Opportunities abound to make a difference in ME/CFS, but the Open Medicine Institute (OMI) may have hit on the quickest way to do that for the most people.
- Could a simple, inexpensive treatment provide more energy for many?
What if an effective, relatively inexpensive and readily available treatment was available right now? What if all that was standing between you and others receiving that treatment was your doctors lack of knowledge?
What if that could be remedied?
On her recent trip to Sweden with Dr. Peterson, doctors at the Gothries clinic excitedly told the Open Medicine Foundations executive director Linda Tannenbaum about some successes they were having in this difficult to treat disease.
An inexpensive treatment featuring B-12 and folate was helping 20-50% of ME/CFS/FM patients with the MTHFR mutation. They were more energized. Their brain fog was clearing. They weren’t well, but their quality of life was much improved.
That got Linda to thinking … inexpensive, readily available treatment that most doctors don’t know about; that’s the kind of opportunity the OMI and its slate of ME/CFS doctors exists for.
A check with some US practitioners indicated they were having similar results. Dr. Peterson, Dr. Kogelnik and the Gottfries clinic signed up and a trial was born to (hopefully) validate a low-cost way to help many people with ME/CFS have more energy and mental clarity. Primary care doctors have no clue about B12 and even your ME/CFS expert may not know about the MTHFR mutation (which affects methylation).
- An early study found low B12 levels in ME/CFS and doctors have talked it up, but no one has assessed its effectiveness in ME/CFS – until now.
This hundred person, placebo-controlled, double-blinded, international trial will determine how how effective B-12/Folate is. It begins in March, 2014.
Drug companies won’t fund a B-12 study. This is going to take help from the ME/CFS community.
Let’s get more options out to people with chronic fatigue syndrome everywhere. Let’s get them a study they can print out and say to their doctor “Get me tested and if positive, get me help.
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Wow! What a coincidence. I have been taking B12 for 4 years now, but last week I started to take folate. As I have been changing more things last week I cant say anything for sure, but the $ 6 bottle for pregnant women sure could be helping me a lot!
I have been on vitamins with folate before, but stopped them for several reasons.
I am very curious how this trial will end up!
Thanks for mentioning this research!
Excellent that this is getting started!
An important part is that the substantial effect of this treatment is, as I understand it, is only in ME/CFS patients with a mutation in the MTHFR gene. It will be very interesting to see how big that subgroup is.
Here is what the Swedish National Society for ME patients (RME) is telling their members:
All ME/CFS are recommended to have their folacin and homocysteine measured. If the folacin value is low, or if the homocysteine is high, then a gene analysis should be done, looking at the MTHFR-gene. If there are mutations on 677 or 1298, and they are sensitive to the vitamins B12 and folate, treatment with B12 and folate can bring substantial improvement (life-long treatment is then usually needed).
We’ve seen some patients with the MTHFR gene get much, much better with treatment.
However, many ME/CFS patients don’t have the mutation. Some of them can still get some improvements from B12 shots, but usually only limited or temporary improvements.
This research is needed! Let’s get donating!
I have been on B-12 inj Hydroxy now 1cc every day sub Q and then 3cc 2 times weekly im . Also 200 mg Folate for years. My Endocrinologist and Infec Disease Dr. rec to me. This is not anything new to me. Could not do without either of them.
If I miss a day-I know it.
San diego #1
Thanks for relaying your experience San diego#1
200mg of folate? Are you sure you don’t mean 2mg?
unbeleivabe, I’ve just stumbled across this deficency/treatment with my specialist and GP. I am at a very low point but I know it is working already. Now extremely excited seeing it in print here 🙂
Very encouraging. Are the needed doses far above daily requirement, as with the B1 treatment?
Just so I am clear is this clinic finding it is not 20-50% of their ME patients who are finding B12 and folate helps but 20-50% of people who have ME and the MTHFR mutation who are experiencing a benefit? So even 80 to 50% of people with the mutation are not being helped? I still of course think this is a very interesting discovery and obviously could help a lot of people. Thanks
My understanding is that it’s 20-50% of the people with the MTHFR mutation. I believe that the 20-50% number is based on general observation and that the OMI was being conservative when it used that number. I think we’ll have to see what the study tells us. The doctors at the Gothries clinic were, however, apparently quite impressed with the response rates they were seeing.
Thanks 🙂
Thanks so much for publishing this article. I am homozygous A1298 and Methyl B12 and Methyl Folate have helped me. I am not sure if I have CFS but I definitely have Fibromyalgia. I would love to find out what the dose they took.
Thanks!
I have tested positive heterozygous for MTHFR 677 mutation. Does anyone know whether candidates for this study/treatment need to be homozygous for the mutation? Or is this treatment showing promise for heterozygous as well? Many thanks!
Are there any self-tests available for the folacin and homocysteine that can be ordered online?
