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'Recovery' from chronic fatigue syndrome after treatments given in the PACE trial

Discussion in 'Latest ME/CFS Research' started by Sam Carter, Jan 31, 2013.

  1. Dolphin

    Dolphin Senior Member

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    Lots of good points, thanks.
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  2. biophile

    biophile Places I'd rather be.

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    Re: Occupational Aspects of the Management of Chronic Fatigue Syndrome: a National Guideline.

    Ross et al (2004) review mentioned on page 14:

    Last year I wrote harshly about using this to support CBT/GET. "Associated" with restoring the ability to work does not mean actually restoring said ability. Basically, three of the four studies had uncontrolled comparisons, and the employment data on the remaining study was based on only 2 people.

    Then the national guidelines explores the evidence for itself. Page 19 has the method for selection of papers for critical appraisal. Page 21 has the grading of reviewed evidence. Page 22 has the limitations of the literature review.

    Grade A: At least one meta-analysis, systematic review or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results.

    Grade B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+.

    [etc C and D]

    Page 25 has "4. Treatments for CFS that have been shown to improve work outcomes."

    Evidence for CBT ("A Grade")

    Butler et al. 1991 [40], Deale et al. 1997 [22], Deale et al. 2001 [23].

    22. Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for Chronic Fatigue Syndrome: a randomized controlled trial. American Journal of Psychiatry 1997, 154(3)408–414.
    http://ajp.psychiatryonline.org/data/Journals/AJP/3674/408.pdf

    Deal et al 1997: Oxford or CDC was used. Table 1 seems to suggest similar levels of unemployment between groups. On quick glance I cannot find mention of employment outcomes. According to the national guidelines:

    In other words it appears that the WASAS is being confused with employment outcomes.

    23. Deale A, Husain K, Chalder T, Wessely S. Long-term outcome of cognitive behavior therapy versus relaxation therapy for Chronic Fatigue Syndrome: a 5-year follow-up study. American Journal of Psychiatry 2001, 158(12)2038–2042. http://psychiatryonline.org/data/Journals/AJP/3731/2038.pdf

    Deale et al 2001: Similar proportions of patients were employed, but patients in the cognitive behavior therapy group worked significantly more mean hours per week : 35.57(8.11) hours vs 24.00 (4.97) hours, p<0.04.

    I do not recall all the criticisms for this study but I remember being somewhat surprised when first hearing about them because I did not realize it was that bad. FWIW, this is the only study in the national guidelines which actually has relevant evidence for employment outcomes, and the much larger and better conducted PACE Trial (which showed no improvements in employment outcomes) trumps it anyway.

    Interesting quote: "Predetermined criteria for 'complete recovery' required that patients no longer met chronic fatigue syndrome criteria, were employed full-time, and scored less than 4 on the Fatigue Questionnaire and more than 83 on the Medical Outcomes Study Short-Form General Health Survey physical functioning scale."

    40. Butler S, Chalder T, Ron M, Wessely S. Cognitive behavioral therapy in chronic fatigue syndrome. Journal of Neurology, Neurosurgery and Psychiatry 1991, 54:153–158. http://jnnp.bmj.com/content/54/2/153.full.pdf

    Butler et al 1991: Was an uncontrolled pilot study, (it was rated 2+ which is "Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal.")

    Evidence for GET ("B Grade")

    "Prins and couper 1998 [27], and White 1997 Fulcher [32]"

    The citation here is somewhat confusing. There is no "Prins and couper 1998". The only mention of Couper is a Cochrane review on CBT not GET. Reference 27 is a CBT study too:

    27. Prins JB, Bleijenberg G, Bazelmans E, Elving LD, De Boo TM, Severens JL, Van Der Wilt GJ, Spinhoven P, Van Der Meer JWM. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 2001, 357:841–847. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(00)04198-2/abstract

    "Patients were eligible for the study if they met the US Centers for Disease Control and Prevention criteria for CFS,[1] with the exception of the criterion requiring four of eight additional symptoms to be present."

    In other words, not a study about CFS.

    32. Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. British Medical Journal 1997, 314:1647–1652. www.ncbi.nlm.nih.gov/pmc/articles/pmid/9180065/

    Fulcher & White 1997: The guidelines graded this as "1+ Well-conducted meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias." and stated that "Patients were followed up by questionnaire approximately one year after supervised treatment stopped. 66% of patients who completed exercise treatment were working or studying at least part-time, compared with 39% of all 66 patients before treatment (95% confidence interval of difference 9% to 44%)."

