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The PACE Trial Invalidates the Use of CBT & GET in ME/CFS: A Review

Bob

Senior Member
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Location
England (south coast)
Full text is open access.

The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review

Mark Vink
30 Mar 2016
J Neurol Neurobiol 2(3)
http://www.sciforschenonline.org/journals/neurology/JNNB-2-124.php

Abstract
The main findings reported in the PACE trial were that cognitive behavioral therapy (CBT) and graded exercise therapy (GET) were moderately effective treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and fear avoidance beliefs constituted the strongest mediator of both therapies. These findings have been challenged by patients and, more recently, a number of top scientists, after public health expert Tuller, highlighted methodological problems in the trial. As a doctor who has been bedridden with severe ME for a long period, I analyzed the PACE trial and its follow-up articles from the perspectives of a doctor and a patient. During the PACE trial the eligibility criteria, both subjective primary outcomes, and most of the recovery criteria were altered, creating an overlap of the eligibility and recovery criteria; consequently, 13% of patients were considered “recovered,” with respect to 1 or 2 primary outcomes, as soon as they entered the trial. In addition, 46% of patients reported an increase in ME/CFS symptoms, 31% reported musculoskeletal and 19% reported neurological adverse events. Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%, as shown in a large survey recently conducted by the ME Association. Medication with such high rates of adverse events would be withdrawn with immediate effect. There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS. The discovery that an increase in exercise tolerance did not lead to an increase in fitness means that an underlying physical problem prevented this; validates that ME/CFS is a physical disease and that none of the treatments studied addressed this issue.
 
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Bob

Senior Member
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16,455
Location
England (south coast)
Bloody brilliant. It's a great overview. Written clearly enough for lay people to understand.

I'm in awe at the way he's pulled so much detailed info together and written it so clearly.

Mark Vink is a patient and doctor. I think he is almost entirely bedbound, but I might have that wrong.
 

jimells

Senior Member
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2,009
Location
northern Maine
In addition, 46% of patients reported an increase in ME/CFS symptoms, 31% reported musculoskeletal and 19% reported neurological adverse events. Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%

This is why the PACE People are trying to hide the data. A true accounting of the harms of their trial could put them in serious legal jeopardy.
 

Asa

Senior Member
Messages
179
"There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS..."

Question, please. What exactly is meant by "no difference in long-term outcomes"? I'm wondering if anyone who reported a worsening of symptoms, for example, felt that they experienced a significant and/or prolonged relapse? Did the relapse end before the "long-term outcomes" data was reported? (Does that make sense?)
 
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13,774
Some of this doesn't sound right to me. It's really easy to make mistakes with PACE, so even if a lot of this looks good, I wouldn't assume it's all right without checking the details for yourself. (I'm migrained, so am using the sick role to escape this responsibility).

The strongest card PACE has got against it's critics is that it's such a confusing mess that critiques can often slip up themselves.
 

A.B.

Senior Member
Messages
3,780
"There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS..."

Question, please. What exactly is meant by "no difference in long-term outcomes"? I'm wondering if anyone who reported a worsening of symptoms, for example, felt that they experienced a significant and/or prolonged relapse? Did the relapse end before the "long-term outcomes" data was reported? (Does that make sense?)

This refers to there being no significant differences between the four intervention groups.

They made a mess of the intervention groups by later mixing treatments when they should have stuck to one treatment per group for the sake of clarity.

Reporting of harms was a criminally bad mess, if I understand it right, one could deteriorate significantly in the second half of the study without registering as worsened because the protocol required worsening to persist for two evaluations in a row... but since the second last evaluation was about half way through the trial, relapses would just disappear from the data. Additionally it was up to doctors and therapists to decide if the worsening was due to the treatment or something else, but the people referring to or delivering CBT and GET probably believed that CFS was psychosomatic and that nothing bad could have happened.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
this is so good and goes into something ive found myself when some try to assess me during me/cfs studies which I struggled to make the researches understand -wrong assaessment questions being asked causing them to miss how sick I are....

the part in the full thing at the first graph, where he a severe me person who can no longer stand, sit or walk uses this assessment graph they used in the study and finds by their graph due to the wrong questions not relevant to our illness being used, he would be deemed to have only minor me/cfs and hence not been included.

for those who cant read whole thing. I suggest to scroll down to graph and read that part if u can.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Question, please. What exactly is meant by "no difference in long-term outcomes"? I'm wondering if anyone who reported a worsening of symptoms, for example, felt that they experienced a significant and/or prolonged relapse? Did the relapse end before the "long-term outcomes" data was reported? (Does that make sense?)
We know almost nothing about the nature of adverse reactions because they've not released the data, and no adequate data have been published with regard to relapses and length of relapses.
 