This is essentially what many in the CFS community are already doing by trying one of the methylation protocols. The key is to use the active forms of b-12 (methylcobalamin, adenocobalamin, and hydroxycobalamin ) and folate (5-methyl tetrahydrofolate )
And for $100 – you can do you own genetic testing at 23andme.com. Get the raw data and pass it through genetic genie and voila you can see if you have the mutation
23andME recently got whacked by the FDA and for the moment at least is no longer providing interpretations of its test.. I guess you can still ,as you say, get the raw data.
The controversy seems, in part, to be about how much information the FDA thinks consumers should be getting outside of doctors offices. It really has resonance with Simon’s recent blog. http://www.fastcompany.com/3022891/innovation-agents/exclusive-what-really-drove-23andme-and-the-fda-apart
There are three core points of dissonance between the FDA and 23andMe. The first is their level of faith in consumers. The FDA is tasked with protecting consumers, even from themselves. Among the objections the agency has to 23andMe is that DNA test results may provoke consumers to seek unnecessary treatments, self-medicate in dangerous ways, and take on needless anxiety about conditions for which there is no treatment. In contrast, 23andMe stresses that consumers are capable of managing their own medical care–and should have more information about it. The company highlights specific instances where customers’ DNA tests led to helpful, positive medical interventions. The FDA’s stated concerns at this stage revolve around hypotheticals, not observed cases of consumer-created medical mistakes.
From their website
https://www.23andme.com/ancestry-only-notice/?redirect=BDwkqaZZzJrX5bomvDBs6g-9MEB62k9YErEq89Jgw0Y=
Welcome to 23andMe.
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.”
23 and me is only providing the raw data and ancestry information. However, you can go to http://www.geneticgenie.org and upload your raw data and it will provide a report and discussion of the results for MTHFR and related genetic abnormalities. I believe the donation requested for that is $10.
Is there any published info on which form(s) B12 they will be using? Are they going to use folate or folinic acid? Thanks.
What are the doses they are using for the trial of B12 and folate? Is it just methylb12? I already take a supplment with folate in it as well as loads of liquid methylb12, b6, and bentofiamine. Perhaps I need a higher level of folate to experiment. My supplement (thorne b complex #12) has 200mcg as calcium folinate and 200mcg as L-5 methyltetrahydrofolate. I take liquid 5000 methylb12 by pure encapsulation.
However this turns out it’ll be great to get some hard data on this subject :). I love it that Peterson and Kogelnik and the Gothries Clinic are getting involved in a trial of a treatment the patient community has shown so much interest in.
B12 was one of the first things checked when I was diagnosed with ME/CFS seven years ago; my B12 was out of the ball park in the ‘HIGH’ range–nothing wrong with my B12 levels–everything wrong with the energy–B12 is supposed to be energizing.
Low plasma B12 and low plasma folate has been found in studies of depressive patients. It is not specific for CFS and we know the Fukuda criteria includes al lot of depressive patiënts. These type of patiënts don’t respond well on antidepressiva. Maybe they will benifit from this treatment.
The problem with Serum B12 test is the fact it is unreliable because the inactive B12 in blood can be as much as 80% in whole blood, so any negative test result is questionable in symptomatic patients, look up UK NEQAS B12 Alert
I’m not in the study but I do get my B12 perscription from the Gottfries clinic. We are talking mega doses here, I have 2-3 injections per week. For me, it is crucial for my quality of life. When I take my injections regularly I’ve hardly got any brain fog and I just function better over all. The improvement was immediate, one shot and the fog lifted! I have no idea if I have the mutation or not, though. I should also add that my bloodwork showed no abnormalities previous to starting the injections.
Thanks Anna – that’s great news! Thanks for sharing that.
