Therapies 'moderately improve' CFS

Where did the story come from?

The study was carried out by researchers from Barts and The London School of Medicine, King’s College London, and other UK institutions. Funding was provided by the UK Medical Research Council, the Department of Health, the Department for Work and Pensions and the Chief Scientist Office of the Scottish Government Health Directorates. The study was published in the peer-reviewed medical journal The Lancet.

What kind of research was this?

This randomised controlled trial investigated the effectiveness of three different therapies for treating CFS when used in combination with specialised medical care (SMC) provided at a specialist care centre. The three different therapies were cognitive behavioural therapy (CBT), graded exercise therapy (GET) and adaptive pacing therapy (APT). The control condition, against which they were all compared, was SMC alone, without any of these therapies.

A randomised controlled trial such as this is the best and most reliable way of assessing the effectiveness and safety of different interventions. This particular study has some strengths, including its large size and long treatment duration (one year). It also has some limitations, in that the groups could not be blinded to their treatment and the outcomes were rated by the participants themselves, which could have introduced bias into the results. Also, the longer-term effects of the treatment, beyond the duration of the trial, are not known.

What did the research involve?

Between 2005 and 2008, 641 people with CFS were recruited from six specialist CFS clinics in the UK. All participants met the Oxford diagnostic criteria for CFS where people with psychosis, bipolar disorder, substance misuse, an organic brain disorder, or an eating disorder were excluded but where depression and anxiety were not necessarily reasons for exclusion. The researchers say that participants meeting the international criteria for CFS and the London criteria for myalgic encephalomyelitis were separately analysed in subgroups. The average age of the participants was 38, 77% of them were female and 93% were of white ethnicity.

Treatment was given over 12 months, and participants were randomly assigned to receive one of four treatments:

Specialised medical therapy (SMC) alone (control treatment)

This was provided by a doctor with specialist expertise in CFS and involved education, advice and symptomatic medications as required (for example, to treat pain or insomnia).

SMC plus cognitive behavioural therapy (CBT)

The aim of CBT, the authors described, was “to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability”. This involved strategies such as establishing a healthy sleep-activity-rest pattern, addressing any fears, problem solving, and the participant working with the therapist to gradually increase physical and mental activity.

SMC plus graded exercise therapy (GET)

This established the person’s physical activity level and then gradually helped them increase this towards the target of 30 minutes of light exercise five times a week.

SMC plus adaptive pacing therapy (APT)

This aimed to “achieve optimum adaptation to the illness”. The researchers helped the person to prioritise, plan and pace their activities so that they avoided fatigue. As the researchers say, this intervention was more of a “pilot” treatment, for which treatment manuals are not currently available.

The researchers’ main outcome of interest was the participants’ own ratings of how they felt after 12 months of the therapies. These included fatigue levels as measured on the Chalder fatigue questionnaire (score range 0–33, lowest score being the least fatigue) and physical function on the short form-36 physical function subscale (score range 0–100, highest score being best function). The participants knew which treatment they had been receiving, but the statistician analysing the outcomes did not.

What were the basic results?

Thirty-three participants (5%) did not complete the study, but there were similar drop-out rates between the four groups. At the beginning of the study, the groups had similar physical function and fatigue scores (average score in all participants was around 28 for fatigue and 38 for physical function).

After 12 months, the CBT group had average fatigue scores that were 3.4 points lower than those in the SMC alone group (95% confidence interval [CI] 1.8 to 5.0 points). Fatigue scores in the GET group were 3.2 points lower than the SMC alone group (95% CI 1.7 to 4.8). There was no difference in fatigue score between SMC and APT groups.

The CBT and GET groups also demonstrated improved physical function scores. Compared with SMC alone, average physical function scores were 7.1 points higher in the CBT group (2.0 to 12.1), and 9.4 points higher in the GET group (4.4 to 14.4). There was no difference in physical function score between SMC and APT groups.

There were similar numbers of serious adverse events or serious deteriorations between groups (including death, hospitalisation, severe disability and self-harm). These occurred in 1% (2 out of 159 participants) of the APT group, 2% (3 out of 161) of the CBT group, 1% (2 out of 160) of the GET group, and 1% (2 out of 160) of the SMC group.

