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

 

Thanks Cort, for analysing the paper properly. Sadly, there don't seem to be many other journalists out there worthy of the name. I haven't seen any newspaper noticing how dramatically the PACE trial has flopped: "Get out and exercise, say scientists" is the order of the day, across all papers.



Yes Sean, and thank you again for the positive spin I need so much right now. However, I'm afraid that the following is also true as a corollary, and I have to put it this way:

"By any vaguely rational, empirical, and ethical real world standard these remain truly pathetic numbers, that simply do not deliver any practical, meaningful improvement whatsoever in the health or social and economic capacity of patients. But they can manipulate the definitions and stats, and spin the results as much as they want."

Getting really good evidence that CBT and GET are next to useless (where useless is defined as "normal 'care' from CFS specialist centres in the UK"), and getting this evidence direct from the proponents of CBT/GET themselves...even this is not new. I fear we may be naive to place our hopes for any enlightened change in policy on an understanding of the science (assuming of course that we accept that this paper is science, and its authors are scientists - which personally I do not).

Just as journalists worthy of the name apply a sceptical attitude and strive to dig beneath the surface of claims made by those with vested interests, scientists worthy of the name do not twist and manipulate their own science, move the goalposts halfway through, and manipulate the media in order to convey a message in support of political goals.

When I see behaviour such as that observed in the PACE trial - the grossest of many examples being the decision to stop using actometer data halfway through because that data would have proved the purported benefits of the therapies to be illusory - then I am reluctantly compelled to observe that the clearest evidence-based conclusion I can reach from this study is that its authors are fraudulent, and that their aim is deception, in pursuance of their own interests, their own prejudice, and their own hidden agendas.

And just as when I learned that the UK's Science Media Centre - whose job it is to 'help' the British press to put published science in its proper context - is run by a group of former revolutionary communists with a publicly stated agenda of defending science itself by suppressing information about the victims of scientific progress (see LobbyWatch, Martin J. Walker, and the history of Living Marxism magazine and its online reincarnation Spiked)...and when I learned that the SMC advisor to the media in areas relevant to us is one Simon Wessely...I find myself wondering whether those of us who believe in science can afford to trust that what our newspapers call 'science' still deserves that name in a world where the dominance of insanely powerful financial vested interests distorts the playing field so severely.

I would like to simply take the paper at face value, as Cort has done, and celebrate what the paper actually proves: that CBT/GET delivers an almost-negligible benefit to a small proportion of people wrongly diagnosed with ME/CFS, and that the UK's "specialist care centres for CFS" are even less effective than CBT and GET at delivering benefits to UK patients.

But when the paper's authors have redefined a disease themselves in such a way as to exclude people suffering from the disease and include people who do not have any of the major symptoms of the disease; when they have manipulated their protocol to remove the physical evidence which would have shown that their findings were an illusion; when they have defined 'normal treatment' as the treatment available at specialist centres shunned by most people with ME/CFS; when they have invented their own concept of 'pacing' to mean something that is nothing like 'pacing' and then used this study to claim that pacing doesn't work; when they have re-defined recovery and meaningful effects halfway through their study; when they have used the most fatigued 15% of patients seen in GPs' surgeries to define a 'normal' level of fatigue; and when they are psychologists who have performed all their analysis using their own questionnaires which they are masters at manipulating in ways that I cannot hope to unravel...when they do all these things, the fact that they still can't deliver more than a tiny improvement in those questionnaire scores they decide to publish seems to me far less significant evidence than the abundant evidence that the study's authors are frauds and charlatans.

Is CBT an effective treatment for some people diagnosed with ME/CFS? It seems totally unreasonable to most people to question that these therapies can be helpful to some people. "Nobody is claiming it cures you," they cry, "but there is plenty of evidence that it helps some people, and it's the best we've got - so why on earth are you so implacably opposed to something that might help you?"

