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Chronic fatigue trial results 'not robust', new study says

Just seen this article on the BBC News site - I imagine there will be similar on other sites.

Chronic fatigue trial results 'not robust', new study says

Fresh analysis of a controversial study, which recommended exercise and psychological therapy for people with chronic fatigue syndrome, suggests their impact is more modest than first thought.

The PACE trial found the treatments to be "moderately effective", leading to recovery in a fifth of patients.

But this new analysis finds "no long-term benefits at all".

The authors of the original trial in 2007 said they stood by their findings.

That randomised trial was designed to examine the effectiveness of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis, or ME.

Its findings were positive, but patient groups like the ME Association have always been critical of the way the trial was designed and the way the results were reported.

Goalposts 'moved'

There has also been controversy over the release of data from the trial, with some arguing it should be made available to all researchers for further analysis.

The PACE trial reported that 59% of patients who received CBT and 61% who had exercise therapy had improved overall, compared with 45% in a control group.

When the results were re-examined, after data was obtained under a Freedom of Information request, researchers found that just 20% of CBT patients and 21% of GET patients improved, along with 10% of control patients.

Figures for those who recovered were originally reported as 22% for patients in each of the CBT and GET groups, but this reduced to 8% in the latest re-analysis.

Writing in the journal BMC Psychology, lead author Dr Carolyn Wilshire, from the University of Wellington in New Zealand, said the PACE trial moved the goalposts by changing the way treatment success was measured after the trial had begun.

She added: "Until there is positive evidence to suggest otherwise, the conclusion we must draw is that PACE's treatment effects are not sustained over the long term, not even on self-report measures.

"CBT and GET have no long-term benefits at all. Patients do just as well with good basic medical care."

Modestly effective treatment

The ME Association, which part-funded the new study, said it was no surprise that "impressive claims for recovery following CBT and GET are not statistically reliable".

Dr Jon Stone, consultant neurologist at the Western General Hospital in Edinburgh, said better treatments for chronic fatigue syndrome were needed, or more effective forms of rehabilitation.

"Until we have these, the question is whether it is better to offer a modestly effective treatment supported by data from many other trials, with a realistic discussion of its pros and cons, than none at all."

The three authors of the original PACE trial - Prof Michael Sharpe, from the University of Oxford, and Prof Trudie Chalder and Dr Kimberley Goldsmith, from King's College London, said the new analysis had used only part of the data from the trial.

They also said many other trials and meta-analyses had replicated the findings of the PACE trial.

"In conclusion, we find little of substance in this critique and stand by our original reports."

NICE is currently updating its guidance on the diagnosis and management of chronic fatigue syndrome.

bbc.co.uk/news/health-43490335

[ Edited to add link to newly published paper. Which is why BBC has put a story up today! 22/03/2018 ]

Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT

Carolyn E. WilshireEmail authorView ORCID ID profile, Tom Kindlon, Robert Courtney, Alem Matthees, David Tuller, Keith Geraghty and Bruce Levin

BMC PsychologyBMC series – open, inclusive and trusted20186:6

doi.org/10.1186/s40359-018-...

© The Author(s). 2018

Received: 29 May 2017

Accepted: 22 February 2018

Published: 22 March 2018

bmcpsychology.biomedcentral...

29 Replies
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The PACE authors find little substance in the critique? Bull! Seriously ill ME patients fought to get the data released, one still seriously ill as a result of the effort. The data has been analaysed and the whole trial found to be exceptionally poor due in part to outcome switching during the trial and subjects being considered recovered whilst worse at the end of the intervention.

They are protecting their careers and getting very jittery as they face complaints to the GMC regarding fraud. The PACE trial is used the world over to demonsatrate how not to run a 5 million pound publicly funded study. The authors have little academic support but powerful friends such as the Science and Media Centre that continues to ignore the science but briefs unsuspecting journalists.

Thanks for posting.

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Thanks Helvella. As somone who was diagnosed with CFS/ME so had to endure the horrors of PACE & the awful results they induced....I can only celebrate final recognition that these methods are ineffective. Alleyluya!!!

When I did it I gradually became worse.....week on week, month on month. They couldnt understand it!! Of course once I was diagnosed with Hypothyroidism & treated I improved!! There is nothing more insulting then being told that if you pace yourself and under take a graduated exercise programme you will recover, that it is all in your mind.......they believe it too!! Naturally I baled out of their programme that did more harm then good!!

I wonder how much money has been wasted on this programme......

There is now something simular running re cancer and exercise.......

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Hear! Hear! wavylines! When will they ever shut up about this bizarre and damaging notion? Surely everyone on the planet now knows it's a load of 💩 but apparently there are still 'hangers on' STILL trying to insinuate that we are nothing but lazy, depressed malingerers! Because of this belief being spread throughout the medical profession, I very nearly killed myself! I became convinced I was a failure and a weakling, even though I know that's not really how I am! Oh! it makes me so angry! 😩 x

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The study cost £5 million and CCGs are paying £3-4000 a pop for CBT and GET services from ‘specialist clinics’. Given the legal cases that are surely not far off now a very expensive therapy.

