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Have any peer reviewed studies for other CFS/ME treatments matched the effectiveness of Rituximab?

Discussion in 'Rituximab: News and Research' started by Jesse2233, Feb 12, 2017.

  1. Jesse2233

    Jesse2233 Senior Member

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    I've searched high and low for other reputable peer-reviews studies matching the 2/3rds clinical response rate of Fluge/Mella's Rituximab paper and found nothing.

    I've seen a lot of self reported data from various doctors on treatments like anti-virals, IVIG, interferon, prebiotics, and immunomodulors, but nothing peer reviewed or published in a journal as reputable as PLOS ONE (where the Rituximab trial was published).

    Has anyone seen any comparable studies that I'm missing?
     
  2. Hip

    Hip Senior Member

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    Ampligen has passed phase III clinical trials, and is the only drug that has been approved (in Argentina) for the treatment of ME/CFS. Ampligen is expensive, costing around $15,000 a year (excluding the medical costs of the infusions). Though the clinical response of Ampligen seems much lower than rituximab.

    The Staphypan® Staphylococcus toxoid vaccine passed clinical trials, and was a pretty effective, very cheap, safe and largely side effect-free treatment of ME/CFS and fibromyalgia. A revolution in ME/CFS treatment. But then the manufacturer took Staphypan off the market. Go figure.
     
  3. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    I think there are two different issues here.

    One is the quality of the trial methodology. I suspect there are few if any other trials with reliable methodology.

    The other is the result. For rituximab we still do not have a clear cut result. At 6 months it looked as if about 50% more patients responded to rituximab than did to placebo. But at 3 months there was no significant difference and that was the primary endpoint. So Fluge and Mella are keen to point out that we do not yet have any hard efficacy data. The 6 month result might have been a chance finding amongst a lot of ups and downs.
     
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  4. Jesse2233

    Jesse2233 Senior Member

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    Thanks Professor, point taken on methodology

    Regarding your second comment, why does it matter that the primary end point was 3 months if clinically significant results were seen thereafter for up to 36 months? What's the probability that those responders were collectively experiencing an unrelated remission of symptoms?
     
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  5. Jesse2233

    Jesse2233 Senior Member

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    The Staphypan® story is fascinating. Couldn't make it through the whole thread. Did you ever end up taking the Russian version @Hip? If so, what was the effect?
     
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  6. user9876

    user9876 Senior Member

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    moderated with many others
    With a fluctuating disease it you look at the difference between groups there is a chance that there will be a significant difference between the groups at some point. So if you allow for the choice of a point after completion there is a danger that it just reflects chance. Having said that the delay seems to make some sort of sense for Rituximab (to me at least) so I do believe (or hope?) the results will be replicated.
     
  7. Hip

    Hip Senior Member

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    Myself and 4 others who tried the Russian Staphylococcus toxoid vaccine found it had a noticeable mood boosting effect, and for me it also a noticeable motivation boosting effect, but it did not seem to help the ME/CFS symptoms.

    However, we may have been using the wrong vaccine, because there are two versions of the Russian vaccine, one stronger than the other (the strong one is the "absorbed" vaccine, which contains an adjuvant). We inadvertently used the weaker one.

    So I want to repeat my testing with the other stronger version of the vaccine.
     
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  8. Jesse2233

    Jesse2233 Senior Member

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    Interesting. Can Dr Gottfries provide any guidance on whether your Russian versions match the original formulation of Staphypan?
     
  9. Hip

    Hip Senior Member

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    We already know that there is a difference in formulation, as we were able to find the ingredients for both vaccines. The only common ingredient is the alpha toxoid.
     
  10. Jesse2233

    Jesse2233 Senior Member

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    Thanks, interesting. From the studies it seems that the Staph vaccine is at least as effective as Rituximab or Ampligen but with fewer side effects, a lower cost, and an easier dosage process

    Did those studies use the Canadians Consesus Criteria for selection of subjects?
     
  11. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    I agree with user9876's point. If you check to see if the weather is better than expected twenty times you have a pretty good chance of finding it better than expected on at least one occasion - where better than expected is better than 95% of days. With any trial of this sort there turn out to be scores of ways of looking for evidence of improvement and so you cannot attach any reliability to any result picked out in retrospect - which is what the 6 month result was. Once the code is broken and the study is unblinded, as it was at 6 months I think, then you cannot be sure that the results are not just the result of wishful thinking on the part of physician or patient.

