CBT combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study, 2020, Wyller et al

It's the same essentially as with Crawley's LP study--the journal has twisted itself into pretzels to not call out the researchers. It is really disgraceful. I'm putting together another letter to the journal and Dr Godlee and hopefully Jo and the others will join me again.

 

I do not think it is an established term. There is no particular reason why a trial should not be exploratory and randomised but exploratory is a pretty meaningless term unless you state what it is you are exploring. Phase 1 and 2 studies may be considered exploratory but normally it is made clear that you are exploring the tolerability of the treatment or dose range.

What I think is the con here is the idea that has grown up that it is legitimate to do a trial to explore how feasible it is to do a trial - i.e. a 'feasibility study'.

My impression is that it is reasonably clear that this trial was not originally exploratory. It was a randomised trial designed to test efficacy.

 

A quick comparison at the two versions and this is not even close to be OK. Complete white-wash, including the fact that reading the new version does not show there has been a retraction, or any problem. Just a minimal rewrite that addresses nothing at all. This infinite tolerance for failure is beyond ridiculous.

If anything BMJ is showing how thoroughly the process is corrupt, this has nothing to do with science. Obviously betting on the fact that almost nobody cares what happens to us and when in doubt people will simply side against the vexatious bothersome activists. They may be right, for now, but wow will this look bad if and when the suspension of disbelief lifts that we are, in fact, actual human beings worthy of basic respect.

Because this is extremely disrespectful, wrong on the facts, wrong on basic ethics and the rule and letter of what scientific research is even about. But of course this isn't scientific research, this is "evidence-based medicine", where everything goes as long as this is what most people want.

 

I posted this over on the ME/CFS NICE guidelines thread;
https://www.s4me.info/threads/nice-...ates-and-delays-2020.12690/page-5#post-287751

this paper is another prime example

 

A news site about research in Norway wrote a rather good article about the study back in June. The article has now gotten a clearly visible update stating the following:

This study is retracted - The journal BMJ Pediatric Open has retracted the study we're writing about in this story. The article has been replaced with a new version where the conclusions have been scaled down. You can read more about the process at Retraction Watch

(hastily translated by me)

They published the article in English as well, but that version has not yet had an update on the retraction.

 

Really highlights the massive conflict of interests these publishers have, and how that, instead of rising above it as they should do, it's almost as if conceding to those COI forms an integral part of their business model. It's quite revolting.

 

Virtually all paediatric research is CF

 

Sounds like heads you win (get grant funding) and tails you win --- Pity about the mugs who pay for this (PACE was funded by UK Tax payers) and those who suffer the resulting flawed Government policy (inappropriate treatments).

 

Nina E. Steinkopf has read the new publication and shares her analysis:

Is it considered good research practice to retract an article, change the title, the results and conclusion, and then re-publish it with a completely new ID-number? The criticism still stands and the article should be retracted.

Enligish version: The music therapy study was retracted, amended and re-published: The results are worse than first reported
Norwegian version: Musikkterapi-studien er trukket tilbake, endret og re-publisert: Resultatene er verre enn først rapportert

 

Good analysis. Many of the figures changed, best I can tell is because of this:

Is not found in the update (below table 3), which would explain how some values like steps/day changed by quite a lot. I have no idea how this "principle" is valid, specially in a disease known to have wild fluctuations and sudden massive deterioration (and no sudden massive improvement).

Setting aside that 7k steps/day is at best mild idiopathic fatigue and in no way representative of ME/CFS, obviously. None of this is valid, everyone involved in this should be ashamed of themselves.

 

It's a shame the authors seem unable to accept what the data is telling them. Seems obvious that this is not a good intervention and quite possibly is harmful.

 

I can't remember the details now, but a few months ago I remember thinking that Steinkopf had made a mistake with claiming that the CBT group was "more depressed, more fatigued, had more pain and a lower level of function". Maybe I was wrong, and I don't have time to check now, but I thought I'd mention that now so people can double-check before assuming that was all right. edit: This was with the first paper, I've not properly read the new one yet and have no idea what that says.

 

Looking at the table of results, there are hardly any differences between the groups. The only difference that stands out is some of the daily steps measurements. Maybe I'm missing something but I find it strangely difficult to motivate myself to care enough to look more closely.

 

I think this result shows what pwME have been trying to tell them for years: The symptoms of ME/CFS correlate strongly with physical activity, and that there is a causal relationship - too much activity will lead to worsening symptoms. I think the authors' "surprise" may be because they simply don't get this. Given their approach does not have GET or incremental exercising in it, then maybe - without them even realising it - their patients have simply been learning to pace themselves better, learning to listen to their bodies and back off when they need to. Maybe something about their intervention was fostering that, even though that was not the authors' intention. Maybe unwittingly the authors have demonstrated what pwME have been trying to tell them all this time. Maybe, like PACE, they have proved something useful ... just not what they presumed they were going to prove.

[my bold]

 

The graph from indicates that for 'fatigue' the treatment group did not do worse than then control group.

@Kalliope - might it be worth a Norwegian querying this with Steinkopf?

 

One can read these results as the intervention harming patients, or as helping patients to pace themselves better. But which one is the correct interpretation? And what does the intervention actually consist of? Even after reading the description it's not clear. They say there was no fixed plan to increase activity but maybe that just means patients were told to increase activity levels on their own judgment.

That steps per day is the only meaningful difference between the groups suggests I think the possibility of harm is more likely. Either way the treatment is useless and it shows how grossly the authors misunderstand the problem they're trying to treat.

 

Well, it is not as if regularly finding contrary evidence in his studies has ever led Wyller to drop his theory about "sustained arousal" either...