VITAMIN D - REMEDIES FOR MS AND AUTOIMMUNE DISEASES?
Translated from German by Google
Original has several charts in German VitaminD.Net
- Vitamin D has treated Multiple Sclerosis and autoimmune diseases for 16 years – Coimbra April 2018
- Dr. Coimbra interview covering Vitamin D, Magnesium, Folate, Vaccines - Oct 2018
- Multiple Sclerosis Coimbra Protocol stories on Facebook
- Dr. Coimbra discusses Vitamin D, Magnesium, Folic Acid, B12, Autism, Depression, etc – Sept 2018
- Guide for patients on high doses of Vitamin D – Coimbra 2017
- High-Dose Vitamin D Therapy – book July 2018
Interview with Dr Coimbra on High Dose Vitamin D for Multiple Sclerosis and Other Autoimmune Diseases: The Coimbra Protocol. Success rate 95 percent.
The Coimbra Protocol: Vitamin D for the Cure of Multiple Sclerosis?
For a long time, the connection between vitamin D and multiple sclerosis has been explored. Dr. Coimbra from Brazil claims now: Multiple sclerosis is treatable. Dr. Coimbra and his team have successfully treated thousands of patients with multiple sclerosis, in many cases with complete normalization of all symptoms and clinical parameters. Its "Coimbra Protocol" therapy is essentially based on a single element: high-dose vitamin D.
If the therapy is started on time, the results can be dramatic: virtually blind people start to see again and people leave their wheelchairs. We spoke to Dr Coimbra about the critical role of vitamin D in autoimmune diseases.
The Discovery: High Dose Vitamin D in Multiple Sclerosis
Table of contents
- And this knowledge is unknown in the medical world?
- What do you mean by "physiologically realistic"?
- So your dose was 10,000 IU?
- Why does vitamin D help with autoimmune diseases?
- What exactly does vitamin D do in the immune system?
- What exactly is this Th17 reaction?
- And how is this TH17 reaction getting out of hand? By the vitamin D deficiency?
- What does vitamin D resistance mean? What do I have to imagine?
- Is that your hypothesis or is there evidence for that?
- Autoimmune diseases are increasing - does that mean these mutations are spreading?
- Does vitamin D resistance inevitably lead to autoimmune diseases?
- At the moment many other mechanisms are discussed for many autoimmune diseases, what do you think?
- The Coimbra Protocol: Process and Content
- Why PTH?
- Can you please explain how this setting works?
- Vitamin D PTH regulation
- A diet with very low calcium intake?
- How different are the vitamin D doses required?
- What is the best dose interval for vitamin D in this context? Daily, weekly, monthly or yearly?
- Do you use oils or capsules?
- Effect of the Coimbra Protocol on autoimmune diseases
- How many patients have you treated with your protocol so far?
- Apart from vitamin D, you give two cofactors: magnesium and vitamin B2. Can you explain why this is necessary?
- And what about vitamin K2?
- It is also the question of how RCTs are suitable for nutrients ...
- So you think RCTs are unethical in this case?
- Are not they trying to prove their concept to reach more people?
- You have an incredible body of documented cases, why was not it published?
- Can you explain to our readers why approving the ethics committee is so important?
- So you would say this knowledge is suppressed?
- So research is anything but independent?
- Fortunately, the topic is now being discussed.
- MS Prevention – 10,000 IU daily
- Mentioned studies
Dr. Coimbra: I did research on laboratory rats with models of neurological diseases, with the aim to test new diagnostic possibilities. In this process, I found a tremendous amount of published research that, strangely enough, was consistently neglected in medical textbooks. I wondered why this information was not used in clinical practice - because, in fact, some of that was very important basic information for prevention and therapy. Slowly, I personally became convinced that a large number of patients would benefit greatly from various insights that are not described at medical congresses or in textbooks because they could reduce the sales of expensive medicines. At some point, I was convinced
This knowledge is still not available in popular textbooks and the majority of doctors today do not know about the central importance of the vitamin D hormone. So we began to administer vitamin D to patients suffering from neurodegenerative diseases. My first interest was in Parkinson's disease patients and I began treating them with vitamin D at physiologically realistic doses.
