Rapamycin Pilot Treatment Trial for ME/CFS

I guess that it is highly likely that the treatment will occur in the context of paying for consultations at least.

The problem is that in this context you cannot get any meaningful evidence of 'response' unless it is large and consistent - in which case ten patients would be enough.

 

I agree with all the criticism.
If I would be a RA patient I would be very disappointed with this trial.

Unfortunately in the world of ME CFS patients, this is as good as it gets.
Maybe there is 1, maybe 2 double blind controlled trials taking place for ME CFS at this moment.

So, although heavily flawed, I’m already happy that this research potentially can bring us one tiny little step forward to understanding and treating MECFS.

Longing for the day that we will be able to enforce the same high standards existing for other immune illnesses with the same rigorisity to all future ME CFS research.

#RealPolitik

 

"We need to raise $350,000 for our Rapamycin pilot trial! We're not funding drug costs, but we're testing biomarkers 4 times per enrollee. And autophagy markers make this study unique! On #GivingTuesday put your donation on #ME treatment trials!"

 

So has this 'trial' been through peer review of any sort I wonder?
I think it is fine to ask for charitable donation but normally that is to provide funds for projects independently deemed of value, like DecodeME. Even with a peer review system things can be pretty random but without it there is no guard against patients pouring money into projects that will tell us nothing.

 

My understanding from Cort Johnson’s two blogs on rapamycin on healthrising.org on July 6 and Nov 14, 2023 is that the Simmaron study is “designed to provide data needed to get funding for a more rigorous placebo-controlled trial.”

More information on rapamycin treatment can be found on Dr Alan Green’s site rapamycintherapy.com as well as in the published papers
of Mikhail Blagosklonny and Matt Kaeberlein, whom Green calls the foremost experts on the theory and practice of rapamycin. Veronica Galvan’s group in San Antonio Texas is also doing excellent research on rapamycin, using mice. Green has the largest clinical practice and experience so far with rapamycin treatment.

The usual effective dosage for
people is 6mg once a week, but Green says it can be as low as 2mg every 3 weeks. Side effects are minimal, unlike the serious side effects with the high doses needed to prevent the rejection of organ transplants. Green also explains why taking rapamycin every day will be ineffective, and research studies in which this is the protocol show no benefit.

 

Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
https://classic.clinicaltrials.gov/ct2/show/NCT06257420

 

100 is pretty big for an observational pilot study. They could've gone for an RCT with that kind of number. Rapamycin, btw, is also known for immunosuppression of microglia.

 

The trial registration was updated a few days ago:

• The enrollment has increased from 100 to 150
• People with long COVID are now eligible to participate as well.
• Primary outcomes have been expanded from just SF-36 to also include MFI and Bell scale.

ClinicalTrials.gov

Edit: This is interesting because someone recently posted on Reddit that they are in the study and it is finishing up. Maybe a sign of encouraging results so they want to expand to long COVID?

Though there are probably other possibilities. Maybe they had no good results so they wanted to give it a shot with LC before giving up on this drug.