PACE Trial : expensive nonsense

Stonebird 


PACE Trial : expensive nonsense


Voices of the people


Please note , this summary is offered as a service to people with Severe ME , who are not in a position to scan the literature. It is offered as a source of information and hope. If anyone objects to their comments being included here, please let me know and I will immediately remove them. Thank you.


On 23 December, NICE deferred its decision on whether or not it will update its guideline on CFS/M.E., pending the results of the PACE trial.

"That the findings of the PACE trial are completely at odds with the patient voice is of grave concern. Treatment for people with M.E. cannot be limited to therapies which only some find effective. Patients need to have a choice of real treatments."   Action for ME


Mike 

A similar study to the PACE trial, which was carried out in Spain by Dr. Joaquim Fernández Solà in “Hospital Clinic of Barcelona”, and published in January 2011, found NO benefits from CBT and GET when compared to standard medical care. The abstract can be found here: http://www.ncbi.nlm.nih.gov/pubmed/21234629
Reply



http://cfsuntied.com/blog2/2011/02/18/pace-and-other-cool-acronyms/




Scríbhneoir páirt-aimseartha



Once again, the CBT/GET brigade are out in force, scoffing at medical ethics and wilfully putting the health, wellbeing and even the lives of millions of M.E. sufferers at risk. A hugely publicised trial, published today in The Lancet, has been claimed to show that the treatments are safe and effective for “chronic fatigue” patients. Another of its main findings is that pacing, the treatment method judged by the vast majority of M.E. patients to ameliorate their symptoms, is ineffective.


These are hugely problematic and troubling claims on too many levels to cover in one blog post. For one, “chronic fatigue” as defined by the report’s authors means the Oxford Criteriafor M.E. This is a hugely inclusive definition which, by design, covers patients with undiagnosed psychiatric disorders and unrelated physical illnesses who do not meet the objective criteria for M.E./C.F.S. Not surprising, then, that one of the report’s authors claimed that “CFS clinic doctors should be trained to diagnose psychiatric disorders”. The report ignores and denies the World Health Organisation definition of M.E. as a neurological disorder (benign Myalgic Encephalomyeltis, WHO ICD-10 G93.3).



http://nighearain.wordpress.com/2011/02/18/the-pace-trial-this-is-not-a-good-day-for-people-with-mecfs/

Clouty



The cohort did not include ME patients (which is a neuro-immune disease) as it was chosen using the Oxford Definition which excludes patients with neurological symptoms.


We selected participants in accordance with Oxford criteria for chronic fatigue syndrome.11 These criteria require fatigue to be the main symptom, accompanied by significant disability, in the absence of an exclusionary medical or psychiatric diagnosis (psychosis, bipolar disorder, substance misuse, an organic brain disorder, or an eating disorder).11
2/ The patients were chosen from those attending CFS Clinics - pwME generally refuse to go to, or drop out early from said clinics, as they offer nothing helpful for someone with an organic disease.
3/ the benefits shown were measured subjectively, when there was an objective measure available, which was used earlier in the study. Why did the study design not include measurement of activity via a pedometer or actometer?
4/ Standard medical care with a consultant will not include anything that we have actually found helpful for ME, as the NICE guidelines preclude B12 therapy, diet supplementation, anti-biotic therapy, etc,. So I'm not surprised that lot did not improve much.
5/ Lies, damn lies, and statistics: one of the first things to look out for is the scale. Here, it is expanded by dint of starting the vertical axis at 18, with that field reduced by over 50%. This dramatasizes the movement in the results.
6/ 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.
Meanwhile, in the world of real science, Eric Klein of the Cleveland Clinic explains how XMRV infection works in the recent Monkey study...http://webcasts.prous.com/AUA2010/html/1-en/template.aspx?section=20&idl=11920&idcl=1&eid=574



http://www.guardian.co.uk/society/2011/feb/18/study-exercise-therapy-me-treatment





Gob987



These so called scientist are trying to trick the public.

The Department of Health in England has repeatedly stated in Parliament that they accept the World Health Organisation’s classification of ME/CFS as a neurological condition of unknown cause (WHO ICD-10: G93.3). Why then does the PACE trial use the Oxford criteria for “CFS”, which specifically excludes those with neurological signs? The existing scientific literature on the neurological disease ME/CFS shows that this disease affects every system in the body and that numerous physiological abnormalities have been documented.




http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



Jane



For £5 million public funding, this is expensive nonsense.