    However, AFAIK the comparison of improved occupational status was uncontrolled at 12 month follow-up because it was a crossover study which did not account for dropouts or compare with the controls that only did the flexibility program instead of the exercise program The authors acknowledge this weakness but then dismiss it by claiming that spontaneous improvement was an unlikely explanation because it didn't occur in a "similar sample" in another study. The sparse details are on p1651. Table 6 of Ross et el points out that follow-up figures are "based on the number of patients enrolled" and at 15 month follow-up from baseline the rate of employment went from 39% to 47% (no control group).

    The evidence has never been strong and is now clearly overshadowed by the PACE Trial.
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  3. Legendrew

    Legendrew Content team

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    Is the general consensus that CBT/GET are of little to no use then? I've been suffering for a year and living with pacing as i'm a little skeptical of CBT/GET since they seem a little silly when they serve to make me feel more ill.
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  4. Valentijn

    Valentijn Activity Level: 3

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    I probably made my post on the subject at http://forums.phoenixrising.me/inde...n-in-the-pace-trial.21628/page-18#post-373446 while you were writing your novel post :D

    Basically 12% of the CBT group was misdiagnosed (1 cancer, 2 celiac) yet were included in the followup data anyhow. That was more than enough to seriously alter the results and remove any statistical significance. And even if we take those results seriously, they're cherry picking outcome measures, as there's no difference in many of them.

    Also, Oxford was used.
  5. Valentijn

    Valentijn Activity Level: 3

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    It's the consensus among most CCC/ICC defined ME/CFS patients and medical researchers. The BPS (psychological) groups are really the only holdout, though they make up for it by being prolific in their views. Governments also tend to prefer the BPS views because they offer the cheaper solution.
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  6. Esther12

    Esther12 Senior Member

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    It's possible that some people may find them helpful, but if you've found them unhelpful, and the models which underpin them don't seem to apply to you, then there's a good chance that they'll do more harm than good.

    There are a lot of misleadingly positive claims made about CBT/GET for CFS from those who make money from/build careers on them.

    Sorry to hear about your ill-health. I'm wary to give any advice to anyone with CFS, as the evidence about how best to respond seems so poor, and it's likely that lots of people with different problems end up with the diagnosis. If I was in your position, I would try to just do what I felt like, and do what made me feel best in the short-term (partly because this is the opposite of what I was told to do!). Hopefully you will start to improve soon, and it does seem that those who have been ill less long are more likely to improve. Best of luck.
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  7. Simon

    Simon

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    Full text here

    As far as I can tell (based on fig 1) the distance walked with a 30m course was 17% higher than when the same people walked over a 10m course. Though those other studies suggest the effect generally might be less than this.
  8. Bob

    Bob

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    Re the 6MWDT...
    Good point. White's response to the criticisms of the 'recovery' definition was something along the lines of the CBT group performing better than the SMC group, however they measured the improvements. That answer fails to respond to the criticisms and, of course, it ignores all the objective measures, none of which showed better outcomes in the CBT group.

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  9. Graham

    Graham Senior Moment

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    But they only costed for 12 actometers to be shared amongst all 640 patients. How on earth did they expect that to work out without hitches?
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  10. Dolphin

    Dolphin Senior Member

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    Don't know. But not sure we know yet that they ran out of them/had any problems?
  11. user9876

    user9876 Senior Member

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    I was wondering if the faster people are able to walk then the greatest difference turning would make. I'm assuming that people will accelerate to their natural walking speed over a few meters and then have to slow abit to turn.

    I was also thinking that the reason for the differences in stroke cases may be because people can loose co-ordination after a stroke hence turning may take more time.
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  12. Graham

    Graham Senior Moment

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    Well the form for their use suggests that patients would be expected to wear them for 1 week. 640 patients, one week at start, one at end, allow 1 week changeover, 12 actometers: 640 x 3 / 12 = 160 weeks. That would assume utter efficiency. Allowing for holidays (like Christmas) and occasional difficulties in maximising efficient use, then I guess that would fill 4 years pretty solid. I think they had 3 centres, so say 4 actometers each. If just one actometer broke down then that could slow the results of that centre down by a good six months (or by however long it took to get another one, and rejig the schedule).