I am opposed to it because it was no help whatsoever to me: talk therapy was as harmful to me in relation to my mystery illness as it was helpful for coping with and then overcoming clinical depression. I am resistant to accepting that CBT is a useful option because the evidence only shows that a small proportion of people with my illness tick boxes on questionnaires to say that they thought it helped a tiny bit. I am sceptical as to whether it really does help people because the only evidence I've seen regarding whether it really is helpful (the Dutch study) shows that although people reported an increase in their physical activity, the suppressed actometer data reveals that their physical activity had not increased.

So I am reluctant to give ground and accept that there is a role for therapies like CBT in managing chronic illness because it seems crystal clear to me from all the available evidence that what these therapies achieve is simply to persuade people to con themselves into believing they are a little bit better...or perhaps even less than that: CBT can reprogram patients who are asked "How do you feel?" such that they are more likely to say "Fine, thank you".

I am not into self-delusion: most people might not make this choice, but I want the truth, whether it makes me feel happy or not. I don't want to be reprogrammed so as to imagine that my problem is less serious than it is, reprogrammed to accept my illness, reprogrammed to tell everybody that the reprogramming was helpful to me. Reprogramming myself to help myself escape the spiral of depression is one thing; reprogramming myself to deceive myself about my physical illness is quite another.

And I don't want to be reprogrammed by people who have stated repeatedly that they don't believe the cause of my illness will ever be found; people who have blocked any attempt to investigate the physical aspects of the illness; people who have massive influence over what all the newspapers in my country say about my illness; people who are exposed as liars and frauds to anyone who has eyes to see and a heart to care.

And I don't think I would serve my fellow men and women well by accepting this tactical retreat and conceding that there is a place for these charlatans in the therapeutic process, most especially at a time when they are poised to roll out a massive expansion of their services in place of genuine medical services and in place of genuine medical research. I think I would be remiss in my moral responsibility if I put to one side what I have learned about the methods of these crooks as a tactical measure in order to gain wider credibility.

Positive thinking is a very popular philosophy. "You can do anything you want if you put your mind to it" is a lie heard all too often, and one that people who favour truth rather than self-interest cannot accept. The corrolary - "You failed because you didn't try hard enough" - is an insidious consequence. Such philosophies based on self-deception are in the interests of the haves who need to believe they deserve their good fortune, and they play into the hands of those who wish to blame and punish "have nots" for not having anything.

So I will want to be clear in future, if I am going to accept that there is a place for CBT in the management of chronic illness. I will want to offer advice about the subject that is rational and evidence-based whilst respecting the right of the individual to make their own decision - like this:

"There is some limited evidence that a small proportion of people with chronic illnesses who undergo CBT say afterwards that they believe that it helped them. In the case of ME/CFS there is very little evidence as to whether these improvements they believe in are real or illusory, but what little evidence there is suggests that patients are more likely to say that the CBT increased their activity levels even though objective measurements show that their activity levels are unchanged.

For what it's worth, in my personal opinion CBT does nothing but help you to deceive yourself and others that you are not as sick as you really are, and only a minority of people are capable of this self-deception and content with employing that strategy. But if you personally feel comfortable with deceiving yourself in this way in order to feel a little more positive about life, then that therapy - unlike the more effective treatments that researchers refuse to study and are in the process of making illegal - is freely and widely available to you in the UK. Since you pay for the availability of that treatment through your taxes whether you like it or not, it is entirely up to you to decide what you want to do."

What have we learned about ME/CFS from the 5m PACE trial? Nothing that we didn't know before: CBT/GET are crap treatments that only deliver small imaginary benefits; the UK's "specialist treatment centres" are even worse and are rightly shunned; psychologists are allowed to continuously move any and all goalposts and define "pacing" as "not pacing" and use that sleight of hand to claim that pacing doesn't work; and more research is desperately needed.

Real research, though. By honest people, and by scientists next time, please.

Well said, Mark.
In particular, GET and CBT based on GET fall right into those philosophies you mention: "you can get better if you try hard enough" and the corollary, "you're not getting better because you're not trying hard enough".

 

I think we need to demand two follow up studies on this patient sample.

1. Objective activity meters (whichever version they used at the start) to measure the outcome after treatment. Like they should have done without being asked.

