Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington

https://www.sciencedirect.com/science/article/abs/pii/S0022399921001781

Journal of Psychosomatic Research
Available online 28 May 2021, 110533
In Press, Journal Pre-proof

Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome
P.D.White a
J.Etherington b
a
Wolfson Institute of Preventive Medicine, St Bartholomew's and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
b
Pure Sports Medicine, 12 Finsbury Square, London, UK
Received 16 March 2021, Revised 20 May 2021, Accepted 20 May 2021, Available online 28 May 2021.

https://doi.org/10.1016/j.jpsychores.2021.110533Get rights and content

Highlights


•
Participants were no worse after graded exercise therapy than control interventions.

•
No more participants withdrew from graded exercise therapy than control interventions.

•
More participants dropped out from trial follow up after graded exercise therapy.

•
Graded exercise therapy probably is safe when properly prescribed and supervised.



Abstract
Objectives
Graded exercise therapy (GET) is an effective treatment for chronic fatigue syndrome (CFS), but concerns have been raised about its safety. Two randomised controlled trials have not supported these concerns. We further assessed safety outcomes in all ten published trials of GET for CFS.

Methods
We undertook meta-analyses of three outcomes: Self-ratings of Clinical Global Impression (CGI) change scores of 6 or 7 (“much worse” or “very much worse”), numbers of participants withdrawing from treatments, and numbers of participants dropping out of trial follow up. We provide risk ratios (95% confidence intervals (CI)), comparing GET with control interventions.

Results
The 10 trials involved 1279 participants. CGI scores of 6 or 7 were reported by 14/333 (4%) participants after GET and 26/334 (8%) participants after control interventions (RR (CI): 0.62 (0.32, 1.17)). Withdrawals from treatment occurred in 64/535 (12%) participants after GET and 53/534 (10%) participants after control interventions (RR (CI):1.21 (0.86, 1.69)). Drop-outs from trial follow up occurred in 74/679 (11%) participants after GET and 41/600 (7%) participants after control interventions (RR (CI): 1.51 (1.03, 2.22)). The certainty of this evidence was rated low by GRADE, due to imprecision.

Conclusions
There was no evidence of excess harm with graded exercise therapy by either self-rated deterioration or by withdrawing from GET, in comparison to control interventions. More GET participants dropped out of trial follow up in comparison to control interventions. Future research should ascertain the most effective and safest form of graded exercise therapy.

Keywords
Chronic fatigue syndrome
Graded exercise therapy
Safety
Adverse outcomes


© 2021 Elsevier Inc. All rights reserved.

See this post for the full paper:
https://www.s4me.info/threads/adver...ome-2021-white-etherington.20767/#post-347678

 

The failure of "evidence"-based medicine in a nutshell: you can cherry-pick whatever you want however you want it and even a small number of biased artificial experiments is more than enough to overrule decades of endless complaints and reports in real life. The certainty of the evidence was low but nonetheless it supports beliefs and that's what matters.

Serious but we legitimately need restraining orders against these creeps. Not gonna happen but this is sick. Millions of lives are destroyed by this mediocrity and the people responsible are wining and dining in peace and quiet, advising governments, committing endless violence unto people and showered with praise for it.

And it's so damn easy. They really think nothing of it, it takes no effort from them, this is barely a week-end's work here. And obviously this is explicitly to influence Cochrane and NICE and it's fine, no problem, this is perfectly normal in this profession. Total madness.

 

Just for historical background (there might be other relevant documents as well):

https://www.virology.ws/2016/01/07/...al-really-prove-that-graded-exercise-is-safe/

https://www.s4me.info/threads/updated-the-pace-trial-harm-video.14794/#post-255417

https://www.s4me.info/threads/new-video-the-pace-trial-part-2-harm.10616/#post-188309

https://www.s4me.info/threads/articles-that-are-critical-of-cbt-get.63/#post-1044

All are worth (re)reading / (re)viewing for context. I'm sure there's much more out there.

 

From the paper
"Received 16 March 2021, Revised 20 May 2021, Accepted 20 May 2021, Available online 28 May 2021."

So that looks like a clear response to the draft NICE guideline, in my opinion. Quickly write something up in an attempt to provide 'new' evidence that GET is safe - well, "probably safe", as this puts it, which isn't exactly a ringing endorsement.

Given that its a meta-analysis of studies that have been, at best, rated low quality, I'd like to think that this will be seen in the same light.