How did the researchers interpret the results?

The researchers concluded that CBT and GET can safely be added to specialised medical care to “moderately improve” outcomes for CFS. They say that APT is not an effective addition.

Conclusion

This well-designed randomised controlled trial was carried out using established methods and was rigorously conducted. Its strengths include its large number of participants, the fact that all participants met standard diagnostic criteria for CFS, the reasonable duration of the trial to assess the effect of treatment (one year), and the fact that only a few people (5%) were lost to follow-up.

The trial provides evidence that cognitive behavioural therapy and graded exercise therapy, in combination with specialised medical care, give greater improvement in physical function and fatigue scores than specialised medical care alone.

The authors consider these to be “moderate improvements”, which is an appropriate conclusion. Compared with specialised medical care alone, CBT plus specialised medical care improved fatigue scores by 3.4 points on a 33-point scale, while GET plus specialised medical care improved scores by 3.2 points. Physical function score improvements were 7.1 for CBT and 9.4 for GET on a 100-point scale.

It is also worth pointing out that everyone in the trial received expert care for CFS at specialised care centres. It is unclear how effective CBT or exercise therapy combined with standard GP care would be.

The study has some limitations, however, including the fact that the longer-term effects of these interventions beyond one year are not known. It must also be noted that participants in this trial could not be blinded to which treatment they received. As outcomes were rated by the participants themselves, this could introduce bias. For example, if the participant believed the treatment would be helpful or not, this could have an effect on how they rated their health before and after the treatment.

This trial supports the potential role of CBT and exercise therapy as additional treatments in the care of people with CFS. As stated in an accompanying editorial, further study is now needed to identify how such therapies can be most effectively used in combination with optimal medical care.

Dr Fergus Macbeth, Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, 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.”

Amended: May 10 2011

Chronic fatigue syndrome (CFS)

Dr Charles Shepherd, medical adviser to the ME Association, and who has ME, describes the symptoms, diagnosis and treatments for ME, also known as chronic fatigue syndrome.

Comments

30 Comments about ‘Therapies 'moderately improve' CFS - Health News - NHS Choices’

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Comments are personal views. Any information they give has not been checked and may not be accurate.

garch2010 said on 26 February 2011

I think maybe the issue is with honesty. If the UK medical establishment put their hands up and admitted that cfs/me:

1. given all reasonable evidence, is a neurological disorder
2. a disease that is poorly understood by current medicine
3. that CBT GET would not discourage other lines of research or adversely influence funding into the organic causes of cfs/me
4. that CBT GET is a stop-gap intervention whilst research is in progress into the organic causes of cfs/me
5. that CBT GET in no way implies a psychosocial cause of cfs/me

then maybe people would respond more favourably to CBT GET. The problem is that if the UK government and it's agencies admit it is not psychosocial (all in the mind), then the flood gates would open with respect to insurance claims against private insurance companies and welfare claims against the department of work and pensions. Claims on this scale could cause the failure of insurance companies and the government knows this. It is these conflicts of interest and the lack of official recognition of the WHO guidelines that get peoples backs up.

A nightmare for

Honeyandlemon said on 26 February 2011

Hello everyone,
I’ve never posted anything on a site before but I think you are right -that this trial is so important it gives people with CFS/ME a chance to have a sensible discussion so that people will listen.
My family’s life has been turned upside down since my husband was diagnosed with CFS/ME several years ago and I could fill pages with stories of its effect on every part of our lives. However, he has a supportive GP and we live near a recently established specialist NHS centre. So, after spending (wasted) hundreds on all sorts of ‘treatments’ he was seen by a doctor at a specialist NHS clinic and referred to someone properly trained in GET.
Everyone was professional, sensitive and most importantly understanding of his experience. We were quite nervous about GET because we’d heard some real horror stories, but he went to the first appointment, was reassured, and after that he made huge improvements which have turned our lives around. I also know someone with multiple sclerosis who tried GET after a really bad relapse. Of course it didn’t cure her MS but she can now walk further than she ever dreamt possible.
I would like to think everyone who might benefit from the treatments in this trial could be referred by their GP to have the sort of service we received. I hope this study will make people realise that ME can improve and we need investment in more services.

