Discussion in 'BioMedical ME/CFS News' started by Sly Saint, Jan 7, 2020.
Interesting. It seems to be written by the patients, one of whom is also a doctor. I think there seems to be sufficient interest in LDN for a clinical trial to be set up. They say themselves that is what is needed.
If I recall correctly, last year the ME/cfs Clinician Coalition said they think an LDN trial is a priority.
I should probably know this, but is there a good outline of the proposed mechanism of action of Naltrexone? I've seen several places where it's suggested it might work in ME/CFS, but I don't recall any explanation of how it's meant to work, beyond vague-ish statements around 'immune system modulation'
Yes, they did. I’ve not heard anything it recently.
Interesting that one ME/CFS patient obtained the maximum benefits on a dose of 12 mg daily (6 mg two times per day). This is higher that the typical LDN dose of around 4 mg daily.
It suggests that if you notice benefits at 4 mg, it's worth trying higher doses to see if further benefits arise.
Someone on Facebook posted that the Younger LDN trial that was listed to start in 2016 has been suspended due to low participant turnout. That person posted
Note : Younger did an LDN trial in Fibromyalgia while at Stanford.
Dr. Enlander in the USA started using it years (decades?) ago.
Why a drug trial matters:
1) for the drug to be designated as a treatment for a particular disease.
2) to establish safety and effectiveness for a particular patient population, and to establish most recommended dosage
3) so physicians know it is safe to prescribe to their patients (here in Canada off-label medication prescription is discouraged amongst physicians), and that the physicians have knowledge about side effects, contraindications, warnings, and dosage.
4) so patients can get their prescription covered by their health insurance. While LDN is supposedly dirt cheap, the cost of compounding adds up for those who are not covered and on social assistance
5) so we gain an understanding of exactly what LDN does instead of hearing from case reports.
These can be true for any drugs. The scientific process is what makes us move forward. My personal view is that LDN is not the miracle drug, but I would like to see formal trials while we are waiting for the next drug in line.
I notice none of the 3 patients mention what would seem to me to be an obvious thing to do before claiming a drug is helping them - trying a period of time without the drug to see if their symptoms get worse again. Even better would be to get someone trusted to help them to double blind test themselves.
I assume these patients came across each other on line, since they are in different countries. Presumably they also came across people who had tried LDN and found it didn't help. It might have been better to include some of them too.
I'm having a hard time understanding why case reports are published or how they can be useful, unless it's about some rare disorder or to explain the practicalities of an intervention
It seems that all the biases and problems we face in understanding wether a treatment works, are simply ignored in case reports like this one. I would think that's rather unscientific, and misleading rather than useful.
Perhaps I'm missing something. Can someone help explain?
The only reason I can see for publishing such anecdotes is to help with funding applications for a clinical trial. Would it actually help? I don't know.
Isn’t it that in effect the Drs are saying this is interesting and worth further investigation. We keep saying Drs who prescribe off label should make their approach known so it can be investigated isn’t case reports the way of doing that.
All research has to start somewhere.
If doctors are giving off-label treatments then I think the right thing to do is to record outcomes as good as possible and publish these (a bit like Oli Polo did). Then we would have some very crude sense of safety and maybe even effectiveness (if patients don't improve at all that could suggest treatment doesn't help, and it might not be indicated to proceed to a randomized controlled trial. Publishing such negatives results would make sure other doctors don't have to figure this out on their own.)
Cherry picking a handful of cases to suggest a treatment works isn't a helpful start in my view. I don't understand why scientific journals are keen to publish such reports.
But perhaps I'm missing something?
Yes, I agree, but we've heard of LDN for a long time and we shouldn't be there now. We should see published trials by now.
"These case studies are presented in the hope they will lead to randomised clinical studies defining the role and dose of naltrexone in treating people with chronic fatigue syndrome and myalgic encephalomyelitis compared with usual care or placebo. However, as naltrexone is out of patent, funding for such studies is problematic, despite the drug itself being relatively cheap. Most large studies are funded by large pharmaceutical companies, and there is no incentive for them to continue research of drugs once they are off-patent. However, we intend to replicate the approach of pharmaceutical companies by designing any clinical studies with licensing requirements in mind and will seek advice from the Medicines and Healthcare Products Regulatory Agency to this end."
The discussion gives an answer: there are no commercial benefits for a clinical trial, patients who want to try it, can do it with off-label prescriptions. If even Jarred Younger doesn't succeed in setting up a trial, it must be a very hard thing to do, I would think
There are a few - just not that many, and none exclusively in ME/CFS (as far as I can see).
- Younger et al. (2014) The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. https://www.ncbi.nlm.nih.gov/pubmed/24526250
- Patten et al. (2018) The Safety and Efficacy of Low-Dose Naltrexone in the Management of Chronic Pain and Inflammation in Multiple Sclerosis, Fibromyalgia, Crohn's Disease, and Other Chronic Pain Disorders. https://www.ncbi.nlm.nih.gov/pubmed/29377216
Yes, I know. I meant in ME/CFS
Separate names with a comma.