Trial of CT38 for ME/CFS by Cortene Inc.: big claims being made...

I think the problem is that we do not yet know if anyone was helped. Feeling better after receiving a drug is not the same as being helped by it. That is why we have controlled trials.

 

Hello @Trish. But, was´nt the Rituximab Trial based on an untested hypothesis? I am not suggesting that the Cortene Trial would be any better but it is certainly built on a hypothesis very similar the "Metabolic Trap" hypothesis, which I personally find to be quite convincing (that is my subjective view of this). What do you think?

 

Indeed. I think what I meant to say was, if Davis and Phair have similar ideas to Cortene, it would mean much. But as you say, it is quite early to tell if the trial is successful. Let us hope that it will result in a positive outcome.

 

That was an email sent to people on a mailing list. Is that hype?
They say themselves it's too early to say more.
It's just an update for interested people, and I'm thankful for getting this info.

 

sounds like Cortene maybe not so much http://birdbeeme.com/hello-again/

Nice, sensible blog post here on her web site (esp. point about positivity) http://birdbeeme.com/how-to-treat-a-chronically-ill-person-what-to-do-and-not-do/
(not Cortene related--please split post if needed)

 

They most likely will still publish something even if it is a null result. (which wouldn't surprise me, unfortunately)

 

Any results on this

 

A new blog post about this. Somewhat positive...

 

Or it just represents questionnaire answering bias because the study was not blinded....

 

https://twitter.com/user/status/1167235337451692033

 

Just because CRF2 activation is necessary & sufficient to produce learned helplessness, that doesn't mean that LH is the only thing that it can cause. Just did a bit of googling and there seemed to be plenty of other things mentioned in relation to CRH (corticotropin releasing hormone).

 

From the registration of the trial:

"The primary endpoint will be the change in the average total daily symptom score (TDSS), over 28-day periods immediately prior to the first treatment (pre-treatment) and immediately prior to exit from the trial (post-treatment). The TDSS is the sum of 13 individual symptom scores, each recorded daily by the patient on a 6-point scale (0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe). [...]

The secondary outcomes will assess function (assessed by patient record and, Fitbit monitoring), effects on vitals, orthostatic intolerance (assessed by standing tests at enrollment and exit) and general health status, as well as safety assessments."

 

Hmmm ... my wife has never given up, and never ceases to keep striving! But she still has ME.

 

So far this model does not even remotely capture PEM from what I can see. Its another chronic fatigue model. I hope I am wrong.

PS ... unless they are not working on learned helplessness as a model.

 

Well. At least they've had the honesty to pre-register the outcome most likely to be subject to bias as the primary outcome, instead of switching it later, I guess?

 

How fitbit data matches with symptom scores will be interesting. For the record I was using symptom scores to titrate treatments, in a clinic, in 1993. These were used regularly, but objective measures were determined from time to time.

 

I'll want to see the paper to see the definition of 'reacted' here. Especially given the high placebo response in the Rituximab trial.

 

How I read VanElzakker’s concern: Cortene is simply recreating the LP/Cognitive therapy theories in pharmaceutical form...


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