Science Media Centre publish expert reaction to the PACE Study

March 7, 2011

Press release issued by the Science Media Centre, 17 February 2011

Expert reaction to Lancet study looking at treatments for Chronic Fatigue Syndrome/ME

The study made the first definitive comparison of various treatments for CFS/ME to deduce the most effective treatments.

Dr Alastair Miller, Consultant Physician at Royal Liverpool University Hospital, Clinical lead for CFS services in Liverpool, Independent assessor of trial safety data for PACE trial and Principal Medical Advisor, Action for ME, said:

“Although NICE have previously recommended graded exercise and CBT as treatments for ME/CFS, this was on the basis of somewhat limited evidence in the form of fairly small clinical trials. This trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported. It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.

“It is clearly vital to continue our research into biological mechanisms for ME/CFS but recent ‘false dawns' for example, over the role of retroviruses (XMRV) have shown how difficult this can be. In the current absence of a biomedical model for the causation and the absence of any pharmacological intervention, we have a pragmatic approach to therapy that works and we should use it.”

Dr Derick Wade, Consultant and Professor in Neurological Rehabilitation and Clinical Director, Enablement Directorate, Oxford Centre for Enablement, said:

“CFS is common, and it is vital to know whether treatments proposed and/or used are safe and are effective. Randomised controlled trials provide the best and only reliable evidence on safety and effectiveness of any intervention in any condition. The trial design in this study was very good, and means that the conclusions drawn can be drawn with confidence.

“This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits.

“Research needs to investigate both treatments and factors that increase the risk of developing CFS. However, it is probably more effective to research treatments, and proving a treatment is effective starts to give clues about causative factors.”

Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:

“We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild or moderate CFS/ME. These findings are in line with our current recommendations on the management of this condition.

“We will now analyse the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline. Until then, healthcare professionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS.”

Dr Esther Crawley, Consultant Paediatrician and Clinical Lead for the Bath Specialist Paediatrics Chronic Fatigue Syndrome/ME Service, said:

“All children with chronic fatigue syndrome and their parents are desperate for new research to understand how to treat this condition. The next step is to do a study like this for children to find out if these treatments work.”

Prof Willie Hamilton, GP in Exeter and Professor of Primary Care Diagnostics, Peninsula College of Medicine and Dentistry, said:

“At least half of patients improved with CBT or GET. The study also allays fears that CBT or GET may be harmful. There are a minority of patients who didn't see improvement so the next step must try and find treatments to help them.

“This study matters: it matters a lot. CFS/ME is common, and causes a lot of suffering. Up until now we have known only that CBT and GET work for some people. We didn't know if pacing worked. This caused a real dilemma – especially for those in primary care. We didn't know whether to recommend pacing, or to refer for CBT or GET. Worse still, not all GPs have access to CBT or GET, so ended up suggesting pacing almost by default. This study should solve that dilemma.

“At a patient level, I now know what to suggest to my patients. Almost as important, it sends a powerful message to PCTs – and the soon-to-be-formed GP consortia – that they must fund CBT or GET. NICE proposed that before this study came out – the evidence is even stronger now.”

Dr Brian John Angus, Clinical Tutor in Medicine and Honorary Consultant Physician, University of Oxford and Centre Leader for the PACE Trial in Oxford, said:

“This study is the largest ever done in CFS/ME and as such is critically important. The study should reassure patients that there is an evidence based treatment that can help them to get better and there is no need to worry about harm from the treatment. The other significant result is that looking at different ways of classifying the condition through different diagnostic criteria do not make any difference to the effect of treatments.

“We do not know what the underlying cause of CFS/ME is. There is ongoing research to find the cause, and I have been involved with this, but none of these studies has shown any consistent evidence of cause never mind any rationale for treatment. However in the meantime I see many patients in my clinic who need help with their fatigue. This was a pragmatic trial to help patients while there is no other treatment available.

“It was extremely rigorous. It was large and it was randomised. The study was carefully conducted in the manner of a drug intervention study to not only establish the superiority of one treatment over the other but also to carefully report any side effects or harm from those treatments. Since the treatments were therapies and not drugs stringent efforts were made to ensure the ‘purity' of each treatment and to rapidly report any adverse effects. As a trial this involved a huge amount of checking and cross checking.

“This should mean that GET and CBT should be widely available throughout the country. Despite NICE recommendations I still see patients who are unable to access any treatment for their CFS/ME in their local GP area. Travelling is obviously difficult for patients with CFS/ME. The increase in the availability of CBT therapists for other conditions should be mirrored for CFS/ME.

“The trial was conducted to a high ethical standard. Patients were fully informed and randomised to the different treatments. It was rigorously performed. The study has definitively shown that there is no harm associated with GET.”

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, by Peter White et al, published in the Lancet at 00.01hr UK time Friday 18 February 2011.

To contact the above please contact the Science Media Centre on 020 7670 2980

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13 thoughts on “Science Media Centre publish expert reaction to the PACE Study”

  1. Hmm. Well, the PACE trial (1) was a £5 million publicly funded UK study which has caused much controversy (2,3) since its inception in 2004. Of over 3,000 volunteers, 641 remained to assess the final study outcomes.

    The patients were chosen from CFS Clinics – people with ME/CFS generally refuse to go to them, or drop out early, as they offer nothing helpful for someone with an organic disease.

    The cohort was then filtered using the Oxford Criteria (4), which excludes patients with a neurological condition. Myalgic Encephalomyelitis means painful muscles and brain and spinal chord inflammation. In this study, supposedly on ME/CFS patients, no neuro-immune conditions were tested. Blood tests were carried out, and patients were rejected if there were signs of inflammation indicating organic disease.

