Treating patients suffering from myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) with sodium dichloroacetate, Comhaire 2018

So, for what it's worth, here's my n=1 prediction and result, based on the published formula and method.

First, just to note that, according to my reading around, sodium dichloroacetate is considered safe at a dose of 400mg a day if taken with B1 in particular, and alpha lipoic acid, to prevent neuropathic damage (which is reversible anyway, when it's stopped). (People using it for cancer take much higher doses).

That being the case, and since it's plausible that it might influence energy production, I put my numbers into the equation, and got a P of 0.99, ie, a high probability of success was predicted.

I have been ill more than 3 times longer than the median duration of patients in the paper, and had high scores on all the fatigue measures relevant to the formula.

I decided to give it a try. I thought about enlisting the aid of my carers to blind test it, but decided against, so I knew I was taking it. It's quite bitter tasting when dissolved in distilled water, which was how I took it, since that was cheaper than buying the capsules, which were anyway the wrong dose.

I took 400mg per day, the dose used in this study, obtained from the same company as in the study, for 30 days, the same length of time as in the trial. I also took, or was already taking, all the other elements of the nutriceutical.

I had mild nausea and gas a few times during the first three days, and no other side effects. I don't know which of the elements of the formula caused this. I don't usually get nausea, so it's likely it was the DCA and/or associated supplements that caused it.

Result: it made no discernible difference. DCA had no effect on my ME.

 

I've had a message from someone trying to work out this formula in their own case, and was reminded that there is seemingly an error in the paper. So to save anyone else puzzlement, the number you calculate is not p, but logit (p) where,

logit (p) = ln {p/(1-p)}

So, e^logit (p) = p/(1 - p), and solve for p.

In Comhaire's Fig.2, logit (p) runs from 0 to 1. I asked him about this, but he didn't clarify. Presumably a typo; presumably it should be p, not logit (p) on the axis.

For anyone with brain fog or math-aversion, m.wolframalpha.com will do the calculations for you. There are apps for mobile devices.

 

This is a proof of principle, pilot, pragmatic trial. It is what it is, not more or less.

 

What I found is that the calculated formula alows for rather clear differentiation between reponders and non-responders. The (p) in the "logit(p)" means the probability that a particular person does belong to the group of responders (probability between 0 and 1). It is commonly called the "predicted probability".

 

THis comment is perfectly correct. The vertical axis shows (p) not logit (p). Thank you!

 

I just struggle to understand the point of such a trial it doesn't tell us anything, people have good days and bad days, it is impossible to know how many participants would have reported feeling better at the end point if they had had no treatment at all and we know from studies of homeopathy and such like that open label subjective trials are all but guaranteed to give positive outcomes from placebo effect alone. I'm sorry but it just seems like a massive waste of everyone's time especially when a placebo group could have been included so easily for such a treatment.

As for as for subdividing the responders after the trial, I might do a trial where I ask participants to try to predict the result of a coin toss, after the results are in I will divide them into two sub-groups, those with psychic powers (guessed correct), and those without psychic powers (guessed wrong), I probably won't bother with any controls that would be excessive for a pilot study.

 

It is strange indeed. The formula generated by the logistic regression analysis with stepwise elimination also includes the total score of the FSS. It is an observation, not an explanation. I try to inform those among you who are interested in the evolution of my research. I hope you appreciate that, and that you also understand the work to be in progress. Some findings intrigue me as much as they do intrigue you.

 

The trial will be initiated as soon as, and provided that the DCA is officially accepted and registered as a food supplement.

 

Why do you need it accepted as a food supplement, afaik this is not the case for pharmaceuticals

 

@ME/CFS - Thank you for contributing to this thread. I'm interested in learning about your follow up work with sodium dichloroacetate. I see that it is also being investigated as a treatment for Leigh's Syndrome to treat lactic acidosis.

ETA: Looks like sometimes referred to as "Leigh's Disease" otherwise Leigh Syndrome.

 

Several papers, and my own experience from history taking, suggest that "things in the past" and lack of emotional binding during infancy and youth are reported by some patients. This, evidently, is their own subjective feeling. Also patients mention that they feel vulnerable when exposed to external pressure. Other patients have been educated in a spirit of authoritarian parenthood (you MUST do this, MUST do that, you may not spend time on things that are not useful, etc.). Once again this is the subjective feeling of (commonly female) patients. I, as an observer, can not objectively assess these claims. The latter is probably not so important, since it is the personal emotional feeling of the patients themselves that counts.