Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS, 60% of Patients Show No

Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS: 60% of Pa

You can view the page at http://forums.aboutmecfs.org/content.php?369-A-Hitch-in-its-Step

 

Stuff like the actometer-removal stands out for me: the moving of the goalposts: that blatantly points towards manipulation of data and hence possible fraud. Also, the actometer data from the Dutch study suggests that all the self-reported measures were illusory which undermines the whole thing and undermines all questionnaire-based results - and pulling out clear referenced facts on all that, including dates, timelines, comparison with timelines for the UK decision to pull them, is a crucial job that I haven't seen done here yet (Dolphin I guess you have that to hand?). Emphasis on that issue would achieve multiple goals.

Just to be clear here... actometer's weren't a part of the Pace protocol. But in the comments section for that paper White says that there was a plan to use actomemters, but that these were droppped because of the inconveniece thaty'd cause patients (?!). So it's a worthile point, but I didn't want people to get it confused with the numerous changes to aspects of Pace which had been officially announced in the protocol.

The only data on it (I think) is in that comments section: http://www.biomedcentral.com/1471-2377/7/6/comments

 

Just to be clear here... actometer's weren't a part of the Pace protocol. But in the comments section for that paper White says that there was a plan to use actomemters, but that these were droppped because of the inconveniece thaty'd cause patients (?!). So it's a worthile point, but I didn't want people to get it confused with the numerous changes to aspects of Pace which had been officially announced in the protocol.

The only data on it (I think) is in that comments section: http://www.biomedcentral.com/1471-2377/7/6/comments

Yes, that's a good summary, Esther12.

 

Is this true??

It was written by someone posting in the comment section of an article about the Pace Trial.

"as it is part funded by DEPARTMENT OF WORK AND PENSIONS. They would definitely have a biased opinion prior to research that the results of the research will SAVE THEM MONEY. "


Is it normal for this department to partially fund a study?

It is true and is very unusual from everything I have heard. I don't think the figure was ever calculated. Doing some rough figures it may be in the order of UK150,000 perhaps (i.e. they weren't a big funder). Dr. Mansel Aylward may have helped get them the money - he know works in the UNUMProvident centre in Cardiff.

 

Michelle, you make some good points.

Here's the press release for what it's worth. It didn't give too many numbers away:

The Lancet publish the results of the PACE study, 18 February 2011

TRIAL SHOWS THAT COGNITIVE BEHAVIOURAL THERAPY AND GRADED EXERCISE THERAPY ARE SAFE AND EFFECTIVE TREATMENTS FOR CHRONIC FATIGUE SYNDROME

Despite previous evidence that both cognitive behavioural therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome (CFS), some patients organisations have reported that these treatments can be harmful and instead prefer pacing and specialist medical care (SMC). The PACE trial, published *Online First* and in an upcoming /Lancet/, shows that while CBT and GET have positive effects on CFS when combined with SMC as compared to SFC alone, adaptive pacing therapy (APT) with SMC is no more effective than SMC alone. The *Article*is by Profs Peter White (Barts and The London School of Medicine, UK), Trudie Chalder (Kings College London, UK), Michael Sharpe (University of Edinburgh, UK) and colleagues. The trial is funded by the UK Medical Research Council and various departments of UK governments.

CFS, sometimes called Myalgic Encephalomyelitis (ME), is a long-term, complex and debilitating condition that causes fatigue and other symptoms such as poor concentration and memory, disturbed sleep, and muscle and joint pain. The cause of the condition affecting some 250,000 people in the UK aloneis unknown.

SMC consists of advice about CFS, including avoidance of activity extremes, and rest and self-help strategies. APT is based on the theory that CFS is an irreversible condition that leaves patients with a limited amount of energy, and that individuals adapt their lives to this available energy through use of a daily diary. CBT is based on the premise that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue. GET helps a CFS patient gradually step up their level of physical activity to counter the deconditioning that has set in as their activity has fallen. Walking is a popular choice for this.

In PACE, 640 patients were assigned to one of SMC alone (160 patients), SMC/CBT (161), SMC/GET (160) and SMC/APT (159). After a follow-up of one year, mean fatigue and physical function scores had improved more after CBT and GET than after both APT and SMC alone. Serious adverse reactions to treatment were recorded in two APT patients (1%), three CBT patients (2%), two (1%) GET patients, and two (1%) in the SMC-only group.

The group plans to report in the near future on cost-effectiveness of these various treatments, and say that since even CBT and GET only offer a moderate improvement in symptoms, research into new effective treatments must go on.