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The type of CBT used in the PACE trial does not use the supportive and encouraging approach that people normally think of when they think of CBT. Instead it is aimed at changing "false illness beliefs" and coercing people into doing exercise they are not well enough to do, on the assumption that people are "thinking themselves ill".

(If you've gone through this then you already know this.)

As far as CBT for cancer is concerned I don't think coercion is involved, nor is there any attempt to persuade people that their cancer is "all in their head" and they aren't really ill.

I'm sure the use of the term "CBT" for treating ME/CFS, which is completely different to "normal" CBT, was done deliberately to frame people who complained as mentally ill attention seekers who just wanted to lie in bed all day. Because for those who didn't realise the CBT was not the "ordinary" type of CBT any complaints about it would seem to be bizarre, and would confirm that people with ME were mentally ill whingers.

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You've hit the nail on the head humanbean ~ a double whammy for sick people who just want to get well! Aarrrgggg !! 😨 x

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Well tis true they do acknowledge you have cancer but there is a perverted logic that if you exercise whilst youre feeling terrible you will feel better. Afraid I went through this one too (havent I be lucky haha!) & my oncologist was lovely telling me people dont get what chemo does. However I well remember the terrible lecture from cancer support & the fliers I was given telling me that those that walk for 30 mins a day have a much lower reoccurance of cancer!!! This when I was all out to move from my bed to the toilet in the next room!!! I even remember a so called support worker on their helpline when I was crying down the phone out of sheer fear due to the extremeness of my symptoms telling me to take a 30min walk and putting the phone down. All heart!

But at least occ health, physio amd psychologist werent telling me to just get moving, setting goals for improvement week on week that you cant hit like with the lovely PACE regime!!!! Modern version of medieval torture......

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Dead people can’t have cancer - I guess they call it a result in reducing it. This is outrageous, common sense gone out the window, guilt tripping really seriously ill people to flog themselves to death trying to force a body, already in the throws of outright war fare against a potentially deadly threat, to waste precious energy on totally unnecessary activity. It is as if we lost touch with reality thinking rest is a crime and compassion is risable. When I was horribly overt with hypo getting a measily 25mcg Levo walking half a mile would take me hours it was far worse than running a marathon. Why is there this obsession with the medical profession to demand the messages to rest from a sick body are overridden for some absurd exercise protocol of no value whatsoever and more than likely highly detrimental to fragile health.

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I may be missing something here, but I'm not sure why the BBC are calling this 'news'. The Journal of Health Psychology published a special issue in August 2017, debunking every aspect of the trial. The editor all but accused the authors of the PACE trial of fraud. Dr Myhill actually has, and is making a complaint to the GMC.

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It is because of the new paper I have now added to the post.

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Thanks.

I haven't yet had time to read the whole thing, but a first glance at the abstract isn't terribly encouraging. The PACE debacle was examined forensically and at length in the JHP last year, but was reported in none of the mainstream media, so far as I'm aware.

journals.sagepub.com/doi/fu...

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This paper builds on those pieces and involves some of the same authors. The battle is still on for the remainder of the data that Prof Sharp seemingly can no longer access, whilst being the lead researcher on a follow up study with the same data and participants.

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Thanks for that. I wasn't aware of these developments.

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Wow didnt know that Hillwoman. And thank heavens for Dr Myhill!!!

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And I wonder if its the same people behind the cancer and exercise trendy approach!!

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The Biophychosocial model (BPS) has permeated the whole of health care. This together with gender bias is why so many people are ignored when they report illhealth, women with issues because we are women and men with the same issues because Thyroid issues happen to women right? They are also trying to paint ME as a women’s issue in the US, another form of gaslighting. They seem to believe in magic wands to wave over a group of patients and all symptoms will go away by simply believing.

We have already tried that!

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I didn't realise that ME was being painted as a "women's issue" in the US. When did that start happening and how is it being done?

I know that ME is being redefined now as a "Medically Unexplained Symptom", rather than a separate entity in its own right. In other words, the powers-that-be are trying to "disappear it", just like they are trying to disappear IBS, fibromyalgia, migraines, painful periods, painful intercourse and loads of other symptoms :

See bottom of page 6 in this document :

jcpmh.info/wp-content/uploa...

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I will see if I can find the links but senior member of important body keeps speaking and writing about it effecting mainly women. It’s like the mythical beast in an odyssey: chop off one head and 7 more appear to counter. Anything rather than acataullly look at the evidence.

Also in USA ME CFS toolkit no longer recommends PACE CBT and GET (their clinical guidance) but they refuse to send out rebuttal of previous guideline so not really concerned. Seems to be wide open for legal challenge from patients harmed.

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Oh Humanbean what an awful document. It actually puts cfs/me under the title of 'Functional somatic syndromes by speciality'

Words fail me.....