The daily dose recommended internationally today is a paltry dose, well below the physiological dose. The physiological dose, as has been recently demonstrated, is a minimum of 7,000 daily units for adults with a normal body mass index, the same amount that the body can produce in just 10 to 20 minutes of exposure to the sun, depending on the level of exposure Body surface, the body position (lying or standing), the pigmentation of the skin, age and the position of the sun. Incidentally, sunscreens block the body's ability to produce vitamin D and should not be used until enough vitamin D has been produced.
So 10,000 IU is a physiological dose, not a super dose. But most doctors still consider this dose to be potentially toxic. Today, the recommended dose is still 600 international units - although this figure is proven to be the result of a miscalculation! 600 international units are recommended, but if a person is exposed to the sun for only 20 minutes, he / she can easily produce 10,000 units! This is a clear discrepancy between medical practice and the current state of scientific knowledge.
Yes, so we started giving 10,000 units in neurodegenerative diseases. One day a patient with Parkinson's came for his second visit, after 3 months of daily intake of 10,000 IU, and this patient had a vitiligo lesion on his face, which had decreased significantly in the few months of administration of 10,000 IU. This led me to look in the medical literature for information regarding the effects of vitamin D on the immune system. I was surprised by the enormous amount of publications that were already available in 2001-2002.
Impressed with this first result, I started giving the 10,000 units of vitamin D to patients with multiple sclerosis. MS is a very common autoimmune disease in neurology, with very devastating effects. This first daily dose was also given in other autoimmune diseases such as psoriasis, lupus, rheumatoid arthritis. We were amazed to see how much better these patients were, even though they did not get completely symptom free. But that was the starting point: the recognition of the great value of vitamin D in the treatment of autoimmune diseases.
Vitamin D is the largest regulator of the immune system and modifies the function of thousands of genes in every cell of the immune system. It is a substance for which there is no comparable second.
I will make a comparison to explain what I mean when I say that so many genes are regulated by vitamin D in their activity: Imagine a high-rise with many rooms. Imagine that thousands of doors in this skyscraper can only be opened or closed by a single key. You can compare this skyscraper with every cell of the immune system, and the key with vitamin D.
In the case of a vitamin D deficiency, the patient can no longer regulate the activity of thousands of biological functions within the cells of the immune system - ie stimulate or reduce them - a lack of this one substance thus results in a catastrophe for the immune system!
People with vitamin D deficiency are therefore susceptible to numerous autoimmune diseases such as multiple sclerosis, autoimmune polyneuropathy, Guillain-Barré syndrome, rheumatoid arthritis, psoriatic arthritis (and psoriasis itself), myasthenia gravis, polymyositis and systemic lupus erythematosus - just a few to call.
Vitamin is a modulator, an immunomodulatory substance that does not suppress the activity of the immune system in general but modulates it. And we know that vitamin D specifically suppresses the kind of immunological reaction that causes autoimmune diseases. It is called the "Th17 reaction". Virtually all autoimmune diseases are caused by such an abnormal reaction that is not normal, not physiological. Vitamin D, as far as I know, is the only substance that is able to selectively inhibit this particular response without affecting other immune responses. On the contrary: Vitamin D even enhances the ability of the immune system to attack viruses, bacteria and other microorganisms!
The Th17 response is caused by overproduction of an immune messenger or cytokine called "interleukin 17". The production of interleukin 17 is a natural phenomenon and is beneficial in controlled amounts. However, overproduction of interleukin 17 is not a natural phenomenon. And vitamin D regulates this interleukin-17 production. An autoimmune disease is thus the result of a dysregulation of the immune system, which produces an uncontrolled Th17 reaction. And vitamin D is just the substance needed to re-regulate the immune system.
