Jonathan Edwards
Senior Member (Voting Rights)
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.
-
New Forum Software Installed (Still a few issues but reopening the forum) More details.
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.
Hi @Hank G, welcome to the forum.
I'm afraid I can't agree with your comment. Until there is a double blind trial, we can't know whether it works for anyone. Nor do we know whether the side effects will be worse for people with ME than GET as you suggest. That is simply not known until after the trial. I think it's irresponsible to encourage people to try drugs simply on the grounds that they are currently being tested.
I assume you are familiar with the Rituximab story which looked so promising in early trials, but turned out not to be a beneficial treatment for ME after all. And some people were give Rituximab privately before the trial results came out - a waste of their money and at risk to their health from possible side effects from what turned out to be an ineffective treatment.
Dudden
Established Member (Voting Rights)
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?
Hi @Dudden. No I don't see that it makes any difference whether there is a hypothesis or not. As I understand it, the hypothesis the Cortene test is based on is unproven. We can only know if a drug is effective if it has been properly tested.
Dudden
Established Member (Voting Rights)
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.
Inara
Senior Member (Voting Rights)
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)
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)
Snow Leopard
Senior Member (Voting Rights)
They most likely will still publish something even if it is a null result. (which wouldn't surprise me, unfortunately)
Semmelweis
Established Member
A new blog post about this. Somewhat positive...
Snow Leopard
Senior Member (Voting Rights)
Cort said:
Or it just represents questionnaire answering bias because the study was not blinded....
Saz94
Senior Member (Voting Rights)
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).
Saz94
Senior Member (Voting Rights)
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."
feeb
Senior Member (Voting Rights)
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.
