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Comments on the Vinitsky protocol

Discussion in 'Detox: Methylation; B12; Glutathione; Chelation' started by richvank, Apr 8, 2010.

  1. richvank

    richvank Senior Member

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    Hi, all.

    Ive been asked to comment on the protocol described by Dr. Alan R. Vinitsky in his article entitled 21st Century Miracle Treatment? and in his U.S. Patent Application number 20080045448, dated February 21, 2008, which was apparently initially filed on August 18, 2006, which is entitled, Reversing Autonomic Nervous System Dysfunction by Potentiating Methylation.

    Dr. Vinitskys protocol bears strong resemblance to several other protocols that are being used to treat methylation problems in autism, chronic fatigue syndrome, vitamin B deficiency, and other disorders. I dont know who came up with this type of treatment first. I know that it was not I, since I based the so-called Simplified Treatment Approach on the complete treatment program used by Dr. Amy Yasko. In addition to these two protocols, there is also the protocol developed by the researchers and clinicians involved in the Defeat Autism Now! (DAN!) project, the protocol developed by Freddd of Salt Lake City, and the protocol developed by Prof. Martin Pall.

    The feature that all these protocols have in common is that they include forms of folate and vitamin B12 at relatively high dosages, as well as some additional supplements. Though these protocols have not all been expressly developed with the intent to stimulate the methylation cycle, they do have this effect.

    In the case of Dr. Vinitskys protocol, the preferred form of folate is folic acid, and the preferred form of B12 is hydroxocobalamin, though his patent application includes the full range of forms of these nutrients that are used in all of these protocols. Dr. Vinitsky prefers sublingual administration of these nutrients, though again, his patent application includes other routes as well.

    One unique feature of his protocol is that he adds the folic acid in liquid form to the tablet of hydroxocobalamin, and they are administered together, sublingually.
    As far as I know, there is no other protocol that uses this combined mode of administration.

    In addition, Dr. Vinitsky prefers a mass ratio of 5 to 2 for folic acid and hydroxocobalamin. That is, he recommends adding 5 milligrams of folic acid solution to a 2-milligram sublingual hydroxocobalamin tablet. He suggests taking this approximately 3 times per day, though this is not a rigid recommendation. If this program is followed, the daily dosage of folic acid is then 15 milligrams, and the daily dosage of hydroxocobalamin is 6 milligrams.

    Here are my comments:

    1. With regard to the use of a form of folate and a form of B12, with some supporting nutrients, I think all the protocols agree in this regard.

    2. With regard to the choice of hydroxocobalamin, I of course agree with that, and it is also part of the Simplified Treatment Approach.

    3. With regard to the choice of folic acid, I dont think this is the best choice, because all the functions of folate in the body are performed by tetrahydrofolate and its one-carbon derivatives. Folic acid is not useable by the body unless and until it is chemically reduced by the enzyme dihydrofolate reductase (DHFR) to tetrahydrofolate, and this is a very slow reaction, particularly in some people. While Dr. Vinitsky argues that folic acid offers advantages of binding glutamate and formaldehyde, as far as I have been able to learn, it does not do that unless it is first chemically reduced to the biochemically useable forms of folate. So my opinion is that it would be better to use folinic acid or 5-methyl tetrahydrofolate, which incidentally are also included in his patent application.

    4. With regard to his recommendation to mix the two nutrients together and take them sublingually, I think that is a good idea. Normally, folate is absorbed in the earlier part of the small intestine, while B12 is absorbed in the terminal ileum. While there are probably more people who have difficulty absorbing B12 normally, there are also some people who cannot absorb folate normally, such as because of celiac disease. So mixing them together and taking them sublingually should give better assurance that they will be absorbed into the blood, and that they will be presented to the cells at essentially the same time, which could be advantageous, because they are used together to support the methylation cycle. So I would say that Dr. Vinitsky has a good idea here.

    5. With regard to the dosages he recommends, I think the folate dosage is rather high, but this may be necessary to compensate for the fact that folic acid is not very well utilized by the bodies of many people. If he were to use folinic acid or 5-methyl tetrahydrofolate instead, he would likely be able to use smaller dosages. I note that for the hydroxocobalamin, one of his dosages is the amount I have suggested in the Simplified Treatment Approach, so if this is taken three times per day, it would be three times the daily dosage. I think it will depend on the individual as to whether this is too much, or whether it is satisfactory. Im not able to make a judgment about what total dosage per day is best. There are differing philosophies as to whether it is best to go slow so that the resulting symptoms are more tolerable, or to push through the symptoms by consistently taking larger dosages. My approach has been to be cautious and to recommend going slowly, but it is possible that the other approach will get a person to recovery sooner. I just dont know the answer to this, and I think a controlled study would be necessary to determine it.

