Adverse events and deterioration reported by participants in the PACE trial of therapies for CFS

[Valentijn]

However, this contradicts their 2011 Lancet paper which states that "There were more serious adverse events in the GET group than there were in the SMC group (p=0·0433)."

So it would seem that they deliberately excluded the category for which there was a statistically significant difference, and substituted it with a closely-related category (barely) lacking a statistically significant difference.

They do it with no explanation of that omission, no mention of such a switch, and then label it as if it were the same category in which there was a significant difference.

 

[alex3619]

Switching things is their stock in trade, they do it for definitions of commonly used words a lot.

 

[A.B.]

Switching things is their stock in trade, they do it for definitions of commonly used words a lot.

One could say they are giving CBT to their study results.

 

[Sean]

One could say they are giving CBT to their study results.

Naughty, bad, uncooperative, delusional, in denial, anti-psychiatry data. A course of CBT for you!

 

[biophile]

It's suddenly become open access! A nice bit of bedtime reading!

Did you have any nightmares later on? Things can get a little hairy and scary in the ...

Game of definitions.

Switching things is their stock in trade, they do it for definitions of commonly used words a lot.

 

[Griffin]

Switching things is their stock in trade, they do it for definitions of commonly used words a lot.

As documented in
http://www.meactionuk.org.uk/Hoopers-initial-response-to-PDW-letter.htm

 

[alex3619]

When one patient in a study could be assigned a category of significantly disabled, abnormal function, normal and recovered, on the same data, you know there is a problem. The PACE publications contain the evidence that discredits them.

 

[alex3619]

Did you have any nightmares later on? Things can get a little hairy and scary in the ...

Game of definitions.

So who is the one person who can see intelligently and clearly in this Game of Definitions? Where is our Tyrion? (A Game of Thrones reference.)

 

[Dolphin]

(This was posted on a mailing list I'm on with regard to Dr Miller. The person said I could re-post it. I asked her and she said her comments related to the PACE Trial rather than the GETSET trial)

"He (DrM) reviewed all the adverse events for the PACE trial and is on the steering committee for the GETSET trial.”

What he actually did was ignore adverse events by declaring they had nothing to do with taking part in the trial/CFS – in his opinion.

I’m aware of patients made extremely ill who are still housebound / bedbound and one who was hospitalised and very nearly died. The laters GP was furious that these extreme adverse events were dismissed.

It’s easy to dismiss things if you can get an expert medical advisor to sweep things under the carpet that you don’t like to hear.

Eminence based medicine not evidenced based medicine.

 

[Dolphin]

(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/

 

[Dolphin]

Trial By Error, Continued: Did the PACE Trial Really Prove that Graded Exercise Is Safe?
January 7
http://www.virology.ws/2016/01/07/t...al-really-prove-that-graded-exercise-is-safe/

PR thread: http://forums.phoenixrising.me/inde...-did-pace-really-prove-that-get-is-safe.42264

 

[Dolphin]

I'm also rather disappointed in the lack of detail regarding SAEs and SARs. Non-serious Adverse Events are broken down by category, but there is 0 data about the serious events and reactions.

In the appendix to the Lancet 2011 paper, the 47 Severe Adverse Events are listed (though not together with which trial arm they are in). We are given the 10 Severe Adverse Reactions and the trial arm they are in.

 

[RogerBlack]

Crashes with ME are often temporary, though they don't have to be. For some of us that is a few days to a week or two. This will downplay the impact and in most cases they probably will fail to detect it if measured at two time points.

Indeed.
I note http://forums.phoenixrising.me/inde...me-frame-and-recall-reliability-in-cfs.46521/

Which is a reasonable paper trying to work out how long people can remember symptoms.
It's not very long.

 

[alex3619]

Which is a reasonable paper trying to work out how long people can remember symptoms.

Ummm, I remember them. When I get them again.

 

[Dolphin]

Table 4 gives data on the numbers and percentages of patients in the PACE Trial who have the following. I'm not sure if we were given this data before.

All depressive disorders
Major depressive disorder
Minor depressive disorder
Dysthymic disorder
All anxiety disorders
Generalised anxiety disorder
Fibromyalgia

 

[ash0787]

The not remembering symptoms thing is very relevant to me as I experienced this just this week,
I remember the constraining effect it has on my life like not being able to look out of a window, but not some of the specific details like a high frequency flickering of the vision when the eyes are closed. I don't necessarily see how its relevant to PACE though because gauging general level of health is not affected by that, it wouldn't change peoples ability to write down how ill they felt before and after participating in the trial.

Having had the sort of depression that causes 'fatigue' in the sense that people end up sleeping in the middle of the day, its easily distinguishable from CFS, its a coping strategy for extreme mental stress and complete lack of motivation, not a physical lack of energy, and those people would not experience PEM.