Hi Pp9144....

I too suffer from cfs/me. I am a professional, but not in medicine. About 6 years ago I contracted a nasty virus and have never been the same since. I have spent much time getting up to speed on neuroendocrinology, etc as I do not like to be at the unsympathetic mercy of poorly informed primary care doctors. I have been to my GP twice and I will not go again. I am hanging onto my career by my fingernails.

I'm posting here because it is a high visibility site. Medical professionals and the Press won't bother looking at cfs/me sites and forums. But they will look here.

It is important to use "their" language as they will more likely take notice. Using emotive non scientific language will just make them switch off, they will just think "yup, just confirms my suspicion that these guys have a mental illness". The more irrational the language, the more it will confirm their skewed views.

Remaining calm and objective is critical to the debate. The more we argue the case on this basis, the less they can accuse us of a psychosomatic illness. The more emotive and irrational the language, the more we play into the psychiatric lobby view of cfs/me. It is hard at times, but essential if we are to move the debate from the psychosocial model of cfs/me to the organic model.

User532728 said on 26 February 2011

Surely this is a forum for patients and their carers/families etc? Surely also 'professionals' from specific disciplines have their own peer reviewed forums where their colleagues with similar training and professional backgrounds can digest and comment appropriately on any views expressed. Are your voices not heard amongst your fellows ? Why is that ? The general public are not in a position to make judgements on such specific view points.

garch2010 said on 25 February 2011

It is clear that CBT GET help some. That is not the issue here. The issue is about the integrity of the science in the study. As I've said before I am a professional statistician. I could easily demonstrate the full moons are very highly correlated with affective state e.g depression. Depending on how I choose to sample the data, in other words what I choose to include or exclude has a material bearing on the results. This does not mean that a full moon "causes" a bad mood, it just means my choice of statistical techniques, sampling and null hypothesis testing were poor. The point is that the science was of poor quality. Don't just take it from me, read this letter to the Lancet from an Emeritus Professor of Medicinal Chemistry:

http://www.meactionuk.org.uk/Hooper-response-to-PACE-Trial-Press-Release.htm

User532728 said on 25 February 2011

Please note that my comments have been posted in reverse order (Parts 1 - 4) so please scroll down then back up. Sorry.

AdPart 4
It seems to me that the PACE trial has not said that it has found a cure. It has clearly helped a number of people. GET has definitely helped me, I would recommend it to anyone-but make sure you really get GET from someone properly trained. This point is important because I wonder in the AFME survey how many different versions of GET people had received?
Finally I believe that it is time to move towards reconciliation between patient groups and the medical profession. Something is clearly wrong when medics have death threats made against them. I know how much anger comes with this illness, how vulnerable you feel how difficult it is assess peoples intentions when you have had extreme fatigue for month after month after month. I can see also how easily this anger this energy can be harnessed and how destructive it can be. Lets all use this to move forwards to work together to help those who can be helped with the knowledge we have now and lobby for more funding for more research to get to the bottom of this illness so that we can all be helped, so that we all the cured.

Part 3
I understand full well the history of this illness and the controversy surrounding it. I believe in a healthy opposition that challenges and questions in a healthy open debate. My experience of these forums over the years (and this is the first one I’ve posted anything on – I was too exhausted before) is that there appears to be a protest body out there with extreme views that will do anything in their power to stifle or prevent anyone that is remotely supportive of ‘mainstream’ medical treatments from having their voice heard. Previously I have seen postings that immediately challenge the diagnosis of people who have posted comments – saying for example that they couldn’t possibly have the illness or that they must be a medic pretending to be a patient. Any dissenting views are shouted down. A post that was removed from this forum stated that this group were ‘fighting for us’ – let me assure you that you are not fighting for me, I absolve you of that responsibility.