    6. In any case, my position continues to be that it is necessary for a person to work with a licensed physician while on a treatment to lift the partial methylation cycle block, to make sure that any adverse effects that may arise will be promptly and properly dealt with.

    Best regards,

    Rich
  2. Kati

    Kati Patient in training

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    Rich, I am reading "And the band goes on", the story of HIV/AIDS. A lot of people have made money out of the gay population selling vitamin packages called "MEN". The author then mentioned that NYC probably had the most expensive urine in toilets in the whole world.

    Vitamins will not cure an infectious retrovirus.

    I know some will not agree with me. But I'd save my money for the more expensive but eventually evidence-based antiretrovirals.

    Best of luck, and with respect, Kati
  3. richvank

    richvank Senior Member

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    Hi, Kati.

    Thanks for the response. Everyone has to decide what seems to be the best bet for them. I'll be very interested to see how the XMRV picture develops. It would be great if it turns out that safe, affordable and effective antivirals will be the answer for everyone.

    In the meantime, lifting the methylation cycle block does help to restore the cell-mediated immune response, which is what is needed to combat and defend against viruses over the long haul, so it might still be worth it to keep this type of treatment in mind.

    Best regards,

    Rich
  4. dsdmom

    dsdmom Senior Member

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    Rich, I notice that you often reference the need to work with a physician while using the simplified protocol to deal with any adverse reactions. My question is this - what are the expected reactions and what/how exactly would a physician be able to help or deal with them that one could not do on their own?

    Thanks!
  5. richvank

    richvank Senior Member

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    Hi, dsdmom.

    Below is a compilation of the reactions that were reported by various people who tried this treatment, during the first 6 months that it was out. I first posted it on July 18, 2007. Most of the people who reported their responses were on the ProHealth cfs/fibro board. Note especially the last section.

    Best regards,

    Rich

    The following symptoms of CFS have been reported to have been corrected by various PWCs on this treatment. Note that these are gathered from reports from many PWCs, so that not all have been reported by a single person.

    1. Improvement in sleep (though a few have reported increased difficulty in sleeping initially).
    2. Ending of the need for and intolerance of continued thyroid hormone supplementation.
    3. Termination of excessive urination and night-time urination.
    4. Restoration of normal body temperature from lower values.
    5. Restoration of normal blood pressure from lower values.
    6. Initiation of attack by immune system on longstanding infections.
    7. Increased energy and ability to carry on higher levels of activity without post-exertional fatigue or malaise. Termination of “crashing.”
    8. Lifting of brain fog, increase in cognitive ability, return of memory.
    9. Relief from hypoglycemia symptoms
    10. Improvement in alcohol tolerance
    11. Decrease in pain (though some have experienced increases in pain temporarily, as well as increased headaches, presumably as a result of detoxing).
    12. Notice of and remarking by friends and therapists on improvements in the PWC's condition.
    13. Necessity to adjust relationship with spouse, because not as much caregiving is needed. Need to work out more balanced responsibilities in relationship in view of improved health and improved desire and ability to be assertive.
    14. Return of ability to read and retain what has been read.
    15. Return of ability to take a shower standing up.
    16. Return of ability to sit up for long times.
    17. Return of ability to drive for long distances.
    18. Improved tolerance for heat.
    18. Feeling unusually calm.
    19. Feeling "more normal and part of the world."
    20. Ability to stop steroid hormone support without experiencing problems from doing it.
    21. Lowered sensation of being under stress.
    22. Loss of excess weight.


    The following reported symptoms, also gathered from various PWCs trying this simplified treatment approach, are those that I suspect result from die-off and detox:

    1. Headaches, “heavy head,” “heavy-feeling headaches”
    2. Alternated periods of mental “fuzziness” and greater mental clarity
    3. Feeling “muggy-headed” or “blah” or sick in the morning
    4. Transient malaise, flu-like symptoms
    5. Transiently increased fatigue, waxing and waning fatigue, feeling more tired and sluggish, weakness
    6. Dizziness
    7. Irritability
    8. Sensation of “brain firing: bing, bong, bing, bong,” “brain moving very fast”
    9. Depression, feeling overwhelmed, strong emotions
    10. Greater need for “healing naps.”
    11. Swollen or painful lymph nodes
    12. Mild fevers
    13. Runny nose, low grade “sniffles,” sneezing, coughing
    14. Sore throat
    15. Rashes
    16. Itching
    17. Increased perspiration, unusual smelling perspiration
    18. “Metallic” taste in mouth
    19. Transient nausea, “sick to stomach”
    20. Abdominal cramping/pain
    21. Increased bowel movements
    22. Diarrhea, loose stools, urgency
    23. Unusual color of stools, e.g. green
    24. Temporarily increased urination
    25. Transiently increased thirst
    26. Clear urine
    27. Unusual smelling urine
    28. Transient increased muscle pain


