Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS, 60% of Patients Show No

Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS: 60% of Pa

You can view the page at http://forums.aboutmecfs.org/content.php?369-A-Hitch-in-its-Step

 

thankyou for putting this into perspective for us, Cort. Once again, you excelled.
I did notice something- maybe a dropped word? in the intro "Peter White, the main author of the study, had been way out in front of the - declaring that the study...."
great job!

 

Thanks Helen...that whole paragraph was problematic...thanks for catching it so quickly.

I really found the trials result underwhelming - some benefits around the edges - but nothing that struck at the core of the disorder; ie I felt it was a stunning failure for the thesis that CFS is a behavioral disorder. They put so much into this study. After I ended looking at it I began to wonder if Peter White got out in front of it because the results were pretty poor and he felt he needed to prepare the ground.

During their 6 minute endurance walk they didn't even break into a 'healthy walking' pace - not even close. (I think I at least could have done that ).

This really should be the end of the idea that CBT/GET somehow cure people and allow the field to move on...I certainly hope so.

 

As a group, I wonder if we would be smarter to be very vocal, laugh, and celebrate the weak results, rather than the level of anger I read in the forum. We might get better press....

 

As a group, I wonder if we would be smarter to be very vocal, laugh, and celebrate the weak results, rather than the level of anger I read in the forum. We might get better press....

I have long thought that the best way to go would be just to acknowledge that it has some effects in some people - and then move on. If we can just focus on the limited effects it has - I think we're in the clear.

I do recognize that CBT practitioners with their sometimes wild claims have made that course of action difficult.

 

Baseline Walking Test results:

Pacing CBT GET Specialist
Baseline 314 333 312 326
52 weeks 334 354 379 348

the trial failed spectacularly.

They can manipulate the definitions and stats, and desperately spin the results as much as they want, but by any vaguely rational, empirical, and ethical real world standard these remain truly pathetic numbers, that simply do not deliver any practical, meaningful improvement whatsoever in the health or social and economic capacity of patients. Any relative advantage of CBT and/or GET over the others is absolutely minimal, a Pyrrhic statistical victory that offers no comfort to the advocates of those therapies.

Like I said before, they had to get a clear win on this, but even under the most favourable of conditions they have completely failed to deliver any substantial therapeutic result, let alone one free from serious methodological issues.

Bottom line is they had every chance to prove their theory, their model, and they failed. Big time.


Don't want to get people's hopes up too far or too quickly, but I genuinely cannot see the CBT/GET model recovering from this. This PACE result, on top of poor FINE results, and a whole lot of other stuff, means it is pretty well scientifically dead as a primary therapeutic or explanatory model.

How long this fact takes to filter through the system and make a positive change to the daily lives of us patients remains to be seen. The hard times are not over yet.

•••••••••••••••••••••••••••••••••••••••

I think we need to demand two follow up studies on this patient sample.

1. Objective activity meters (whichever version they used at the start) to measure the outcome after treatment. Like they should have done without being asked.

2. A follow up assessment, including activity meters, at 104 (or maybe 156) weeks. Preferably by an independent team.

Let's get this one done and buried properly. So there are no questions left about how ineffectual this approach is.

 

Don't want to get people's hopes up too far or too quickly, but I genuinely cannot see the CBT/GET model recovering from this. This PACE result, on top of poor FINE results, and a whole lot of other stuff, means it is pretty well scientifically dead as a primary therapeutic or explanatory model.

I wish that were true but in the UK, this study has been on our national news media with a very positive spin ("exercise helps people with ME!"). I've had the first of my friends email me when it came out and say, "hey, have you seen on the TV that exercise can help people with ME?" It's not just what treatment might be forced on us down the line, it's what people in our lives believe about us as a result of this crap - that we can help ourselves but for our own weird reasons aren't doing so.

Where's my unhappy Scotsman... oh yeah... :headache:

But thanks for putting this in perspective, Cort - I haven't been able to bear to read much about this story since it came out. ME in the UK is so in the political grip of psychiatry and CBT/GET that other voices can't get heard in the medical journals and media.

But at least we patients can go armed with the facts to our doctors...

I hope I'm wrong, Sean!

 

I found it interesting that the CFIDS Association quoted Peter White from the Discussion section of the study as actually acknowledging that “Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed. The effectiveness of behavioural treatments does not imply that the condition is psychological in nature.”

Ya think?!