2. A follow up assessment, including activity meters, at 104 (or maybe 156) weeks. Preferably by an independent team.

Let's get this one done and buried properly. So there are no questions left about how ineffectual this approach is.

There are follow-up studies planned. I think the authors have permission to follow them for up to 5 years e.g. look at people's medical records (?).
However, I'm not sure I can remember many/any of the details - and they may not have said what the details were. So we may only get to hear what they want us to hear.

The independent team idea is interesting.

 

One thing we do know Cort, is that it only 'helps' a fairly small proportion of patients - less than half of the subset of ME/CFS they selected here - to any extent at all, and it helps those people to a very small extent. Whether the benefits will prove to be sustained, I rather doubt. And that is out of a group that has been carefully selected to contain nobody with immune abnormalities, neurological problems, etc. Was it about 40% of them that you said were already on anti-depressants and were diagnosed with psychiatric conditions? Any analysis of whether those were precisely the patients who tended to see a benefit?

We would next need to understand exactly who it helps, who it doesn't help, and who it is harmful to - and the only way to know that would be yet more expensive psych studies (noooo!!)...carried out by people who aren't fraudulent (ain't gonna happen).

Out of that highly selected group of people who don't have ME symptoms, still about 1% experienced serious adverse effects. That's low, but it's hardly insignificant! There's a comment on the other main discussion thread of PACE that looks at the detail of those adverse effects - and we are talking here about serious adverse effects that will often lead to the patient's death. So while the numbers of those experiencing harmful effects in this particular study are low, that would be no consolation of you were part of that 1%, and since the cohort represents less than 25% of the profile of those diagnosed with ME/CFS, and goes out of its way to exclude those genuinely ill, what would be the risk level for the wider group? Exactly who is at risk, and who is not?...

I won't have the numbers exactly right here, but they seem to stack up something like this: "providing you're in the 25% subset of patients diagnosed with ME/CFS who we looked at, then after a year of this therapy you have a 40% chance of a 9% improvement in fatigue levels (ignoring those who dropped out of the treatment of course), and at least a 1% risk of serious harm that could cause your death" - and that doesn't sound like a great deal to me, especially when we all know these are the best results they were able to deliver.

It seems to me absolutely critical to query exactly who the patients are who are at risk of being killed by this treatment, and to emphasise most strongly that the PACE trial provides no evidence whatsoever that these 'therapies' are safe for the types of people who were excluded from the study. By the authors' own findings, the majority of people diagnosed with ME/CFS and referred to the trial by CFS 'specialist centres' were not considered suitable for inclusion in the trial, so it's dangerous territory indeed because in reality, here in the UK, at least, these treatments are now going to be pushed on to all of those people, regardless of whether they would have been excluded from the PACE trial.

Based on the study's own findings, we can be reasonably confident that, in the real world, some people will die as a result of these treatments. We can also be confident that any benefits they do deliver will be very small indeed.

And note that with both CBT and GET, the therapies are delivered by human beings, according to very different assumptions and beliefs on the part of the individual therapists, and within a different cultural context in the UK compared with the US: CBT and GET are not just CBT and GET and that's it, well-defined: when we talk about those therapies we are not talking about something as homogeneous as a real medical treatment. I do not believe that the therapies are so consistent and rigorous that one psychologist is just as good as the next. I do expect that they got their most effective people involved in this study: the people who deliver good results. We already know that if you get nurses to do it, it doesn't work at all - and to me it's obvious that this helpful result can now be used to claim that these therapies must be delivered by trained psychologists, and nobody else can do it: very handy for the profession. And so I further expect that the general standard of therapy and the results of real-world CBT and GET will be even worse than what the PACE study found.

And so I would be interested to see league tables of the results achieved by the individual therapists - if we have to have them at all.

Most people I've spoken to who don't have ME/CFS - including my family - seem to struggle to understand why patients would be so resistant to the idea that CBT or GET might help. They figure if there's something that might help, why reject it? Some figure that if you're so resistant to the idea, maybe that implies that actually you do need such therapy. My guess is that most people in the wider world will find your line on this much more reasonable, and it will be an easier sell, politically.