Patients with autoimmune diseases have a genetically inherited resistance to the action of vitamin D. This resistance to the immunomodulatory effect of vitamin D is a partial resistance, not complete. Because of this resistance, these people are predisposed to develop autoimmune diseases.
The exact mechanism of this resistance is not yet clear. There are already several known diseases associated with various genetic mutations of the vitamin D receptor, which make these people resistant to vitamin D. Such resistance may also be due to a change in the enzymes responsible for the conversion and activation of vitamin D, the two hydroxylases. There are many different ways in which resistance can arise: a mutation of the first hydroxylase, the second hydroxylase, a change in the vitamin D receptor itself, or a genetic modification of the protein that binds and transports vitamin D.
This is not just a hypothesis, this is certain: polymorphic changes to one of the two vitamin D hydroxylases (especially 1-alpha hydroxylase) or the vitamin D receptor or to DBP (vitamin D binding protein) have been reported in several Studies related to autoimmune diseases identified and reported.
Not necessarily, but the impact of genetically modified vitamin D metabolism on multiple diseases - not just autoimmune diseases - has worsened in recent years, possibly due to the avoidance of sun exposure and the excessive use of sunscreen. This leads to a high prevalence of vitamin D deficiency, which has increased the prevalence of autoimmune diseases. For these people would need significantly more vitamin D instead of less and less.
And what determines what type of autoimmune disease a patient develops from this resistance?
There are several factors that may preferentially direct the autoimmune response to a particular tissue, organ, or system. One factor is the inherited functions of the immune system, such as the histocompatibility system, the so-called "HLA genotype". Another factor can be infectious diseases that challenge the immune system in various ways.
Some people have this genetic predisposition to autoimmune diseases but have not yet developed autoimmunity. We believe that something else in addition to this genetic predisposition is necessary to trigger these diseases. The most common, I would even say, probably ubiquitous triggering factor - at least in relapsing remitting MS, since we have found almost no exceptions among thousands of patients with autoimmune diseases - is a stressful life event or a prolonged stressful time. This seems to be very similar in most autoimmune diseases.
I am firmly convinced that the increase in the prevalence of autoimmune diseases mainly depends on three factors: First, the inherited, partial resistance to the biological effects of vitamin D. Second, a vitamin D deficiency, caused by poor exposure to the sun. And third, an emotional factor, a triggering factor that leads to an activation of autoimmune diseases in people who have the other two predisposing factors.
We do not rule out that other factors could also play a role in the process, but even though these factors should actually contribute to the development of autoimmune diseases, the role they play is likely to be secondary to the pathophysiological importance of vitamin D. ,
After their initial success, over the years they developed a fairly simple protocol to treat virtually all autoimmune diseases, with amazing results. How does this protocol work?
Basically, the treatment consists of only one element: Vitamin D. We need very high doses of Vitamin D to get complete control of the disease. The dose is not the same for all patients, but must be adjusted individually for each patient to the level of its resistance. We have developed a method to adjust the daily single doses for each patient using laboratory tests: The level of resistance can be determined by measuring the parathyroid hormone (PTH).
The inhibition of PTH expression in the parathyroid cells is one of the biological effects of vitamin D and a good marker because it is the final result after a long chain of biological processes - the two consecutive hydroxylations, the transport in serum by DBP and finally the VDR activation. So we measure the final effect at the end of this chain: lowering the level of parathyroid hormone. It's a way to measure resistance without knowing what the exact cause of this resistance is. It does not matter if the reason is this mutation, or that, or if there are multiple simultaneous reasons for the resistance to vitamin D.
When you administer vitamin D, vitamin D inhibits the production of parathyroid hormone. If I measure hormone levels before administering vitamin D and then again after two months of administering a constant daily dose of vitamin D, I can use the reduction in PTH levels as an indicator of the biological response to vitamin D. This is exactly the parameter we use for each individual case to adjust the vitamin D dose. After a first test, we give a daily dose that needs to be maintained for 2-3 months to measure the extent of PTH inhibition, which can tailor the daily dose.
