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Edzard Ernst:

kun je een studie zo ontwerpen

dat de uitkomst altijd positief is?








Alhoewel het onderstaande artikel "evidence-based behandelingen" met supplementen betreft,

zijn de vier principes voor een gegarandeerd "positief" resultaat van je eigen onderzoek

ook van toepassing op een deel van het research naar "bewezen" effectieve therapieŽn voor "CVS"...


Zo gaat men binnenkort in Australie onderzoek doen naar het objectief gemeten effect van CGT.

De participanten worden geworven via advertenties, nieuwsbladen etc.


Wie reageren op een dergelijke oproep?

Dat zullen vooral mensen met "chronische vermoeidheid" zijn.

ME-patienten? Denk dat het er niet veel zulen zijn...






Can one design a trial such that it inevitably produces a positive result?


Published Saturday 07 September 2013



Can one design a clinical study in such a way that it looks highly scientific

but, at the same time, has zero chances of generating a finding that the investigators do not want?


In other words, can one create false positive findings at will and get away with it?

I think it is possible; what is more, I believe that,

in alternative medicine, this sort of thing happens all the time.


Let me show you how it is done; four main points usually suffice:

  1. The first rule is that it ought to be an RCT,
  2. if not, critics will say the result was due to selection bias.

    Only RCTs have the reputation of being 'top notch'.


  3. Once we are clear about this design feature,
  4. we need to define the patient population.


    Here the trick is to select individuals

    with an illness that cannot be quantified objectively.

    Depression, stress, fatigue...the choice is vast.


    The aim must be to employ an outcome measure

    that is well-accepted, validated etc.

    but which nevertheless is entirely subjective.


  5. Now we need to consider the treatment to be "tested" in our study.
  6. Obviously we take the one we are fond of and want to "prove".


    It helps tremendously, if this intervention

    has an exotic name and involves some exotic activity;

    this raises our patients' expectations which will affect the result.


    And it is important that the treatment is a pleasant experience;

    patients must like it.

    Finally it should involve not just one but several sessions

    in which the patient can be persuaded

    that our treatment is the best thing since sliced bread -

    even if, in fact, it is entirely bogus.


  7. We also need to make sure that,
  8. for our particular therapy,

    no universally accepted placebo exists

    which would allow patient-blinding.


    That would be fairly disastrous.

    And we certainly do not want to be innovative

    and create such a placebo either;

    we just pretend that controlling for placebo-effects

    is impossible or undesirable.


    By far the best solution would be

    to give the control group no treatment at all.

    Like this, they are bound to be disappointed

    for missing out a pleasant experience

    which, in turn, will contribute to

    unfavourable outcomes in the control group.

    This little trick will, of course,

    make the results in the experimental group look even better.

Thatís about it!


No matter how ineffective our treatment is,

there is no conceivable way our study can generate a negative result;

we are in the pink!


Now we only need to run the trial and publish the positive results.


It might be advisable to recruit several co-authors for the publication Ė

that looks more serious and is not too difficult:

people are only too keen to prolong their publication-list.


And we might want to publish our study in one of the many CAM-journals

that are not too critical, as long as the result is positive.


Once our article is in print, we can legitimately claim

that our bogus treatment is evidence-based.


With a bit of luck, other research groups will proceed in the same way and

soon we will have not just one but several positive studies.


If not, we need to do two or three more trials along the same lines.


The aim is to eventually do a meta-analysis

that yields a convincingly positive verdict on our phony intervention.







Met dank aan Manja, die me attendeerde op dit artikel.