It would be an easier way out, and a line that people would find more reasonable. I really would like to take that line if I could. I do actually believe there is an important place for talk therapies, meditation, mind/body, and really above that just the personal support of somebody who at least gives the appearance of caring, in all illnesses. I can accept that there's a place for CBT for some people - the problem is that we don't know which ones - but in any case I don't believe that CBT is remotely the best of all the options in terms of these non-medical techniques. Actually, I very much suspect they are all broadly speaking as good as each other, in practice, and that in every case the quality of the therapy depends most critically on the quality of the therapist themselves and their own personal beliefs.

And I see my friend with MS already being offered CBT as part of a CBT expansion programme I had warned him about, and I see CBT being rolled out ever more widely, and as someone who has been interested in counselling for a long time, who has friends who are counsellors, and who has tried a lot of different counselling modalities, CBT is not my favourite model at all, nor the model favoured by the compassionate people I know and respect in this field.

In general, I prefer the person-centred approach, personally: so how does that compare, as a treatment? Unknown of course: "there is no evidence and we are determined that there never will be, so STFU" - but there's 1.5m of our money sitting waiting for them to submit proposals, and god help us that's where I fear the money will go: on more and different psych-based studies to try and increase that pathetic percentage of theirs.

They delivered the warning shot: somewhere this weekend I read them musing about getting those 25% of patients who are bedbound involved in the study. They will try to get that studied too, make no mistake. The fact that those patients are the most likely to die from the treatment is not the sort of thing that appears to concern these people, but I don't personally consider that to be an acceptable risk.

 

I'm interested in more information in this too.

Yes, this is important to nail down.

It doesn't sound like Peter White.

Certainly doesn't. If he did say it in the formal paper, then did peer review actually work (to some degree) and require him to seriously qualify and limit his therapeutic claim?

 

First they gathered people who met the Oxford Criteria and had a physical function score of >65.

This should be <=65 (i.e. less than or equal to 65)

 

Acer2000 said:

I'd also like to point out that the CAA should have responded to the press release of this study with the same criticism that Cort used in his post. The fact that they didn't is disturbing. Aren't they supposed to be advocating for us? The fact that they gave a "neutral" quote to the media isn't good enough. They should have been out in front of this. WTF

YES! This was my thought too (see comment #8). Their analysis of the study was helpful, but had NO EFFECT ON HOW THE STORY WAS TOLD! That is what their job is (or maybe it isn't; they do seem to have completely abdicated any public relations activity and that may be just as well given their effectiveness at it). Cort is certainly welcome to write a letter to the NY Times, but that's closing the door after the proverbial horse has left the barn. It's too late. Every doctor in the English-speaking world and beyond has been told that exercise will cure ME/CFS and as patients, we have very little ability to change their minds.

CAA needed to have made sure to have sent their press release to all the media outlets the White et al group sent theirs to and laid out exactly what Cort and many of the commenters have said here about how flawed this study was. They need to give the journalists the headline. The quotes. The main narrative. Journalists, whether because they have no time or are just lazy (or both), are not going to read the study. They are not going to do much beyond read the press release, maybe call two quotes, and then write it up in their own words in the space of maybe an hour TOPS before moving on to their next assignment(s) for the day.

PR is not an arena for "inside voices." It's the loudest and most manipulative voice that wins. Always.

 

There is a Spanish study on GET and CBT for MECFS patients based on the Fukuda criteria: "Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up."

