Acute Corticotropin-Releasing Factor Receptor Type 2 Agonism Result in Sustained Improvement in ME/CFS - Pereira, Bateman et al, 2021

We wrote a blog post about this study a while ago. Think I forgot to post it here:

https://mecfsskeptic.com/intime-the-results-of-cortenes-ct38-trial/

 

here is the list of author matching the initials, and their affiliation:
Gerard Pereira1*, Hunter Gillies1, Sanjay Chanda1, Michael Corbett1, Suzanne D. Vernon2, Tina Milani2 and Lucinda Bateman2

• 1Cortene Inc., Burlingame, CA, United States
• 2Bateman Horne Center, Salt Lake City, UT, United States

 

I attended. You should be sent link to recording.Only 8 attended.
They were set up to do CPET but they had trouble with their machine and had to abandon testings. She mentioned that CPET testing would have been great but you need to be set up with appropriate staffing that has expertise and know the protocol and patient community. Ideally as well there would need to be equipment back up in case one set is out of order, as repairs can take weeks to be done.

I commented about the men-only healthy cohort in phase one. She mentioned that there were no difference between men and women in the patient cohort, so did not feel it was a huge issue in regards to dosing.

I mentioned the need of more objective measures; she had made comments on how the Fitbit is not a perfect measures, she made the comment about when she wore it herself and got a bunch of extra steps just by doing laundry.

She recognized that this study only had modest improvements and that the paper titled was hyped.

Overall, this made me feel that just going through the motion of clinical trial for our field, by a clinician in our field is a very good thing. It was not a perfect trial, and I am not entirely sure that the hypothesis will be sustained, but I think there has been knowledge gained by clinicians, researchers and drug companies.

I may have missed a few things, and if I my memory comes back I will update as an edit in this post.

 

Or they could just use old-fashioned pedometers.

Are blinded actigraphs a thing?

 

I made the comment that I recognized that Fitbits can be inaccurate, and the example I gave her was simply riding my scooter on the sidewalk, with the Fitbit recording steps for each cracks of the side walk.
It prompted her to bring up that they are working (or already have) an ankle device that measures time when the leg is horizontal (resting state) vs walking or feet on the ground.

 

Merged thread
Media coverage:
Clinical trial provides preliminary evidence of a cure for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) and Long Covid

This is a press release, not independent coverage, thus them hyping it up as a potential cure.

 

This is by no means a potential cure. Their primary outcome measure was their total daily symptom score, a questionnaire where patients rank each of 13 items on a 0-5 scale. There was no control group. Even in the group they selected because they improved the most, their symptom score dropped from 29.1 to 22.9, hardly a cure. In the same group, SF-36 physical functioning scores rose from 27.9 to about 35, on a scale of 0 to 100. There patients are still sicker than people with cancer, heart failure, or diabetes.

What did objective measures show? A decrease in steps measured by a FitBit that wasn't significant.

What can we conclude? Very little. This unblinded study led to small improvements in self-reported outcomes. It could well be a placebo effect, but who knows? A phase 2 trial will tell us more. However, I'm not holding my breath.

 

Yiish. Open label has limited utility but if you have no controls then it has none. Not much to conclude from this because of this weakness.