Conversation with Dr. David Systrom on OMF's First Clinical Trial
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- Опубліковано 8 лис 2023
- Today Dr. David Systrom sits down to chat about OMF's first clinical trial, The Life Improvement Trial (LIFT). This clinical treatment trial is a major step towards understanding and treating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) more effectively.
What is The LIFT?
Conducted under the direction of David Systrom, MD, Director of our Harvard Collaboration and Jonas Bergquist, MD, PhD, OMF’s Chief Medical Officer and Director of the Uppsala University Collaboration, The LIFT is a randomized, double-blind placebo trial that will investigate two particular drugs: Pyridostigmine (commonly known as Mestinon) and low-dose naltrexone (LDN) separately and together as a combination.
Dr. Systrom speaks more on trial setup, expected timelines of the trial, why this is an important first step, and more.
Adjusting to LND was pretty brutal for me (vivid night terrors) but after two rough starts it was worth it. I have been on it for more than a year and I have been the most functional I have been in 10 years or more. I look forward to the study results and considering a trial of Pyridostigmine. I so appreciate Open Medicine Foundation's work and updates. You are making a difference.
LDN was a no go for me. But I’ll be interested to hear more about Mestinon. I spend every red cent on supplements including a lot of natural anti-inflammatories. Thx for your work!
LDN took me from low end of severe, sleeping up to 16 hrs/day, and/or crashing every few hours while awake, heavy brain fog - to a 50% improvement. Better productive sleep, eliminated daytime crashes / naps, and brain fog substantially lifted. I could finally leave the house a bit for errands and occassionally socialize. Mood improved and I stopped taking Lexapro. It normalized my chronically elevated CRP levels. All this occurred within 11 weeks. When I stopped taking LDN about 9 months later, no symptoms returned or worsened. Never did I have any negative side effects. I am always surprised to hear there are others who struggle with LDN. I am ready to try other drugs that may be helpful. I still struggle with PEM and fatigue, and just restarted LDN to see if it further helps. I've been off it for a year. Would like to try other drugs.
I really appreciate this elegantly designed study of two meds being used off label. Thank you OMF and Dr. Systrom!
I wish OMF the best of success in this trial. I still feel, however, that they are ignoring structural brain and spine issues. I've tried LDN without success. Maybe Mestinon is worth a try.
Wonderful to hear all that information. What a great step forward. Thanks for all you do.
Thank you so much for doing this research! Please keep us posted on this channel and through other ME organizations
Had severe ME, now managed to get a little better.
A lot of it was supporting acetylcholine. Anything that supports synthesis of acetylcholine (alpha gpc..., b1) or prevents degradation like huperzineA helps tremendously with symptoms across the board. Pain, movement, energy, cognition, speaking, reading, digestive.
I'm absolutely convinced that acetylcholine plays a huge part
Mestinon is a good choice
Agreed, I always think of myasthenia gravis (caused by antibodies to the acetylcholine receptor) when I see someone with droopy ME-eyes, usually in more severe cases.
I agree. I researched Acetylcholine after developing some problems with sexual function following 10ish years on the contraceptive pill. I was convinced Acetylcholine was involved somehow but was never able to test the theory. Looking back, I'm somewhat convinced this was the start of my health problems although I didn't develop MECFS until 11 years later. I couldn't test my theory and now 18 years on I finally have a mestinon prescription thanks to POTS. I'm only just titrating up so will have to report back on the sexual function and if it was my answer! But things are compounded now, thanks to perimenopause and severe ME. So I guess this isn't a fair test?! 🤷🏻♀️🤣
This isn’t surprising. In the late 90’s there was a consistent finding across several small studies - elevated levels of an organochlorine pesticide called lindane. About 3x the normal range and higher in ME/CFS than those with known toxic exposure. Since then lindane has been largely phased out in agriculture, but continues to be used for treatment of scabies and lice. Since it’s persistent in the environment, high levels of lindane can still be found in bee honey. In fact, Mestinon is used in combination with neurotoxin pesticides such as permethrin, DEET, and chlorpyrifos are used to generate mouse models for Gulf War Illness (GWI) which can be clinically indistinguishable from ME/CFS. Chlorpyrifos is an organochlorine pesticide.
Other research that was buried in the 90’s by the DoD was research looking into visceral (and cutaneous) leishmaniasis (a trypanasome parasite) in connection with GWI. An extraordinarily high percentages of veterans had it - almost 60% in the Pacific Northwest if my memory is correct. And not surprisingly, only the DoD and CDC has access to the assays that work for detection. The alternative is a bone marrow biopsy. I’m not sure if there has ever been any good research into the prevalence of leishmaniasis in the ME/CFS population. Leishmaniasis can be asymptomatic, but start showing disease as the immune system gets worn down. It’s common to see this in some canine breeds.