Part 2
Almost two years ago I was offered GET again but this time from a qualified and experienced NHS Physiotherapist. My experience was so different and so much better that now I realise that my first experience had been a poor cousin to this. The therapist worked very closely with me. They were at all times sensitive to where I was, my abilities, my limitations what else was happening in my life. They also challenged and encouraged me but never bullied or pushed me too far they were brilliant. I established a baseline of activity and built in a very slow and controlled way from there. If I felt like I was going too fast we pulled back. The process was always very much in tune with me and where I was. Over time my gains increased and became much more robust to a point where I was walking for 30-45 mins 5 times a week whilst maintaining a healthy balance in my week. I met friends at the pub for example and really had the energy to be there to enjoy it. I went on outings with my children and did things in places that both were way beyond my reach previously. All my friends and family noticed how different I was-in their words ‘I was back’. I am not cured but my baseline activity levels are considerably higher I can take a lot of enjoyment in life now, I really can.

Part 1
I have had CFS for some years now. I was diagnosed by my GP and this was confirmed by more than one specialist. Over the years I have experienced how deeply affecting and awful this illness is. My sense of frustration, rage and anger has been extreme at times as I struggled to hold on to any sense of myself and my previous life in a fog of debilitating fatigue where every cell in my body felt exhausted. My career slipped away as did most of my friends and even my family took a distant step back. After very lengthy periods in which I was virtually housebound (I got out to walk to the post box across the road for example) I remember being taken on a short drive in our local area and looking in disbelief at how the world had changed-new shops and even buildings had sprung up. I felt like rip van winkle. The drive was short because it was so stimulating that it exhausted me.
Over time (years) my condition moderated and I took a course of GET from a private therapist-This had short to medium term benefits but was not sustainable. I experienced acute fear when out of the house with my new found energy and stamina (though limited)-fear of relapsing which from experience could come on in a matter of a few minutes. I found ways of successfully dealing with this limiting ‘psychological’ aspect of my illness, an aspect which I understand is shared by many other people with chronic illnesses such as cancer.

Speedbox said on 24 February 2011

It stinks that whoever moderates here is removing well thought out, articulate posts, simply because they disagree with the pace findings. At least three posts from last night have vanished.

If you're going to put up an article such as this then you should allow everyone to respond, regardless of wether of not they agree or disagree.

Whatever happened to letting people make their own minds up?

User532113 said on 23 February 2011

You have successfully increased the one star 'unhelpful' count from 365 to 789 in less than half an hour - what an achievement. Well done to all those out there fighting to prevent those of us who have alternate views from getting a look in or You obviously take your 'war' very seriously.

Will the people who have added more than 300 to the one star count in less than 15 minutes this evening please stop trying to skew every internet forum on this awful illness. I have this illness and am sick of those people who pour bile, score and anger any where where CFS comes up. You have revealed your intention and resources by your ability to skew a survey by so much in so little time. Leave those of us with this illness who wish to make up our own minds and give those a chance who are trying to find ways of helping us do so.

athomeinrwanda said on 21 February 2011

On February 18th 2011 the “Lancet” featured a major new medical trial, reporting that psychotherapy and exercise are “moderately effective” for treating ME. However back in Sept. 2001 the prestigious “Journal of the American Medical Association” had arrived at exactly the same conclusions. We ask, why was it necessary to duplicate ten-year-old American research in the UK, at a reported cost of £5m? To put this colossal waste of scarce resources in context - the entire budget for NHS ME clinics in England in 2003 was £8.5m.

In Jan. 2010 the suicide of ME patient Lynne Gilderdale received saturation coverage in the UK media. There are still thousands of other ME patients like her, housebound and completely neglected by the NHS and Social Services. A generous injection of £5m would go far towards meeting their needs.

It is said that treatments described in the “Lancet” are safe, and can cure some ME patients. However these claims are not actually supported in the published article.

A patient’s return to full-time employment is the most convincing proof that medical treatment has produced a cure. We know that the researchers originally collected information on “hours of employment/study, wages and benefits received”, but for some reason they have not published these figures.. If they have found a cure, what pretext can they have for withholding these highly significant post-treatment employment statistics?