Chronic fatigue syndrome (CFS) produces physical and neurocognitive disability that significantly affects health-related quality of life (HRQL). Multidisciplinary treatment combining graded exercise therapy (GET) cognitive behavioural therapy (CBT) and pharmacological treatment has shown only short-term improvements. To compare the effects on HRQL of (1) multidisciplinary treatment combining CBT, GET, and pharmacological treatment, and (2) usual treatment (exercise counselling and pharmacological treatment) at 12 months of follow-up. Prospective, randomized controlled trial with a follow-up of 12 months after the end of treatment. Patients consecutively diagnosed with CFS (Fukuda criteria) were randomly assigned to intervention (n = 60) or usual treatment (n = 60) groups. HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form questionnaire (SF-36). Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Questionnaire (HAQ) and comorbidities. At baseline, the two groups were similar, except for lower SF-36 emotional role scores in the intervention group. At 12 months, the intervention did not improve HRQL scores, with worse SF-36 physical function and bodily pain scores in the intervention group. Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL. The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis.

http://www.ncbi.nlm.nih.gov/pubmed/21234629

Unfortunately, it has no press-release that journalists can copy/paste into their articles. Anyone can send this to David Tuller or Amy Dockser Markus?
Can someone get hold of the complete article?

 

Response

There is a Spanish study on GET and CBT for MECFS patients based on the Fukuda criteria: "Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up."



http://www.ncbi.nlm.nih.gov/pubmed/21234629

Unfortunately, it has no press-release that journalists can copy/paste into their articles. Anyone can send this to David Tuller or Amy Dockser Markus?
Can someone get hold of the complete article?

I also think this part of Cort's comments is key:


The fact that the treatments were not particularly effective for anyone suggested they were generic treatments that might have produced the same results for anyone with a chronic illness and thus may have said little about the differences between the definitions.

From people's other comments I think we can dig up trials that show that CBT has a similar effect on people who have cancer, hiv, etc. That actually suggests that it doesn't touch the underlying cause at all just like in these diseases.

 

Is there a little hope ? The Lancet Early online publication 18/2/2011 available on the ME Association org uk site - click news (top) item then full text Lancet at base. The study clearly states CFS only (OK so we all know it's the same thing - just degree). The Interpretation stands out - CBT and GET can safely be added to SMC (Specialist Medical Care) to MODERATELY improve outcomes for chronic fatigue syndrome ...... Added to seems to place both in a secondary "role" to medicine - one assumes it is in place before add ons. And doesn't gel with wild Press assumptions. In the UK there is no proper medical care - they do not understand nor know how to treat (and no will whatsoever) and GET/CBT are pressured on all as "medical". The psycho researchers appear as the tail trying to wag the dog of real medicine.

 

Acer2000 said:


YES! This was my thought too (see comment #8). Their analysis of the study was helpful, but had NO EFFECT ON HOW THE STORY WAS TOLD! That is what their job is (or maybe it isn't; they do seem to have completely abdicated any public relations activity and that may be just as well given their effectiveness at it). Cort is certainly welcome to write a letter to the NY Times, but that's closing the door after the proverbial horse has left the barn. It's too late. Every doctor in the English-speaking world and beyond has been told that exercise will cure ME/CFS and as patients, we have very little ability to change their minds.

CAA needed to have made sure to have sent their press release to all the media outlets the White et al group sent theirs to and laid out exactly what Cort and many of the commenters have said here about how flawed this study was. They need to give the journalists the headline. The quotes. The main narrative. Journalists, whether because they have no time or are just lazy (or both), are not going to read the study. They are not going to do much beyond read the press release, maybe call two quotes, and then write it up in their own words in the space of maybe an hour TOPS before moving on to their next assignment(s) for the day.

PR is not an arena for "inside voices." It's the loudest and most manipulative voice that wins. Always.

Unfortunately, White et al. had an advantage as they had the data. The CAA did not and indeed very few people in the UK seemed to have the paper before the midnight deadline. In such circumstances, it's not easy to do a press release that is there for the first round of coverage. Indeed, people were having to deal with journalists "blind" on Thursday, where journalists had the embargoed press release.

 

One thing we do know Cort, is that it only 'helps' a fairly small proportion of patients - less than half of the subset of ME/CFS they selected here - to any extent at all, and it helps those people to a very small extent. Whether the benefits will prove to be sustained, I rather doubt. And that is out of a group that has been carefully selected to contain nobody with immune abnormalities, neurological problems, etc. Was it about 40% of them that you said were already on anti-depressants and were diagnosed with psychiatric conditions? Any analysis of whether those were precisely the patients who tended to see a benefit?