 

There’s something extremely appropriate about the fact that P White is affiliated with an Institute of Preventative Medicine.... just think how many people he has prevented from accessing medicine over the years.

 

And another thing (nothing new, it's all been said before on the forum but worth repeating I think).

"Graded exercise therapy probably is safe when properly prescribed and supervised."

How many times have we heard that any exercise therapy that the fatigue clinics provide is individualised to the patient? However the studies that this paper looked at didn't do individualised treatment - they were meant to provide a standardised routine. So what is White and Etherington saying here? It almost reads as if it's a complaint about the clinics themselves, that they are to blame for reports of harm because they deviated from the magic formula that the BPSers dreamt up, which their low and very low quality studies have shown is "probably" safe.

I don't know why I'm bothering to post this. There is nothing to see here, it's just a couple of desperate charlatans, frantically trying to rebuild the crumbling castle that they built on sand.

 

Of course, it might be that they are trying to influence the new Cochrane review of exercise for ME/CFS by flooding it with garbage data like this.

 

Does @Jonathan Edwards know J Etherington I wonder?

He is a Consultant Rheumatologist? Also has Forces rehab links.

"SPECIALIST INTERESTS
Rheumatology, Sero-negative Arthritis, Ankylosing Spondylitis, Reactive Arthritis, Psoriatic Arthritis, Rehabilitation: Complex Injury Assessment and Management, Covid-19 Rehabilitation and MSK Conditions: Bone Health & Bone Stress Injuries

CURRENTLY WORKS AT
Medical Director and Consultant in Rheumatology and Rehabilitation Medicine at Pure Sports Medicine

WORK EXPERIENCE
Armed Forces, as the Director of Defence Rehabilitation and Defence Consultant Advisor in Rheumatology, Rehabilitation and Sport and Exercise Medicine, NHS England as National Clinical Director for Rehabilitation and Clinical Director at the Defence Rehabilitation Centre, Headley Court

OTHER EXPERIENCE
Current President of the Faculty of Sport and Exercise Medicine UK and Master’s degree in Sports Medicine"

https://puresportsmed.com/team/dr-john-etherington-cbe

ETA: To correct name of Rheumatologist, thanks @Trish

 

Here you go, @Trish. I don't feel at all well enough today to offer a thorough critique, but a few random thoughts:

This seems more like an attempt to influence the NICE process rather than being a useful & original contribution to the literature. They seem particularly concerned that the NICE draft's determination re GET will render ethical approval of further trials impossible ("these issues require exploration in future trials, but the current draft NICE guideline, which bans GET, would make ethical approval of any such future trials unlikely").

They also suggest that trial drop-outs may be due to an overly high intensity of GET, arguing for a tailored approach; they criticise the utility of drawing conclusions from patient surveys. The comment that "high intensity aerobic activity and anaerobic activity can feel unpleasant, particularly if an individual is unaccustomed to exercise or recovering from illness and this may have encouraged drop-out from the trials" suggests that they do not consider an as-yet-undetermined organic cause a viable explanation for PEM. All very predictable.

Etherington is a military rehabilitation specialist; White declares that he advises the MoD on its Armed Forces Compensation Scheme. Perhaps some FOIs would produce interesting information...

Oh, and an acknowledgement of Paul Garner for his help. How nice.

 

In other news, tobacco company Phillip Morris is happy to report groundbreaking research in the safety and good taste of their sweet, sweet cigarettes, they go so smooooooth down your throat. The latest publication in the Journal of Tobacco is Good research settles all excessive worries and fears about cancer being an outcome of this natural product.

How often does it happen that the creators of a treatment model, who did most of the research themselves, then evaluate their own research, safety, efficacy and cost-effectiveness? I'm seriously asking how often does something like this happen? Published in their own journal (more or less but let's face it it is).

This is exactly like students writing their own course and exam, doing the exam, grading the exam then evaluating their overall performance of both doing the exam and grading it. And everyone gets a perfect grade because it's pass-fail. None of this is serious.

At this point obviously the blame lays entirely in the school administration and supervisors, but it's clear that this school of thought has neither, can do whatever they want and nobody cares.

 

But the researchers are so eminent and free of selfishness or bias. Their work has been peer-reviewed. Are you not impressed?

 

Not only has their work been peer reviewed but it has been peer reviewed by researchers equally “eminent and free of selfishness or bias”. And we know that this is true because the peer reviewers are all from the same grouping of academics working in over lapping university departments and with the same profound understanding of their subject.

However could this possibly go wrong?