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A Little Poisoning Along the Road to ME/CFS
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PACE Trial and PACE Trial Protocol

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 12, 2010.

  1. Dolphin

    Dolphin Senior Member

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    It would seem to me that there is plenty of potential that managing one's diabetes better could lead to better glycaemic control/lowering of HbA1c in some people which could improve scores on average. For example, I have a distance relative, a widower, who prays every night he won't wake up - this was even before he had many complications from the diabetes. He has bags of sweets in his house and generally doesn't look after himself as a diabetic should.

    I'm no expert on diabetes but some or all of these would seem to be true:
    (i) diet can play a big part in controlling it. There is some foods (and drinks) one should generally avoid or only take in very small quantities. If a person wasn't doing this well, a motivational program (which Simon Wessely said was involved in intervention) would likely improve HbA1c levels.

    (ii) more exercise can stabilise blood sugar levels as far as I know (at least in type 2 but I think I've seen also in type 1). There would be plenty of people with diabetes who for one reason or another haven't prioritised this/aren't doing enough/could do more exercise.

    (iii) measuring blood sugar levels - some people may not do this sufficiently often to calculate when to eat/how much to eat and when to take insulin. Related to this point is whether people take their insulin at the optimum times.

    (iv) adherence to other drugs that might help with blood sugar control.

    So to me, I can see how a management program or if necessary a CBT program if somebody wasn't complying well enough, could on average improve scores in diabetes.

    Such a program could be indirect also. For example, taking the example of my depressed distant relative: if his depression was treated, he might be more motivated to follow diabetes advice.

    In ME/CFS, I think it is much less clear cut what we should be recommending people. In particular, I'm not convinced about the model underlying GET and GET-based CBT.

    So just because a CBT intervention might help on average in diabetes, doesn't tell us that much about what a GET-based CBT intervention (for example) will do in ME/CFS.
     
  2. oceanblue

    oceanblue Senior Member

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    Oh, I see, thanks. CBT seems to be used to increase adherence to a self-management programme. It's not, as Simon Wessely implied, that changing patients beliefs about their illness magically improves the underlying physiology of things, it's just they get better at doing sensible things with diet/medication/self-care which directly impact on blood sugar levels. I mean, it's a good result if it improves people's health but says nothing about the ability of CBT to fix 'medically unexplained' problems. For someone who champions the idea of 'evidence-based medicine' he really does play fast and loose with the evidence.
     
  3. Dolphin

    Dolphin Senior Member

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    This CDC study:
    http://archinte.ama-assn.org/cgi/reprint/163/13/1530
    gives a weighted* prevalence for Respondents fatigued for 1+ month: a prevalence of 10.84% (=29566/272,838) i.e. a lot lower than the Pawlikowska for for 6+ months.

    * i.e. adjusting for sample - this is a good one to have

    ETA:
    11.Jason LA, Jordan KM, Richman JA, Rademaker AW, Huang CF, McCready W, Shlaes J, King CP, Landis D, Torres S, Haney-Davis T, Frankenberry EL. A community-based study of prolonged fatigue and chronic fatigue. J Health Psychol 1999; 4: 926.
     
  4. oceanblue

    oceanblue Senior Member

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    Dolphin, thanks for digging out those studies, I can't even find stuff on my own computer now.

    To Recap from all these studies:

    One month+ fatigue rate:
    David 1990: 10%
    Jason 1999: 5.0% - 7.7%
    CDC (Reyes 2003): 10.8%
    Pawlikowska 1994: 38%

    6 month+ fatigue rate:
    Jason 1999: 2.7% - 4.2%
    Pawlikowska 1994: 18%

    Jason & Reyes studies are population studies so the most reliable.

    And of course, the Cella cohort used as 'normative' by PACE are slightly more fatigued than the Pawlikowska cohort.
     
  5. Dolphin

    Dolphin Senior Member

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    Aside: I used to do a lot of searches for terms in my folder that has all the research paper; however after an "upgrade" of (free) Acrobat Adobe reader, it no longer searches the contents of pdfs which is frustrating.
     
