NICE guideline for ME/CFS is unethical – Dr Diane O’Leary, Kennedy Institute of Ethics | 23 August 2

[Hutan]

For GET/CBT, the answer is yes. I found two (so far) published studies which reported objective improvements compared to a control group.

@joshualevy, if you are saying there are two studies supporting GET and/or CBT that have no fatal flaws, please list them. (In a new thread as we have wandered off topic.)

Are you saying that because there are no sufficiently powered studies supporting other treatments yet, CBT and GET must be correct? That is, are you saying that because Hypothesis Y has not been adequately investigated and proven yet, that is evidence that Hypothesis X must be correct?

The utility of CBT/GET and whether there are any sufficiently strong studies to unreservedly recommend specific biomedical treatments are two separate questions.

The sad irony of your argument is that, if ME had not been captured by those who believe the illness is a result of patients' faulty thinking and behaviour, perhaps we would have had many successful trials of real treatments by now.

 

[Snow Leopard]

The real question (and it is an important question) is this: Why has there not been a single controlled, intervention study published in the last few years that found that GET or CBT did not work? There have been six that show it does work.

Which of them showed it "does work"? Specifically, which used objective outcomes?

If you like unblinded trials with subjective outcomes, then I have a lot of "alt-med" therapies you might enjoy. They all seem to "work"* and have little to no side effects.

*Why is there a double standard in accepted trial quality between psychological therapies and other therapies?

Further on this, none of the PROMS used satisfy best practise - none have been tested for patient acceptability and relevance.

None of the researchers have bothered to measure what patients believe is meaningful improvement. They've simply assumed we care about small changes on subjective questionnaires (some of them mistakenly think that the perception of fatigue itself is the central problem). That is an arrogant mistake on their part, they would have found otherwise if they'd ever bothered to ask.

 

[Molly98]

The real question (and it is an important question) is this: Why has there not been a single controlled, intervention study published in the last few years that found that GET or CBT did not work? There have been six that show it does work.

Possibly because a very influential knight, master of the dark arts and all things cunning and devious, and his round table of psychobabblers, control all the funding, know the right people in the right places and make threatening phone calls if people oppose their belief system or heaven forbid try to follow another line of research. They have quite literally gobbled up all research funds for years, and now they want more for their MEGA bollocks.

 

[Valentijn]

They all show various forms of GET and CBT work, and don't cause serious side effects.

No, the CBT/GET studies are too methodologically flawed to show anything, except perhaps that it's easy to bias a trial.

Actually, I think it would be a great idea to compare all the studies which show that GET/CBT is the best treatment, to all the studies which show that some other treatment is better (any other treatment).

Why? We don't need to prove that there's a better alternative to establish that CBT/GET are useless and even harmful. Though if we look at the long term results in semi-controlled trials, we can see that a lack of treatment is just as ineffective as CBT/GET are.

For GET/CBT, the answer is yes. I found two (so far) published studies which reported objective improvements compared to a control group.

There's a few old ones using objective outcomes - and piss-poor criteria, where baseline data shows a lack of actual disability. Wiborg 2010 shows there is no objective improvement when using actometers.

 

[joshualevy]

There was a BMJ article on how PACE did not support the NICE guidelines usage of CBT and GET - http://www.bmj.com/content/350/bmj.h227/rr-20

I think that if you can not tell the difference between a letter to the editor, and a research result, then there is not much I can do to help you understand. But just to be clear, I was asking for the result of a experiment or clinical trial which shows that some treatment works better than GET/CBT. I'm not asking about letters to the editor or opinion pieces of any kind.

 

[A.B.]

There's a few old ones using objective outcomes - and piss-poor criteria, where baseline data shows a lack of actual disability. Wiborg 2010 shows there is no objective improvement when using actometers.

I know of one placebo controlled trial of CBT for CFS where there was a credible control intervention.

Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial.

Results: Neither dialyzable leukocyte extract nor CBT (alone or in combination) provided greater benefit than the nonspecific treatment regimens.

https://www.ncbi.nlm.nih.gov/pubmed/8430715

Translation: CBT was no better than placebo (the patients taking the placebo believed they had a chance at getting genuinely effective treatment).

 

[Sbag]

I think that if you can not tell the difference between a letter to the editor, and a research result, then there is not much I can do to help you understand. But just to be clear, I was asking for the result of a experiment or clinical trial which shows that some treatment works better than GET/CBT. I'm not asking about letters to the editor or opinion pieces of any kind.

Thanks for pointing out my failings!, sorry i used the wrong word in my post. I know it is not a research piece but it looked to me that someone was trying to point out the same things being discussed here. So I thought it would be useful to see and might lend weight to anything that comes out of this. I had overlooked the fact that you only wanted experimental results in reply to your post. As it is not in line with your request I will remove and refrain from commenting in future.