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Bob

Senior Member
Messages
16,455
Location
England (south coast)
"Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%"
I don't understand how these figures are obtained. The adverse reactions were reported as being similar across groups, if I remember correctly, in which case I think it's not helpful to suggest that more participants were negatively affected by CBT or GET without checking the full unpublished data. But I may have misunderstood.
 
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jimells

Senior Member
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2,009
Location
northern Maine
I don't understand how these figures are obtained.

I think he is over-reading the data here. These percentages are the difference between how many responded to the follow-up questions and the much lower number of participants who did the follow-up step test and walking test.

I don't think there is any evidence to show why so few participants did the follow-up step test and walking test. They may have been harmed by the "treatments", they may have gotten sicker because that is the natural course of the disease for many of us, or there may be other reasons for not doing the follow-up tests.
 

CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Location
USA
The author did a brilliant job! Well worth saving and presenting to any doctor who tries to tell you that exercise will help you "recover."

The protocol stated: “‘Recovery’ will be defined by meeting all four of
the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or
less, (ii) SF-36 physical Function score of 85 or above, (iii) a CGI score
of 1, and (iv) the participant no longer meets Oxford Criteria for CFS,
CDC criteria for CFS or the London criteria for ME” [4]. Yet even though
the authors chose these themselves, during the trial they “changed three
of the thresholds for measuring recovery from our original protocol
 

Dolphin

Senior Member
Messages
17,567
Extract:

At 52-week follow up the objective outcomes showed the following: the step test, a reliable objective measure of fitness [46], showed no significant improvements in any of the 4 treatment groups; the 6MWT results showed that ME/CFS patients would remain on the waiting list for a lung transplant [55] following treatment deemed effective by the PACE trial; employment rates did not differ significantly between the 4 treatment groups, the number of patients claiming state sick pay and disability benefits increased following CBT and GET [45], and the number of patients in receipt of income protection or private pensions had actually doubled in the CBT and GET groups [45] and the authors deemed it too much of a burden [60] for patients to wear a 26 g weighing Actometer [59] at the end of the trial even though the PACE trial concluded that CBT and GET were moderately effective, and that 22% of patients in the CBT and GET groups recovered following successful treatment [5]; therefore, it should have been less of a burden to wear the Actometer at the end of the trial then at the beginning and these figures should have decreased dramatically and not gone up.
 

Sea

Senior Member
Messages
1,286
Location
NSW Australia
I don't understand how these figures are obtained. The adverse reactions were reported as being similar across groups, if I remember correctly, in which case I think it's not helpful to suggest that more participants were negatively affected by CBT or GET without checking the full unpublished data. But I may have misunderstood.
It would be good to make the same calculations for the other groups too. The author says that an increase in symptoms for the APT and SMC group would be expected following the Step Test and 6MWT. I haven't looked to see at what time points the worsening of symptoms was. It may have been better to argue this percentage was harmed by the trial rather than GET and CBT specifically.

These percentages are the difference between how many responded to the follow-up questions and the much lower number of participants who did the follow-up step test and walking test.
No I don't think so

In the PACE trial, 46% of participants reported an increase in ME/CFS symptoms; 31% and 19% reported musculoskeletal and neurological nonserious adverse events, respectively [64]. It’s unclear how large the overlap was between these three groups and therefore the proportion affected by CBT and GET would have been between 46% and 96%
46% increase in ME/CFS symptoms + 31% musculoskeletal non-serious adverse event + 19% neurological non-serious adverse event = 96%
Not knowing the overlap he puts it between 46% and 96%