  6. Snow Leopard

    Snow Leopard Senior Member

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    The Diabetes study results reflect the same sort of dishonesty we've come to expect from UK psychiatrists. Those wonderful results? Well guess what - the 95% CI overlaps.
    http://www.annals.org/content/149/10/708.figures-only
    http://www.annals.org/content/149/10/708.full.pdf html

    The secondary measures were also statistically insignificant.

    If this was a drug therapy, it wouldn't get approval.
     
  7. oceanblue

    oceanblue Senior Member

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    My understanding is that 95% error bars can overlap up to halfway and the difference in means will still be significant, so motivation vs std care is not significant but motivatin+cbt vs std care is just significant - but probably not clinically important. This from the text:
    Also, cbt+motivation was not significantly better than motivation alone. Hard to see the point of cbt, then. Oh, and although they gave the cost of cbt as 80 a session, they didn't do the sums to for a whole course: about 1,100 for a piddly benefit, if you're interested.

    Anyway, it's hardly the triumph that Simon Wessely implied.
     
  8. Snow Leopard

    Snow Leopard Senior Member

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    I think the 'rule of thumb' is 25% of the bars - but in that case, the only significant result was at 12 months and not at 6, 9 months which is rather strange. It is difficult to conclude that the therapy was beneficial from these results.

    Edit - note, "25% of the bar" = "50% of one arm", corresponding to approximately p=0.05.
     
  9. Angela Kennedy

    Angela Kennedy *****

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    And even in this diabetes scenario- the above example might benefit more from supportive counselling therapies (If they guy has issues around not wanting to wake up- that sounds like psychological distress to me, and that might be why he's not following the correct diet either.)
     
  10. oceanblue

    oceanblue Senior Member

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    Yes, I've seen different rules of thumbs, probably best to use the actual data and confidence limits (Table 2). The text I quote above is for the time-weighted average (-0.25% (CI, -0.49% to -0.01%)) rather than any one time point, which is presumably the most relevant measure. So I think the statistically significant claim is valid (just), though probably not a useful benefit.
     
  11. Dolphin

    Dolphin Senior Member

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  12. Snow Leopard

    Snow Leopard Senior Member

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    Thanks Dolphin.

    Edit - nevermind, not really concerned with the specific statistics question I had.
    If the time averaged results were from 3-9 months for the usual care (to exclude the bump) and 6-12 months for CBT, I'm not convinced that there would be a difference with p<0.05.
     
  13. oceanblue

    oceanblue Senior Member

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    Leaving aside the issue of statistical significance, I don't think these results are of clinical importance anyway. To put the final HbA1c levels achieved with CBT, of about 9%, into context here's some info about HbA1c levels, http://www.diabetes.org.uk/hba1c
    So the time-weighted average improvement of 0.25%, giving a final level of about 9%, still leaves patients well over the target level for those at greatest risk of hypoglycaemia and the gain is only a very small step towards that 7.5% target (let alone the 6.5% target that represents 'good control').
     
  14. Sean

    Sean Senior Member

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    Any biophysical therapy that delivered such small gains would be ignored, except maybe as a possible source of not particularly promising research ideas.
     
  15. Dolphin

    Dolphin Senior Member

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  16. Snow Leopard

    Snow Leopard Senior Member

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    I agree, thanks.
     
  17. Dolphin

    Dolphin Senior Member

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  18. Dolphin

    Dolphin Senior Member

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    AfME Interaction Piece on the PACE Trial

    AfME Interaction Piece on the PACE Trial:
    http://www.afme.org.uk/res/img/resources/PACEinIA76.pdf

    I found it disappointing. Derek Pheby made a few good general points but there were lots more that weren't made - I think the regular contributors to this thread could do a lot better/add a lot more.
     
  19. oceanblue

    oceanblue Senior Member

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    ME Association and others request PACE data according to protocol

    From the MEA website:

     
  20. Bob

    Bob

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    Just thought I'd re-post this correspondence sent to Angela from the Lancet, in case people aren't aware that the Lancet has an 'independent' Ombudsman to make complaints to.
     

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