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SMILE trial results - MEA critique

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Oct 12, 2017 at 11:58 AM.

  1. charles shepherd

    charles shepherd Senior Member

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    MEA Review: The SMILE trial – a lesson in how not to conduct clinical trials in people with ME/CFS | 12 October 2017
    The SMILE trial was an attempt to determine the efficacy of the Lightning Process® when delivered in addition to specialist medical care in the treatment of ME/CFS for children and adolescents.

    Rather than attempt to place all of our review on this blog, we have made it available to view online or download as a pdf. file.

    The full review explains why we have reached the conclusions we have and we would recommend you try and read it if you are able.

    Some extracts from the full review follow, beginning with a summary statement from Dr Charles Shepherd.

    Continued here:

    http://www.meassociation.org.uk/201...-trials-in-people-with-mecfs-12-october-2017/

    NB: This is a long and detailed critique of both the protocol for the trial and the results
     
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  2. markielock

    markielock staying independent, one day at a time

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    Thanks @charles shepherd :)

    Literally the first sentence in the review:

    "The SMILE trial is one of the worst examples of a clinical trial supposedly designed to assess the acceptability, effectiveness and safety of a treatment for ME/CFS that I have come across".

    Right to the point, I like it. I shall continue my reading.
     
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  3. charles shepherd

    charles shepherd Senior Member

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    NB:

    The full review of the SMILE Trial can be downloaded or read online, as a pdf. file version.

    You may need to download Adobe Acrobat reader if you don’t already have it installed.

    CS
     
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  4. Graham

    Graham Senior Moment

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    Thanks for producing the review, Charles.

    How many lessons do these people need before they realise that what they are doing is utter rubbish? If my sixth-form students had ever produced such work as coursework for their A-levels, we teachers would have gone home despondent that our teaching had been so poor, and that the students had learned so little.

    I'm thinking of producing a chocolate-therapy trial: there's not going to be any treatment, but children who give better answers on the second questionnaires will be given a large quantity of chocolate. I won't actually do any objective testing, just in case it doesn't show any change. What could go wrong? I'm going to call it The Bribing Process. Now all I need is a million pounds or so to set it up, and access to a hundred or so children.
     
  5. Esther12

    Esther12 Senior Member

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    Thanks a lot for doing that. I thought there were a lot of good points included.

    Some bits I wasn't so sure about, eg:

    I understood what you were getting at here, but thought that the phrasing made it sound less persuasive than it could have been. As Jonathan Edwards makes clear, it's the combination of a nonblinded trial and subjective self-report outcomes that are the real problem. The nature of an intervention like LP means that problems with bias really cannot be avoided for subjective self-report outcomes. The document does follow up by talking about potential use of a sham therapy control group, and that's a sensible point, but I thought the above sentence could have been better phrased.

    That description of LP makes it sound rather more respectable than it is imo (although I realise that it's hard to get clear information on exactly what the LP is).

    I think that they were included in the SMC only group, which I think is the right way of doing it for their primary analysis - sticking to their allocation per randomisation. There was some discussion of this in the thread on SMILE. I think that this is also relevant to the third additional concern mentioned. I think that these numbers on this do add up okay, although it would be nice to have more details included.

    I'd have liked more information on what was actually provided as a part of SMC, and particularly if there ended up being any group differences in what was provided, but I also think it's okay to have a group where participants are able to choose what aspects of the available treatment they made use of. If 'standardised medical care' tends to allow this sort of personalisation in routine clinical practice, why shouldn't it be able to in a trial (so long what is involved is properly reported).

    Did it? I can see Phil Parker being pleased with that endorsement from the MEA.

    As I feel bad only pulling out the bits I had concerns about, I thought I'd also highlight this good summary which was near the end of the document:

     
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