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Article: Analysis of five hallmark studies from the Netherlands, 2018, Twisk and Corsius

Discussion in 'PsychoSocial ME/CFS Research' started by FrankTwisk, Feb 2, 2018.

  1. FrankTwisk

    FrankTwisk New Member

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    An in-depth analysis of five hallmark studies of
    the Dutch Expertise Center for Chronic Fatigue (NKCV) confirms that
    cognitive behavorial therapy combined with a graded activity protocol (CBT+)
    has no objective positive effect on the (health) status of
    patients diganosed with chronic fatigue syndrome (CFS).

    The outcomes of the analysis
    confirm the image of the controversial PACE-trial:
    the (far-reaching) conclusions with regard to the proposed positive effects of CBT+
    are by no means substantiated by the data published by the researchers.

    A recent study of principal PACE trial investigators confirms
    that ‘graded activity’ has a negative effect on a subgroup of CFS patients.

    In spite of claims to the contrary
    the effect of CBT+ on patients diagnosed with Myalgic Encephalomyelitis (ME),
    a neuromuscular disease, has never been analysed.

    ARTICLE:

    An analysis of Dutch hallmark studies confirms the outcome of the PACE trial:
    cognitive behaviour therapy with a graded activity protocol
    is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis.

    Gen Med Open. 2017. 1(3): 1-12.
    doi: 10.15761/GMO.1000117.
    Twisk FNM, Corsius LAMM.

    Abstract

    Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS)
    are considered to be enigmatic diseases.

    Several studies propose that
    the combination of cognitive behaviour therapy with a graded activity protocol (CBT+),
    justified by a so-called (bio)psychosocial (explanatory) model,
    is an effective treatment option for CFS (ME).


    Objective

    A critical review of five Dutch hallmark studies
    that allegedly support this claim.


    Methods

    An analysis of the five CBT+ studies with special attention to
    the patients studied,
    the criteria (subjective and objective measures and cut-off scores)
    used to select participants and
    to define improvement and recovery,
    the consistency of the definitions of caseness
    (being diagnosed as a CFS patient at entry)
    versus the definitions of improvement and recovery after CBT+, and
    the objective effects.


    Results

    The studies investigated suffer from various methodological flaws.

    Apart from these methodological shortcomings,
    the claim that CBT+ is an effective treatment option for CFS
    is not substantiated by the data reported.

    Some studies investigated CFS patients,
    other studies investigated CF patients, labelled as CFS patients, or
    combinations of CFS and CF patients.

    No study investigated the effect of CBT+
    in a group of patients meeting the (original) diagnostic criteria for ME.

    The effects of CBT+ on subjective measures,
    for example fatigue and disability,
    if present, are insufficient to achieve normal values.

    Impressive recovery and improvement rates
    are based on very loose criteria for subjective measures.

    Cut-off scores for subjective measures
    used to define improvement and recovery in studies
    show overlap with cut-off scores for CFS caseness
    in one or more of the other studies.

    More importantly, looking at the objective measures,
    the proof of clinical improvement after CBT+ is lacking.


    Conclusion

    Solid evidence of effectiveness of CBT+ for CFS, let alone ME,
    is lacking in the five hallmark studies.

    The lack of objective improvement indicates CBT+ is ineffective.

    This conclusion confirms
    the outcome of the large-scale PACE-trial in the UK.


    Keywords:

    Myalgic Encephalomyelitis, chronic fatigue syndrome, cognitive behaviour therapy, graded exercise therapy, measures, effectiveness



    http://www.oatext.com/pdf/GMO-1-117.pdf

    http://www.hetalternatief.org/Summary NKCV GMO 2018.pdf
     
    TiredSam, Jan, Atle and 29 others like this.
  2. Trish

    Trish Senior Member (voting rights)

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    Hello, @FrankTwisk, welcome to the forum, and thank you for posting this paper which I see you co-authored.

    I have only read the abstract and the conclusion so far, but it looks excellent. Thank you for all your hard work on this.
     
    Jan, Atle, Inara and 18 others like this.
  3. JemPD

    JemPD Established Member (Voting Rights)

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    Indeed.
     
    Inara, Dolphin, Solstice and 3 others like this.
  4. Solstice

    Solstice Established Member (Voting Rights)

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    I think @Lou Corsius is the other author? Big thanks to him too.
     
  5. Tom Kindlon

    Tom Kindlon Senior Member (Voting Rights)

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  6. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Good to see the Knoop et al., 2007 full recovery paper being criticised.
     
    lycaena, Inara, Valentijn and 4 others like this.
  7. Dolphin

    Dolphin Senior Member (Voting Rights)

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    I believe there is a small error here. It should see a score of 60 or more not 61. They are talking about PACE Trial.
     
    Inara, Luther Blissett and Esther12 like this.
  8. Dolphin

    Dolphin Senior Member (Voting Rights)

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    They are talking about the average scores. Probably some individuals did reach "normal levels", indeed we know some did in Knoop et al, 2007.
     
  9. Dolphin

    Dolphin Senior Member (Voting Rights)

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    I don't think this is a strong point with these data. The dropout figures are given in table 1 and similar between the intervention and control groups.
     
  10. Dolphin

    Dolphin Senior Member (Voting Rights)

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    I think this is the only outcome measure that could be referred to for this point within these 5 trials:
    There could have been individuals who deteriorated in the trials but I don't believe such data was published. There is some evidence from surveys that some people report being made worse by CBT.
     
  11. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Some comorbidities like fibromyalgia are not listed. I imagine some of the patients did have such comorbidities in which case the comorbidity rate is higher than 23%.

    Also this use dthe CDC criteria so some of the initial sample probably had comorbidities but were excluded from the research study but in clinical practice might still get the diagnosis of CFS.

    So I'm not convinced about this point.
     
    Last edited: Feb 5, 2018
  12. Inara

    Inara Senior Member (Voting Rights)

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    But the reasons for drop-out in the control and intervention group are most probably different.
     

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