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"These Dangerous ME/CFS Exercise And Symptom Denial Trials Must Come To An End"

Dolphin

Senior Member
Messages
17,567
The brazenly obvious propaganda campaign launched by the SMC last week to promote the SMILE trial gave far too much credence to what is perhaps one of the most horrifying examples of the inept ethical approval standards. Obviously, the researchers who developed the CBT/GET program used in MECFS clinics have no desire to see their life’s work superseded by the pebble-dashing of a snake oil salesman, but promoting the idea that the Lightning Process ‘inexplicably works’ in some cases is more about damaging the perception of the illness in the minds of both NICE guideline and Science writers. The intent is most likely to implant the thought in ME/CFS sceptics “They’re being cured by the ravings of a charlatan, this proves the disease is based on false illness beliefs and there is no underlying biological mechanism”. The perfect elixir of confirmation bias for the kind of sceptic who is ignorant of their own psychiatric pre-conceptions about ME/CFS.
I'm not sure if this is the reason, but I do agree that Lightning Process appearing to be effective affects the illness' credibility.
 
Messages
2,391
Location
UK
The only thing I would say regarding the statement that SMILE should have been preceded by blinded trials on adults - you can't blind such treatments I don't believe, which of course is all the more reason for needing truly objective measures.

Also, regarding school attendance as an objective measure. I did comment elsewhere that I think it highly possible that some of the secondary consequences of ME could be enough to keep young people away from school, especially as it can severely affect their ability to socialise and "fit in", and join in with what others are doing. Helping kids learn to cope with some of those secondary issues could well account for the improved school attendance. Possibly of some good if it helps them cope better, but if it encourages them to push their physical body too hard and badly crash?!
 

Alvin2

The good news is patients don't die the bad news..
Messages
3,000
Can't read the article but in Narcolepsy the dream analysis/psychological theory was very persistent and refused to die until the disease mechanism was discovered.
 

Wonko

Senior Member
Messages
1,467
Location
The other side.
Given that the participants don't know what LP is all about, it could have fairly easily been blinded IMO. All you'd need to do is train up some fake LP practitioners with some similar style mumbo jumbo, hopefully a bit less unethical and coercive, but just as convincing. then get them to "train" the control group. Even if each arm talked to each other they wouldn't know which was which.
 

Michelle

Decennial ME/CFS patient
Messages
172
Location
Portland, OR
The intent is most likely to implant the thought in ME/CFS sceptics “They’re being cured by the ravings of a charlatan, this proves the disease is based on false illness beliefs and there is no underlying biological mechanism”.

Ah, this makes some sense, I suppose. I've been trying to wrap my head around why Crawley & Co. would do this study. I mean, their form of CBT is not all that different from LP, so I can see why intellectually they would see a certain kinship with it. But the whole point of all these ridiculous RCTs that they do is to give their work the aura of "science." By now trying to give a scientific mantel to something that is so obviously voodoo, it risks people questioning whether Crawley is scientific at all. Poor Ben Goldacre's head must be close to exploding from the dissonance of his personal affinity for Wessely and the BPS group -- to say nothing of maintaining the authority of "Science" over those "anti-science" ME patients -- and a RCT suggesting that NLP is a proper treatment of anything.
 
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Sean

Senior Member
Messages
7,378
Poor Ben Goldacre's head must be close to exploding from the dissonance of his personal affinity for Wessely and the BPS group -- to say nothing of maintaining the authority of "Science" over those "anti-science" ME patients -- and a RCT suggesting that NLP is a proper treatment of anything.
Well Ben Goldacre knows what to do about it.

The question is does he have courage and integrity to do it?

Time for you make your bones, Mr G.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
If, and I mean its not certain, they are trying to change perspective on ME and CFS toward psychogenic causation by comparison to LP then they are playing with fire. First, LP might do better than them. Second, seeing biases in SMILE might be easier, and from there its a short hop to seeing them in the CBT/GET studies. Its similar biases in play.

I regard it as extremely likely that any perceived useful effect is due to bias. The bias in LP might turn out to be worse than the one in this form of CBT. In other words, it might be more successful as bias.

We are far past the point where every study needs realistic objective outcomes. School attendance is only part of it. Assessment of grades and other activities, total activity as measured by an actometer, etc., should be required as measures. What good is attendance if, and this is hypothetical, they go from A students to F students? We need to know about not just participation but quality of that participation, and schools do regularly assess students, its part of education.
 

A.B.

Senior Member
Messages
3,780
These Dangerous ME/CFS Exercise And Symptom Denial Trials Must Come To An End

These clinial trials continue to be done because because they're accepted as evidence. We must get NICE and other authorities to reject unblinded clinical trials with subjective primary outcomes because they do not provide any useful information about the real efficacy of the treatment.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
Yes. It would have been interesting and more valuable if there had been a third arm with a different " talking" approach with a similar explanation for stress response and controlling with breathing etc but without SMC.