1/ The cohort was chosen from the CFS clinics - people with ME generally refuse to attend or drop out early

2/ The cohort was chosen by first filtering with the Oxford Definition, which excludes people with neurological disease. Myalgic Encephalomyelitis is a neurological disease

3/ The benefits shown were measured subjectively, when there was an objective measure available, which was used earlier in the study. Why did the study design not include measurement of activity via a pedometer or actometer at final outcome?

4/ Standard medical care with a consultant will not include anything that we have actually found helpful for ME, as the NICE guidelines preclude B12 therapy, diet supplementation, anti-biotic therapy, etc,. So I'm not surprised that lot did not improve much.

5/ Lies, damn lies, and statistics: one of the first things to look out for is the scale. In the graph showing overall results, it is expanded by dint of starting the vertical axis at 18, with that field reduced by over 50%. This dramatasizes the movement in the results.




http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



contramundum



I really don't understand how this study even got the go ahead? How can people with a severe neurological illness of which the cause is not known, be helped by these kind of "treatments"? Treatments, by definition, can only be implemented when the cause is known.

Most people with M.E. suffer from post exertional malaise in which the outcome of activity and exercise can cause huge amounts of pain, discomfort and in some cases long term damage.

I suspect that within the cohort chosen for this study, there were many people who don't even have M.E. but probably CFS, which is entirely different, but still of an unknown cause.

What a huge waste of money!




http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



Nicola Karen Reiss 



Oh right, so with two research Master's degrees under my belt, and a wealth of experience teaching and working at universities such as Cornell and UEA, I'm unable to figure out that exercise would cure my illness? I've been sick for 4 years, unable to work for 3. I loved my job. When I first became ill I pushed myself, always believing that exercise was good for me - I did yoga for hours, I walked and walked.... until I was on the point of collapse. Exercise made my condition worse. Far worse. This is no ordinary disease. This study has confused people with minor 'fatigue' problems with those who have the neurological illness M.E. (myalgic encephalomyelitis) as defined in the Canadian Consensus Criteria. The people who ran this study have links to the insurance industry and have much to gain from perpetuating the dangerous myth that 'chronic fatigue' is the same as M.E.



http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread






bullybeef



ME - Myalgic Encephalomyelitis. It would be nice if the actually name of this disease is spelt correctly first!

Recently, this following study regarding the retroviral link to ME/CFS was published and written about it the WSJ: 
http://blogs.wsj.com/health/20.../

Also here is a clip of a brief lecture by one of the researchers from the above study. It is a very sobering listen: 
http://webcasts.prous.com/webc...=

Finally on the PACE trail website they have printed this following disclaimer with regards to GET/CBT therapy, based upon their study reported today: 
http://www.pacetrial.org/trial...

“These treatments should only be delivered by appropriately qualified healthcare professionals, who have received appropriate training and continued supervision in their use. The treatments described were not designed to be stand-alone self-help approaches. No responsibility is accepted by the authors for the application of treatments described in these manuals outside of the PACE trial. The PACE trial team are unable to respond to queries or comments regarding the use of these manuals or the treatments described.”

So, to publish treatment techniques that are only to be used by trained researchers whom were directly involved in the PACE trails is very contradictory. They also openly confess that these treatments are not to be used as self-help approaches; why is that, if their research is as conclusive as they suggest, why doubt the approaches?


To also suggest that the researchers involved in the PACE trails cannot be help responsible should the treatments have adverse effects on patients is surely an ethical issue, and to then close themselves off from making any public comment seems very surreptitious.

Finally, why publish results like, and not present the disclaimer publicly in the article? Surely if there is any doubt in these treatments, it should be written into the publication.
And one last comment to investigate, at the very bottom of the article link below, it lists the institutions whom funded this study. So why are the Department of Work and Pensions involved in the funding? It has been reported that the DWP have never funded any study into any disease ever, so why ME?: 
http://www.thelancet.com/journ...

Answer: If it can be agreed that ME is of a physcological nature, the DWP can refuse benefit payments for a physical disease. It always comes down to costs, and researching, treating, and caring for people with ME would simply be too costly for our government. CBT/GET therapies are the easiest and cheapest therapies to offer.