    Finally, the responses reported below are more serious, and I would classify them as adverse effects of the treatment. This list includes all the adverse effects of which I am aware at the time of writing this article, but I suspect that as more PWCs try this treatment with the assistance of their physicians, this list will grow. I am describing these as they have been reported on the ImmuneSupport CFS discussion board by the PWCs who experienced them. Though this information may be incomplete, and cause—effect relationships are difficult to determine exactly from the available information, I’m hopeful that it will be helpful to clinicians and other PWCs:

    1. One person had had a history of severe pesticide exposure and also autonomous multi-nodular goiter, which she described as follows: “Gradually the right lobe grew to over 4 cm x 4cm, and had to have right lobe out. . . This same surgeon made the decision to leave the left lobe in, as I had always had trouble with thyroid med back then too. So, they restarted my Synthroid and I stayed on that for [a] few more years. I ALWAYS had shortness of breath and became VERY tachycardic upon ANY activity. . .” This person started the simplified treatment approach on March 21, 2007 (actually using higher dosages than suggested for FolaPro and Intrinsi/B12/folate). On May 19, she went to an emergency room with tachycardia, chest pain, trouble breathing, trouble sleeping, elevated blood pressure and fever of 100.7 F. She was admitted to the hospital and released the next day. No evidence was found for heart attack. This person later reported the following: “I followed up with my PCP and had CT scan of neck and chest and my goiter is causing tracheal compression, again, and breathing is VERY hard. . . My area hospitals can't do this surgery because my goiter grows substernal, deep in my chest.” This person has expressed a desire to continue the simplified treatment approach, but is currently exploring the possibility of first having additional surgery on the multinodular goiter.

    2. A second person had a history of lung problems due to both carbon monoxide exposure and exposure to molds, as well as heart-related symptoms. She started part of the simplified treatment approach on May 27, 2007. After having been nearly homebound for ten years, she was able to begin riding a bicycle. However, in early July, 2007, she went to an emergency room twice with severe breathing problems (shortness of breath), a fever of 99.8 to 100.1 F. that eventually lasted for sixteen days, and severe chest and left arm pain. No evidence was found for heart attack. She was diagnosed with an enlarged left atrium and diastolic dysfunction. She has currently discontinued the simplified treatment approach and is under the care of cardiologists.

    3. A third person had a history of autoimmune disease, including Sjogren’s syndrome. After her fourth dosage of combined FolaPro and Intrinsi/B12/folate, she experienced “a moderately severe autoimmune flare, with numerous joint and soft tissue issues, fatigue, pain, etc.” She also experienced a severe flare of Sjogren’s syndrome, with “very dry mouth, dry eyes, and severe eye pain.” Six days after discontinuing the supplements, she had a thorough ophthalmology workup and was diagnosed with autoimmune scleritis. She has been given topical steroids and has reported that her eyes are greatly improved.

    4. At least two persons experienced a temporary termination of peristalsis of the gut and consequent constipation after beginning the simplified treatment approach. In these two cases, induction of diarrhea cleared material from the gut, but did not restore the peristalsis. In both cases, peristalsis restarted twelve days after terminating the folate-containing supplements. One of these persons had a history of treatment with psychotropic drugs, including Klonopin. About 18 hours after starting to get relief from the constipation, she became very sick, with “vomiting, vise-like headache, and shaking.” She had many bowel movements over a ten-hour period, and then began to feel better. The other had a history of autoimmune diseases, including Sjogren’s syndrome and Autoimmune Ovaritis, as well as diastolic dysfunction.
  6. dsdmom

    dsdmom Senior Member

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    Thanks, Rich. In the cases of discomfort, etc, do you recommend working through and that they should eventually get better? Or if one can not even do a low dose without eliciting a reaction should they stop completely?

    Also - a question I keep meaning to ask. As many of us obviously have sensitivities, do you recommend starting with one supplement and working your way up to the recommended dosage before adding in another supplement (so you know what supplement in particular could be causing the problem) or should you start them all at the same time?