The aim is to reach a serum PTH level near the lower limit of the normal range. We avoid complete suppression of PTH to avoid potentially toxic doses of vitamin D. It is not possible to completely suppress PTH because the patient is in danger of developing hypercalcaemia and thus kidney damage. Thus, PTH is also a safety parameter for us. If I do not suppress PTH, I can be sure I will not give toxic doses of Vitamin D. I can balance the dose on exactly the specific biological resistance to the effect of vitamin D that the individual has for genetic reasons.
Kidney stones - such as calcium oxalate - may still be present in some patients, as they may always be in a tendency to produce excessive oxalate, regardless of vitamin D therapy, but we have not seen any hypercalcaemia or hypercalciuria. That is one of the reasons why it is so important to maintain a minimum daily water intake of 2.5 liters during the protocol.
But PTH is strictly regulated by hormonal control circuits and is mainly dependent on the calcium level. And because of this regulation, there is no direct relationship between 25-OH-D and 1,25-D levels. Is not it too easy to use that as the only parameter?
In fact, the level of PTH drop in response to a test dose of vitamin D can only be used reliably to determine the individual's resistance to the biological effects of D, if all other variables that significantly affect PTH levels are under reasonable control. As you already said, calcium levels - and not vitamin D - are the most important factor in PTH synthesis. Simply because the primary function of PTH is the control of the calcium level. Therefore, a change in calcium level may overshadow or enhance the inhibitory effect of vitamin D on PTH synthesis, making it impossible to use the PTH changes to tailor the dose of vitamin D for a particular resistance. That is the reason,
Yes, but here too an exact measure is required. If they overdo it and are on a diet with too little calcium, the calcium in the blood will come close to the lower limit of the normal range, despite the high level of vitamin D. Thus, PTH increases despite the inhibitory effect of vitamin D and one then vitamin D can not be adjusted properly, because PTH levels are always high despite vitamin D.
On the other hand, patients who do not follow the recommended diet and consume large amounts of foods rich in bioavailable calcium also distort the procedure. Because when the calcium level approaches the upper limit of its normal range due to the increased uptake in the intestine, PTH is inhibited, so that vitamin D is no longer the main inhibitor of PTH. Under such circumstances, PTH would be low and would falsely indicate that an adequate dose of vitamin D has been achieved to suppress disease activity.
They are very different. Doses range from 30,000 to over 100,000 IU per day. We usually start with 1000 IU per kilogram body weight and then set the dose exactly according to the laboratory results.
These doses are considered toxic in conventional medicine ...
They are also toxic to people who have a normal response to vitamin D - but not to vitamin D resistance. It is also important to understand that the therapeutic use of vitamin D is very different from general prevention! The therapeutic use of vitamin D always requires the guidance and supervision of a physician with special training to analyze each individual case and to determine the right dose. Otherwise, serious damage to your health may occur. People who follow our protocol should follow a special low-calcium diet, with no dairy products and at least 2.5 liters of water a day. Also calcium in the urine and blood must be carefully monitored. These are measures to protect the kidneys. Apart from this,
We started by assuming that daily sun exposure is the natural supply for humans and therefore a good rule to follow in therapy. In addition, as we administer vitamin D to patients with impaired vitamin D metabolism, we have tried from the beginning to exclude all factors that could minimize the benefit. Thus, the administration of vitamin D on a daily basis seemed to us to be a good decision, since the change in blood concentrations in this way is low, possibly producing a more stable effect. Looking at current knowledge of the dynamics of vitamin D3 metabolism, we are convinced that monthly or yearly dosing would be totally inappropriate to control the activity of autoimmune diseases.
Vitamin D is liposoluble. Therefore, vitamin D is better absorbed and should have a better effect when mixed in a lipid carrier - so soft gels or oils.
So far you are primarily treating patients with MS. What is the success rate of the protocol in multiple sclerosis?