So, how much should I take and in what form? I’ve taken Stress Tabs (B-complex) and sub-lingual B complex with no positive results at all. I know I have poor digestion/absorption. I really need some advise on this. I’m pretty much on my own, except for on-line advise, as I have no insurance and can’t even keep up on our bills…have never met an MD that knew anything about ME, really. Have had a few chiro’s who’ve given me nutritional advise, but can’t afford to take everything they recommend, and have also had bad reactions to any extra thyroid or adrenal supplements, natural or not…I had real levels of Vit D and it took 3 prescription strength 3-month doses to get it up to normal~I don’t think I was absorbing the first 2 forms…I take vit D daily, but don’t know if I’m absorbing it….I do very poorly in the winter, but have had severe depression pretty much year-round for the past 5 yrs or so…It’s hard to function. I just wanna sleep ’til spring! Then the last 2 springs were really, really bad…I just want some relief! Having to live this way for another 10-20 years seems unbearable…and I seem to get worse every year. The fatigue was the worst ever last August! Must’ve had a virus or something…just mopping my kitchen floor wore me out~I get out of breath and feel like colapsing with an hour’s work…I know there are people much worse off than me, but that doesn’t make ME feel any better…
I would stop the high dosis vit D and see if you get better. Vit D can be toxic for ME/CFS patiënts. http://www.youtube.com/watch?v=v8DtUnY7gEM&feature=c4-overview&list=UUxrPmgVwJ7-gLqZJK_qLeFg
Would appreciate feedback. Thanx!-
If you are on Facebook, search for the group Pernicious Anaemia/B12 support group, I feel you would benefit from it very much
Thank you Rich Van Konynenburg – http://www.cortjohnson.org/treating-chronic-fatigue-syndrome-mecfs/treatment-protocols/methylation-treatment-plan-chronic-fatigue-syndrome-me-cfs-konynenburg-ph-d-ii/
I was tested for MTHFR a few years back and came back negative. I’ve tried folate in the past and it makes me really sick. I’m not sure what to think about this study. Is it a waste of money and time? It doesn’t seem that a lot of people with ME would have this MTHFR gene. And it’s not what is causing ME. So why spend money and time looking into it. I guess if I had the MTHFR gene I would want some answers.
I think what i’m trying to say is if a unknown doctor and researcher was doing this study I would be fine with it. But to have in my eyes big hitters like Peterson and OMI spending their time and money on this seems like a waste. I need them to work on the big stuff to get to the heart of our disease. Like what is causing it. I feel like i’m running out of time, life is going by so fast and we need a big break through. I don’t know maybe it’s just me being selfish.
Readyforlife
I was told by one of the docs involved in this study that he was finding that 95% of his patient population has these mutations- clearly far above that occurring in the normal population. Hence why they are wanting to look at the issue to see what scientific validity there is to the whole thing.
You make GOOD sense with your comments, Readyforlife!
This seems like a good place to mention something I have noticed recently.
I have tried dear old Rich Van K’s idea of B12 and folate for years, trying to make it work for me, because I have faith in him. I figured out that hydroxy-B-12 agreed with me best. But the vitamins were always too strong for me, making me detox too hard and making me feel worse instead of better. (even though I believed they were good for me on some level) So I resorted to taking very tiny amounts of them.
Then I tried a new vitamin called Garden of Life Vitamin Code Raw B Complex. I am able to take a half-dose (one capsule) daily and it makes me feel better! The company tells me the form of B-12 in it is like the B-12 found in food. The exact chemical composition of it is proprietary, so they won’t say what it is. If Rich Van K were still alive, I’d be rushing to tell him about this.
So the upshot of what I want to say is: if the simplified methylation protocol feels too strong for you, try this vitamin. If people flunk out of this trial because it makes them detox too hard, try this vitamin.
Forebearance
I’m out here in the sticks (Iowa) with no good CFS-knowledgeable physician, so I am generally reduced to just trying things out, a self-made guinea pig. I was already taking a lot of vitamin supplements, including a multiple, so that was no problem. Last year I decided to try a version of the protocol. I took FolaPro, Actifolate, methyl B12, and lecithin, in addition to my usual vitamins, minerals, and massive doses of vitamin C.
I noticed that small doses of the folate supplements were indeed energy-enhancing to me. But I worked my way up very gradually. I almost got up to a full 1/4 tab daily of both folate pills, and then had a crash, a relapse in October. Did I overdo? Probably. I was doing more shopping, cooking, a bit of work around the house, besides a lot of work and play on the internet. I really did have more energy. I did not seem to crash from the added activity, at least not for a while. And then it all started going downhill.
Now let me offer an idea, a guess, as to what might have happened. I believe the folate did enhance energy production, presumably through unblocking methylation problems.However, I now recall that in one of Dr. K’s lectures I say on the internet, if my recollection is correct, he showed how the people who responded to the protocol and also felt better also saw decreased GSH (glutathione), not increased. To me, this means increased oxidative stress.
According to Cheney, energy production at the mitochondria is stymied by a breakdown in the enzyme system that is supposed to mop up and remove the superoxide radical that occurs as a result of turning glucose and oxygen into ATP (cellular energy units). If energy production is forced up, then oxidative stress might be increased.
Is this what happened in my case? Did increased energy lead to increased oxidative stress on the cell, which eventually led to a relapse? My palpitating heart tells me this is a possibility.
I think Dr. K was really onto something, but my experience would suggest caution for anyone trying the protocol. Listen VERY carefully to your body, and enjoy the increased energy — if the protocol is effective for you, but make sure you don’t let yourself go without a full night’s sleep and regular rest periods, and other healthy habits. I now see the pre-crash warning signs I was having, but 20/20 hindsight is not much good now, except as a future caution.