    So the probability of patients reporting remissions that had nothing to do with the drug is seriously real.
     
  12. nandixon

    nandixon Senior Member

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    I hope it works for you but my hunch is that the staphylococcal cell walls need to be present to get the original Staphypan effect. See my post here.
     
  13. Jesse2233

    Jesse2233 Senior Member

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    Meaning the original formulation preserved with mercury?
     
  14. nandixon

    nandixon Senior Member

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    @Jesse2233, Meaning any successful formulation may need to have the staphylococcal cell walls be present. (Or, if they were known, the actual anti-inflammatory TLR2 ligands present in the cell walls that I think might be responsible for Staphypan's beneficial effect.)
     
  15. deleder2k

    deleder2k Senior Member

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    Does it? I haven't read all the staph studies, but I looked at one, and it didn't use SF36. Perhaps someone can do some digging and compare them.
     
  16. Jesse2233

    Jesse2233 Senior Member

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    I see, so the question is around whether the Russia vaccines have it?
     
  17. nandixon

    nandixon Senior Member

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  18. Gingergrrl

    Gingergrrl Senior Member

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    I know nothing re: the Staph vaccine so everything I am replying to is purely in regards to Rituximab...

    I don't really understand the significance of this b/c according to my doctor, you do not truly know if RTX has worked in any given patient until about six months after B-Cell depletion. So a patient could not have any improvement at 3-mos but then have an improvement at 6-mos and this is considered successful. Why would the Fluge & Mella Study not follow this same pattern and assume that improvements at 6-mos were due to chance?

    @Jonathan Edwards Would this be the same for patients in the study (or who try RTX in general) who have had symptoms that did not fluctuate (or did every single patient who was selected have a relapsing/remitting type of illness)? I can only speak for myself in that when I had an improvement to a specific symptom, it was striking and noticeable both to myself and to all who know me (vs. other symptoms which have not yet improved). I have not been able to try RTX yet (so for me it was the combination of MCAS meds & IVIG) but none of my doctors would ever attribute what they are seeing to chance or coincidence. I have no guarantee that RTX will work for me but if it does, we will know it has worked vs. it being chance. (This is not directed at @user9876 but used your quote to explain my question).

    I don't understood how this could possibly be the case? Many physicians assume or wish the patient can get better with "wishful thinking" or CBT/GET or mindfulness/yoga or all kinds of things but when someone actually uses a specific treatment and then gets better and remains better, wouldn't it be from that treatment (especially if the person has been progressively getting worse for several years and did not have a fluctuating form of their illness)? Thanks in advance.
     
  19. Hip

    Hip Senior Member

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    From my reading of the Gottfries studies, I got the impression that Staphypan was not quite as effective as rituximab in terms of the degree of ME/CFS symptom amelioration, but probably not lagging too far behind rituximab.

    It is a little bit hard to gauge the efficacy of Staphypan in the clinical studies, because Prof Gottfries used an unusual scale of ME/CFS disability, the Comprehensive Psychopathological Rating Scale (CPRS), which I have not been able to get hold of (but some info about the CPRS is here).

    In his large clinical trial of 100 patients with both fibromyalgia and ME/CFS, he found that 33% of treated patients obtained a 50% reduction in symptoms on the CPRS.

    Though his smaller clinical trial of 28 patients with both fibromyalgia and ME/CFS gives a more tangible sense of the improvements gained: in this trial, he says that in a follow-up study of 23 patients, the vaccine treatment was continued for 2 to 6 years, and 50% were rehabilitated successfully and resumed half-time or full-time work.

    Resuming half-time or full-time work means that you either have improved to the point that you only have mild ME/CFS (mild ME/CFS patients are usually able to work), or means that you are in near full remission.


    It was very unfortunate that Staphypan was discontinued by the manufacturer soon after the publication of Prof Gottfries's clinical trials in Sweden; had that not occurred, I am sure we would have had these trials replicated elsewhere, to add to the evidence base for Staphypan.



    The CCC was published in 2003 I think, so was not available at that time Gottfries conducted his studies. I think he used the CDC criteria, but you'd have to check the studies.
     
    Last edited: Feb 13, 2017
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  20. IreneF

    IreneF Senior Member

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    Psychopathological Rating Scale? Wouldn't that measure ... psychopathology? I can assure you that I am not a psychopath.
     

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