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Treating patients suffering from myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) with sodium dichloroacetate, Comhaire 2018

Discussion in 'BioMedical ME/CFS Research' started by Indigophoton, Mar 10, 2018.

  1. Indigophoton

    Indigophoton Senior Member (Voting Rights)

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    The new paper mentioned later on in this thread, authored by Frank Comhaire, @ME/CFS, has been published,
    http://www.medical-hypotheses.com/article/S0306-9877(18)30105-1/fulltext
     
    Last edited: Mar 10, 2018
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  2. Londinium

    Londinium Senior Member (Voting Rights)

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    At best all one can say about this trial is that it supports the need to have a proper double-blinded trial. In the responders it really does look like a decent response in self-report score (though with the emphasis on 'self-report'!) - but they were given 'extensive explanation on the details of the trial' which is almost guaranteed to increase placebo effect.

    One thing that isn't clear is, whilst further investigation found other potential causes for fatigue in the non-responder group (which is to be expected, especially using Fukuda, due to the high rate of misdiagnosis of ME/CFS), whether the same investigation was performed in the responder group. Or is it only those who didn't respond who were subject to this investigation for other causes of their symptoms? If that latter I would think that's a gigantic red flag.

    As for the claim 'Remarkably, it seems to be predictable which patients will or will not respond favourably to the nutriceutical treatment' I would need more than a small pinch of salt. Too few patients to do a proper statistical analysis and so the predictive formula included in the paper is most likely worthless.

    Overall, it would be good to see this tested in a more rigorous trial; prior to that, I wouldn't be rushing out to source Sodium Dichloroacetate any time soon.
     
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  3. Trish

    Trish Moderator Staff Member

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    So we have an open label trial for only 30 days measured by a subjective 7 point 'fatigue' scale.

    Then after the results come in, half the patients have improved and half haven't. So what? It's a fluctuating condition, and some people have a stronger placebo effect than others.

    And after you look at the results you divide them into two groups based on those results, improvers and non-improvers, and hey presto, the improvers did better than the non-improvers. Of course they did, because you divided them that way.

    This proves nothing.
     
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  4. Alvin

    Alvin Senior Member (Voting Rights)

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    This strikes me as a get rich quick scheme.
    BTW the author has been mentioned on the forum before
     
  5. Indigophoton

    Indigophoton Senior Member (Voting Rights)

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    @Alvin I think that may be a tad unfair - the patent may well belong to the institution rather than Comhaire personally, and it seems to be a common practice. For instance, Fluge and Mella patent stuff too. I can't imagine the supplements being used in this paper cost much compared to drugs, and they're all available individually anyway.

    What would be interesting would be a proper, blinded and controlled trial. Since the paper claims improvement happens fast, needing only a month to be seen, it would seem that a blinded RCT to see if the results stand up would be relatively quick and easy to do. Do you have any plans to do this @ME/CFS?
     
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  6. Trish

    Trish Moderator Staff Member

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    I agree, I really don't understand why it wasn't done with this trial. It would have been easy to use the same patients, and run it for 2 months, with each patient getting the treatment for 1 month and placebo for another, with neither patient nor researcher knowing which they were getting first. Then unblinding the results afterwards would give a double blind with all the patients acting as active treatment and control for a month, so direct comparison could be made. And surely use at least SF36 physical activity scale, not just a fatigue scale.

    Edit to add: It's possible that this treatment may in fact be effective. I really hope it is, as a simple nutriceutical treatment with small danger of side effects is much more appealing to me than a scarily powerful cancer drug with serious side effects. But we can only judge it on the information provided here - and this information tells us nothing. Such a wasted opportunity.
     
    Last edited: Mar 11, 2018
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  7. Valentijn

    Valentijn Not a moderator

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    This isn't research - it's a sale pitch.

    He has multiple such patents, and is completely resistant to using appropriate methodology. He writes papers to support his business, not to learn anything about ME/CFS or what works to treat it.
     
  8. Indigophoton

    Indigophoton Senior Member (Voting Rights)

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    I have exchanged a few emails with Frank Comhaire, and I have let him know about this thread.

    He is very clear that a double blinded, controlled trial is needed, and is keen to do this. What is needed now for this to happen is funding.

    He is aware of the limitations of fatigue as a measure, and of the need to carefully characterise the patient group.

    I hope that funding can be found, and that a double blind controlled trial can be done: not only would it be interesting from a treatment point of view, but also for any additional light it might shed, whether through positive or negative results, on what is going on in ME.
     
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  9. Seven

    Seven Senior Member (Voting Rights)

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    Can somebody explain to me please what is refractory ME? never heard of the term.
     
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  10. Indigophoton

    Indigophoton Senior Member (Voting Rights)

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    Refractory in medicine usually means resistant to treatment or cure. Presumably in this context it refers to the fact that the patients had had CBT and GET, and tried assorted alternative treatments, without success.
     
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  11. ME/CFS

    ME/CFS Established Member (Voting Rights)

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    As the number of patients who are included into the pragmatic trial increases, it becomes evident that it is possible to predict with reasonable confidence who will, and who will not respond favorably to the treatment. For the scientist among you: the area under the ROC curve is 0.90.