We would next need to understand exactly who it helps, who it doesn't help, and who it is harmful to - and the only way to know that would be yet more expensive psych studies (noooo!!)...carried out by people who aren't fraudulent (ain't gonna happen).

These predictors are mentioned in the trial protocol http://www.biomedcentral.com/1471-2377/7/6 :

Predictors
1. Sex

2. Age

3. Duration of CFS/ME (months)

4. 1 week of actigraphy [18] (as initiated at visit 1 with the research nurse)

5. Body mass index (measure weight in kg and height in metres)

6. The CDC criteria for CFS [1]

7. The London criteria for myalgic encephalomyelitis [40]

8. Presence or absence of "fibromyalgia" [41]

9. Jenkins sleep scale of subjective sleep problems [37]

10. Symptom interpretation questionnaire [34]

11. Preferred treatment group

12. Self-efficacy for managing chronic disease scale [32]

13. Somatisation (from 15 item physical symptoms PHQ sub-scale) [35]

14. Depressive disorder (major and minor depressive disorder, dysthymia by DSMIV) (from SCID) [30]

15. The Hospital Anxiety and Depression Scale (HADS) [38] combined score

16. Receipt of ill-health benefits or pension

17. In dispute/negotiation of benefits or pension

18. Current and specific membership of a self-help group (specific question)

Here's what the main paper says:

We plan to report relative cost-eff ectiveness of the
treatments, their moderators and mediators, whether
subgroups respond diff erently, and long-term follow-up
in future publications.

What data that will see the light of day may only be data that suits the authors given their willingness to not use the prespecified primary outcome measures along with some secondary ones.

 

In general, I prefer the person-centred approach, personally: so how does that compare, as a treatment? Unknown of course: "there is no evidence and we are determined that there never will be, so STFU" - but there's 1.5m of our money sitting waiting for them to submit proposals, and god help us that's where I fear the money will go: on more and different psych-based studies to try and increase that pathetic percentage of theirs.

There is this study which also has a subgroup analysis for CFS. Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313894/pdf/11271868.pdf

Chronic fatigue in general practice: is counselling as good as cognitive behaviour therapy? A UK randomised trial.
Br J Gen Pract. 2001 Jan;51(462):19-24.

Ridsdale L, Godfrey E, Chalder T, Seed P, King M, Wallace P, Wessely S; Fatigue Trialists' Group.

Department of General Practice, Guy's, King's and St Thomas's School of Medicine, King's College, 5 Lambeth Walk, London SE11 6SP. L.Ridsdale@iop.kcl.ac.uk

Comment in:
Br J Gen Pract. 2001 Apr;51(465):317-8. </pubmed/11458490>
Br J Gen Pract. 2001 Apr;51(465):316-7. </pubmed/11458489>

Abstract

BACKGROUND: Fatigue is a common symptom for which patients consult their doctors in primary care. With usual medical management the majority of patients report that their symptoms persist and become chronic. There is little evidence for the effectiveness of any fatigue management in primary care.

AIM: To compare the effectiveness of cognitive behaviour therapy (CBT) with counselling for patients with chronic fatigue and to describe satisfaction with care.

DESIGN OF STUDY: Randomised trial with parallel group design.

SETTING: Ten general practices located in London and the South Thames region of the United Kingdom recruited patients to the trial between 1996 and 1998. Patients came from a wide range of socioeconomic backgrounds and lived in urban, suburban, and rural areas.

METHOD: Data were collected before randomisation, after treatment, and six months later. Patients were offered six sessions of up to one hour each of either CBT or counselling. Outcomes include: self-report of fatigue symptoms six months later, anxiety and depression, symptom attributions, social adjustment and patients' satisfaction with care.

