• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

GETSET (white) in Lancet 22/06/17

R

RogerBlack

Senior Member
Messages
902
The ethics committee, Research and Development (R & D), and the trial steering and data monitoring committees approved this change (in June 2013) before any outcome data were formally examined.
Click to expand...

Isn't that a lovely phrase.
It might if you were to read it casually read "before any outcome data were examined", whereas the two are about as far apart as could possibly be.
I would assume without checking that the ethics committee involved had a significant number of the PIs in this trial, and PACE-related ones, as well as camp-followers.

Also - how can the 12 month results be unavailable, hasn't it been considerably more than 12 months since the study ended?
One wonders on FOIA.
 
J

John Whiting

Messages
2
I'm not sure what the real quality of life and functionality benefits of this study claim. The programme they received, on quick review, does not seem unduly harmful. The benefits are only those at three months, and do not translate into long term benefits. How less fatigued these patients are is still a tough question to be certain about, given the multidimensional nature of this symptom. I don't know if PEM was reduced.

The inferences do not necessarily imply a psychosomatic basis for ME/CFS. Nor can one extrapolate that additional exercise would induce further improvements, or if such improvements are sustainable or stress resistant.

The exercise programme used is not a very heavy protocol, and in a way, it is a form of pacing, where less fatigue would be expected anyway. We can't say that a heavier workout would be just as helpful, or would be harmful, based on this study.

It is highly unlikely that the results of this study imply a true change in the underlying pathology of ME/CFS.

The big problem has nothing to do with the study itself, but the general consequences of the study in terms of interpretation by unqualified individuals who know very little about ME/CFS.

The benefits here are very small, but could be blown out of all proportion, and certainly would not be of any help to the more severely affected cases of ME/CFS.
 
Jonathan Edwards

Jonathan Edwards

"Gibberish"
Messages
5,256
[QUOTE="Large Donner, post: 866842, member: 16773]
Can you really see NICE taking on the Lancet and also their own part they have played over the last numerous years and saying, "hey all this GET and CBT stuff has always been useless and even often harmful, get me a hotline to Theresa May and the DWP.... and who's that guy who runs the retraction blog we need to contact him .......we need to fire Richard Horton and the PACE trial must be retracted."

It stands to reason that if NICE retracts CBT and GET from its recommendations the PACE trial would have to be retracted from the Lancet and NICE would have to answer to PWME for all the wasted years and potential harm they have caused.

The true data from the PACE trial shows that CBT and GET the long standing treatments for ME recommended by NICE do not work and have never worked. NICE would be taking themselves down and I just cant see them doing that, it would just lead to one big cluster fuck and theres no way they will be allowed to do that.[/QUOTE]

None of this follows I suspect. NICE consists of whoever happens to be there at the time. They have no interest in papers being retracted. The main motivation is saving money. And why not save money by scrapping all that CBT and GET? The fragility of the BPS position may soon to emerge. Somebody sold a lot of phoney stuff to th UK government a while back. Politicians are always ready to cut friends out if circumstances change. They seem to be changing every five minutes at present. And sooner or later the DWP is likely to wake up to the fact that they were connned.
 
Wolfiness

Wolfiness

Activity Level 0
Messages
482
Location
UK
Does anybody remember an (I think) S. American exercise trial whose own authors retracted it after they realised that all patients' improvement occurred in first 2 weeks and then hit a ceiling?
 
Wolfiness

Wolfiness

Activity Level 0
Messages
482
Location
UK
Jonathan Edwards said:
And why not save money by scrapping all that CBT and GET? The fragility of the BPS position may soon to emerge. Somebody sold a lot of phoney stuff to th UK government a while back. Politicians are always ready to cut friends out if circumstances change. They seem to be changing every five minutes at present. And sooner or later the DWP is likely to wake up to the fact that they were connned.
Click to expand...
They probably already know that! But politically they can't afford to abandon their Arbeit Macht Frei approach. It's not about money. It's about scapegoating the disabled for votes. I don't think the DWP reforms have anything to do with savings: they are all about demonstrating to voters that no disabled person is resting on your dollar.
 
Last edited:
Cheshire

Cheshire

Senior Member
Messages
1,129
After four months the mean fatigue score of the exercise group was four points lower than in the control group, on a scale of 100, which researchers said was a moderate but significant impact. Physical function was also six points higher.
Click to expand...

Without considering the limitations others have talked about (unblinded trial, subjective reports...), how desperate (or dishonnest, or both) must you be to present such poor results as "positive"? Seriously?

These researchers are the best propaganders for their own crap, CBT really changes the way you see the world. When you constanly repeat "it works, it works, sure it works", you end up believing it does. Does it really is not the question, CBT only acts on thoughts, not in the real world.
 