I have not fully thought this through, and it may be you can go on thinking about it different ways for ever, but the way this trial apes PACE does seem an obvious unnecessary flaw. As far as I am aware they compared LP with 'SMC' plus LP and 'SMC' included GET and CBT of some sort. But it would have been much more appropriate just to compare LP with CBT/GET to see which was best. That of course would have had the risk of showing LP gave better results than CBT/GET. It would not have been blinded in a strict sense but it would have reduced the risk of a placebo effect due to thinking one treatment was supposed to be 'extra' or 'new' or 'better' because it was what the trial was about.

In fact in PACE 'SMC' amounted to nothing at all, and was used as a baseline comparator for comparing three 'active' treatments. In this case it was not nothing at all, but another inadequately tested treatment protocol.

As Wonko points out, sham arms would have been easy to design for LP since it is so weird and arbitrary itself. Very likely the outcome would be that it does not make any difference what you do as long as you tell the patients they are supposed to say they are better and you then ask them if they are better.
 
Messages
3,263
But it would have been much more appropriate just to compare LP with CBT/GET to see which was best. That of course would have had the risk of showing LP gave better results than CBT/GET. It would not have been blinded in a strict sense but it would have reduced the risk of a placebo effect due to thinking one treatment was supposed to be 'extra' or 'new' or 'better' because it was what the trial was about.
In practice, adding a second treatment is hard, because then the researcher allegiance effects kick in. So this is the observation that a treatment that is trialled as the researchers' "treatment of interest" tends to do systematically better than the "comparison" treatment, irrespective of what the treatment is.

There are probably lots of reasons you get this effect. It could be due to the way therapists are trained, or the therapists' actual beliefs in what they are delivering - which might affect the way they engage with the person, or the subtle hints they communicate about their optimism. It also seems to be the case that when a treatment is used as a comparison for another treatment, it tends to be implemented in a weaker form than when its given as the treatment of interest. So the cards are kind of stacked against any comparison or sham treatment.
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
In practice, adding a second treatment is hard, because then the researcher allegiance effects kick in. So this is the observation that a treatment that is trialled as the researchers' "treatment of interest" tends to do systematically better than the "comparison" treatment, irrespective of what the treatment is.

There are probably lots of reasons you get this effect. It could be due to the way therapists are trained, or the therapists actual beliefs in what they are delivering - which might affect the way they engaged with the person, or the subtle hints they communicate about their optimism. It also seems to be the case that when a treatment is used a comparison for another treatment, it tends to be implemented in a weaker form than when its given as the treatment of interest. So the cards are kind of stacked against any comparison or sham treatment.

Absolutely agree, Woolie. Shams need to be set up in a sophisticated way and it may be beyond human nature to do them really well. You probably need to train up two lots of people who now nothing about the content of the test treatment without telling them whether they are learning 'real' or sham techniques. That of course means you cannot use people committed to the validity of a method and that is hard. However, in this case they could at least have promoted the trial as comparing LP with CBT, with no implications for which was the 'test' treatment. Presumably they realised that that might lead to a nightmare result for CBT. They could also have tested various variations on a theme, like LP without holding hands and shouting or whatever, to test the contribution of component actions. Very likely LP trainers would not realise that they were potentially being asked to take part in a study that might show none of the components mattered.
 
Messages
3,263
However, in this case they could at least have promoted the trial as comparing LP with CBT, with no implications for which was the 'test' treatment.
Yes, this might have worked.

The only way to do it really is to collaborate with researchers who have a professional interest in the "other" treatment. They select and train their own therapists. So it might have been possible to compare it to a CBT programme designed and delivered by CBT acolytes.
 
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PhoenixDown

Senior Member
Messages
456
Location
UK
The only thing I would say regarding the statement that SMILE should have been preceded by blinded trials on adults - you can't blind such treatments I don't believe, which of course is all the more reason for needing truly objective measures.
But you can offer sham treatments alongside the real treatments like they do with sham acupuncture.

I agree that objective measurements are necessary.
 

andyguitar

Moderator
Messages
6,595
Location
South east England
For what it's worth my take on this is that it is impossible to change the way that Dr Crawley and others think about this illness. The solution is to come up with credible scientific evidence that proves the symptoms are generated by an organic process, that it is possible to test for that process and interupt it so as to bring about a cure. So it comes down to funding for research. I am looking into how and where to get that funding and in a couple of weeks will be meeting someone who MIGHT be able to get the ball rolling. So cross your fingers for me.