I hope your paper can investigate and look a little more closely at what lies behind this treatment for a disease that has been listed as a neurological disease, in the same bracket as MS, since the 1960s. If CBT/GET is so successful for ME, why not treat MS patients with it?



http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



chemilyx



How do you think you would feel if you had an illness in which you had little hope of recovery because scientists don't know the cause, let alone a treatment. Your recovery is based on pure chance and time more than anything you can control. Every single day is a struggle for understanding, let alone anything more. As a neurological condition, it affects your body in most ways - it's a completely pervasive illness which affects every ounce of who you are and who you can be. Everything is a struggle. How dare you have the audacity to publish something so badly thought out. Have you ever thought, for a second, about how a sufferer might feel to read this? Try and put yourself in a patient's position and just think, for a god damn second. I hope doing so will make you remove this crap and issue a public apology for it.



http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread
Maldon



The work of real scientists confirm that Myalgic Encephalomyelitis (ME/CFS) is an inflammatory Neuro-immune disease that is not improved by exercise or behavioural modification as erroneously asserted in Backwards Britain.

“These findings are consistent with an activated inflammatory response. Shockingly, the mean QOL (quality of life) scores as regards limitations on physical functioning were very, very low (in ME sufferers), similar to those found in people with AIDS and multiple sclerosis” (Advances in biomedical understanding of ME. Neil Abbot. Vance Spence. InterAction May 2004).


Professor Nancy Klimas University of Miami Medical School, and Director of HIV/AIDS Research Miami Veterans Centre describing ME/CFS:
“…there is a chronic inflammation, neuro-inflammation, and it upsets the whole balance of your systems…the patients become terribly ill…. The immune system is really cranked up; it’s a tremendous amount of inflammation. I think that if doctors could get this in their heads that it’s .. like lupus or one of these really inflammatory disorders…it is that level of inflammation. There’s a tremendous amount of inflammatory stuff going on, and there’s a lot of inflammation in the brain itself”




http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



Katyak



Can't believe an article of this ilk has appeared in the Indy. The Headline is of the sort one would expect in a tabloid paper. And the journalism is unbalanced and sloppy.

The PACE trial had so many flaws in design that, if it were a bridge, it would have collapsed long before the first car even got close to crossing it. One of the many flaws being the (Oxford) criteria used to recruit people, which are so broad they could include about a quarter of the UK's population at any one time (Professor Leonard Jason, an epidemioloist, has published good quality evidence showing the problems and skewed results attained using such vague criteria as the Oxford). Indeed, anyone with a neurological illness was deliberately excluded from the trials and, er, the Department of Health (as well as the WHO) defines ME as a neurological illness. Get your head around that one if you can!

And it was not 640 'severely affected' people with ME - I can't belive the Indy got that wrong. Anyone with severe ME would have been unable to attend the clinics where these trials were run. In fact, the researchers had problems recruiting people to take part, a high drop out rate, and included no housebound or bedbound (ie severe) patients. Please check the details.


This is a day not of hope but of despair for ME sufferers. We have slipped through the looking glass to a world where illusion is reality and reality illusion, where policy-based evidence (for this is what the PACE trials effectively are) replaces evidence-based policy.


The Indy used to be a source of impartial journalism about ME. What happened?







http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread



Lucy Clark



I am truly ashamed of the Independent right now and I cannot even begin to explain how angry the headline makes me and how detrimental it is to those of us who suffer with M.E. I am not one of those M.E. militants who people stereotype as not wanting to get better or refusing to try out treatments. I have tried everything from CBT, NLP & hypnotherapy to a CFS Management programme run by the NHS. None of which have worked. I have had M.E for 14 years and this is the most unhelpful thing I have heard. Pushing yourself to the limits does not help, this is something I have learnt the hard way and although I continue to push myself, it has not helped me to recover and at times has made me worse. The more exercise I do, the more pain I get and I have tried to build it up but once it gets to a point it is too painful to carry on and just makes it worse. Congratulations for giving credit to a 'study' which will only hinder those with M.E's road to recovery.



http://www.independent.co.uk/life-style/health-and-families/health-news/got-me-just-get-out-and-exercise-say-scientists-2218377.html#disqus_thread

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