RESULTS: One hundred and sixty patients with chronic fatigue entered the trial, 45 (28%) met research criteria for chronic fatigue syndrome; 129 completed follow-up. All patients met Chalder et al's standard criteria for fatigue. Mean fatigue scores were 23 on entry (at baseline) and 15 at six months' follow-up. Sixty-one (47%) patients no longer met standard criteria for fatigue after six months. There was no significant difference in effect between the two therapies on fatigue (1.04 [95% CI = -1.7 to 3.7]), anxiety and depression or social adjustment outcomes for all patients and for the subgroup with chronic fatigue syndrome. Use of antidepressants and consultations with the doctor decreased after therapy but there were no differences between groups.

CONCLUSION: Counselling and CBT were equivalent in effect for patients with chronic fatigue in primary care. The choice between therapies can therefore depend on other considerations, such as cost and accessibility.

Releated study:
Free full text:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313893/pdf/11271867.pdf

Chronic fatigue in general practice: economic evaluation of counselling versus cognitive behaviour therapy.

Br J Gen Pract. 2001 Jan;51(462):15-8.

Chisholm D, Godfrey E, Ridsdale L, Chalder T, King M, Seed P, Wallace P, Wessely S; Fatigue Trialists' Group.

Department of Neurology, King's College of Medicine, London. chisholmD@who.int

Abstract
BACKGROUND: There is a paucity of evidence relating to the cost-effectiveness of alternative treatment responses to chronic fatigue.

AIM: To compare the relative costs and outcomes of counselling versus cognitive behaviour therapy (CBT) provided in primary care settings for the treatment of fatigue.

DESIGN OF STUDY: A randomised controlled trial incorporating a cost-consequences analysis.

SETTING: One hundred and twenty-nine patients from 10 general practices across London and the South Thames region who had experienced symptoms of fatigue for at least three months.

METHOD: An economic analysis was performed to measure costs of therapy, other use of health services, informal care-giving, and lost employment. The principal outcome measure was the Fatigue Questionnaire; secondary measures were the Hospital Anxiety and Depression Scale and a social adjustment scale.

RESULTS: Although the mean cost of treatment was higher for the CBT group (164 Pounds, standard deviation = 67) than the counselling group (109 Pounds, SD = 49; 95% confidence interval = 35 to 76, P < 0.001), a comparison of change scores between baseline and six-month assessment revealed no statistically significant differences between the two groups in terms of aggregate health care costs, patient and family costs or incremental cost-effectiveness (cost per unit of improvement on the fatigue score).

CONCLUSIONS: Counselling and CBT both led to improvements in fatigue and related symptoms, while slightly reducing informal care and lost productivity costs. Counselling represents a less costly (and more widely available) intervention but no overall cost-effectiveness advantage was found for either form of therapy.

PMID: 11271867 [PubMed - indexed for MEDLINE]

 

They delivered the warning shot: somewhere this weekend I read them musing about getting those 25% of patients who are bedbound involved in the study. They will try to get that studied too, make no mistake. The fact that those patients are the most likely to die from the treatment is not the sort of thing that appears to concern these people, but I don't personally consider that to be an acceptable risk.

The FINE Trial was supposed to cover this group. Based on their prespecified endpoint and outcome measure, they didn't find any difference!

At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435).

Free full text: http://www.bmj.com/content/340/bmj.c1777.long

 

Unfortunately, White et al. had an advantage as they had the data. The CAA did not and indeed very few people in the UK seemed to have the paper before the midnight deadline. In such circumstances, it's not easy to do a press release that is there for the first round of coverage. Indeed, people were having to deal with journalists "blind" on Thursday, where journalists had the embargoed press release.

Hi Dolphin, I am not a huge fan of the CAA but you raised a very good point. Kim McCleary was probably ambushed by reporters who had more information than she did. We have to be careful about jumping to conclusions without the facts. It would really help if she posted a personal press release detailing the issues, and explaining what happened. Bye, Alex

 

Unfortunately, White et al. had an advantage as they had the data. The CAA did not and indeed very few people in the UK seemed to have the paper before the midnight deadline. In such circumstances, it's not easy to do a press release that is there for the first round of coverage. Indeed, people were having to deal with journalists "blind" on Thursday, where journalists had the embargoed press release.