 

[AndyPR]

Thanks for pointing out my failings!, sorry i used the wrong word in my post. I know it is not a research piece but it looked to me that someone was trying to point out the same things being discussed here. So I thought it would be useful to see and might lend weight to anything that comes out of this. I had overlooked the fact that you only wanted experimental results in reply to your post. As it is not in line with your request I will remove and refrain from commenting in future.

I'm sorry that you felt that you had to remove your post. I felt that it added to the discussion taking place here - joshualevy doesn't get to dictate what is or isn't a valuable contribution, especially when casting judgement in such a rude way.

 

[Wonko]

I'm sorry that you felt that you had to remove your post. I felt that it added to the discussion taking place here - joshualevy doesn't get to dictate what is or isn't a valuable contribution, especially when casting judgement in such a rude way.

I second this

 

[Sbag]

I think that if you can not tell the difference between a letter to the editor, and a research result, then there is not much I can do to help you understand. But just to be clear, I was asking for the result of a experiment or clinical trial which shows that some treatment works better than GET/CBT. I'm not asking about letters to the editor or opinion pieces of any kind.

After initially getting upset about the reply to my post I have calmed down and I'd like to say that I was replying to the thread as a whole which was started by Charles and wasn't just about alternative evidence - there are plenty of other posts on this thread which don't offer links to research papers so I'm not sure why my post was singled out for criticism.

It is a response to a study and there are actually many others there as well. As there are some very critical ones it is good to see who else is highlighting the errors in the study and where additional support might come from if indeed anything is put forward to NICE to highlight the ethical issues as per the topic of this thread.

Before slamming the link you might want to check at the bottom of it where the author has provided a long list of references that he has used. I haven't checked them all out but there might be something that is in line with your request for "experimental or clinical" information. I haven't had the energy to go through them so they might all be irrelevant so apologies in advance if this does increase your opinion of me having little knowledge of what is relevant information and feeling like you might need to explain things to me. Just to address this concern I'd like to say I was a PhD scientist and have written and published my own papers so I am aware of the difference between an experimental result and a response to one. I am also aware that in responding to papers some people do include citations to other work so hopefully there might be something that is of help to you.

 

[docsimsim]

That's not true. Just off the top of my head there was Sandler and Worm-Smeitink in 2016, Wiborg in 2015, Janse, Schroder, and Qure all published in 2017: That's six studies in the last three years. The problem is they all reinforce the NICE guidelines. They all show various forms of GET and CBT work, and don't cause serious side effects. There is plenty of new evidence. The problem is, it all supports the NICE guidelines as they exist now.

As long as studies supporting GET and CBT are published at a rate of 2 per year, and studies showing GET and CBT are dangerous and/or are not the best treatment are published at a rate of never, there is no reason for NICE to change anything.

The real question (and it is an important question) is this: Why has there not been a single controlled, intervention study published in the last few years that found that GET or CBT did not work? There have been six that show it does work.

@joshualevy. But if trials such as PACE's positive results on CBT/GET are due to overinflated recovery figures due to various forms of 'data massaging' (switching outcomes post hoc etc), then doesn't that render their conclusions null and void? I wonder if we were to go through all RCTs done on CBT/GET and ME, we might not find similar bias forming methological errors?

But i think the fundamental problem we patients have is the lax/inadequate selection criteria used in these trials, which means many of the subjects don't have ME but CF which can be psychosomatic and is known to respond positively to CBT/GET. Until this deliberate decades long conflation of ME and fatigue is stopped we are fighting a losing battle it appears.

 

[Valentijn]

But i think the fundamental problem we patients have is the lax/inadequate selection criteria used in these trials, which means many of the subjects don't have ME but CF which can be psychosomatic and is known to respond positively to CBT/GET.

I doubt any psychosomatic disorders exist - at any rate, none are proven. PACE contained a lot of non-ME patients, but long-term results were still null, which suggests that CBT/GET are ineffective for any fatiguing illness.

 

[user9876]

That's not true. Just off the top of my head there was Sandler and Worm-Smeitink in 2016, Wiborg in 2015, Janse, Schroder, and Qure all published in 2017: That's six studies in the last three years. The problem is they all reinforce the NICE guidelines. They all show various forms of GET and CBT work, and don't cause serious side effects. There is plenty of new evidence. The problem is, it all supports the NICE guidelines as they exist now.

As long as studies supporting GET and CBT are published at a rate of 2 per year, and studies showing GET and CBT are dangerous and/or are not the best treatment are published at a rate of never, there is no reason for NICE to change anything.