    Thanks again!
  7. richvank

    richvank Senior Member

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    Hi, dsdmom.

    Yes, I have recommended lowering the dosages until the symptoms are tolerable, and sticking with the treatment. Some people crush the folate-containing tablets and pick up a small amount of the powder with a wet toothpick, and that's the daily dosage they use, at least initially. Hopefully the tolerance will improve over time, as toxins are mobilized and excreted, lowering the body burdens of toxins.

    I might add that not everyone agrees with this approach. Freddd, on this forum, recommends going to higher dosages and staying with them, "pushing through" the symptoms. I've heard that Kenny de Meirleir has also recommended to at least one of his patients to stay at high dosage of B12 when the symptoms intensify. I think the argument is that if you stop, you lose ground and have to go through all of it again. I don't know if that is true or not. I do know that some people abandoned methylation block treatment completely because they couldn't tolerate the symptoms when I first suggested it, and that's part of the reason I've recommended going "low and slow." The other part is that some people have had some pretty significant adverse effects, as I reported above, and I think the consequences for these people might not have been very good if they had just kept "pushing through."

    Yes, starting with one supplement and adding others as tolerated is a good idea. I have suggested starting with the multi, in order to take care of any nutritional deficiencies before stimulating the methylation cycle more strongly with the B12 and folates. Some people omit the phos serine complex on the grounds that it may lower their cortisol even further, whicih may be true at first. I do think that some support for the phospholipid membranes is helpful, because they have usually been badly damaged by the oxidative stress in CFS. Dr. McLaren Howard at Acumen Lab frequently finds damage to the mitochondrial membranes in CFS. Dr. Hokama frequently finds positive test results on his test on CFS patients, which is sensitive to an epitope found on cardiolipin. Cardiolipin is almost exclusively found in the mitochondrial membrane, again indicating damage to this membrane. The unsaturated fatty acids in these membranes are the most vulnerable substances in the cell to damage from oxidative stress. So maybe phos choline or essential fatty acids type supplements could be substituted, for those who don'l want to take phos serine complex.

    Best regards,

    Rich
  8. dannybex

    dannybex Senior Member

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    The Multivitamin / Iron gets a bad rap?

    Hi Rich, and thanks so much for posting your views on Vinitsky's version of the b12/folate protocol.

    The multi you mention...is that the one recommended by Amy Yasko?

    The reason I ask, is because it specifically doesn't have any iron (or copper?) in it, which leads me to a question I've been wanting to ask on various boards for a long time. I think Cheney, Pall and others also recommend avoiding iron...but...

    Why does iron get such a bad rap? I have read that it increases oxidative stress, etc., but isn't it also essential for proper immune function, isn't it necessary to help the body's immune system deal with bacterial, viral or other pathogens?

    I can understand if one has excess iron, high ferritin levels, etc., to avoid iron, but if one is at the low end when it comes to hemoglobin, hematocrit, etc., counts, wouldn't iron (and/or copper) be a critical, essential nutrient to include?

    Could we actually be worsening our condition by avoiding these blood building, and immune balancing nutrients?

    From:

    http://lpi.oregonstate.edu/infocenter/minerals/iron/

    "Iron is required by most infectious agents, as well as by the infected host in order to mount an effective immune response. Sufficient iron is critical to several immune functions, including the differentiation and proliferation of T lymphocytes and the generation of reactive oxygen species (ROS) by iron-dependent enzymes, which are used for killing pathogens."

    "Decreased myoglobin levels in muscle cells limit the amount of oxygen that can be delivered to mitochondria for oxidative metabolism. Iron depletion also decreases the oxidative capacity of muscle by diminishing the mitochondrial content of cytochromes and other iron-dependent enzymes required for electron transport and ATP synthesis. Lactic acid production is also increased in iron deficiency (20). The ability to maintain a normal body temperature on exposure to cold is also impaired in iron-deficient individuals."

    Thanks Rich,

    Dan

    also: http://www.ajcn.org/cgi/content/abstract/31/4/660
  9. serenity

    serenity Senior Member

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    Austin
    "Vitamins will not cure an infectious retrovirus."

    i am so with ya Kati :)
  10. Dreambirdie

    Dreambirdie work in progress

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    For some of us the drugs just aren't an option.