I just wish the CAA had been ahead of the game with a good press release saying exactly what you're saying here, Cort. The way this has been spun is about as Orwellian as it gets. Journalists don't just need context. They need to have the whole thing spelled out for them. With ready-made quotes. Perhaps even in a picture book with monosyllabic words...

 

Many people declined to assessed or to engage in a randomized treatment (n=398) (Its possible that these people included people afraid of being assessed the GET or CBT protocols). A good number of people simply refused to be assessed (n=143). Another chunk of people (n=139) couldnt follow the protocols for one reason or another (too sick?).

I was attending an NHS ME/CFS clinic when the PACE trial was recruiting and was told that I fitted the inclusion criteria. I was also told that if I was randomised I wouldn't be able to have my treatment tailored to me and because I was too ill to travel to the hospital without ill effect, I wouldn't be able to survive any treatment that involved group sesssions of CBT or GET at the hospital. So because I was one of the bedbound/housebound patients, I was quite actively discouraged from taking part. I took this as a humane action on the part of the person treating me!

While we were discussing the trial, I asked whether I could see the trial protocol in order to help me decide whether to take part and was told that I couldn't. My motivation (which I don't think I made explicit) was that I didn't want to take part in a badly designed trial that would be a waste of money and a risk to patients. I wouldn't have taken part without seeing the protocol. Other patients who are clued in to the politics of the situation might have felt the same way, and such patients are likely to be those who have been ill enough for long enough to have been forced to inform themselves. I've been ill for 25 years; the patients in the trial had been ill, on average, for a tenth of that (2.5 years).

The very high rate of psychiatric morbidity in the cohort suggests to me self-selection of people who are aware that they have psychological problems being willing to put themselves forward for a trial that includes a psychological approach. Overall, I think there are very serious self-selection biases in the trial, which makes it all the more surprising that the benefit was so small but less surprising that serious adverse effects weren't seen more often.

 

thankyou for putting this into perspective for us, Cort. Once again, you excelled.

I totally agree!

 

Brilliant Cort - just an immediate reaction - before reading in full.

 

Thank you Cort for writing this article. You saved me a lot of time.
I support the idea of ridicule or laughter instead anger, frustration, or outrage. We haven't tried that tactic yet, to my knowledge.
Imagine a headline "Patients debunk x million $ government study" or "Government continues to waste millions of tax payer's $ on bad science"
Now to find some journalists who are willing to do more that just copy/paste government and corporate press releases.
Keep up the good work.

 

Very surprised that with the wrong cohort studied and most of them short time CFS/MErs (makes me wonder where all the longer sick ones were? were they all too sick to even enter the study?), that the results came out as bad as they were.

If one also considers the time which went into the therapies (both of the patient and the doctor) and the money if it wasnt a study.... are those extremely poor improvements worth it? Did they really achieve anything at all? (were the patients really more able?).

............

I'd like to see this study in press releases in truth of what it really did show. Im disappointed that the CAA didnt put out a good press release of how things really were such as Cort has done. We need the reality of these therapies out there. (hey Cort.. maybe they should hire you to work for them!! You tell it how it is).

Helen.. yeah.. lets throw parties. Parties for the truth being shown
It's clearly time for them to be studing completely different therapies to CBT, GET .. enough money has been spent on those near useless therapies!! Let's celebrate that they hopefully will move on to find something which really could help us.
.........

A study examining the effectiveness of a wide swath of physicians in the US - including ME/CFS specialists (eg. Drs. Peterson, Holtorf, Cheney, Bateman, Klimas, Bateman, Lapp, Enlander) alternative practitioners and MD's, in combination with or without behavioral therapists, would tell us a great deal about the state of art of ME/CFS treatment.

I do wonder what the results would of been for the specialist group had been a "real" CFS/ME specialist instead of one of those english ones of the psych views.

 

There are just a few points for US readers.

Adaptive pacing is not at all like pacing. It involves keeping a diary and adhering strictly to a tight schedule. No sleep during the day, rests for a specific number of minutes at a certain time for instance. It is very difficult to do and completely ignores how a person is feeling. It is the complete opposite of the pacing that helps patients where you listen to your body. In some ways it is worse for ME than GET as you can do your daily walk when you feel up to it and pace yourself the rest of the time.

PDW hates pacing and has called this travesty pacing so as to discredit the patient experience. Doctors will now tell us not to listen to our bodies when that was never trialled at all.

They did not find that CFS and ME responded the same way. They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards. Also, PDW has his own meaning of PEM, it is the soreness you experience when you are deconditioned then exercise. This trial said nothing about neuroimmune disease.