The real question (and it is an important question) is this: Why has there not been a single controlled, intervention study published in the last few years that found that GET or CBT did not work? There have been six that show it does work.

FINE showed that similar approaches did not work and PACE showed that CBT and GET did not work. The problem is the methodologies used as simply not up to standard. If you use subjective measures with an open label trial then you will get reporting biases especially when different interventions set different expectations. When looking at the more objective measures I think all trials with any reported show no improvement.

NICE should be reviewing things carefully and not falling into methodological traps but perhaps the experts are so shy of being named because they are the ones pushing the bad methodology.

The safety issues are interesting but most trials fail to test them. PACE did about the best job but still failed to measure any patient compliance. Ignoring patient reports of serious harm (including from specialist centers) is not acceptable - taking this approach NICE would still accept Thalidomide for treating morning sickness!

 

[user9876]

@joshualevy. But if trials such as PACE's positive results on CBT/GET are due to overinflated recovery figures due to various forms of 'data massaging' (switching outcomes post hoc etc), then doesn't that render their conclusions null and void?

PACE improved their figures through data massaging as we have seen from the release of limited data. But even then they had positive outcome due to flaws in the trial design.

But i think the fundamental problem we patients have is the lax/inadequate selection criteria used in these trials, which means many of the subjects don't have ME but CF which can be psychosomatic and is known to respond positively to CBT/GET. Until this deliberate decades long conflation of ME and fatigue is stopped we are fighting a losing battle it appears.

I would disagree here the results were poor whoever was selected and a function of reporting biases when looking at the objective measures. They can't claim success for any patient group.

 

[docsimsim]

I doubt any psychosomatic disorders exist - at any rate, none are proven. PACE contained a lot of non-ME patients, but long-term results were still null, which suggests that CBT/GET are ineffective for any fatiguing illness.

But psychosomatic fatigue patients aren't harmed by CBT/GET, the worst that can happen is that it is of no benefit to them. ME patients are harmed by CBT/GET. That's why adequate selection is so important

 

[Valentijn]

But psychosomatic fatigue patients aren't harmed by CBT/GET, the worst that can happen is that it is of no benefit. ME patients are harmed by CBT/GET

So? An ineffective treatment is a waste of time and resources for everyone, even if it's not proven harmful.

 

[A.B.]

But psychosomatic fatigue patients aren't harmed by CBT/GET, the worst that can happen is that it is of no benefit to them. ME patients are harmed by CBT/GET. That's why adequate selection is so important

If someone really has psychosomatic chronic fatigue they need their own treatment for that, not CBT/GET aimed at reversing the false illness to suffer from a neurological disease that involves exertion intollerance. Assuming psychosomatic chronic fatigue even exists and isn't just more nonsense.

 

[anni66]

Given that it is not a usual form of CBT, arguably there is harm to others - it is all geared back to blaming the patient when "recovery" is not at the desired pace( no pun intended).
Effects on self esteem etc can have serious consequences; if combined with certain medications (SSRIs), then potentially disastrous.
If any type of CBT trials utilize the same methodology, then perhaps its efficacy generally is grossly overstated?

 

[Jonathan Edwards]

That's not true. Just off the top of my head there was Sandler and Worm-Smeitink in 2016, Wiborg in 2015, Janse, Schroder, and Qure all published in 2017: That's six studies in the last three years. The problem is they all reinforce the NICE guidelines. They all show various forms of GET and CBT work, and don't cause serious side effects. There is plenty of new evidence. The problem is, it all supports the NICE guidelines as they exist now.

As long as studies supporting GET and CBT are published at a rate of 2 per year, and studies showing GET and CBT are dangerous and/or are not the best treatment are published at a rate of never, there is no reason for NICE to change anything.

The real question (and it is an important question) is this: Why has there not been a single controlled, intervention study published in the last few years that found that GET or CBT did not work? There have been six that show it does work.

But actually NONE of them have showed they work because the methodology does not allow them to show that. That is why there is no new evidence. None of these trials are evidence for anything. Note that none of them are controlled trials in a scientific sense. They have comparators but not controls. Science requires research to have good enough methods to produce actual evidence. If you cannot tell from the research what did what that is not evidence.

So we have no new evidence from the position of having no evidence in the first place for CBT and GET. The tricky part is getting NICE to accept that there never was any evidence.

 

[A.B.]

@Jonathan Edwards do you see any major problems with this one?

I know of one placebo controlled trial of CBT for CFS where there was a credible control intervention.

Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial.


https://www.ncbi.nlm.nih.gov/pubmed/8430715

Translation: CBT was no better than placebo (the patients taking the placebo believed they had a chance at getting genuinely effective treatment).