In about 95% of patients with MS, the disease remains under our protocol in permanent remission. While patients receive this high dose of vitamin D, the disease remains inactive, with no signs of new lesions - neither clinical nor laboratory. About 5% of patients achieve a partial result, which means that they have improvements but do not achieve complete remission of disease activity. We investigate the reasons why these 5% do not achieve complete response from MS. So far, we see five main points: The most important is a high level of stress. Emotional stress can seriously affect the outcome of this treatment. The other elements that affect the success of this therapy are smoking, frequent alcohol consumption, the habit of taking hot baths, and recurrent infections - usually the urinary tract. This is all but not specific to vitamin D, as these factors generally can accelerate the development of MS, even in patients undergoing traditional treatment.
Personally, I have already treated more than 1,600 MS patients and a similar number of patients with other autoimmune diseases. Five other physicians have been working under our supervision since 2013 in our clinic treating an even larger number of autoimmune disease patients. There are now several doctors worldwide that I have trained and who use our protocol, so the total number must be several thousand patients. One of them, a Portuguese doctor I trained a year ago (2015), recently told me that his clinic treated more than 400 patients from several European countries and Africa last year alone.
That's a lot of experience! They also treat many other autoimmune diseases such as psoriasis, vitiligo, Crohn's disease ... !!!!Are the results of the treatment equally good for all of these diseases?
Our protocol is a highly effective treatment for all autoimmune diseases we have treated so far. In all these diseases, we have achieved complete control of the disease with the same protocol.
The use of vitamin D in the treatment of autoimmune diseases is not directed to a particular disease, but to regulate the immune system. Under the action of vitamin D, the immune system increases the number of so-called "regulatory T-lymphocytes", which regulate the immune response. At the same time, the abnormal Th17 response - the mechanism of autoimmune disease in general - is selectively inhibited by vitamin D. These two things are extremely important for the control of any autoimmune disease.
So autoimmune diseases such as chronic inflammatory bowel disease, Crohn's disease and ulcerative colitis are all cases that we have treated and fully responded. The patient lives completely free of any manifestation and symptoms of the disease and leads a normal life. The same goes for psoriasis and vitiligo - again, we have a 95% success rate of complete symptom resolution.
It is a little different in neurological disorders. We have successfully treated isolated optic neuritis, Guillain-Barré syndrome (GBS), autoimmune polyneuropathy, and severe myasthenia, and again, in 95% of cases, we were able to achieve complete suppression of autoimmune activity. But unfortunately that does not mean that the older, long-lasting and irreversible damage caused by the immune system automatically disappears. Unfortunately, paraplegia that has been present for years in an MS patient or long-term joint deformity in a patient with rheumatoid arthritis can not be reversed. All other symptoms of disease activity such as inflammation, chronic fatigue, pain, swelling, redness, local heat, however, all recently acquired disabilities can be resolved. In general, all the damage that has formed up to one year before the start of treatment can almost completely regress with high doses of vitamin D.
!!!!How do you rate your results: Do you think autoimmune diseases can be "cured" or is it the only way to keep them in permanent remission?
We do not have an answer to this question. We are not talking about a "cure". Instead, we have optimized our protocol to the point of effectiveness and safety to achieve a complete remission in the largest number of patients without any side effects. Hypothetically, the immune system in some patients may eventually "forget" after several years of no relapses that it once had autoimmune aggression. Although this hypothesis may prove correct in some patients, several factors may influence the duration of treatment required, including the duration of disease activity prior to the initiation of high dose vitamin D therapy and the achievement of emotional stability.
We can not rule out the possibility that a large number of patients - perhaps most of them - will need to take high doses of vitamin D indefinitely to keep their disease on track for long-term remission. We assume that eventually we will be able to develop laboratory and clinical criteria for the selection of candidates for which a reduction in the daily dose of vitamin D is possible.
At the moment we are very happy and satisfied that we were able to achieve a complete remission of the disease and a regression of the last acquired disabilities. This is a great reward in itself. Patients have their lives back. A complete remission is a great success, considering how severe these diseases are.