Far from the treatments being safe, they found that with all four approaches being tested, “non-serious adverse events were common”. (Their words). Their two recommended treatments had side-effect rates of 89% and 93% respectively. The real truth is that, until the pathological causes of ME are discovered, NHS doctors are groping in the dark. Patients are being subjected to treatments, very often with unpleasant after-effects, for little benefit.

garch2010 said on 21 February 2011

It seems to me that there is a very great deal of overlap between CFS/ME/FM and Post Traumatic Stress Disorder. The differentiating symptoms being the affective disorder elements. The overlapping symptoms being those of dysfunctional HPA (hypoactivity – common in late stage PTSD subgroups), immune deregulation, autonomic disturbances and pain perception.

To differentiate between affective etiology and non-affective etiology I think it would be better to refer to CFS/ME/FM as Post Insult Adaptation Disorder, or PIAD. Although the word “stress” is a good description as it can describe both an affective etiology as well as an environmental etiology, its use is now highly bound to, and corrupted by association with a range of affective disorders.

Insult is a better choice of term as it does not infer or imply affective etiology. The overlaps between PTSD also imply some type of complex multi-system adaptive failure. In other words the failure of neural, gene expression, neurochemical, neuroelectrical, neurosteroid and hormone homeostasis mechanisms.

I think research could move forward with much greater speed if the researchers could approach CFS/ME/FM from a multidisciplinary, non reductionist and non linear perspective. Clearly the human system is a highly adaptable non-linear system and the notion of a basal homeostatic state is archaic. It’s like comparing the age of determinism in physics with the age of quantum theory. Not all problems can be reduced to a simple set of linear laws, be them in physics or in medicine. The human system will deploy all the body’s mechanisms of adaptation to achieve the optimal state, which is to maximise the survival of our genome with the minimum energy requirement.

Come on guys (medical community), time to step up to the plate. It is okay for a psychiatrist to express an interest and opinion in endocrinology or immunology without endocrinologists or rheumatologists getting upset. Work together!

Bullfinch said on 21 February 2011

This study just reeks of the assumption that M.E doesn't really exist (it's all in the mind, psychological, it's just laziness, etc). "Oh, just do graded exercise" to address this illness feels much like "oh, just go out for a walk and a bit of fresh air, that'll make you feel better" which is basically the ignorant response I've had for most of my time whilst sufffering with M.E.

Why don't they actually ASK PEOPLE WITH M.E what they think? I'm sure most, if not all would say this study and approach is utter rubbish. It's insulting. It feels like no-one wants to actually listen to sufferers themselves.

Whenever I leave the house or do any form of walking (which is the only exercise I can manage), as soon as I get home I fall asleep for hours and I am done for for the rest of the day/evening - not to mention the days/weeks afterwards a relapse this can cause where I'm completely bed-ridden.

Don't even get me started on counselling/therapy...

Rather than rely upon subjective self-reporting measures, which are notoriously subject to bias, would it not be better to use truly objective measures of function:

Such as:

1. Autonomic nervous system performance
[A Matched Case Control Study of Orthostatic Intolerance in Children/Adolescents With Chronic Fatigue Syndrome, Pediatric Research, feb 2008 – Volume 63 – Issue 2]

2. Immune performance, TH1/TH2 responses
[Evidence for T-helper 2 shift and association with illness parameters in chronic fatigue syndrome (CFS), PMCID: PMC3018761]

3. HPA performance
[Does hypothalamic–pituitary–adrenal axis hypofunction in chronic fatigue syndrome reflect a ‘crash’ in the stress system?, Medical Hypotheses, June 2009]
[Model-Based Therapeutic Correction of Hypothalamic-Pituitary-Adrenal Axis Dysfunction, PLoS Computational Biology, 2009]

4. Cardovascular performance
[Impaired cardiovascular response to standing in Chronic Fatigue Syndrome, European Journal of Clinical Investigation]

5. HRV characteristics
[SVM Based Chronic Fatigue Syndrome Evaluation, Bioinformatics and Biomedical Engineering, 2008. ICBBE 2008.]