The authors conclude: We affirm that cognitive behaviour therapy and graded exercise therapy are moderately effective outpatient treatments for chronic fatigue syndrome when added to specialist medical care, as compared with adaptive pacing therapy or specialist medical care alone. Findings from PACE also allow the following interpretations: adaptive pacing therapy added to specialist medical care is no more effective than specialist medical care alone; our findings apply to patients with differently defined chronic fatigue syndrome and myalgic encephalomyelitis (ME) whose main symptom is fatigue; and all four treatments tested are safe.

In a linked *Comment*, Dr Gijs Bleijenberg, and Dr Hans Knoop, Expert Centre for Chronic Fatigue, Radboud University NijmegenMedical Centre, Netherlands, say: The central role of cognition in relation to fatigue might explain why graded exercise therapy is effectiveand adaptive pacing therapy is not. They note that /in adaptive//pacing patients learn to focus on the fatigue in order to stop in time, which does not seem to help, while in graded exercise patients learn that they are able to do more than they thought possible.

They conclude: Remarkably in this context, confidence in the treatment at the start is substantially lower with cognitive behaviour therapy than it is with adaptive pacing therapy. Despite lowered confidence in cognitive behaviour therapy, this therapy is more effective than is adaptive pacing therapy. Patients confidence in treatment can only change if a change in abilities is perceived, which generally seems to happen in cognitive behaviour therapy.

 

Just to be clear here... actometer's weren't a part of the Pace protocol. But in the comments section for that paper White says that there was a plan to use actomemters, but that these were droppped because of the inconveniece thaty'd cause patients (?!).

If the actometers, which are designed to be as unobtrusive and convenient as possible to wear, are too much hassle for patients, then the patients must be pretty physically limited to start with.

The lack of objective activity measures seriously limits the validity of the already modest results.



Also found these, not sure if they have been posted here before. Overall they seem to indicate a high validity for actometers as a measure of overall activity, but that pedometers are not so reliable.

The use of pedometer and actometer in studying daily physical activity in man. Part I: Reliability of pedometer and actometer.
W. H. M. Saris and R. A. Binkhorst
EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
Volume 37, Number 3, 219-228, DOI: 10.1007/BF00421777

The purpose of this study was a critical evaluation of pedometer and actometer for estimating daily physical activity.
Both instruments were tested for reliability on a carriage with movements in different directions. To obtain comparable data of different pedometers it was necessary to adjust the spring tension very carefully. The reliability of the individual actometer was satisfactory, but there are large differences between the watches. Therefore, a correction factor (C.F.) was introduced.
Some experiments were carried out on a treadmill. 9 Children (aged 56 years) and 6 young adult males (aged 2131 years) walked and ran at different speeds. The energy expenditure was calculated from formulas. The pedometer overestimates the actual step rate with 0.10.3 counts per step during fast walking (69 kmh1) and fast running (15 kmh1). It underestimates the actual step rate with 0.20.7 counts per step, while walking slowly. It was shown that the pedometer does not reflect the differences in energy expenditure levels at different speed very well. The actometer units per step increases more or less proportional to the speed of walking and running. In contrast to the pedometer results the actometer results are more related to the energy expediture levels at different speed.
The results of this study suggest that the actometer might be a valid indicator of the daily physical activity in terms of energy expenditure.


The use of pedometer and actometer in studying daily physical activity in man. Part II: Validity of pedometer and actometer measuring the daily physical activity.
Authors: W. H. M. Saris and R. A. Binkhorst
EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
Volume 37, Number 3, 229-235, DOI: 10.1007/BF00421778

The validity of the pedometer and actometer for estimating the daily physical activity was evaluated by means of an observation study. The physical activity in a classroom of 11 pupils of a kindergarten was assessed by means of a pedometer, actometer and by observation. Besides this an activity questionnaire was completed by the infant-quide. On basis of the individual observation it is clear that the infant-guide can give valuable information about the activity of the children at school.
The results of the pedometer attached to the waist and the actometers attached to the ankle were significantly correlated with the results of the observation method. The wrist actometer showed a smaller but still significant correlation with the other variables. Implications of this findings are discussed in regard toward the physical activity. The pedometer results point out that when the percentage of intense activity is high the pedometer tends to underestimate the level of activity.
The actometer results indicate that such a motion recorder gives a reliable estimation of activity in children. The findings are discussed in terms of the practical applications of the actometer in the research of daily physical activity and the physical rehabilitation treatment of certain diseases.


