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The Biggest Chronic Fatigue Syndrome Treatment Trial Begins: Fluge/Mella On Rituximab -

Discussion in 'Latest ME/CFS Research' started by heapsreal, Jan 20, 2015.

  1. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    australia (brisbane)
  2. Sidereal

    Sidereal Senior Member

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    Fascinating stuff.

     
  3. deleder2k

    deleder2k Senior Member

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    How sophisticated and thorough isnt this study going to be? I am celebrating with a beer.
     
    Last edited: Jan 20, 2015
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  4. Sidereal

    Sidereal Senior Member

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    I am continually blown away by these guys.
     
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  5. A.B.

    A.B. Senior Member

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    I was impressed by the RituxME trial protocol. They will select patients that fulfill the Canadian criteria and have been ill for several years at least. The outcome measures include measured physical activity. While it is standard in other areas of research, a large double blind placebo controlled study for ME is not. Patients will be tracked over a long period of time, so we should get a clear picture despite any symptom fluctuations. The substudies seem relevant and could yield very useful information together with the effect of Rituximab. According to this article the exercise substudy will include two day CPET.

    The weakness is that it will still rely heavily on self-report measures. However, one can have much more confidence in these due to the long duration and blinding.
     
    Last edited: Jan 20, 2015
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  6. deleder2k

    deleder2k Senior Member

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    I agree, but they also use Sensewear + the cycle test. I think the cycle test will be beneficial to prove whether a patient is better or not after RTX. If I got it right there is no way of faking or "placeboing" a cycle test.
     
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  7. Sherlock

    Sherlock tart cherry etc. for joints, insomnia

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    This is what is talked about by every low fat vegan guru in the diet wars, so there should be lots of studies on that in the setting of impairment by high fat ingestion.
     
  8. Forbin

    Forbin Senior Member

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    In 1975, there was an outbreak of cases resembling ME/cfs at Mercy San Juan Hospital in Carmichael, California, a suburb of Sacramento. These cases, however, were distinguished by severe vascular involvement, leading investigator Erich D. Ryll, M.D. to term the illness "Infectious Venulitis."

    The CDC investigated and documented 45 cases. The largest percentage of cases by occupation were among ICU nurses. Four cases were non-hospital contacts of employees. One case was an ICU patient. Additional cases were reported later.

    Below is a link to Dr. Ryll's 30-year-follow-up report on this outbreak:

    http://www.iacfsme.org/LinkClick.aspx?fileticket=DFTt0/5WSAU=&tabid=477

    [Bolding mine.]
     
    Last edited: Jan 22, 2015
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  9. lansbergen

    lansbergen Senior Member

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    Endothelium function testing is good but they should also test epithelium.
     
  10. Sasha

    Sasha Fine, thank you

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    They're using actimeters at baseline and at the end of the trial.
     
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  11. Sidereal

    Sidereal Senior Member

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    And they're using 2-day CPET at three study sites on patients who are not severe so as to not induce a prolonged crash.
     
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  12. Aurator

    Aurator Senior Member

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    If, when the present study is complete, similar results (i.e. fairly positive ones) to those of the first study emerge, and if the UK study now under way meets with positive results likewise, what practical changes, if any, can we expect the experience of the trials to bring to the treatment of the disease in the short or medium term?
    Am I being unduly pessimistic when I envisage yet more encouraging trial results and pats on the back for all involved being greeted by a sphinx-like impassiveness on the part of the authorities whose co-operation (and money) we ultimately need if there are to be any positive changes in the treatment patients actually receive?
     
    Last edited: Jan 20, 2015
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  13. WillowJ

    WillowJ คภภเє ɠรค๓թєl

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    It is the right study design, being a sizeable blinded RCT, so should get some attention. Will require replication by another group before the governments think about changing any treatment recommendations, although if they are smart, they would fund more such studies.

    I do not know how many countries will expect studies to be done in-country, but we have a good start with 3 countries working on trials.
     
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  14. Kati

    Kati Patient in training

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    3 countries? What is the third country after Norway and UK?
     
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  15. alex3619

    alex3619 Senior Member

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    Vance Spence in the UK was working on endothelial issues in ME going back to before 2000. He is also a patient though, and I suspect had funding issues.
     
  16. alex3619

    alex3619 Senior Member

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    None in the short term. Some in the medium term. If we want more we will have to fight. If the science shows something then its a great goal of advocacy to fight for it. Competing interests will always try to oppose advances. In the end though its psychobabble that has no biomarkers that always loses.

    Psychobabble wins early because its unsubstantiated appeal to doctrine. Then there are biomarkers. Then attitudes change. Then the research funding and opportunities change. Then even more findings are made. The psychobabble is dead on this specific disease, and continues fighting to hold its ground with other diseases and disorders it has claimed.

    In the long term biomedical science trumps psychobabble.

    Please let me be clear that not all psych (-iatry or -ology) is psychobabble. Some are trying to put these disciplines on an even better scientific basis. Its just that the worst issues and dogma are pervasive and damaging, and need to be addressed. So I don't use "psychobabble" lightly. If I have anything disparaging to say about these professions as a whole (and not individuals) its that they have allowed this to continue without sufficient challenge. In the long run it may be psychs who are our best allies - but we are definitely not there yet.
     
    Last edited: Jan 21, 2015
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  17. alex3619

    alex3619 Senior Member

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    My best guess is that those with better resources will be able to get some cutting edge treatments, including possibly Rituximab, in three to five years. It may take another decade before this is routinely available to most patients.

    This of course presumes that studies like the phase 3 Rituximab study go as expected. I have to say that I think the countdown to the release of the results may be the most tense and exciting time in ME history. Just look at how we reacted to XMRV ... and multiply that by ten. These are not just tests but treatments.
     
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  18. Sasha

    Sasha Fine, thank you

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    The Open Medicine Institute have a Rituximab/Valcyte RCT listed as their first research priority on a list that's been up for a couple of years now:

    http://phoenixrising.me/archives/17128

    It's costed at $7.65 million and there's been no update on it: presumably they haven't been successful in getting funding.

    Prof. Carmen Scheibenbogen in Germany had been interested in doing a Rituximab trial but I think she ran into problems and abandoned it.

    I'm not aware of any other country running a trial.

    @Jonathan Edwards, do you know of a rituximab trial on ME/CFS, other than the UK and Norwegian ones?
     
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  19. Bob

    Bob

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    From the Simmaron article, genetics study section:

    "To further elucidate possible clues, we are also working on exom-sequencing of families with many affected individuals among first- and second-degree relatives, sequencing all coding parts of the genome (with flanking introns) both from affected and healthy family members."

    "exom-sequencing" and "flanking introns"? The mind boggles! (I've never heard of these before!)
     
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  20. Bob

    Bob

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    This has been discussed on another thread in the rituximab section of the forum, but thought I'd post it here as well. Looks interesting.
     
    Simon likes this.

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