U

user9876

Senior Member
Messages
4,556
RogerBlack said:
Isn't that a lovely phrase.
It might if you were to read it casually read "before any outcome data were examined", whereas the two are about as far apart as could possibly be.
I would assume without checking that the ethics committee involved had a significant number of the PIs in this trial, and PACE-related ones, as well as camp-followers.

Also - how can the 12 month results be unavailable, hasn't it been considerably more than 12 months since the study ended?
One wonders on FOIA.
Click to expand...

The question may be what information was the ethics committee given to approve the change.

We have seen the effects of their previous changes in PACE and they have seen the PACE and other data and so when requesting changes they know that in previous data their biggest chance of success it a short term change in the CFQ.
 
U

user9876

Senior Member
Messages
4,556
AndyPR said:
I'm eagerly waiting to see the MEA use all of their influence within the CMRC to ensure that the CMRC issues a statement highlighting all the flaws and limitations with this study - after all, they are the experts on our condition aren't they? ;)
Click to expand...

I can't imaging they would do that. But it is really important that those involved understand the flaws of using subjective measures for open label trials especially ones which try to change patients perception of symptoms. This is pretty basic yet they don't seem to understand.

Also the use of poor questionnaire and pretending they are scales should be stopped.

Perhaps the CMRC should have a track at their upcoming conference looking at ways to improve trial quality. Perhaps Crawely could give a talk where she says the way to improve quality is to threaten and shout down critics.
 
trishrhymes

trishrhymes

Senior Member
Messages
2,158
I think it is highly irresponsible of the authors to publish just the 12 week data, when they must by now also have access to the 1year follow up data.

Both the PACE and FINE trials had their highest between group difference at the 12week stage, with the difference disappearing by 1year for FINE, making it a null trial, and at 2 years for PACE, making that a null trial too.
 
L

Londinium

Senior Member
Messages
178
user9876 said:
I thought the SMCs expert reactions were interesting in that they did include a statistician who rubbishes the trail a bit (although he doesn't pick up all the issues). In the past they have avoided such comment.
Click to expand...

I thought the next comment was even better:

Prof. Chris Ponting, Chair of Medical Bioinformatics and Principal Investigator at the MRC Human Genetics Unit, Institute of Genetics and Molecular Medicine, University of Edinburgh, said:

“The beneficial effect was for fewer than 1 in 5 individuals, for an unblinded trial, and there was no consideration of long-term benefit or otherwise. The study could also have exploited actometers that would have more accurately measured participant activity.”
Click to expand...

Not exactly a ringing endorsement is it?

Nice to see at least some dissenting opinion at the SMC, are we finally seeing some cracks in the pro-GET facade? Sadly these comments didnt make their way into the Telegraph article.
 
V

Valentijn

Senior Member
Messages
15,786
user9876 said:
I thought the SMCs expert reactions were interesting in that they did include a statistician who rubbishes the trail a bit (although he doesn't pick up all the issues). In the past they have avoided such comment.
Click to expand...
The SMC probably hasn't had any recent donations from the relevant researchers or institutions. It would explain their relative lack of enthusiasm for psychobabble lately.

trishrhymes said:
I think it is highly irresponsible of the authors to publish just the 12 week data, when they must by now also have access to the 1year follow up data.
Click to expand...
I expect they're hoping to sit on null results for as long as possible, and get as many publications out of it as possible.
 
Last edited:
Forbin

Forbin

Senior Member
Messages
966
Cheshire said:
After four months the mean fatigue score of the exercise group was four points lower than in the control group, on a scale of 100, which researchers said was a moderate but significant impact. Physical function was also six points higher.
Click to expand...

Without considering the limitations others have talked about (unblinded trial, subjective reports...), how desperate (or dishonest, or both) must you be to present such poor results as "positive"? Seriously?
Click to expand...

I was going to point this out also, but it appears that the Telegraph article got this wrong. The exercise group was 4.2 adjusted points lower on the Chalder Fatigue Scale, which goes from 0 to 33 [not 0 to 100]. Presumably, the scores are "adjusted" due to differences in the initial means of the two groups (the unadjusted difference was 3.8, not 4.2). When this scale was tested in the past against CFS sufferers and a "community sample," the mean “Likert” scores were 24.4 (SD 5.8) for CFS, and 14.2 (SD 4.6) for the community sample.

The scale can also be read as going from 0 to 11 if read "bimodally" (or if you're in the heavy metal band "Spinal Tap.")

http://www.goodmedicine.org.uk/files/assessment, chalder fatigue scale.pdf
 
Last edited:
You must log in or register to reply here.