    So either their maths wasn't up to it and they planned it badly, or they were never really serious about using them in the first place.
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  13. Graham

    Graham Senior Moment

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    In defence of the possibility that the short distance did reduce the results, it is true that many people with ME, like those with strokes, have poor balance.

    But here's the big question as far as I am concerned: if they didn't work out how many actometers they would really need, and didn't work out how to conduct the 6 minute walk test properly so that the results could be compared with healthy folk, was it because of incompetence, or was it that they were just going through the motions of having some objective data to obtain funding, whilst really only wanting to concentrate on the subjective assessments? It isn't scientific to speculate on their motivation, but it is appropriate to draw attention to the fact that neither of these objective tests were properly researched or prepared.
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  14. Sean

    Sean Senior Member

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    Completely justified questions.
  15. taniaaust1

    taniaaust1 Senior Member

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    It may well depend on what subgroup you fit and what your illness is caused by.. generally the ME subgroup, its general consensus things like GET can do more harm then good so best for many to be avoiding. Only you youself probably will know whether CBT/GET is likely to help you or not, if it doesnt seem like good idea for you, it probably isnt.

    I dont think everyone can be lumped in one basket, CBT/GET it does help a "few" "CFS" people but it harms more ME people
  16. taniaaust1

    taniaaust1 Senior Member

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    Maybe they planned from the start and knew it wouldnt be wise to use them, hence what I'd call a "token purchase" (how could it be called anything else).. maybe they were used just so they could "say" they used them during their trial. The word "acrometers" helped make their study sound better didnt it to everyone.

    (or maybe it was also a word used to help get patients to agree to be in this study? .. "hey we are doing a study and are going to use acrometers to study the real effects if this therapy, will you partake?" who knows.. I bet there is a very good reason why they said they were using those!! but werent really serious about them. ("token purchase" as ME/CFS patients had complained they werent used in previous studies???). Whatever the reason for them were, I think it was done as part of a deception. They set out wanting to show these therapies were good and didnt care about much else.. well not in getting the truth out anyway.

    Most medical professions do not dig deep into studies to realise how poor they are (they wouldnt expect studies as poor as the PACE trial to be being published).. so to most, this is a study in which "actometers" were used. Its all part of the misleading deception which Im sure is purposely put out there (who'secret pay books are people like Wessely on). My CFS specialist who hasnt read the fully study and doesnt know all the details, thinks the PACE trial was a great one.
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  17. Dolphin

    Dolphin Senior Member

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    It is interesting if their trial was funded, after going through peer review, based on using actometers as outcome measures, and then they go and drop them. I am not sure I know exactly when they did so.
    ukxmrv likes this.
  18. taniaaust1

    taniaaust1 Senior Member

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    Ive been wondering that too dolphin..if they said it just to make sure they were given a funding grant, either way if it was that.. that's deception too thou more along a criminal line I would think.
  19. biophile

    biophile Places I'd rather be.

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    Re how PACE managed to share 12 actometers between 640 patients. Remember that the trial recruitment process alone occurred over a period of about 44 months:

    "We recruited 641 participants from consecutive new out patients attending six specialist chronic fatigue syndrome clinics in the UK National Health Service between March 18, 2005, and Nov 28, 2008, and completed outcome data collection in January, 2010."

    That statement is from the 2011 Lancet paper, but most of the recruitment progress (up to July 2008) is graphed in a patient newsletter: http://www.pacetrial.org/docs/participantsnewsletter3.pdf

    So, Action for ME, at the time, agreed it was "sensible" to drop actigraphy. Oh, the herculean burden of wearing a "wrist watch sized accelerometer" for one week to gather crucial data! As others haver already noted, this decision coincided with emerging data from other trials which demonstrated no significant increases in objectively measured activity on average. This would have challenged the ongoing claims about CBT and GET effectively increasing physical function, a rather inconvenient fact for those promoting it for CFS. Which reason is more likely the real one?
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  20. biophile

    biophile Places I'd rather be.

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    Thanks! When first looking at the paper, I wondered how much of that was the learning effect, but all the tests were done in random sequence:

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