Measuring Activity Level with Actometers: Reliability, Validity, and Arm Length.
Authors: Eaton, Warren O.
Child Development, v54 n3 p720-26 Jun 1983

The gross-motor activity of 27 three- and four- year-olds was assessed through teacher ratings, parent responses to the activity scale of the Colorado Childhood Temperament Inventory, and data from uncalibrated actometers worn by children during free play. Activity scores composited across multiple actometers had high reliability and correlated strongly with the other two measures.


Correlations of pedometer readings with energy expenditure in workers during free-living daily activities.
Hiroshi Kashiwazaki, Tsukasa Inaoka, Tsuguyoshi Suzuki and Yasuyuki Kondo
EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
Volume 54, Number 6, 585-590, DOI: 10.1007/BF00943345

... The whole day readings of the pedometer for all the subjects moderately correlated (r=0.438,p<0.05) with the net energy cost (NEC) as determined by subtracting the sleeping metabolic cost from the energy expenditure (clerical workers:r=0.781,p<0.01; assembly workers:r=0.188,p>0.05). The correlation analysis of the pedometer readings with the NEC in three activity phases in a day (work, commuting and staying at home), showed that the extent of the relationship differed by job types and activity phases. The best correlation was obtained during commuting in both of the job types (clerical workers:r=0.843,p<0.01; assembly workers:r=0.743,p<0.01). During work, a quite strong correlation (r=0.889,p<0.01) was obtained with the clerical workers but not with the assembly workers. No significant correlations were found in the data while the subjects were at home. The capacity of the pedometer to detect the impacts of body movements, and the characteristics of activity, are responsible for the differences in correlation. The limitations of the pedometer suggested in the present study must be taken into account if the device is to be used for measuring physical activity. A particular advantage of the device appears in its use for a sedentary population without regular srenuous exercise or static contractions.


Approaches to estimating physical activity in the community: calorimetric validation of actometers and heart rate monitoring.
Avons P, Garthwaite P, Davies HL, Murgatroyd PR, James WP.
Dunn Clinical Nutrition Centre, Cambridge, UK.
Eur J Clin Nutr. 1988 Mar;42(3):185-96.

The relationship between actometer measurements, heart rate monitoring and energy expenditure during exercise and resting periods was assessed in a whole-body indirect calorimeter on 12 young male volunteers. Equations derived from these studies were applied to actometer measurements taken during a further 7 d recording in free-living conditions to predict daily energy expenditure over 1 week on an individual basis. Actometers proved to be a satisfactory means of estimating energy expenditure and heart rate monitoring improved the estimates in a few selected subjects. Indirect measures of energy expenditure could be developed by this approach but individual calibration is essential.


Measuring activity using actometers: A methodological study
Warren W. Tryon
JOURNAL OF PSYCHOPATHOLOGY AND BEHAVIORAL ASSESSMENT
Volume 6, Number 2, 147-153, DOI: 10.1007/BF01350169

Actometers are men's self-winding mechanical wristwatches that have been modified such that they measure activity rather than time. Actometers can be used to obtain longitudinal naturalistic measures of activity concerning a variety of clinical populations. However, no systematic methodological research has been conducted with regard to the site of attachment and the duration of measurement necessary to ensure valid results. This article presents the results of a methodological study designed to answer these questions. The mean activity levels associated with the Left Wrist and Ankle were nearly equal to those associated with the Right Wrist and Ankle. The Ankle readings were substantially greater than the Wrist readings because the subjects' legs were longer than their arms. The data from Week 2 were the same as those from Week 1.

 

GET helps a CFS patient gradually step up their level of physical activity to counter the deconditioning that has set in as their activity has fallen.

The proven false assumption of deconditioning certainly needs challenging.

 

The proven false assumption of deconditioning certainly needs challenging.

Actually, I'm willing to stipulate that they completely reversed deconditioning -- and obtained only a tiny fraction of the improvement needed to restore health. The false assumption concerns the degree to which the drop in activity in this disease is the result of deconditioning, not the cause.

My take on the measurements is that all the common gains for different treatment modalities are the result of either a Hawthorne effect or interventions to prevent "adverse outcomes". These should be expected to disappear if treatments are expanded.

In ordinary practice, doctors are typically unaware of adverse events unless these are forcefully brought to their attention. (Memorable quote during a call from a hospital bed: "YOU HAD A SEIZURE?!!" ) Pushing GET without careful attention to adverse events comparable to that in the study, with appropriate interventions, is a recipe for disaster. This has direct implications for safety, effectiveness and cost.

 

The proven false assumption of deconditioning certainly needs challenging.

Yes, it certainly does.
I think that this trial is excellent proof that ME is not caused by, or perpetuated by, either deconditioning or psychological factors.
If it was then the best CBT and GET available to patients, would have done more than a 10% reduction in fatigue levels.
But unfortunately it won't be so easy to convince the establishment of that!