Yes, I noticed that all the press articles were published on Friday, before the public had access to the paper. And then the media, and patient organisations shut down for the weekend, so the biased press articles could not be easily challenged all weekend.

But apart from that, it's going to take everyone quite some time to analyse all the data in the study. It's an $8m study, which was prepared and carried out over a number of years with vast resources. The patient community can't analyse that data, interpret it, and work out what it all means over night. But I'm really hoping that all the patient organisations are going to come down hard on this study, and rebut it strongly.

 

The FINE Trial was supposed to cover this group. Based on their prespecified endpoint and outcome measure, they didn't find any difference!


Free full text: http://www.bmj.com/content/340/bmj.c1777.long

Yes, it's important for our community to remember that the PACE Trial is just part of the UK's government-funded study into CBT and GET. The FINE Trial (Fatigue Intervention by Nurses Evaluation) investigated severely ill, house-bound and bed-bound, patients and was published a few months ago. The result of the study was a complete failure to improve the functioning of severely ill patients. Of course the failed FINE Trial was published without any accompanying fanfare or media coverage. The study used GET, which they conveniently renamed as "pragmatic rehabilitation" (conveniently renamed because it didn't work), and a form of counselling. 'Pragmatic rehabilitation' is described as "a programme of gradually increasing activity designed collaboratively by the patient and the therapist", so in other words it's GET.

But it is a very important study for us to be aware of, because it's a UK government-funded study that proves that psychological therapies do not work for severely ill patients.

Objective
To evaluate the effectiveness of home delivered pragmatic rehabilitation—a programme of gradually increasing activity designed collaboratively by the patient and the therapist—and supportive listening—an approach based on non-directive counselling—for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME).

Conclusions
For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME.
http://www.bmj.com/content/340/bmj.c1777.long

 

From people's other comments I think we can dig up trials that show that CBT has a similar effect on people who have cancer, hiv, etc. That actually suggests that it doesn't touch the underlying cause at all just like in these diseases.

That would be a very interesting thing to do... I wonder if there's any data available for CBT success rates with other diseases... It's worth looking into.

 

Wouldn't such comparisons be meaningless unless you were looking at CBT designed to convince the patient that they are not ill and they need to overcome their fear of taking actions which will worsen their symptoms?

Let's see, how about a study of CBT for Lupus patients designed to convince the patient they really don't have fatigue and aches and pains, and need to overcome their fear of sitting out in the sunshine?

 

Wouldn't such comparisons be meaningless unless you were looking at CBT designed to convince the patient that they are not ill and they need to overcome their fear of taking actions which will worsen their symptoms?

Let's see, how about a study of CBT for Lupus patients designed to convince the patient they really don't have fatigue and aches and pains, and need to overcome their fear of sitting out in the sunshine?

Yes, I'm inclined to agree. CBT to encourage diabetics to stick to a regime that is good for their diabetes (say) is a bit different from CBT for CFS which may be about encouraging "bad" habits/be based on incorrect information about CFS.

The manuals used in this trial can be downloaded:
CBT treatment manual
http://www.pacetrial.org/docs/cbt-therapist-manual.pdf

CBT participant manual
http://www.pacetrial.org/docs/cbt-participant-manual.pdf

 

I was thinking about the cohort and added this:

Patient Cohort - Another consideration involves the types of patients involved in the survey. More people were eligible for the study than participated in it. Almost 400 people (n=398) did not want to participate in the randomized treatments (probably did not want to try GET) and 143 refused to be assessed. Another big chunk of people (n=139) couldnt follow the protocols for one reason or another (too sick?). All told more people were eligible for the program and chose not to participate in it (681) than participated in it (641). Plus a significant subset of the community was too ill to participate in the study.

Most people also looked forward to the GET program - a surprising finding for many in the CFS community who have tried to exercise again and again and again fruitlessly. It's possible, therefore, that the strongly exercise intolerant subset of CFS patients avoided the study for fear of being placed in the GET program and that the study ended up top heavy with more exercise tolerant patients who were more likely to be able to withstand the rigors of walking.