I guess however these types of testing are outside of the psychiatrists or therapist domain of expertise as they involve the immune system, the autonomic nervous system, the endocrine system and the cardiovascular system.

To use an analogy, is not obvious to the funding body of this study that if you hire an upholsterer, they ‘aint going to look at, or help much with a broken engine and gearbox. They will just blame the problems with the car on the torn car seats.

cinderkeys said on 21 February 2011

I can't add much to what people have said above about the many flaws in this study. Instead, I'll wonder once again if journalism is dead.

We want real investigative reporting. If you continue to print press releases written by moneyed interests, your readership will disappear.

Architectonic said on 19 February 2011

The study (on page 6) claims that a score of 60 on the physical functioning subscale of the SF-36 is "normal". Anyone who is familiar with this metric knows that this is simply not true.

Where I live, the 25th percentile score is 80 and the 75th percentile score is 100!
http://www.health.sa.gov.au/PROS/portals/0/sa-pop-norm-SF-36.pdf

A score of 60 is only normal if you are elderly.

British data is here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1677870/pdf/bmj00022-0017.pdf

Note that the average score for the 55-64 age range was 77.4!

So what this means, apart from the fact that the study reported that at 52 weeks, only 41% of GET and CBT patients reported more than "minimal" improvements, compared to 31% for APT and 25% for SMC. It means that very few patients have normal physical functioning. This means that most patients will remain unemployed after receiving CBT or GET treatment.

The economic costs of this disease are very large:
http://www.dynamic-med.com/content/7/1/6

Only research into the underlying biomedical pathology and the resulting treatments will ever reduce this economic cost.

garch2010 said on 19 February 2011

You may want to take a look at

http://www.revolutionhealth.com/drugs-treatments/rating/provigil-for-chronic-fatigue-syndrome-cfs-cfids-me?page=4&view=treatment

This drug is approved for narcolepsy only. It is very expensive and is not approved for CFS. However, anecdotal reports seem positive. Please remember that there is likely self reporting bias of its success, in other words people who do not respond well will likely not report as such. Its long term side effects are unknown due to the recency of the drug. One theory of CFS is that of mitochondrial dysfunction. This has not yet been proved beyond doubt, although there is some convincing arguments in favour. If eventually this theory gains acceptance then any stimulants or activating antidepressants may do more damage in the long run. There is some reasonably good evidence that neuroleptics, stimulants, atypical stimulants and antidepressants can cause further damage to mitochondria where there is a genetic vulnerability to mitochondria dysfunction. A famous CFS expert in the US has cautioned the use of such psychoactive interventions for this reason, "Primum non nocere", first do no harm.

Never the less, makes interesting reading. Doubtful whether the NICE would ever approve it as it is very very expensive. Rough estimate, it would cost the NHS 3 million pounds every day to provide it to all CFS sufferers. Not going to happen.

Vikki George said on 19 February 2011

I have severe ME (been bedbound for 9 years) like 25% of all people with it, the trial took place over 5 years but didn't include ONE person with severe ME, not one!

Are they really telling me that CBT or exercise will overcome neuropathic bladder and bowel, daily sickness, no ability to walk, a 15 year constant migraine with light sensitivity and flashing lights and all the other neurological symptoms let alone the heart problems, breathing problems, severe pain and everything else ME has brought into my life....

Stitch31 said on 19 February 2011

Highly disturbing is that this was funded by the Department for Work & Pensions and this is a way for them to shootdown this illness as a "fake illness".

I would ask that the next time a study is done, such BIAS is not allowed to be part of it.

Given that the trial was likely statistically biased because (1) there was no double blind control group, (2) the results were based upon self reporting (3) treatment was highly targeted via enrolment to a specialist centre (ie not via normal GP surgery intervention), (4) biased selection criteria and (5) non participation of those that were too unwell to attend - I'm not convinced the results are statistically significant. And I am a professional statistician so feel reasonably qualified to comment on methodology. I think talk therapists are in fear of their profession as more and more "mental" illnesses are being reclassified as organic neuro-endocrine-immune disorders. Soon there will be no "psychosomatic" illnesses left for these guys to apply their "talk therapy" trade to. Just as Freud's theories are now largely discredited, due to advancements in neuroimaging, neuroendocrinology and immunology - talk therapies will largely be relegated to the waste paper basket of history, or at best of marginal benefit.

jane clout said on 19 February 2011

This article discusses The PACE trial, a £5 million study which has caused much controversy since it's inception in 2004. The overdue results are pure spin.