 

There are some short video segments, related to the PACE Trial, published on The Lancet online...


Interview with Professor Trudie Chalder:
http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962a.html

Interview with Professor Michael Sharpe:
http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962b.html

Lancet TV reports from the press conference in London:
http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962c.html



But I don't recommend watching this patronising drivel, unless you want to blow a gasket!
Not only are they patronising, the videos are also unscientific, factually inaccurate, and completely biased and one-sided.

 

Yes, it certainly does.
I think that this trial is excellent proof that ME is not caused by, or perpetuated by, either deconditioning or psychological factors.
If it was then the best CBT and GET available to patients, would have done more than a 10% reduction in fatigue levels.
But unfortunately it won't be so easy to convince the establishment of that!

Their step counts should have increased more too. No difference for the CBT group and the GET group going around at a slow rate. One might expect a group who did an exercise program for a year (well 6 months and then they were followed) to have a better than average fitness level, especially when many weren't working (presumably) so would have plenty of time to devote to exercise.

 

Here's Action for ME's response to the trial...
It's quite an interesting response, seeing as Action for ME helped to set the study up in the first place!

Letter: ME myths

Date: 23 February 2011

There have been some outrageous headlines in the media recently, following
publication in the Lancet of a five-year, 4.2 million study which compared
different therapies for ME (your report, 18 February).

Let's be very clear on this: exercise and talking therapy cannot cure ME. The
Pace trial does not say it can. What the study says is that some people who have
fatigue as their primary symptom may gain moderate improvements in their
physical functioning if they receive a cognitive behaviour or graded exercise
programme in a specialist chronic fatigue syndrome/ME clinic.

Now, can the UK research community please start focusing on the biology of this
illness?

Sir Peter Spencer

Action for ME
Victoria Street
Bristol

http://news.scotsman.com/letters/Letter-ME-myths.6722712.jp

 

Their step counts should have increased more too. No difference for the CBT group and the GET group going around at a slow rate. One might expect a group who did an exercise program for a year (well 6 months and then they were followed) to have a better than average fitness level, especially when many weren't working (presumably) so would have plenty of time to devote to exercise.

Exactly, the study blows all the myths about ME right out of the water... I really hope that we can all make our objections stick, at least a little bit, and make a positive difference from the results of this study... It's going to be a big fight though, isn't it!

 

There are just a few points for US readers.

Adaptive pacing is not at all like pacing. It involves keeping a diary and adhering strictly to a tight schedule. No sleep during the day, rests for a specific number of minutes at a certain time for instance. It is very difficult to do and completely ignores how a person is feeling. It is the complete opposite of the pacing that helps patients where you listen to your body. In some ways it is worse for ME than GET as you can do your daily walk when you feel up to it and pace yourself the rest of the time.

PDW hates pacing and has called this travesty pacing so as to discredit the patient experience. Doctors will now tell us not to listen to our bodies when that was never trialled at all.

They did not find that CFS and ME responded the same way. They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards. Also, PDW has his own meaning of PEM, it is the soreness you experience when you are deconditioned then exercise. This trial said nothing about neuroimmune disease.

They had great difficulty recruiting for the trial. Anyone who knew anything about it would not enter. There were complaints about the set up from all the patient organizations except AfME so all members knew of the flaws. They were forced to change the criteria for entry and started asking GPs to send along fibromyalgia patients.

It was a mess and the results dreadful despite their best efforts to get a positive result, yet they have been reported as wonderful in the UK and will be used against us. The rest of the world may see them as laughable, rightly, but our plight is enormously increased. Our present government has declared war on the disabled, every single person on benefits is to be reassessed and this paper spells disaster for those of us with ME.

Mithriel

Mithriel, you write, 'They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards'.

Sorry have I been misunderstanding this? I thought the Oxford Criteria meant that neurological symptoms, pem etc.are not required to get a diagnosis of CFS, just fatigue (which could be due to depression, anxiety, burn out and so on these are not exclusions in the Oxford criteria), but neurological symptoms and PEM alongside fatigue does not mean you are excluded from a diagnosis of CFS (in UK often interchanged wih M.E) under the Oxford criteria?

Would really appreciate an answer to this as Mithriel's assertion that people with the classic symptoms of M.E/CFS such as neurological and post exertional malaise would be excluded from a diagnosis under the Oxford criteria - and if true would not be even studied under the Pace trial - has really confused and thrown me. Many thanks in advance.