    But, please, do not start taking sodiumdichloroacetate without medical control! High doses are toxic, and the substance must be taken together with other ingredients which protect against neurotoxicity. Also, the use of sodiumdichloroacetate for the treatment of ME/CFS is protected by a patent, and the substance itself has not (yet) been officially registered as a food supplement. Therefore, sodiumdichloroacetate may be used ONLY within controlled scientific research projects.


    Finally, I would much appreciate that those who wish to comment on my work would do this on the basis of what I have written in my article in "Medical Hypothesis".
     
    Last edited by a moderator: May 30, 2018
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  12. Alvin

    Alvin Senior Member (Voting Rights)

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    Then we would be happy to see such data, though do expect us to pick it apart.

    Believe me, there is no risk of @Alvin doing so. Most of us are weary of taking things that could make us worse, though i get the impression your primary concern is about patent infringement. Am i wrong?

    I noticed this line was edited between when i read it and when i was ready to reply. I believe the original had something about being insulting?
    We are not a tripe swallowing bunch, we pick apart everything, if you want to slip something by us your going to have problems. If something holds up to scrutiny then we are happy to know about it but if something makes no sense we will analyze it to hell, if it only approaches significance we will pick up on that, if something is hyped we will not accept it.
    We are a population who has been treated as below contempt, lied to, harmed, targeted by snake oils, given treatments that make us worse and treated as liars and fakers.

    Don't expect us to accept any sugar coating or anything that doesn't add up.

    That all said we can be brash but if your treatment is legitimate it should hold up to tough scrutiny.
     
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  13. NelliePledge

    NelliePledge Senior Member (Voting Rights)

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    @ME/CFS Dr C Have you considered changing your username to your actual name. Others who are not patients and are here as medics and/or scientists tend to do that. You only really need a username if you are a patient who needs to protect your identity in order to take part. You’ve revealed your identity but only if you’re going to put your name on each post is it going to be clear who you are. Remember people with ME get brain fog and could be confused as to who you are especially as you have picked the most generic username possible.@ME/CFS
     
    Last edited: Jun 15, 2018
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  14. Esther12

    Esther12 Senior Member (Voting Rights)

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    @ME/CFS : Thanks for the additional info, and for being open to being contacted with further queries and suggestions. People here tend to be rightly wary of any sort of positive spin on research.
     
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  15. adambeyoncelowe

    adambeyoncelowe Senior Member (Voting Rights)

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    Is there an option to have a signature in every post automatically? That would be another option.

    I too am keen to see the figures. Walk us through the equation to work out who's going know respond or not, perhaps?
     
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  16. ME/CFS

    ME/CFS Established Member (Voting Rights)

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    Thank you for your comments and suggestions. I am - indeed - a medical doctor, retired professor of internal medicine, endocrinology (diseases of hormone-producing glands) and metabolism at the University of Gent, Belgium. I have practiced so-called allopathic (classical) medicine for 54 years and worked in the field of treatments based on "natural substances" (vitamins, minerals, plant extract, amino acids) for over 20 years. In my field of research I stand openly for what I write and say, by my name.

    Today 33 patients have been followed-up. 13 have been "responders" experiencing significant and persistent improvement of their health condition, and 20 are "non-responders". Based on this cohort of patients it has been possible to mathematically estimate the probability of positively responding to the dichloroacetate treatment, including the score of the Fatigue Severity Scale (FSS), and the the answer to the question 3, 4, 7 and 9 of this questionnaire, completed before the initiation of treatment. The formula for the calculation uses a statistical technique called logistic regression analysis.

    And, no, there is no need to attack me on the fact that I have protected my invention by a patent (as others have done before me, and will do after me). This is a common procedure for any original invention, and must be done before scientific papers are published on the subject. Thank you!
     
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  17. Alvin

    Alvin Senior Member (Voting Rights)

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    There is no must involved here, but that is beside the point in the grand scheme at this time (and you didn't actually answer my question).

    Many points have already been raised from lack of blinding to causation (emotional, professional, socio-economical stress, really :emoji_face_palm:) to methodology and so on. You can take this as insults and attacks or that we demand rigorous verifiable evidence.
     
    Last edited: May 30, 2018
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  18. Trish

    Trish Moderator Staff Member

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    Thank you for this further information, Dr C.

    I am having difficulty understanding your claim of being able to predict which patients will respond.

    I understand you have calculated which of the fatigue scale questions correlate most closely with treatment response in your patient cohort to date.

    What I am not clear about is whether this has successfully predicted response in a further cohort.

    If not, it would seem that all you are doing is calculating a prediction formula on one cohort, then testing it on that same cohort, in which case, of course it will work.
     
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  19. ME/CFS

    ME/CFS Established Member (Voting Rights)

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    Last edited by a moderator: May 30, 2018
  20. ME/CFS

    ME/CFS Established Member (Voting Rights)

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    Your comment is correct. However, it is remarkable that there is apparently such formula that is confirmed each time when new patients are entered. The most important point is that it should be possible to select patients to be enrolled for a double blind trial since it makes little sense to include many cases who will very probably not respond. This, indeed is a retrospective calculation, which could be applied prospectively, though there is little question about its validity.
    Concerning uncontrolled experiments with DCA by patients, I repeat that some messages in different forums already report these. The product was taken as a powder in one case, or in an incorrect dosage in another case. This is not to be recommended !
     
    Last edited: May 31, 2018
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