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Do graded activity therapies cause harm in chronic fatigue syndrome?

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Tom Kindlon

Senior Member
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1,734

Do graded activity therapies cause harm in chronic fatigue syndrome?

Tom Kindlon

Journal of Health Psychology

DOI: 10.1177/1359105317697323 | First Published March 20, 2017



Abstract

Reporting of harms was much better in the PACE (Pacing, graded Activity, and Cognitive behavioural therapy: a randomised Evaluation) trial than earlier chronic fatigue syndrome trials of graded exercise therapy and cognitive behavioural therapy.

However, some issues remain.

The trial’s poor results on objective measures of fitness suggest a lack of adherence to the activity component of these therapies.

Therefore, the safety findings may not apply in other clinical contexts.

Outside of clinical trials, many patients report deterioration with cognitive behavioural therapy and particularly graded exercise therapy.

Also, exercise physiology studies reveal abnormalities in chronic fatigue syndrome patients’ responses to exertion.

Given these considerations, one cannot conclude that these interventions are safe and risk-free.
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https://twitter.com/i/web/status/843868698188365824
 
trishrhymes

trishrhymes

Senior Member
Messages
2,158
Well done Tom.

The abstract is excellent, but the article is behind a paywall, so I can't access the rest.

I always suspected those with ME with PEM would have been unable to keep increasing their activity, and would have self protected by not adhering to the set regime, either by cutting drastically back on other activity in order to do the prescribed walks, or by not doing the exercise as they were told to.

I hope for their sake they did listen to their bodies. In that case there would indeed have been less harm than there might have been, so the trial gives a completely false impression of safety.

That's yet another reason why the trial was invalid. They should have worn activity meters throughout the trial.
 
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charles shepherd

Senior Member
Messages
2,239
Hi Tom

As you know, there are a number of critical commentaries (including one from CS) on the PACE trial awaiting publication by JHP and it would be really great if both public and health professionals could read them in full

The MEA has paid for open access publication of the Wilshire paper on reanalysis of the PACE trial data

Do you know what JHP would change for making these commentaries open access?

Charles
 
T

Tom Kindlon

Senior Member
Messages
1,734
charles shepherd said:
Hi Tom

As you know, there are a number of critical commentaries (including one from CS) on the PACE trial awaiting publication by JHP and it would be really great if both public and health professionals could read them in full

The MEA has paid for open access publication of the Wilshire paper on reanalysis of the PACE trial data

Do you know what JHP would change for making these commentaries open access?

Charles
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I can't remember seeing the figures (usually you get asked if you want to pay for open access).

This is what turned up when I did a search but there is a chance it is not correct:
https://uk.sagepub.com/en-gb/eur/author-information
The standard Article Processing Charge for SAGE Choice articles is 3000 USD/1600 GBP. To view a list of exceptions please visit the SAGE Choice Journal and Pricing Exceptions page.

Please note that for some journals value added tax (VAT) must be added to the APC. Please check the individual journal homepage for clarification. For these journals, if the paying author/institution is based in the European Union, VAT must be added to the APC. Providing a VAT registration number will allow an institution to be exempt from paying this tax, except for UK institutions.
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You may be able to bargain them down to a lower price.

Also if you pay from more than one, perhaps you would get a reduction.
 
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Invisible Woman

Senior Member
Messages
1,267
Great work, Tom!

At one point I had a Dr say to me that trying graded exercise was unlikely to do me much harm even if it didn't work. I sent him a copy of the paper you wrote regarding the under reporting of harms on the PACE trial. That was the end of that discussion. While we wait for the PACE edifice to come crashing down, your papers are helping on the "front line".
 
T

Tom Kindlon

Senior Member
Messages
1,734
Invisible Woman said:
Great work, Tom!

At one point I had a Dr say to me that trying graded exercise was unlikely to do me much harm even if it didn't work. I sent him a copy of the paper you wrote regarding the under reporting of harms on the PACE trial. That was the end of that discussion. While we wait for the PACE edifice to come crashing down, your papers are helping on the "front line".
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Thank you very much. That is nice to hear as papers, particularly when I am the sole author, take a lot out of me.

Here's the paper she is referring to. It's open access:
Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx
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Mary

Mary

Moderator Resource
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17,369
Location
Southern California
@Tom Kindlon - thank you so much for all your work on our behalf! It's very much appreciated! :thumbsup:

I have one question re your abstract where it says:

Reporting of harms was much better in the PACE (Pacing, graded Activity, and Cognitive behavioural therapy: a randomised Evaluation) trial than earlier chronic fatigue syndrome trials of graded exercise therapy and cognitive behavioural therapy.
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When you say "reporting of harms was much better" - do you mean there was more accurate reporting of harm, or that less harm was reported than in other trials? or maybe something else?
 
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Tom Kindlon

Senior Member
Messages
1,734
Mary said:
When you say "reporting of harms was much better" - do you mean there was more accurate reporting of harm, or that less harm was reported than in other trials? or maybe something else?
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More accurate reporting of adverse events. Most ME/CFS trials of CBT or GET don't mention the issue at all. People just assume there were no adverse events because overall people on average either didn't deteriorate or else improved on the measures used. However you can have a group of people who improve on average but have people within the group who got worse, or suffered specific adverse events.
 
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Yogi

Senior Member
Messages
1,132
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joshualevy

Senior Member
Messages
158
@Tom Kindlon Were you able to find any studies which showed harm from CBT or GET? (By harm I mean worse outcomes or worse adverse effects from CBT/GET as compared to either a control group or another treatment group.)

Your abstract implies that there were none, but I wanted to ask directly.
 
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Invisible Woman

Senior Member
Messages
1,267
joshualevy said:
@Tom Kindlon Were you able to find any studies which showed harm from CBT or GET? (By harm I mean worse outcomes or worse adverse effects from CBT/GET as compared to either a control group or another treatment group.)

Your abstract implies that there were none, but I wanted to ask directly.
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Given the BPSers hog all the research fund & not just all the psych research funds......I think not. Why look for something you don't want to find? Much better to let well meaning medics (some of 'em are well meaning) assume that there haven't been any studies because none are needed.

After all - exercise can't possibly harm anyone, right? :rolleyes:
 
Jenny TipsforME

Jenny TipsforME

Senior Member
Messages
1,184
Location
Bristol
It's an ethical issue because people are so pro and against GET. Proponents will design a trial so that only very serious harm is recorded (not necessarily cynically but they don't expect problems). People who already believe it's harmful can't really design ethical research trials because they would be knowingly inflicting harm. This is particularly true when you think of how long people say they are worse (I'm thinking of this quote)

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The best evidence is survey data which unfortunately isn't taken that seriously

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http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

I know this is a pipe dream, but what would be enlightening would be a qualitative study of the original PACE participants asking them about their experiences and perceptions of the study.
 
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