    I'm glad there are other choices. I appreciate all your research on this, Rich, and your ongoing help and support with the Simplified Protocol.
  11. serenity

    serenity Senior Member

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    i can understand what you are sayin Dreambird - i refused drugs as an option for me for over 10 years due to addiction issues. if your body is just way too sensative for them or soemthing, i totally get where you are coming from. so yeh, it's good there are other options out there.
    :)
  12. jeffrez

    jeffrez Senior Member

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    That's not really accurate, though, because by restoring glutathione synthesis to more normal functioning, the immune system is thereby improved, which then obviously helps attack and fight infections much better, reducing the viral load. That's one reason why increasing GSH is shown to help AIDS patients. If you think you are infected with a retrovirus and that's what's making you sick, then restoring GSH by correcting the methylation cycle would combat that retrovirus - which you most likely wouldn't have succumbed to in the first place if methylation and your glutathione production systems were working correctly.
  13. richvank

    richvank Senior Member

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    Hi, Dan.

    You're right. Copper and iron are both essential nutrients. Iron deficiency is perhaps the most common deficiency of essential nutrients, worldwide. This is especially a problem for many women, for the obvious reason. As you noted, there is a concern about free (unbound) iron promoting the Fenton reaction, which gives rise to hydroxyl free radicals, the most reactive kind, because iron can switch between two oxidation states in the body (+2 and +3). It has been suggested that copper might do this, also, because it also can assume two different oxidation states, (+1 and +2), but I don't think that is as well supported in the literature.

    To her credit, Dr. Yasko does recommend running urine essential elements tests and supplementing essential elements that are found to be low. I think it's a good idea to test for the essential minerals levels, too, and supplement if necessary. Ferritin measurement is a good idea to test for iron stores. Red blood cell or whole blood testing can also be used to evaluate copper levels.

    Best regards,

    Rich
  14. richvank

    richvank Senior Member

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    Why Mr.Kite, you're amazing! I couldn't have said this better myself!

    Best regards,

    Rich
  15. Dreambirdie

    Dreambirdie work in progress

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    Hi Rich--

    In my hair analysis results, my copper is (literally) OFF THE CHARTS. And, of course, my zinc is too low.
    Besides supplementing zinc, which I try to do, tho it does make me very nauseaus at times, what else can I do to repair this imbalance?
  16. jeffrez

    jeffrez Senior Member

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    I'm a quick study. ;-) I'm also becoming convinced from your writings and some of my known lab tests that methylation defects *somewhere* are intimately related to my health problems, whether or not they are even treatable at this point (allergic to GSH!).
  17. richvank

    richvank Senior Member

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    Hi, Dreambirdie.

    High copper makes me wonder about Wilson's disease.

    I would suggest running a urine essential elements test to see if copper is high there, too, in order check for Wilson's disease. You could get that through your physician, or directly from www.directlabs.com without a physician's order. If you could get a blood test for ceruloplasmin, that would help to check for Wilson's disease, too. Having your eyes examined for Kayser-Fleischer rings around the outer edge of the iris is another test for Wilson's disease.

    Best regards,

    Rich
  18. dannybex

    dannybex Senior Member

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    Ditto -- (with the exception that I'm a SLOW study...). But I'm so very grateful for all the work Rich has done, for all his generosity in sharing it on so many boards over the years. I hope to get the Methylation Panel, if I can raise the funds, in the next few months.

    THANK YOU RICH!

    d.
  19. JPV

    JPV Senior Member

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    That is not necessarily the case. There are countless stories of AIDs patients reversing symptoms with just supplements, vitamins and diet...

    http://www.keephopealive.org/report18.html/

    Either way, In my opinion it's a bit premature for people to pin all their hopes on XMRV being the cause CFS/FM. In fact the researchers at WPI are very clear to state that XMRV may indeed be just a "passenger" to another condition. Most people seem to ignore these statements from the WPI researchers.

    I believe that Rich Van Konynenburg and Amy Yasko are of the opinion that the CFS is an adult version of autism and that root cause is probably heavy metal and environmental toxins which comprise one's immune system allowing various pathogens to thrive. I'm pretty much in agreement with this line of thought. If this indeed the case, antivirals may provide some relief (and a constant source of income for Big Pharma) but surely won't be a cure. This would entail potentially more complex treatments that enhance mitochondrial function, glutathione production and detox, in which natural treatments seem to be very effective.
  20. maryb

    maryb iherb code TAK122

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    I recovered fully exactly 12 months on from becoming ill the first time with ME, I followed Dr Myhill's supplement and diet protocol rigorously,it was hard work. I just wish I could do it again but now have become sensitized to too many things, I am beginning Rich/Fredds type protocol soon. I believe something will work for each of us, its hard work, not to mention expensive finding it, but we need to do everything we can to help our immune system restore itself.

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