A Novel Nutriceutical Treatment of ME/CFS, 2017, Comhaire

Sorry, yes I agree with you. I'd dropped into a more general comment, and drifted somewhat from the specifics of this thread. I was really meaning it's a problem if not properly accounted for ... but only said half of what I should have.

 

I would have preferred the objective measurements be the primary ones, but there was at least one objective secondary outcome.

There might be a placebo effect. We don't know, because it's subjective outcomes with no control group.

My concern is not with the preliminary study failing to use objective outcomes, but with the author's seeming lack of intent to use objective outcomes in the future, combined with his belief that fatigue is actually the most relevant outcome:

And responding to our ongoing methodological concerns by claiming that we're just focusing on ourselves, and that he's the expert, does not inspire any faith regarding the use of more rigorous methodology in the future:

I always appreciate it when a researcher is interested in a biomedical approach, but I must object when they embrace the same methodological flaws which have allowed psychosomatic researchers to make ridiculous claims over the years. It won't harm public perception of our disease if his research is ever publicized, but the poor methodology means that his research will not be useful to patients until he fixes it.

 

Yes, there may well have been a placebo effect but there was no placebo. Therefore, the effect can't be determined. That's for future trials.

He hasn't commented on objective outcomes in the future so we can't assume he has a lack of intent. Yes, I'd prefer it if the emphasis on fatigue was de-emphasised.

This is a preliminary study. It is not a trial. It's to inform the researcher for the future trials he intends to conduct yet it has been judged completely inappropriately and the researcher has been lectured to.

 

These are supplements that we have been trialing for years. Nothing new here.

 

Perhaps they would like to discuss new scales for the RCT here? I am also concerned about the Chalder scale but would also welcome some hard facts on these supplements. It would be good to be able to offer some suggestions for improvement in the design. The other point I guess is dose soecificity and interactions between the different nutrients and co factors? I suspect this will be quite specific for each subject under test, so some more preliminary work to establish dose variation amongst a wider group may be in order?

I was also thinking we should provide more suggestions and fact based arguments when we discuss these things. If not Chalda scale we should suggest one? Does anybody have any views on this?

I also think if we are dismissive of fatigue ( as we all were earlier in the thread) we should spell out more clearly what are the more important symptoms to monitor/measure. Otherwise it comes across as just quite one sided and combative rather than collaborative.

By way of example Cognitive function as I've discussed earlier probably needs to be broken down into more specific measures (e.g. Short term Memory, coordination, problem solving etc ) along with all the other side effects such as nausea, feeling dizzy, irritable etc.

I can start a new thread to explore this but it may be we have something we can reference in this regard? Welcome people's thoughts on this.

 

Maybe I'm just being unduly pessimistic, but I'm starting to think that people involved in research which promotes specific supplement blends aren't interested in good trial design any more than the people whose research promotes specific psychosocial therapies I'm very much looking forward to being proven wrong about that.

 

I was also thinking that referring them to the CDC criteria for diagnosis or the Canada Working case definition would be a start to measure these diagnostic symptoms as well as fatigue? I have recently discovered for instance that after taking Coenzyme Q10 and discontinuing it and restarting that this definitely has a big affect on my cognitive function.

Perhaps they are deliberately confounding the design to get a result, but I do like to give everyone the benefit of the doubt.

 

Not sure that we should have to spoonfeed information already out there and available for any researcher who cares to look. The CCC have been available since 2003 and are hardly a closely guarded secret, the IOM report is available to download for free.

We are entitled to take a view on whether we consider something worthy of collaboration or not, as for example we did with the MEGA proposal. It may be that having considered a matter we don't feel particularly collaborative, in which case coming across as uncollaborative is entirely appropriate. We can also express ourselves forcefully and tear ideas apart if we feel like it, and anyone who doesn't like that can check the name of the forum.

 

My impression is that carnitine, CoQ10, magnesium, B complex are all somewhat effective. I can clearly do more with the carnitine. They can also be too much and lead to increased or new symptoms if the dose is too high.

 

CoQ10 blew my head off.

 

I see part of the role of the site as being collaborative and a place for all to discuss ideas backwards and forwards in a scientific way (with facts and evidence). it also requires context. That's all I'm saying

 

CoQ10 in particular is, eventually, moderately effective for me. It eventually restores just enough cognitive function to allow me to fry myself in short order.

As such it's reserved for special occasions, when the need to be more cognitively functional is important enough to override the need to be able to move without a lead suit.

Of course coz I'm not routinely using it I keep forgetting to start it early enough, but...that's life

 

Would that be the same CCC that allows 'Post Exertional Malaise and/or Fatigue'?

 

Yes, that's the one. Rather helpfully defines PEM/Fatigue as:

Is that what the FSS accurately and objectively measures?

Also mentions and defines sleep dysfunction, pain, neurological / cognitive manifestations, autonomic manifestations, neuroendocrine manifestations and immune manifestations.

So a study of 10 patients which measures the following:

And where the author refuses to commit to objective outcome measures in future despite friendly and respectful suggestions from the patient community (one-sided and uncollaborative who?) is hard for me to get excited about.

 

Yes, that's right. Within the list, there are a sequence of three symptoms that are 'and/or'

It's a little ambiguous because it could be taken to mean either:

• post exertional malaise and/or fatigue and/or pain

or

• post exertional malaise and/or post exertional fatigue and/or post exertional pain

Only one of these makes sense and it's the second. The CCC lists symptoms in categories. The first symptom category is fatigue as a stand alone symptom. The second category are the post exertional symptoms. It would be strange to list fatigue in the first category and fatigue in the second.

Therefore CCC ME/CFS is characterised by fatigue that is persistent or recurrent. The post exertional category is at least one of three symptoms (malaise, fatigue or pain) with others being optional.

 

in a short "proof of principle" pragmatic trial, reported previously, I have referred to a new nutriceututical treatment for ME/CFS.
In a larger trial, 45% of patients reacted favourably to this treatment, which contains - among other ingrediënts - sodium dichloroacetate, and that has now been protected by a patent (which means that it is prohibited by law on intellectual property the use this substance for the treatment of ME/CFS patients, except under licence granted by the patent owner). The beneficial effect of the treatment has persisted for up to 7 months in the patients who were included in the initial trial. In addition, logistic regression analysis with stepwife elimination has revealed that it is possible to predict the probability that a particular patient will benefit or not benefit from the treatment. The full scientific paper is in preparation.

 

Was it blinded?