..an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome, 2020, Ghelman et al

Discussion in ''Conditions related to ME/CFS' news and research' started by Andy, Mar 15, 2020.

  1. Andy

    Andy Committee Member

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    Full title: A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome

    Open access, https://onlinelibrary.wiley.com/doi/full/10.1002/brb3.1590
     
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  2. Snow Leopard

    Snow Leopard Senior Member (Voting Rights)

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    I'd like to tell these authors that "double blind" doesn't mean what you think it means.

    The only interesting bit of the study, the transcutaneous thermography:
    I still wonder whether the temperature dysregulation is due to venous dysregulation due to nerve damage to the smooth muscles.
     
  3. Hutan

    Hutan Moderator Staff Member

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    Presumably the limb affected by polio is wasted, that is, it doesn't have the musculature of a healthy limb. I would have thought that alone might account for 'hypothermia' compared to a healthy limb. The smaller limb would have a higher surface to volume ratio. Also, if there are fewer muscle cells doing less work, there will be less metabolic activity and lower respiration. But, as you say, nerve damage could cause all sorts of issues, including gut dysfunction.

    Yes, I think it would have been obvious to everyone whether they were receiving the gel-only treatment or the gel + range of therapies including
    • art therapy (water colour painting);
    • a therapy that sounds like a form of speech therapy
    • other physical therapy - warm foot baths, massage, bandaging
     
    Last edited: Mar 15, 2020
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  4. Hutan

    Hutan Moderator Staff Member

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    The gel with active ingredients had the following:
    There was no difference in pain outcome for the gel with active ingredients + no extra treatments (ETG) compared to the gel without active ingredients + no extra treatments (PTG):
     
    Last edited: Mar 15, 2020
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  5. Cheshire

    Cheshire Moderator Staff Member

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    Either the threatment is efficient or not. No need to mention that it is an "anthroposophic" remedy unless you want to promote this cult.
     
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  6. Hutan

    Hutan Moderator Staff Member

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    There's a lot more that could be said about this study, but I'll just summarise a few more points:

    They discarded the data of participants with no end data or who didn't attend enough of the therapy sessions. And then they discarded the data from additional participants in order to reduce the sample size evenly, from 12 per treatment arm to 10 per treatment arm. They don't say how they chose the participants whose data was discarded just to create the even sample sizes.

    They probably claim the study is blinded, but it was only blinded for the gel. The physical therapy arms showed a substantial reduction in pain compared to baselines, but it's impossible to know how much of that was a placebo effect (e.g. wanting to please the therapists, wanting to justify the effort made) and a short term effect following warm water bath of limb, massage and rest with compression.

    They claim that the combination of physical therapy and the gel with active ingredients (the green line) resulted in a faster reduction in pain than the physical therapy with placebo gel (blue line). I think that might be termed 'clutching at straws'.

    Screen Shot 2020-03-16 at 6.36.15 AM.png
     
    Last edited: Mar 16, 2020
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  7. rvallee

    rvallee Senior Member (Voting Rights)

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    Uh uh. Yeah... pass.
    Barely distinguishable from BPS, to be honest, just with a few extra steps, or maybe different steps is more appropriate.
     
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