Discussion in 'BioMedical ME/CFS Research' started by Adrian, Nov 24, 2017.
Not sure about this one as it appears to be open label and assessment via the CFQ. But it is another paper looking at supplements for mitochondria and could relate to this paper
Many patients use these supplements but we don't know how good they are. Fingers crossed for a good blinded followup RCT that will tell us more.
Does anyone have a copy? It's not on sci-hub and I'm interested in how the charted data looks like and in any other things they measured.
Abstract is at https://www.sciencedirect.com/science/article/pii/S2212958817300915
8 out of the 10 authors are from psychiatry departments, which explains this sort of complete disdain for scientific methodology:
Seriously, it's one thing to say "pilot study, can't afford a control, sorry", but their denial of a placebo effect is either a denial of reality or blatant bullshit to make the results look more meaningful than they are. Either way, they are not inspiring any faith in their work.
And the most relevant outcome they can come up with is the fatigue scale proven to consistently show improvement where there is none:
I can't find a full text version, but if the abstract is this bad, the rest is probably a train wreck.
Trial registration is at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370610
It was supposed to be a 20 week trial, so maybe they went with 16 weeks because the results looked better at that point? Chalder fatigue scores were a primary outcome at 20 weeks, so they should have a record of changing that prior to seeing any data, but there's nothing about it in the trial registration even though other changes are mentioned (number of patients recruited).
This is the nutracetical, which doesn't seem to be marketed or sold yet:
Fukuda diagnosis was used as the inclusion criteria. Participants could be undergoing other treatments at the same time, if they were on them 4 weeks prior to starting the trial. I'm not sure what they think ME is (actually, I have a pretty good guess), because they exclude "Patients with known or suspected active and unstable systemic medical disorder."
This makes it sound like patients who took the same nutracetical in the past, or components of it, could be eligible for this study, which suggests potential selection bias of patients already known to have responded well to the treatment:
This should be the data analysis we can look forward to seeing:
Their recruitment target was 30 participants, but they stopped early (at 10) due to "Lack of funding/staff/facilities."
Their hypothesis about ME/CFS causation isn't too bad, assuming it's honest and not just what was said for recruitment:
Is there an outbreak of nutraceutical studies using Fukuda, a fatigue scale and 10 CFS patients at the moment? Has someone recently started selling a "Do it yourself CFS study kit" on ebay, special discount for the first 10 takers? Is some enterprising patent lawyer giving them away as freebies in the hope of drumming up subsequent business when the hopeful "researchers" think they've scientifically proven that they're onto something?
Oh super, I was hoping that a cure for drowsiness was on the way.
The acetyl carnitine will likely help, its the only reason i can still read online posts and think coherently, the B vitamins are a crock (i know some will disagree) the Q10 will help though i find its effect wears off over time, the ALA i don't know.
I don't like testing so many things at once, the results can't be untangled, if one ingredient is doing the heavy lifting the rest are just expensive fillers...
As @Valentijn mentions above the study parameters leave much to be desired.
I logged in just to say you gave me a good chuckle, @TiredSam. Seriously, after spending most of this week weeping whilst reading this forum, I just have to offer a hearty thanks.
I find it a bit frustrating that there may be potential with the supplements but the studies are not good enough to say anything. I see no point in doing such small open label studies especially when measured with a questionnaire.
"Interest in edible beans as nutraceuticals is increasing".
Too complicated for me to understand but @Liv aka Mrs Sowester is certainly on the right track
I wonder if someone is bankrolling this study for expected future supplement profits, it would explain why its bring done and done so badly
I suspect that nutraceutical formulations are just seen as the easy way to make some money, along with a nice patent. A lot of researchers seem incapable of doing quality work, so they're fantasizing about making a grand discovery and quickly retiring to a life of luxury.
They lack the skills and ethics to do the work required to make a real discovery, so they settle for creating an over-hyped quack treatment instead. Of course, that requires doing some crappy trials to create false positive results to use for promoting their bullshit treatment
Just some more information on that study. I was in it. The authors fully understand the current situation me cfs is in and that there is no treatment. The study was run with no money at all but as a side project. The main psychiatrist does not view the illness as psychiatric or as a result of deconditioning. The purpose was to get a larger trial underway (funded) with more stringent criteria and using pedometers as measures and not the chalder scale. The trial was cut short of the 30 people because of a mix up in dosages from a third party which was unfortunate. The study was positive for me.
I can't help but be reminded of The Synergy Trial at Stanford.
The Synergy Trial "evaluated the safety and efficacy of methylphenidate (generic Ritalin), combined with a mitochondrial support nutrient formula over 12 weeks".
"The difference between the two groups did not achieve statistical significance" which was claimed to be "most likely due to the relatively small sample size—87". So, perhaps any future similar studies need a larger sample size to see any effect.
The original Synergy Trial website is gone, but it's still on the Wayback Machine.
Below is a table with the mito supplements from The Synergy Trial, as shown on the Wayback Machine. Notably absent is Coenzyme Q10.
The CFS Nutrient Formula is composed of vitamins, antioxidants, amino acids, and therapeutic dosages of key nutrients that support brain and mitochondrial functioning. The CFS Nutrient Formula is designed to support immune and nervous system functioning in order to enhance the safety and efficacy of the low-dose medication. The CFS Nutrient Formula is not yet currently available as a commercial product. Please see below for a list of the ingredients contained in the CFS Nutrient Formula:"
Thanks, @Holinger for sharing your experience. I'm glad it was helpful for you. Welcome to the forum.
Do you know whether a larger trial has got funding?
Thank you, @Holinger, also from me. Interesting to read about your experience.
Surprisingly low in magnesium.
Bigger numbers are always nice but if there is no statistical significance for 87 patients i don't think 870 patients will fare much better, assuming they all have the same disease. Bigger numbers won't make something that doesn't work, work
Fancy multi vitamin with a few things added. How much would this cost a consumer, i would guess a hell of a lot per dose before patent then the extra patent price padding...
I take two of those ingredients and acetyl carnitine is expensive
Do you happen to recall if data was collected at 20 weeks? The protocol listed it as a primary outcome, but the paper only includes data up to 16 weeks. It would have at least included Chalder Fatigue Questionnaire scores at that point.
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