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The Efficacy and Safety of Myelophil, [..] , for [CFS]: A Randomized Clinical Trial, 2019, Joung et al

Discussion in 'BioMedical ME/CFS Research' started by Andy, Sep 26, 2019.

  1. Andy

    Andy Committee Member (& Outreach when energy allows)

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    Full title: The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

    Open access, https://www.frontiersin.org/articles/10.3389/fphar.2019.00991/full

    I'm dubious about the value of this paper but nice to see this bit :)
     
  2. Hutan

    Hutan Moderator Staff Member

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    It's nice to see research from South Korea. It would be great to hear more about what is happening there e.g. if there are patient organisations.
    I liked quite a lot about this paper. The write-up is clear; we know what they did, including what they did as post-hoc analyses. There's double-blinding and a control treatment. The partial funding from a manufacturer of the herbal medicine is declared. They managed to keep almost all of their participants throughout the trial. They were up front about the null result. They made a reasonable effort at checking for side effects. They say they are happy to share their data.

    Clearly they are going to proceed on to a Stage 3 trial regardless, no doubt because the manufacturer of the herbal medicine is keen for that. But I think it's good that some of these herbs that so many of us try are tested in a rigorous way. If they get a positive result, will I believe it? Maybe not, because of the potential conflict, but hopefully a successful Stage 3 trial would mean that some completely independent work would be done. (Actually I have a soft spot for Chinese tonics with Astralagus and mushrooms and stuff - they taste so bad it's easy to imagine they are medicine.)

    One bad point, which they acknowledge, is a vagueness around diagnosis. Participants had to answer diagnostic questions; there was no clinical diagnosis. I'm not sure about the diagnostic criteria; I'd have to look again, but they did have a requirement for 'PEM lasting more than 24 hours'. They may have a point that quite a few of their participants had very mild fatigue and that it is better to concentrate on more severely affected participants in future trials.

    They used a modified Chalder Fatigue Scale. They are planning to use a different measure in future studies - if I've come across it before, I don't remember it.
    It would be great to bring these researchers into the international community, to standardise approaches and so on.
     
    Last edited: Sep 26, 2019
  3. Trish

    Trish Moderator Staff Member

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    I have done a quick search for the two herbs used. Both are commonly used in traditional Chinese medicine. Both have insufficiently researched claims of efficacy, and some warnings of side effects.

    Here's a review of Astragalus mongholicus It is claimed to have all sorts of effects including as an immunostimulant and anti-inflammatory. It should be avoided by people with autoimmune conditions and those on immunosuppresant treatments.

    Here's a systematic review of Salvia miltiorrhiza. It's used for treating cardiovascular disorders.

    Both have lots of bioactive components that may interact with whatever other herbs they are mixed with.

    Edited to change link.
     
    Last edited: Sep 26, 2019
  4. Snow Leopard

    Snow Leopard Senior Member (Voting Rights)

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    The manuscript is decent but if you can't achieve significance with 49/48 patients, well, I doubt the therapy is very good.
     
    Jaybee00, Marky, Annamaria and 5 others like this.

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