

    Patients with genuine ME require help in the form of benefits and/or critical illness/disability insurance payments, biomedical research on the aetiology, pathology and treatments that tackle the immune system problems and possible social care for some and then there’s all the possible blood screening, training, educational literature, ARVs and other drugs for life and the expense mounts up.

    Far cheaper to brainwash people into thinking that they’re not really ill and are just deconditioned or just ignore those who don’t fall for it.

  12. The Positive Side to the PACE trials

    Looking On The Bright Side I.
    The PACE Trial was originally intended to show the effectiveness of CBT & GET as treatments for ME. What it has done is to prove the opposite – that CBT & GET are virtually worthless as treatments.

    Looking On The Bright Side II.
    Moreover, the trials have pulled the rug out from under the theories that ME is caused by “false illness beliefs” and deconditioning. In fact the PACE fiasco has pretty much exposed the uselessness of the whole approach, and the Psych teams should all go back and crawl under their respective rocks.

    Looking On The Bright Side III.
    The sooner that all these CBT-based ME “Treatment” centres close down, the better. They are doing no good, just absorbing taxpayers’ money.

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