    Initial (5) study design stated an SF-36 score of 75 as a test of ‘recovery’. In the final results, this has been reduced to 60, normative for 75 – 84 year olds. Entry criteria were for an SF-36 score of <65.

    Why did the study design mostly use (see next paragraph) subjective measurements, instead of a pedometer or actometer? Actometers were purchased for use, and the original design intended to use them for assessing final results. This was dropped, presumably because the results did not fit the study's preconceptions (1,5)

    The trial investigators did not use objective outcome measures apart from a six minute walking test in which patients in the CBT arm were able to walk an extra 21 metres in 6 minutes (354m) compared to baseline (1) – a distance well below that of healthy elderly subjects (631m) (6).

    Lies, damn lies, and statistics: one of the first things to look out for is the scale. In the graph of the Chalder Fatigue Scale outcomes, printed in the Lancet, it is expanded by dint of starting the vertical axis at 18 and ending it at 30, showing only 12 points on a 33 point scale. This dramatasizes (to coin a useful word) the "improvement" in the results.

    The subjective and objective results were insignificant. Best case was 6 – 9% improvement. That's over half a million pounds per percentage point.

    One wonders what the results would have been if the health of the patients that dropped out after the trial began were also assessed. 96 patients fulfil that category, with 89 "inadequately treated", out of the total of 641, which makes around one third of the cohort not included in the outcomes (1).

    These results are long overdue. We knew they had not got the results they had hoped for. They have made up for that with spin. No surprise.

    Regarding whether this Graded Exercise Therapy is dangerous for people who do have ME/CFS, I know of one patient who was recovering before she was forced to take this type of treatment. Two years later she was dead, and the autopsy quoted ME as the cause of death (Sophia Mirza). I am in touch with another who is still bedbound, four years after referral to a UK CFS clinic when he was moderately affected prior to treatment.

    I'd also like to point out that the CBT referred to in the PACE study is not the same as the CBT given to other sick people, to help them cope with their disease. It emphasizes ignoring symptoms and changing false illness beliefs.

    Standard Medical Care did not include more than providing a leaflet and prescriptions for pain, insomnia and mood alteration. All patients were in receipt of standard medical care.

    Nothing provided by the NHS NICE guidelines is of use in successfully treating Myalgic Encephalomyelitis, AKA ME/CFS.







    For one participant's experience, click this link [url][/url]

  2. Hard as the above may be to read, particularly for some, but maybe not for the majority of sufferers, there are some key points worthy of note methinks.

    Research into biomedical cause must continue – this is reinforced – though the bit about XMRV might inflame a few I suppose.

    That in the absence of an identified cause, something must surely be in place that is safe and provides additional relief.

    Funding for CBT and GET at PCT level clearly identified as a priority for sufferers of CFS/ME as it is for other chronic illnesses.

    Good that NICE commented that CBT and GET was only of benefit to mild-moderate sufferers. Again this underlines that the trial was only aimed at those not suffering severely at the time.

    Obviously, the deriding critique of pacing was not so good. Yet for many severe sufferers and those moving out of this category, pacing is the only thing that helps.

    Presumably, the fact that the pacing used in the trial is not the same as the pacing prescribed by the MEA explains their letter to the Lancet.

  3. Dr Charles Shepherd

    This press release from the SMC helps to explain why the UK press were so supportive of the PACE trial results when they were first published on-line and why there were very few critical comments in the initial press coverage.

    I will be discussing with MEA trustees what action we could take in relation to the SMC because this organisation is clearly not reflecting a range of medical and scientific opinion when it comes to reporting ME/CFS research.

    This is bad science…..

    1. Dr Charles, I see that the patients who took part in the trial were recruited from CFS/ME clinics. This in itself renders the study unrepresentative as not all areas of the UK have clinics. There is no provisions at all for PWME in Cardiff, where I live. In fact, Cardiff University did some research into ME/CFS a few years ago and I didn’t find out about it until after the research was concluded, despite living less than a mile from the university.

  4. ‘The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments.’

    This is utterly shocking, we essentially have a police state for PWME.

  5. ‘‘The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments.”

    ”It identifies that one commonly used intervention is not effective (and therefore should not be used)”

    I feel sick….
    And scared

  6. When is the Government going to hold an investigation into this disgrace? When are they going to replace the biased SMC?

    1. Public funding goes into the SMC through the MRC and NICE, etc. The Wellcome trust puts in £30,000 of the £400,000 running costs, which is above the 5% the SMC claims no sponsor goes above.

      Other funders include the Associated Newspapers Ltd (ANL) including Daily Mail, Mail on Sunday, Evening Standard & Metro, Imperial College London, The Met Office, etc.

      How very convenient. I guess we will have to wait for the official investigation for this to be changed. People with this disease do not stand a chance under such a regime. It is a disgrace! At least MRV’s are going to sort this lot out.

      Another groups that urgently needs to be shut down is BACME.

  7. @charlie

    That’s right pacing is now illegal. I’d forgotten. 😉

    It’s really very scary. I keep finding myself in tears, then I just get so very angry that they are causing all this stress.

    My MP Alistair Darling has at least – after two very long emails from me! – written to DWP to ask why they partially funded PACE. Will be interesting to see what IDS comes up with. As matter of interest, which Labour MP was Sec of State when PACE actually started? Does anyone know?

  8. I find it deeply frightening too. And I simply don’t know how they are continuing to get away with this terrible treatment of ill people. Who is allowing them to get away with it? And for so long?

    What is awful is that they have gone from passive neglect, which was bad enough, to active (and potentially deeply damaging) intervention.

    I would be very interested to know what our legal position would be if we were forced to do things that had been proven to be damaging to us in order to get help that is available to everyone else (insurance, benefits, medical tests). I’m sure a good lawyer would be able to unpick when conditional help masquerades as a ‘recommendation’.

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