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RCT of a natural killer cell stimulant (BioBran MGN-3) in CFS

Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by adreno, May 6, 2012.

  1. adreno

    adreno PR activist

    A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome.

    McDermott C, et al.

    QJM. 2006 Jul;99(7):461-8. Epub 2006 Jun 29.

    University of Southampton, UK.


    BACKGROUND: Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).

    AIM: To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.

    DESIGN: Randomized, double-blind, placebo-controlled trial.

    METHODS: We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.

    RESULTS: Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.

    DISCUSSION: The findings do not support a specific therapeutic effect for BioBran in CFS. The improvement showed by both groups over time highlights the importance of placebo controls when evaluating interventions in CFS.

    PMID 16809351
  2. adreno

    adreno PR activist

  3. Mark

    Mark Former CEO

    Sofa, UK
    What a shame they only used subjective measures. If I recall correctly, the Ampligen trial showed clinically significant improvements on some objective measures, versus placebo, but the SF-36 results were unchanged or even slightly worse in those patients who had objectively improved. It looks increasingly likely that subjective measures like the Chalder score not only give an illusory appearance of improvement in CBT trials, they may also fail to reveal the objective improvements from medications that are effective. It seems to me that all those questionnaires may well measure nothing more than the patient's general level of positivity and positive thinking - so a patient in a trial who was hoping for a miracle cure and just got a small improvement might actually fill in that questionnaire in a way that suggests they got worse.
    Jenny and PWCalvin like this.
  4. Hope123

    Hope123 Senior Member

    Not only that, but if they really wanted to test their theory, they should have used low NK cell activity directly aside from CDC criteria as inclusion criteria and NK cell activity as outcome measure. At least from the abstract, it doesn't seem like they did that. So, perhaps it might not have worked because the subjects included already had normal NK cell activity or maybe their NK cell activity did not get boosted up enough into the normal range? We won't know if this data was not collected.

    Interesting abstract though, OP.
  5. SOC

    SOC Senior Member

    Is it just me or does anyone else feel that "fatigue scales" are a stupidly simplistic way to evaluate improvement? I mean, we have a HUGE list of symptoms of which fatigue is only one and is not typical fatigue in any case -- PEM/PENE is a better description of our energy impairment. Is this focus on "fatigue" caused by the stupid, idiotic name dumped on us by the CDC? Do researchers really not get that ME/CFS is so much more than "fatigue"?
    Jenny and heapsreal like this.
  6. hixxy

    hixxy Senior Member

    Indeed. When I set my rating on my PR profile. It is not a fatigue rating. It's a a rating out of 10 of how disabled by this disease I am at the moment. All I can say is -- bring on the fatigue!!!
  7. adreno

    adreno PR activist

    I agree that measuring only subjective measures is problematic. OTOH, you could argue that subjective measures are the only ones that count. What good does an improvement in objective measures do, if you subjectively don't feel any better?

    According to the trial, MGN3 was subjectively indistinguishable from placebo. I have heard several members here argue that they can certainly feel if something is helping, or is just placebo. So judging from those arguments, if MGN3 is indistinguishable from placebo, then it doesn't seem like it would improve members health here.

    In my view though, a combination of subjective and objective measures would be best.

    I am also not convinced that MGN3 is better than other immune modulators. It is hard to find independent trials comparing the different compounds and brands.
  8. Jenny

    Jenny Senior Member

    Agree entirely SOC.

  9. HTree


    I did not read everyone's thoughts on this--but immediately upon reading, I think -- Only EIGHT weeks? ALL these AV/immunomodulators etc seem to take At LEAST 6 months to see if there's an effect. At least, from what I've seen and read...
    August59 and ukxmrv like this.
  10. Snow Leopard

    Snow Leopard Hibernating

    South Australia
  11. August59

    August59 Daughters High School Graduation

    Upstate SC, USA
    That's a good point and it is a common mistake, IMO, when they do these test at such short duration because I don't think you will ever have any treatment that will have a genuine effect on the real cause and even a lot of the secondary symptoms that accompany this disease. The antivirals take much longer than that and the viruses they treat are just opportunistic pathogens from a "broken down" immune system as I speculate on this.

    I hope that once Dr. Lipkin and Dr. Montoya (and all of the the people working with them) release some of their information and studies that they might make an attempt to emphasize that these very short 6 - 8 week studies are in most cases a waste of funding. I would guess that depending on the study and what it is trying to achieve has a lot of bearing on this, but in most cases they have to go on out to the 4 - 6 month or longer duration before they will get any useful data. This is something that the funding review committee (if there is still such a group) should be aware of when reviewing these studies that are requesting funding from the NIH and other agencies

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