How can the enzyme system that relieves oxidation produced by the mitochondria (see the Cheney lecture from spring 2013 on YouTube) be enhanced or repaired? That is my question now, because if I ever go back on the folate I want to make sure the cell is really able to deal with the consequences of producing extra energy.
I always love double blinded studies. So many pass off opinion papers as research. I was once told that if the placebo response is to far above or below P=10, it probably wasn’t a well constructed study. It’s unfortunate that some have to have placebos, but it is a huge determining factor in the merit of the study.
I have never been checked for the mutation, hopefully this study will also lead to a better understanding of what tests should be done.
Knowing there are experts I admire on this is icing on the cake.
How do you know what a mutation would be for 677 and 1298 on the MTHFR gene? In other words, if you got only the raw data from 23andME, what would you be looking for?
This could be interesting to see. I have mutation on MTHFR C677T and my CFS specialist here in Australia has had me on both B12 and folate for 4 years. We are also addressing the mitochondrial issues. Here you can get the MTHFR test done at a lab(not have to go through 23andme though I have just ordered a kit)
After 30+ years and working with a forward thinking doctor I think I am on to something and very pleased.
Good luck Maggie!
Hello Maggie,
You are so very, very lucky to have such an educated about CFS specialist! I live in Canberra, and can not find a specialist here. I would be so grateful if you could give me the name and contact of your wonderful specialist.
I have multiple medical conditions, but CFS is ‘the big one’. I hope you can help me out with this information.
With best wishes for your recovery
Ariette
Great to see this study going through- and love that it is being crowdfunded rather than drug company funded!
It’s not being very crowdfunded right now – just $1,500 has been donated to support the project. I’m kind of surprised…I really think this project could help alot of people and make people think about ME/CFS differently. For one thing it opens the rich field of methylation up for researchers. Ideally this study would be the start of several that determine which methylation treatments works best
Thanks Gijs that is an excellent video clip re the vit d being too high/toxic in ME patients. I have had some toxic feeling sick never ending headache problems when I took vit d3 (which I am supposed to as I have osteoporosis to sort out) and came off of it as I eventually through process of elimination found it to be that. Just started the methylaion protocol and a lower dose of vit d3 past coulple of wks as winter and I don’t get outside much, and…. toxic headache and feeling nauseous back again, though not as bad this time, but more out of it/brain fog than usual.
So I am dropping both the d3 and active folate for the moment, will come back to the folate and hopefully will be alittle wiser, but will continue the hydroxo b12 1mg.
Thanks for the helpful clip, very interesting about the over active immune system and inflammation and the doctor using the example of the mountain climber getting herpes after 4 or 5 days due to overactivation/high active vit d. I found this fascinating. Although I’m unclear as to what comes first, the over active immune system, inflammation or high active 125 vit d.
Tim
Does anybody have problems with their doctors if their blood level of B12 shows very high? I have had a really big improvement in ability to exercise and also mood since having 3000 mcg daily transdermal B12 which I believe is Cynacobalamin from Dr Myhill here in the UK.
Tomorrow I am having a blood test for B12 as well as Ferritin and full blood count (my white blood cells were below reference range a few months ago). I am thinking the B12 is likely to be sky high and wondered if this is going to cause problems with my GP.
Pam
For those of us who get bad headaches or migraine with extra methylfolate I think the answer might be that it is converting to glutamate. Excess glutamate is known to cause hyperarousal in the brain and can cause severe overstimulation. I read this from Dr Amy Yasko’s videos on methylation.
This happens to me whenever I go above 200 mcg calcium folinate plus 200 methylfolate and add in any amount of methylfolate. The migraines from hell start and don’t stop until days after stopping the extra folate. I should add that I do eat a lot of natural folates each day in my food, (vegetables, pate and peanuts) so I wonder if this is the reason why.
Almost certainly I have at least one copy of the MTHFR enzyme but more likely homozygeous, that is mentioned because I had a stillborn baby with a neural tube defect way back in 1973 and this enzyme is implicated in neural tube defects (along with B12 insufficiency). I wish somebody had told me about these possible problems years ago and maybe I wouldn’t have developed ME/CFS.
Pam
I have been doing B-12 inj. for a number of years. I know for fact that Dr. Cheney recommended up to 3 1ml inj. a week. I have my GP giving me presc. for my B-12, but I am having problems with a pharmacy on wanting to limit me of my whole re-fill of quantity 30 ml. And, the mfg. of the inj. B-12 is making it only in the 1ml bottle. Whereas, a couple of years ago I could get my 30 ml bottle. The B-12 does give me more energy, if I do 2 cc’s every week or so. Does anyone else have a problem with their pharmacy trying to control your prescription and cutting you short – which is their opinion and not going by my doctor’s prescription?
Merry Christmas~
i think, that you are mistaken I can prove it orthomol isotonic vitamins
any updates on this, Cort / Cort et al (I hope you have assistants! 😉 )?