A critical commentary and preliminary re-analysis of the PACE trial

[RogerBlack]

That's not A valid reason as you can see here https://www.researchgate.net/public...alomyelitis_Chronic_Fatigue_Syndrome_A_Review

I have only skimmed it.
But, though it is a reasonable summary of the field just after the published secondary mediation analysis, and it has lots of reasons PACE is crappy, it can't actually conclusively say 'the numbers were X, they should have been Y", because at that point the data wasn't released.
At least not for the primary numbers in the PACE trial.
It is also not actually published in any peer reviewed journal.

 

[Dr Speedy]

I have only skimmed it.
But, though it is a reasonable summary of the field just after the published secondary mediation analysis, and it has lots of reasons PACE is crappy, it can't actually conclusively say 'the numbers were X, they should have been Y", because at that point the data wasn't released.
At least not for the primary numbers in the PACE trial.
It is also not actually published in any peer reviewed journal.

If you have another look you will see it was published in a peer-reviewed medical journal ...

 

[RogerBlack]

If you have another look you will see it was published in a peer-reviewed medical journal ...

Indeed it is - I had missed that - and just searched on pubmed - which doesn't index it.

 

[Sea]

Doesn't appear to be doing that for me. Maybe it's my ipad. Will have a go on the PC later. Thanks

It doesn't download automatically. Even though you can't read the language there's a click box on the right for donating and a click box on the left for downloading

 

[JoanDublin]

It doesn't download automatically. Even though you can't read the language there's a click box on the right for donating and a click box on the left for downloading

Thank you. I figured it out on the PC just like you said

 

[Sean]

and they think our illness is caused by false beliefs...............

I agree with them that it is perpetuated, at least in significant part, by false illness beliefs.

Their false illness beliefs.

 

[Jenny TipsforME]

a trial such as PACE is impossible to do blind; it has to be unblinded. It would take an awful lot of brain fog to not have some clue what sort of treatment you were getting, be you patient or researcher. Fine so far. But the question is what do you do about that?

I was a participant in a study attempting a CBT sham group [EAS], so it was blinded. I guessed, though I wasn't cheeky enough to askthe others if they knew what was going on (I'm a psychology graduate so may have been more aware). When I read the protocol afterwards I laughed because the researchers weren't allowed to redirect our conversation after starting us off on the same topics as the CBT group. We went off on tangents like what type of alcohol was tolerated best in ME (and set ourselves drinking gin homework!).

The conclusion was

Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME. It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life. There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy.

https://www.ncbi.nlm.nih.gov/pubmed/17014748

Non specific effects of therapy aren't talked about much. Similar to placebo, but not quite the same. I definitely felt some benefit from havinga chance to talk about ME without even a placebo effect (as I guessed I was in a control group).

I am no expert, but from what I read, and based on common sense, you need to reference these "floating" subjective readings against some unambiguous objective measurements; without absolutes to reference against, the subjective values can mean more or less what you want them to mean.

Yes especially with CBT which could in a sense be seen as training to answer the questionnaire differently, whilst doing nothing about the underlying disease (or potentially making it worse with graded activity).

Anyway we now have a peer reviewed paper to reference and hopefully a couple more to come. This is big progress in terms of credibility

 

[lansbergen]

We went off on tangents like what type of alcohol was tolerated best in ME (and set ourselves drinking gin homework!).

WHAT?????

 

[Jenny TipsforME]

@iansbergen it's not in the writeup of the study (!) but our informal study within a study indicated that gin and tonic was tolerated better than eg wine/beer. It's what happens when you don't keep ME participants properly under control! The CBT groups had more structured, directed content.

I now don't drink anything though: ME intolerance plus beta blockers for POTS makes any alcohol a bad plan. If you fancy a drink over Christmas try gin

 

[roller]

yes, drink gin.
drink ethanol.

really bad are only low % alcohols.
red wine the worst of all... lol..

 

[JaimeS]

Yes especially with CBT which could in a sense be seen as training to answer the questionnaire differently

You have a way with words, Jenny!

 

[Jenny TipsforME]

 

[Dx Revision Watch]

https://www.nlm.nih.gov/pubs/factsheets/jsel.html

Fact Sheet
MEDLINE®

Journal Selection

 

[Barry53]

You have a way with words, Jenny!

But more than a ring of truth I suspect

 

[Hutan]

Thanks @Jenny TipsforME

Your findings re gin are noted for future reference. I'm also making a note of that other study you mention - it looks useful when countering the view that CBT is helpful for ME.

The following is from 'Conclusions' and is talking about the primary outcome, the SF-36.

At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients. For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%. Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health. For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively. The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions.

ie
......................................................................................CBT...................EAS.....................SMC
% with at least 15% increase in physical function.........32%..................40%.......................49%
% with at least 15% increase in mental health..............64%...................60%......................53%

So, although I like this idea,

Yes especially with CBT which could in a sense be seen as training to answer the questionnaire differently, whilst doing nothing about the underlying disease (or potentially making it worse with graded activity).

in this case the researchers weren't highly successful with the training in questionnaire answering.

We don't get to see P values testing for real differences between the treatment arms for these outcomes in the abstract. Probably it's mostly pretty random. But, if I had to make a story out of this, I think the evidence points to some people having a mental health benefit when they meet with other ME patients (feeling less alone and sharing tips for coping) but that CBT with a GET component hurts rather than helps physical function.

Tom has added a comment worth looking at on PubMed below the abstract pointing out some issues with the supposed improvement in the objective outcome (walking performance) seen in the CBT arm.
https://www.ncbi.nlm.nih.gov/pubmed/17014748

 

[Jenny TipsforME]

in this case the researchers weren't highly successful with the training in questionnaire answering.

Yes in this case the questionnaire training was below par.
Edit: Though without anchoring subjective questionnaire results to objective meaaures like steps per day or sick days, what we just don't know is how the subjective measures were influenced by CBT.

I think you're right about the mental health boost from meeting up, whether you discuss gin or symptom perception. This chimes with the data and my experience of taking part.

 

[Esther12]

I loved reading this paper (even though my printer messed up and gave me pages confusingly out of order).

A great summary of the problems with the PACE recovery criteria. Really clear and simple on a lot of issues that I and so many others struggle to communicate concisely (I thought it was less clear on the SF36-PF issues than some of the other summaries about, but this is probably the simplest part of the criteria to explain problems with so not such a surprise others did a good job too).

The PACE recovery claims were blatant spin, but the data Matthees helped secure does a great job of illustrating this.

I'm not familiar with the Beekman 6mwt data they use - don't think anyone has used that against PACE before. Sounds damning.

With any critical piece on PACE there's always more that I wish had been included, and that's the case here too, but that may be why I never get anything done. Thanks to all the authors - you're mega-stars.

Thanks also to @Keith Laws, David Tuller and Sam Carter for assisting.

 

[Woolie]

@Jenny TipsforME, the study you were in seems to be of better quality than most. Their conclusions were fairly honest and accurate for a psyc study.

I'm also really interested in the gin conversation!

 

[alex3619]

gin and tonic was tolerated better than eg wine/beer.

I have always been able to tolerate spirits better than things like wine. Indeed I used to be able to drink far more alcohol as whisky than wine.

 

[Sean]

For different effects of various alcohol types, see my post @ #13 on this thread.

Whole thread has good discussions on it.