Guess if they disappear it they dont have to treat it!! Not that they do now.....

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Yet again, 'experts' who have scant regard for the ill, the very people they have been trained to serve.

They are a disgrace & embarrassment allowing themselves to be manipulated by power & money.

Patient's the world over need to stick together, inform ourselves, help each other & stay away from the medical establishment.

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In my opinion all this stuff about ME and Medically Unexplained Symptoms is happening because governments, and the owners and investors of health insurance companies, find that sick people cost too much and eat into company profits too much.

And if people are never cured of anything, then one of two things happens :

1) People die and stop costing money in welfare benefits and pensions.

2) People live in chronic ill-health, making money for all sorts of groups in for-profit medical systems - pharmaceutical companies, insurance companies that never include pre-existing conditions in the things they cover (or they cover for a severely limited time), hospitals, and doctors.

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And yet there is a similar debate going on in the world of nutrition, insulin resistance and diabetes as pretty much worldwide diabetics are encouraging us to eat plenty of carbs. The science for regular substantial carb consumption is based on pretty shaky ground yet people are being told to keep the carbs and the medication rather than advised to experiment.

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Oh yes, I'd read about that too. I'm a fan of Tim Noakes plus others that question and debunk the "high carbs are good for you" rubbish.

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Indeed. I have just read an article on the Times about this ridiculous "therapy".... A totally useless way of NOT treating patients who have been pushed into a dead end road because doctors are unwilling and unable to make a proper diagnosis simply because they do not PUSH to find the root causes of many ill people, who probably need T3 alone or added to T4, and/or B12 injections, etc. It is the unwillingness of the medical profession to seek what the root causes might be. It takes time and money but LOOK how the NHS mispend money, funding useless projects that actually make patients feel much worse! SO many people deserve to be sacked but being the NHS they won't... a cushy job for life. How can we patients make them understand we are not prepared to put up with such bad medical support?

I was "diagnosed" as having CFS by yet another useless haematologist... She spent 3/4 of the consultation saying I must stop injecting B12 - something I did not come to see her about - nd ignored my symptoms, did not even ask me what my medical history was really,even stating bluntly that "nowdays we don't take any notice of low iron level (when mine was so very very low) it was clear she did not want to help me at all. What a waste of money for the NHS.... such people should never be employed, however the NHS is full of such wasters! Yes they are some rilliant people too, but they are in a lower number. I cancelled my appointment at the CFS clinic and spoke to a so-called therapist, telling her what I thought ot their useless therapies.... she was still trying to sell it, stating that their clinic was one of the best!! Best for what?? If it was not so scary and frustrating I would laugh. But I am angry.

Thanks helvella for bringing this situation into the open.

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Good for you JGBH! It is they that waste the money ~ we wouldn't want to go to these places or ask for help if we were well ~ but they will deny us the correct treatment, then accuse us of in compliance, and expect us to jump through impossible hoops just to 'prove' we're not ill! You're better off sorting yourself out! 🍀 x

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I've often thought that doctors don't care about nutrition, but for one of them to say that they don't take any notice of iron is appalling. Low iron and iron-deficiency anaemia are huge contributors to fatigue. And if the problem is severe enough it can cause dreadful chest pain, tachycardia and heart damage.

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The worst thing is that it was a haematologist who had the gall to say that! I went to see her because I am feeling so weak always exhausted unable to cope with simple everyday tasks. But she was not interested... How shocking is that? What sort of medical service is that? Appalling.... What a waste of money for the NHS .... Unfortunately she is not the only one who is paid well to do a bad job! My problem is still not resolved.... She was the 2nd haematologist I saw, having seen one privately who was so unhelpful and who too wanted me to stop injecting B12! However I refuse to accept his arguments, challenging him and he wrote to my GP that I was SO articulate!!! because I destroyed his arguments. Obviously not used to intelligent educated and aware patients challenging him. He had arranged for another appointment “for the form” but I phoned his secretary to cancel the appointment and said I had been most disappointed by the consultation and the patronising way he wrote about me to my GP! No doubt I put his nose out of joints and the other haematologist contacted him and found out that I was not impressed by him. She has been totally unprofessional and made no attempt in trying to find out was my problems were. What’s wrong with haematologists in this country?? GP said “they are all the same”. By that she meant they waited until the condition became very serious before acting!!! What a disgrace!

If anyone knows of a very good and concerned haematologist please PM me his name and where he works. Am desperate..

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Oh JGBH cant help you with a good consultant but sending hugs & my support. In general consultants don't like intelligent debate.....they like to tell patients not be challenged. Theres a few who welcome it but they are rare tbh. I well remember the battle I had with a cardiologist.....it was very difficult as we had opposing views & neither of us would back down & rather amusingly,I think I can say, we were both hugely relieved when we could stop seeing each other!!! I hope time has him reflecting & something good comes out of it eventually for other patients....

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This is a great resource for anyone interested in following this topic in depth: virology.ws/mecfs/.

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