Mark Vink: Assessment of Individual PACE Trial Data: CBT and GET are Ineffective

[Dolphin]

The independent review of the PACE trial found that “46% of patients reported increases in their ME/CFS symptoms, 31% reported musculoskeletal, representing the M in ME, and 19% reported neurological adverse events, representing the E in ME. So that the proportion of participants negatively affected by CBT and GET is between 46% and 96%” [5],

I can't remember the details of this but don't believe it is a balanced discussion of what was found in the PACE Trial. Note that I'm not a big CBT and GET fan, I just want the best evidence to be quoted by patients and the like.

 

[Dolphin]

Therefore the individual data show that CBT and GET could be harmful, in accordance with what patients have been saying for a long time, and with the above-mentioned 2004 study by White et al. [23], which found that exercise causes immunological damage in ME/ CFS.

The White et al. study found increases in immune compounds after exercise. Whether that demonstrates "immunological damage" is not clear at this stage I think it is fair to say.

 

[Dolphin]

Freedom of information requests for raw data, apart from one, were turned down on the basis of being vexatious.

Technically the PACE trial team argues that they only turned down a few on the grounds of being vexatious. But the main point is that nearly all requests were turned down for one reason or another, very often for dubious reasons.

 

[Dolphin]

The day before releasing the figures to Matthees, the PACE trial authors themselves published two new papers with a new interpretation of the figures using the original trial‘s protocol [10,11]. Even though the number of improvers fell from 59% and 61% to 20% and 21% for CBT and GET, respectively (so that it was 3 times higher in the original paper due to the extensive endpoint changes made during the trial), the authors still concluded that “these outcomes are very similar to those reported in the main PACE results paper” [11], even though 59% and 61% are not “very similar” to 20% and 21%. The current analysis found that the number of objective improvers was actually 3.7% and 6.3% for CBT and GET, respectively (and if the effect of SMC was deducted, the rates would be 0% and 1.3%). Therefore, it could be said that the initially presented figures for improvers were inflated 16 and 10 fold for CBT and GET, respectively. This was a consequence of using subjective instead of objective primary outcomes and making an extensive number of endpoints changes during an unblinded trial (without taking the SMC effect into account; if SMC was considered there would have been a 47-fold increase for GET and no one objectively improved due to CBT alone).

The improvement rate that was published in the Lancet was 61% for GET and 45% for SMC. So taking SMC into account, it is an improvement rate of 16% so the 47-fold increase for GET mentioned in the last sentence is incorrect.

 

[Dolphin]

Anyway overall I thought it was a very interesting paper which includes lots of useful points. But I think care needs to be taken before quoting some of the percentages given.

 

[Esther12]

Anyway overall I thought it was a very interesting paper which includes lots of useful points. But I think care needs to be taken before quoting some of the percentages given.

Thanks for going through it like that.

I've not read the article yet (but have just printed it out), but do think it's important to try to avoid people making any exaggerated or unfair criticisms of PACE that could then be turned back against them.

 

[ash0787]

so did anyone actually improve their health as a result of participating in PACE ? if it was an effective treatment where are all the people that have benefited from it, wheres all the youtube videos of people saying how they had this horrible disease for ages and then they ran on a treadmill a few times and talked to someone about how they feel and then miraculously they felt better ?

 

[Jenny TipsforME]

@ash0787 no it seems fairly well established in the other reanalysis paper based on the original protocol that the statistical difference between groups was null. Which means that improvements were due to chance. People did improve in the different groups, but which group they were put in didn't seem to be the deciding factor.

In other words CBT, GET, and this unusual form of pacing, are at the very least a waste of time and money.

What is still unclear, and I'm not convinced from this paper, was the extent it was harmful too.

In a sensible world we should now be able to draw a line under it with the conclusion that CBT and GET don't help ME, as confirmed by the 'definitive' study, and move onto more promising research. However, we all know it's not likely to work like that!

 

[dyfalbarhau]

In a sensible world we should now be able to draw a line under it with the conclusion that CBT and GET don't help ME, as confirmed by the 'definitive' study, and move onto more promising research. However, we all know it's not likely to work like that!

Or indeed, CFS (whatever that is). Even with their greatly expanded cohort with an overgeneralised operationalisation of CFS criteria they couldn't get the results they wanted - they STILL had to play with definitions and data to get their result.

 

[trishrhymes]

One of the most surprising things about the PACE trial, in my opinion, is the fact that despite the 'researchers' doing their best to get the outcome they wanted by:

a) using a wildly broad definition (Oxford, 6 months fatigue) guaranteed to include lots of non-ME patients,

b) trying to brainwash the participants in the CBT and GET groups with lies about the 'proven' efficacy of these treatments

c) the use of solely subjective questionnaires as their measures for improvement and recovery,

- they still didn't manage to show that anyone got better on their already fairly lax protocol criteria of recovery and that even 'improvement' was only slightly and temporarily better than doing nothing.

So they not only proved that CBT and GET are useless for ME, they inadvertently proved they are also useless for anyone with 6 months fatigue, including depression induced fatigue.

 

[user9876]

so did anyone actually improve their health as a result of participating in PACE ? if it was an effective treatment where are all the people that have benefited from it, wheres all the youtube videos of people saying how they had this horrible disease for ages and then they ran on a treadmill a few times and talked to someone about how they feel and then miraculously they felt better ?

One of the reasons for having a trial is it is a complex question in a disease that varies. Some peoples health will have improved but that could happen anyway. Hence the need for the comparison between the different trial arms. Given each person has a random chance of improving and a random chance of getting worse for any given time period then it is important to say are differences between groups likely to be down to random variations between the groups or not. This is where significance testing becomes important because it shows when their is say a 5% chance or less of the differences being due to something other than random variation.

With their protocol defined recovery definition the reanalysis showed that any variation between the groups could be down to randomness. This was quite a generous and subjective definition of recovery.

 

[Jenny TipsforME]

@trishrhymes yes I had a discussion with a clinical psychologist about this. He thought it was poor that they couldn't get better results, especially with the questionnaire training aspect of CBT. You would expect better placebo effects.