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, 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.

Why did the study design only use subjective measurements, instead of a pedometer or actometer?

Lies, damn lies, and statistics: one of the first things to look out for is the scale. In the graph of the study outcomes, printed in the Lancet, it is expanded by dint of starting the vertical axis at 18 and ending it at 30. The Chalder scale has 100 points. This dramatasizes (to coin a useful word) the "improvement" in the results.

The subjective results were insignificant. Best case was 6 - 8% improvement. That's about £750,000.00 per percentage point.

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.

For one participant's experience, click this link http://www.guardian.co.uk/discussion/comment-permalink/9627125

The real science is in the link below. Eric Klein of the Cleveland Clinic explains how XMRV infection works in the recent Monkey study... http://tinyurl.com/5tcrvpn

laura in oregon said on 18 February 2011

austerity measures, here we come! hey, what say we start calling diabetes "pee a lot disorder". we can teach people to drink less water and they won't have to pee so much. you can't exercise yourself out of a chronic viral illness. get real.

cshepherd said on 18 February 2011

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 ME Association recommends, may as a result be 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 (Independent UK) - will lead some doctors to advise inappropriate and over-enthusiastic 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.

A more detailed response from the MEA can be found on our website.

Dr Charles Shepherd
Hon Medical Adviser, ME Association
Web: www.meassociation.org.uk

Pigminton said on 18 February 2011

It is indeed a sad day for those with ME/CFS. A trial which has excluded those suffering from ME (as per the WHO definition) and has shown some improvement in some of those with the mildest of CFS symptoms is being heralded as they way forward for ALL with ME/CFS by the press at large. The devil is in the detail it would seem. ME/CFS is now used as an umbrella term for anyone with fatigue whose symptoms have failed to have been fully investigated by a cash strapped NHS service. A recent study published by the Newcastle CFS Service showed that 53% of the patients referred in a 14 month period had been mis-diagnosed (J.Newton et al). Why is the only research carried out by the MRC of a psychosocial bias with the intent to develop "treatments" that are designed to modify behaviour and change illness belief to effect cure in Neurological disease? Is it then not surprising that anyone with ME/CFS should be outraged at £5million + being spent in this study instead of being chanelled into accurate diagnosis and Bio-research.

blindedbyscience said on 18 February 2011

Nothing could annoy anyone who understands about CFS more than this complete nonsense of a study. If this result was a pill would it be approved if it barely made any difference? As this treatment is the only one approved by N.I.C.E god help us all. CBT is a complete waste of time. HOw is it possible to give yourself physical targets when the one problem that is causing cfs in the first place is the inability to generate energy.

I wrote a book based on my sons inablity to get better, Blinded by Science. If you hate this study please "like" my facebook page so we can kick this form of treatment into touch now.

The Truth Will Out said on 18 February 2011

"This well-designed study used established methods and was rigorously conducted. The year-long trial..."

What planet are you people on?!

It is almost universally accepted that the design of this study was a disaster. It failed to use a recognised or agreed set of criteria to select patients, and this flexed during the study when not enough patients would stay on the program. There was no control group. The results are anecdotal and there was no follow up. It took a total of six years and £5m of public money to achieve a cost per percentage point of improvement of £750,000.

It has been a humiliation and a failure. It has proven absolutely nothing. The ME Association's research report of March 2010 (referenced in their reaction to the PACE Trial here: http://www.meassociation.org.uk/?p=4607) is of far greater scientific value than the PACE Trial is or ever will be.

KateME said on 18 February 2011

This study is incredibly inappropriate.

Kate Taylor.

Therapies 'moderately improve' CFS

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