 

Here's Action for ME's response to the trial...
It's quite an interesting response, seeing as Action for ME helped to set the study up in the first place!

here have been some outrageous headlines in the media recently, following
publication in the Lancet of a five-year, 4.2 million study which compared
different therapies for ME (your report, 18 February).

Let's be very clear on this: exercise and talking therapy cannot cure ME. The
Pace trial does not say it can. What the study says is that some people who have
fatigue as their primary symptom may gain moderate improvements in their
physical functioning if they receive a cognitive behaviour or graded exercise
programme in a specialist chronic fatigue syndrome/ME clinic.

Now, can the UK research community please start focusing on the biology of this
illness?

Sir Peter Spencer

Action for ME
Victoria Street

Short and sweet and right to the point! Very nice!

 

Their step counts should have increased more too. No difference for the CBT group and the GET group going around at a slow rate. One might expect a group who did an exercise program for a year (well 6 months and then they were followed) to have a better than average fitness level, especially when many weren't working (presumably) so would have plenty of time to devote to exercise.

Absolutely - the program was supposed to start, as I remember with something like 15-30 minute walks four or five times a week...(that's from memory - whatever it was I was surprised at how much walking they were doing)......yet at the end they were still toddling along! They weren't even at a normal walking pace..

 

......yet at the end they were still toddling along! They weren't even at a normal walking pace..

For 6 minutes! This is like 1/2 a healthy pace for 1/5 of a minimal health walk or 1/10 of a modest exercise walk. Heart attack victims often do better. (Anyone have a handy reference for walking after heart attacks?)

 

Here's Action for ME's response to the trial...
It's quite an interesting response, seeing as Action for ME helped to set the study up in the first place!

At least The Scotsman printed Action for ME's letter, as they hadn't printed any other responses in the actual newspaper to their article so far (link below), although there were a couple of good comments made online. The headline in the newspaper article was "ME can be tackled by counselling and exercise, say scientists" and the article says "Scientists...believe it could herald a new dawn for the treatment of ME". I agree with the grumpy Scotsman's opinion of that ... :headache:

http://www.scotsman.com/health/ME-sufferers-given-hope-as.6720159.jp

 

Absolutely - the program was supposed to start, as I remember with something like 15-30 minute walks four or five times a week...(that's from memory - whatever it was I was surprised at how much walking they were doing)......yet at the end they were still toddling along! They weren't even at a normal walking pace..

Cort, thanks for this overview, it's really helpful. I read the following in an English newspaper,

'Overall, 60 per cent of patients who received CBT or GET made progress and 30 per cent recovered sufficiently to resume normal lives'.

From reading your excellent overview, I don't see how the quote of 30 per cent recovered sufficiently to resume normal lives fits in? Please can you explain? Many thanks.

 

From reading your excellent overview, I don't see how the quote of 30 per cent recovered sufficiently to resume normal lives fits in? Please can you explain? Many thanks.

The most disturbing thing about the trial is how it has been oversold. "We can cure you... you just need to accept that you'll always be tired!"


I've just collected together a lot of the analysis of there figures here: http://forums.aboutmecfs.org/showthread.php?4926-PACE-Trial-and-PACE-Trial-Protocol/page24 I still don't really understand how they're counting a SPF score of 60 as normal.

edited: I'm getting tired and cranky about this.

 

Cort, thanks for this overview, it's really helpful. I read the following in an English newspaper,

'Overall, 60 per cent of patients who received CBT or GET made progress and 30 per cent recovered sufficiently to resume normal lives'.

From reading your excellent overview, I don't see how the quote of 30 per cent recovered sufficiently to resume normal lives fits in? Please can you explain? Many thanks.

They said this was within 1 S.D. of the norm for the population.
It isn't for most of the populations I have seen and does not represent being healthy.

Basically for the following 10 questions, you score 10 points if one says:
"No, Not Limited At All" to a question and 5 points if one says: "Yes, Limited A Little".

So one could (say) put "Yes, Limited A Lot" to 2 of the questions and "Yes, Limited A Little" to 4 more and still satisfy their recovery-type definition.

Also, a lot of the people in the PACE Trial wouldn't be working - some of the people who scored 60+, might not reach the threshold if they were working at the same time.

4. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?

ACTIVITIES
Yes, Limited A Lot

Yes, Limited A Little

No, Not Limited At All

a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports

b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf

c. Lifting or carrying groceries

d. Climbing several flights of stairs

e. Climbing one flight of stairs

f. Bending, kneeling, or stooping

g. Walking more than a mile

h. Walking several hundred yards (US version has "several blocks")

i. Walking one hundred yards (US version has "one block")

j. Bathing or dressing yourself