They had great difficulty recruiting for the trial. Anyone who knew anything about it would not enter. There were complaints about the set up from all the patient organizations except AfME so all members knew of the flaws. They were forced to change the criteria for entry and started asking GPs to send along fibromyalgia patients.

It was a mess and the results dreadful despite their best efforts to get a positive result, yet they have been reported as wonderful in the UK and will be used against us. The rest of the world may see them as laughable, rightly, but our plight is enormously increased. Our present government has declared war on the disabled, every single person on benefits is to be reassessed and this paper spells disaster for those of us with ME.

Mithriel

 

Well done Cort, that's a great article. I agree we should be discrediting it with positivity - unfortunately angry letters often fall on deaf ears. We need to find a good journalist here in the UK who is prepared to do some intelligent investigative work on our behalf and spill the beans.

 

I laughed when I read "these therapies moved the participants from walking at a puttering around the house rate to just above a puttering around the house rate."

So sad!

This was multi-millions well-spent? Hey, one of you heads of state out there in the World of Too Much Money, throw me some cool multi-millions and see what I can come up with. (First I'll hire all the members of PR Forums as consultants.)

Anyway, thanks, Cort, for laying out the details of the trial.

 

a modest proposal

Wait a minute! The graduation from GET was a 6 minute walk at a comfortable pace, with no examination of aftereffects? (Because "PEM doesn't exist"?) By this measure Ann Cavan's performance at Pacific Fatigue Labs would qualify her for the Olympics.

How about a trial of "Jedi techniques" where we simply have enthusiastic coaches spend minutes to convince people they can draw on "The Force"? That would produce equivalent improvement at lower cost.

This kind of effect has been documented dramatically W.R.T. "firewalking". Perhaps the next study could compare their effectiveness with real Voodoo priests.

In a more professional tone, they have failed to produce results which differentiate improvement from a general "Hawthorne effect" due to being part of a study.

 

CAA's response to the PACE study is very harmful. Pls see my blogpost:

http://forums.aboutmecfs.org/entry.php?809-CAA-to-CNN-amp-NPR-More-GET-and-CBT-Please!

 

OMG!

There are just a few points for US readers.

Adaptive pacing is not at all like pacing. It involves keeping a diary and adhering strictly to a tight schedule. No sleep during the day, rests for a specific number of minutes at a certain time for instance. It is very difficult to do and completely ignores how a person is feeling. It is the complete opposite of the pacing that helps patients where you listen to your body. In some ways it is worse for ME than GET as you can do your daily walk when you feel up to it and pace yourself the rest of the time.

PDW hates pacing and has called this travesty pacing so as to discredit the patient experience. Doctors will now tell us not to listen to our bodies when that was never trialled at all.

They did not find that CFS and ME responded the same way. They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards. Also, PDW has his own meaning of PEM, it is the soreness you experience when you are deconditioned then exercise. This trial said nothing about neuroimmune disease.

They had great difficulty recruiting for the trial. Anyone who knew anything about it would not enter. There were complaints about the set up from all the patient organizations except AfME so all members knew of the flaws. They were forced to change the criteria for entry and started asking GPs to send along fibromyalgia patients.

It was a mess and the results dreadful despite their best efforts to get a positive result, yet they have been reported as wonderful in the UK and will be used against us. The rest of the world may see them as laughable, rightly, but our plight is enormously increased. Our present government has declared war on the disabled, every single person on benefits is to be reassessed and this paper spells disaster for those of us with ME.

Mithriel

Wow, Mithriel! Another brilliant post! I had no idea about there was evil "adaptive pacing" which they used as opposed to helpful "pacing" just like there's evil "CBT" and benign "CBT"! Also didn't know they defined PEM as soreness deconditioned people feel after exercise! That explains A LOT for me (in addition to Oxford def etc).

 

Thanks for the article Cort, it's very helpful.
I think it's important to point out again that the form of 'pacing' used in this trial is not the pacing that we all use intuitively to manage our illness.
I believe that the Adaptive Pacing Therapy was specifically created and formulated for this study, and is very prescriptive, formulaic and systematic, so it is very unlike normal pacing.
So, I wonder Cort, if it might be wise not to call it just 'pacing', in the few occasions that you have in this article, but to always refer to it as Adaptive Pacing Therapy, or APT?
I think it's very important for the patients reading this article to understand that there is a big difference between pacing and the Adaptive Pacing Therapy used in this trial.