Finally! Nunez et al (2011) CBT/GET studied in Fukuda-CFS [outcome as expected]

WillowJ

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Nez M, Fernndez-Sol J, Nuez E, Fernndez-Huerta JM, Gods-Sieso T, Gomez-Gil E. "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." Clin Rheumatol. 2011 Jan 15. [Epub ahead of print] PMID: 21234629

Rheumatology Service, Functional Readaptation Unit, Hospital Clinic, Barcelona, Spain

Abstract

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.
 

WillowJ

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They can no longer say there's no published evidence that GET is harmful. :victory:

If available, can this be added to the library? :peach:


:balloons:
 

biophile

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There have been several Fukuda-CFS studies of CBT before, although it is uncertain how well it was applied and it is a flawed criteria anyway despite being the "lesser of two evils" compared to Oxford criteria. We need a Canadian criteria study on this, no wait we don't, it would probably be disastrous!

Did this study use group CBT (already known to be less effective than single CBT) or did they use the word "group" in the abstract because they were grouping CBT with GET and pharmacological treatment?

They can no longer say there's no published evidence that GET is harmful.
Yes, interesting and frankly about time, I was starting to suspect publication bias or something! ;-)
 

WillowJ

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I agree that Fukuda is seriously flawed. I knew there were some CBT studies supposedly using Fukuda with supposedly positive results (color me skeptical on both counts), but I wasn't sure there was any GET studies even supposedly using Fukuda.

Maybe you're right that this isn't a big deal, though...

I haven't seen the full text, but the only place I could see the use of "group" in the abstract was when referring to the intervention group or the "usual care" group (nice of them to define "usual care" for us; that's not usually done in these studies--my guess is because UK's "usual care" isn't printable in a scientific journal).

Yes, interesting and frankly about time, I was starting to suspect publication bias or something! ;-)
lol, can't imagine why that would be :)
 

Sean

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Decent sample size too, 60 in each arm, so the results have decent statistical clout.
 

biophile

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I agree that Fukuda is seriously flawed. I knew there were some CBT studies supposedly using Fukuda with supposedly positive results (color me skeptical on both counts), but I wasn't sure there was any GET studies even supposedly using Fukuda.
This systematic review on GET included 2 studies which used "CDC" criteria and the introductory text implies that CDC = Fukuda. I liked your emphasis on "supposedly", the criteria can be interpreted differently by different people. Also, one of the "Fukuda" studies on CBT mentioned earlier (Prins et al) dropped the requirement of 4 symptoms, and although this modification was admitted, it was dishonestly published as a "CFS" study.
 

WillowJ

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I'd forgotten about that. There was the official Belgian investigation, too.

Right, about the Prins study that billed itself as using Fukuda but dropped the diagnostic-supportive symptoms... and even when they don't specifically drop the 4/8 symptoms, sometimes they fail to exclude psychiatric diagnoses, or purposely exclude participants with immune or neurological symptoms. There are all kinds of ways to destroy the meaning of a symptom-based diagnosis if you're determined to do so.

Sometimes in the reviews some of the studies with CDC criteria are Holmes, which again can either be mostly psychiatric-classified patients or not, depending on the philosophy of those applying it, but I couldn't get past the first page of that one to check.
 

Rita

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Joaquin Fernndez Sol is one of the three or four Spanish specialists in CFS.
I visited with him three years ago. He had no treatment, said he did not knew the causes of the disease and that we had to accept it, but in his report advised the progressive exercise.
They interviewed him in a Barcelona radio few months ago, and he said that governments did not accept the disease because they could not afford the expense, related to disability pensions. He also said they denied to him grants for research on this disease.
I hope that we have now proofs againts the CBT/GET, that doctors always, with good intentions, recomends for us.
 

eric_s

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So in this case he has now changed his mind, regarding CBT/GET?
I don't understand how a doctor can say someone has to accept a disease, it's the same here, but i don't think that's what a doctor is there for...
They should at least give people hope, that with more research there will be answers. And encourage people to donate for research, if governments don't do it.

Edit: Btw, tomorrow morning i will arrive in Barcelona. I think i will try to meet some people, in the coming weeks. It would be great if we could get some cooperation between Switzerland and Spain, for example for the IrsiCaixa work.
 
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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.
Anyone know what 'exercise counselling' is, or which pharmacological treatments were used? If exercise counselling were 'get plenty of exercise', it would undermine the lack of difference with GET.
 

Cort

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I will try and get this paper. We definitely need to know more. There is something different between GET and exercise counselling that we don't know about. I imagine that the second is envelope therapy - don't cause crashes.

In their summary they suggest that CBT is not particularly harmful or effective but GET is which fits with the UK treatment survey results. In that survey CBT wasn't harmful or very effective but GET was clearly harmful for many people.

It'll be really interesting to see if they can carve out an exercise tolerant group for an exercise intolerant group and what they mean by exercise.
 

urbantravels

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The idea that "exercise counseling" = energy envelope counseling makes the most sense to me, but it would be important to know exactly what they mean by the term.

I'm writing the headline in my mind right now: "Widely used therapy to treat chronic fatigue syndrome may be fatally flawed, study finds."
 

Dolphin

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Letter

Somebody on another forum had read it and said it was group therapy.

Letter to the Editor
Kindlon T. Group interventions based around encouraging CFS patients to increase activity levels have shown modest results. Reply to: A pilot study of the process of change in a group Chronic Fatigue Syndrome management programme. Bulletin of the IACFS/ME. 2009;17(3):84-85
http://www.iacfsme.org/bulletinfall2009/fall09kindlonletter/tabid/396/default.aspx

I think it might be hard to get for a day or two - they are only up to January 14 (this is January 15) on the online first articles at: http://www.springerlink.com/content/102818/
 

Dolphin

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This systematic review on GET included 2 studies which used "CDC" criteria and the introductory text implies that CDC = Fukuda.
I'm not sure if the Wallman study should be bundled in with the others:
Subjects were instructed to exercise
every second day, unless they had a
relapse. If this occurred, or if symptoms
became worse, the next exercise session
was shortened or cancelled. Subsequent
exercise sessions were reduced to a
length that the subject felt was manageable.
This form of exercise, which
allows for flexibility in exercise routines,
is known as pacing.26
 

Hope123

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A full-text of this paper would be valuable if anyone can get it.

This is an important paper because it uses outcome measures (SF-36) that have been used in other studies, IIRC, to show that exercise improves ME/CFS. It is the first paper that I can remember (and please correct me if I'm wrong) that has shown directly in a trial that exercise didn't improve HRQOL standardized outcome measures.

The other component of "exercise counselling" might be that is much more laissez-faire than the treatment arm -- e.g. people might not be monitored as much (even if that monitoring is just physical attendence of therpy sessions) so it might be more like "pacing" in that way also.
 

Dolphin

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I think it might be hard to get for a day or two - they are only up to January 14 (this is January 15) on the online first articles at: http://www.springerlink.com/content/102818/
Actually it's down for January 14 there: You might be able to get it now:
http://www.springerlink.com/content/102818/
although for the first few days after it showed up on PubMed they were only up to January 11 then i.e. some people who couldn't get it then may be able to get it now.