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Cognitive-behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial (2008) Stubhaug

Discussion in 'PsychoSocial ME/CFS Research' started by inox, Feb 7, 2019.

  1. inox

    inox Senior Member (Voting Rights)

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    This trial is from 2008, but paper was made available online 2 january 2018.

    This is the trial that Stubhaug references as the "4 day mindfullness treatment" beeing based on:
    https://www.s4me.info/threads/a-4-d...-one-year-follow-up-2018-stubhaug-et-al.7230/



    https://www.cambridge.org/core/jour...rolled-trial/816FEB91B785A52B1555584829D8FE32

    https://www.ncbi.nlm.nih.gov/pubmed/18310583
     
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  2. inox

    inox Senior Member (Voting Rights)

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    Have not read it, can't access it?

    Do wonder what they used as 'placebo therapy'.

    "comprehensive cognitive-behavioural treatment (CCBT)" must in reality be the homemade mix of talking (to), walking, drawing, mindfullness described in the 4 day treatment?

    Also, at the time I was not following the news, let alone research, so unsure how it was recived. But it can't have made much of an impact, since I haven't really heard it referenced until now, and looking a bit into Stubhaugs background with ME.
     
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  3. Esther12

    Esther12 Senior Member (Voting Rights)

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  4. inox

    inox Senior Member (Voting Rights)

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    Thank you! Haven't got around to make use of sci-hub yet :)


    So, it's patients diagnsed by f48 - neurasthenia, that might explain why this paper isn't mentioned much.


     
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  5. inox

    inox Senior Member (Voting Rights)

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    Ah, so I was wrong, the CCBT is sort of a cbt/get-mix? and the placebo was for the mirtazapine.

    This is kind of confusing, isn't it? So he is aware of the need to blind the medication to get a more reliable result, but yet there is only subjective measures for the therapy arm.
    Edit: missed this - they actually had 'cardiorespiratory fitness', but only as a secondary measure.


    Not able to read the whole paper now, but the overall feeling is that this is far better written than the '4 day' one.
     
    Last edited: Feb 7, 2019
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  6. inox

    inox Senior Member (Voting Rights)

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    Interesting how there is nearly a total overlap between the neurasthenia and oxford criteria.
     
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  7. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    As far as I know nobody has suggested that mirtazepine is of value for CFS or neurasthenia.
    So there are two negative pill type comparators, neither of which are meaningful controls for CCBT.
     
  8. inox

    inox Senior Member (Voting Rights)

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    It seems to be their own idea - here's the rationale:


    But - now I noticed this, it doesn't make sense at all...? Both groups actually had the same treatment - only in opposite order.....?

    Do I need more coffee....? :bored:

     
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  9. Marit @memhj

    Marit @memhj Established Member (Voting Rights)

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    Bjarte Stubhaug and ME-criteria in the 2008 thesis, Link to thesis: http://bora.uib.no/handle/1956/3221

    i.e. p; 49 - 52:

    "The clinical study population were 72 patients with chronic fatigue complaints, fulfilling ICD-10-research criteria of Neurasthenia, F48.0. Illness definition was operationalized [mhjcom: by Stubhaug him self w/ DSM-manual. As you all know, ICD-10 do not create criteria, so the loosly inaccurate term "ICD-10 criteria" do not exist, and If G93.3 is fullfilled you can not give F48 NB! important] by examining ICD-10 criteria. The included patients satisfied the ICD-10-criteria, allowing for mild depressive or anxiety symptoms clinically evaluated to be independent of or secondary to fatigue symptoms.

    The criteria for Chronic Fatigue Syndrome, using CDC-criteria and British/Oxford-criteria, were also examined in the included patient population of neurasthenia (n=72). 65/72 patients fulfilled case definition by British/ Oxford criteria; 29 patients fulfilled CDCcasedefinition." which gives "CFS-Oxford non-CDC (n=34)" [mhjcom: ok, one page to another and the number differ...the dude is :banghead:)

    Anyway, Stubhaugs F48 use gives

    The clinical study population were 72 patients with chronic fatigue complaints,
    fulfilling ICD-10-research criteria of Neurasthenia, F48.0.
    62 patients from the study population fulfilling CFS case definitions of CFS- Oxford or CFS-CDC (excluding patients with neurasthenia non-CFS)
    CFS-CDC (n=28) and CFS-Oxford non-CDC (n=34)

    Stubhaugs F48 n=72 cohort 2008
    13,9 % ~ 14% no ME at all
    38,9 % ~ 39% fullfilled CDC-1994 fakuda
    47,2 % ~ 47% fullfilled Oxford - 1991
    [mhjcom: my "math-brain-calculus" is Lost to the "sea or space", so number could be fault]

    so lets face it; with a dude with chronical neurasthenia lust 2 dust...
     
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  10. Snow Leopard

    Snow Leopard Senior Member (Voting Rights)

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    Both the Mirtazapine + CCBT and CCBT + Mirtazapine groups, as well as the Placebo + CCBT and CCBT + Placebo should have similar results at 24 weeks unless the study suffers from short term biases.

    The reductions in the Fatigue Scale (Chalder) score at 12 weeks were small and not of clinical significance.

    But instead it seems they don't understand the point of the crossover design and prefer just to cherry pick the results that suit their preconcieved conclusion, rather than just accept that this study had null results...
     
    Last edited: Feb 26, 2019
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  11. ladycatlover

    ladycatlover Moderator Staff Member

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    So is this a good enough reason to use mirtazapine? Sounds to me like they're just making it up as they're going along. Of course they don't even use CFS, they just say "chronic fatigue". It's a complete muddle.
     
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  12. Sid

    Sid Senior Member (Voting Rights)

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    Mirtazapine is one of the most fatiguing antidepressants. Possibly the most fatiguing there is. It's a great drug to use if you're trying to make CBT look good.
     
  13. Wits_End

    Wits_End Senior Member (Voting Rights)

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    Really? What do you mean by that, Sid? My caree's GP has just upped her dose of it to try and improve things, so I'm rather concerned.
     
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  14. sb4

    sb4 Senior Member (Voting Rights)

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    FWIW Mirtazapine helped me POTS symptoms significantly when they were real bad. The day after I started taking it I noticed I could stand longer. I speculate this is due to Mirtazapine increasing adrenaline levels (by blocking aA2) and thus vasoconstriction.
     
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  15. Wits_End

    Wits_End Senior Member (Voting Rights)

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    Does it really do that, sb4? I can't see increased adrenaline levels being compatible with restful sleep. Now I come to think of it, my caree has been complaining about feeling as though she's got more adrenaline/cortisol or something in her system since she went on to the increased dose of mirtazapine.

    Oh dear. Makes me wonder what my caree's doing on it, then :( GP was suggesting that we reconsider her medication, but now's not a particularly good time.
     
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  16. sb4

    sb4 Senior Member (Voting Rights)

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    Yeah according to wikipedia it increased adrenaline. It makes you tired because it also is an antihistamine.
     
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