Why would you do a trial for LDN that wasn’t long term? It’s clear from all the first hand accounts that a very high percentage of people that see benefits of LDN happens many months in and in some cases up to a year in. Equally important for LDN users is finding a sweet spot for dosing based on the individual- for example some work really well with a lower dose like 1mg and some work well at the higher low dose dosage such as 4.5mg. There is no definitive dosing that produces the same results for each person. Another important factor it seems how quickly one titrate up there dose and what dose did they start at etc.
Great idea! Hopefully the trial will be effective and the results get down to doctors
Good mix for a trial! I wouldn't call the Rituximab study entirely negative though, just wish they would've investigated more why some responded and others didn't. That's the issue with no marker (yet); you never know for sure what subtype or even disease you're dealing with exactly.
Thank you for the work you do! Look forward to what comes of the trial 🙏🏻
I love this study design, it's going to be such a big step forward - just having that actual evidence of biomedical changes from the drugs and the idea of personalising drug treatments to fit the person, it's just everything we've been hoping for for so long. Whatever the outcome knowledge will take a jump forward in such a truly meaningful way. Omf you are wonderful.
I have been on both drugs (among others) for a year or two now and feel I get good improvement from both of them. I think I had a little difficulty adjusting to the LDN initially but it passed pretty quick.
Thanks for your research
I tried both LDN and Mestinon... LDN helped my brain fog and my pain but over a few weeks I developed anxiety, crying outbursts, increased sensory overload and night terrors and insomnia. I stopped cold turkey and was back to my old self as soon as i did.
Mestinon made my blood pool down into my abdomen and gave me a 3 day long explosive diahrrea, increased eye tears, blurry vision and I fainted for the first time of my life while on the lowest dose. I might have been closed from a cholinergic crisis.
We need to know why triggering the dopamine or acetylcholine production works for some and not others.
Somehow I'm lucky with SSRI (increase serotonin) as it helps my dysautonomia and sensory overload but a lot of ME sufferers can't tolerate them.
Damn, those are some severe side effects!
@@themupsmuppet yes indeed 😅
I have had ME/CFS for over 24 yrs. One if my first symptoms was crying for no reason. It took me 14 yrs to get diagnosed with Pseudobulbar Affect (PBA). If your crying has not stopped, there is a magic pill call Neudexta which will control it. Good luck
What about the people with dysautonomia that have severe reactions to medicines. Anything new i tried made me feel worse or my heart rate go crazy.
Sorry , where & which countries are doing the clinical trials pls ?
Ty
Where can we follow (intermediate) results?
Two year study? And then what, more years more studies? I mean 160 patients / give it to them all at the same time 6 months later you know the results. I hate to simplify this but, it seems crazy two years.
Totally agree. They came up with a vaccine for Covid in a year. We need to fast track these clinical trials. Been waiting over 24 yrs for treatment.
Isn't naltrexone Narcan?
LDN did nothing for me except give me auditory explosive hallucinations.
@@Beth_82 super wierd.
I wish you would not use "cognitively" when you mean "mentally".
what a joke then again this is the latest in academia. I took schizandra berry (including chewing and eating the seeds) and over 3 weeks my orthostatic intolerance and physical fatigue went away, my ferritin increased from 30 to 103 and I have had no regressions, I also got kidney stones in the process which is explained by oxalate buildup which the schizandra berry got rid of. Note, another ME/CFS patient who tried a few berries got way worse but that person has MCAS (mast cell activation syndrome) whereas I have MCS (multiple chemical sensitivities).
Why dont you guys take calls? I tried calling your ??? not sure what to call it but its a number on your website but you guys dont want people calling you so I cant ask a question. I need a Dr here where I'm at who knows about this stuff the "doctors" here know nothing and I refuse to go anymore to ANY so called "DR" anymore I'm fed up and disgusted they dont care and they dont ever help they know nothing. The only thing I'm waiting for anymore is my death which I pray comes like yesterday. Who cares right?
LDN is rubbish for me!!
I am unable to metabolize and process LDN.
Why would you do a trial for LDN that wasn’t long term? It’s clear from all the first hand accounts that a very high percentage of people that see benefits of LDN happens many months in and in some cases up to a year in. Equally important for LDN users is finding a sweet spot for dosing based on the individual- for example some work really well with a lower dose like 1mg and some work well at the higher low dose dosage such as 4.5mg. There is no definitive dosing that produces the same results for each person. Another important factor it seems how quickly one titrate up there dose and what dose did they start at etc.
Why would you do a trial for LDN that wasn’t long term? It’s clear from all the first hand accounts that a very high percentage of people that see benefits of LDN happens many months in and in some cases up to a year in. Equally important for LDN users is finding a sweet spot for dosing based on the individual- for example some work really well with a lower dose like 1mg and some work well at the higher low dose dosage such as 4.5mg. There is no definitive dosing that produces the same results for each person. Another important factor it seems how quickly one titrate up there dose and what dose did they start at etc.