We are able to prove in MS patients through several consecutive annual MRI scans that all recent lesions disappear under our protocol and no new lesions appear. Unless the patient has permanent pre-treatment disabilities, he returns to a normal life. However, the dose of vitamin D must be maintained and we recommend that the patient come for a follow-up visit after two years and then for a second visit after two to five years. We do not yet know how long the patient has to maintain this high dose of vitamin D and for the moment the treatment is for an indefinite period of time.
Apart from vitamin D, you give two cofactors: magnesium and vitamin B2. Can you explain why this is necessary?
All enzymes that convert and activate vitamin D are dependent on magnesium. Since magnesium deficiency is difficult to diagnose, we prophylactically give 100 mg of elemental magnesium to all patients four times a day.
The hydroxylases are also dependent on vitamin B2, not directly, but indirectly because the enzymes oxidize in the phase of vitamin D hydroxylation. Before it can convert another molecule, the enzyme has to be reduced back in a chemical process called reduction. And this reduction process requires the presence of vitamin B2. About 10-15% of the world's total population can not easily consume vitamin B2 due to a genetic change. This can contribute to vitamin D resistance because the hydroxylases do not work well in the absence of sufficient vitamin B2. Here we give high doses of riboflavin (50 mg 4 times a day) to compensate for the lack of absorption and to optimize the hydroxylation of vitamin D.
Both vitamin D deficiency and very high levels of vitamin D lead to increased bone degradation. In the case of vitamin D deficiency due to the resulting calcium deficiency, in the case of high vitamin D levels by stimulation of the osteoclasts, which dissolve the minerals out of the bones. We initially tried to counteract this bone loss by vitamin K2, but vitamin D was ineffective at these doses. Today we use daily exercise as a protective measure for the bones. For people who are not able to do this because of illness, we use biophosphonates. So far we have not been able to detect any side effects, but we are still looking for a natural alternative for biophosphonates.
There is currently no German doctor offering therapy according to this protocol, but we have thousands of patients in urgent need of help. Now detailed interviews for the protocol will be published online through this interview. How do you feel that some people now probably start the protocol on their own?
Periodic monitoring of laboratory parameters such as serum levels of PTH, creatinine and calcium and urine levels of calcium are required to tailor the daily doses of vitamin D. Periodic Dexa scans are required to prevent side effects on bone metabolism. Most people can not get these lab tests on their own and analyze the results correctly, so we do not recommend doing this protocol alone. A list of European doctors who have been trained in our clinic, is now available on the Internet - unfortunately, no German doctor is present.
Hopefully her interview will spark interest here. We offer all doctors and naturopaths that they can come to our clinic for five days and are trained in the protocol for free - they pay nothing for this training! (Contact: ccc.secretaria at gmail.com)
Science and practice of vitamin D therapy
For now, many healers may be hesitant, as no double-blind clinical trials (RCTs) have been performed with your protocol. Why is that the case?
A fundamental problem with RCTs with respect to our protocol is that the therapeutic efficacy of our protocol can not be tested this way. RCTs require the same daily dose of vitamin D to be given to all individuals in the experimental group, and the physician administering the substances must be blind to whether or not they are giving the patient a placebo or the test substance.
In our protocol, the supervising physician must individually calculate the daily dose of vitamin D from the laboratory data. The result is a variety of different daily doses, each tailored to the needs of each particular patient to compensate for his or her individual level of resistance to vitamin D. Thus, the caring physician can not be blind to what the patient is taking.
However, there is at least one RCT where Finnish researchers administered 20,000 IU of vitamin D per week. Unfortunately, this is less than 3,000 IU per day - much less than the minimum dose of 7,000 IU per day needed to correct any vitamin D deficiency or insufficiency in all people. Nevertheless, they showed a reduced number of active lesions after one year of treatment compared to the placebo group on MRI. (1)
This question is very important because doctors can not randomize metabolic diseases. We are obliged to correct them. If a person has been diagnosed with a metabolic disorder by a laboratory - for example, hypothyroidism, a lack of thyroid hormone that is potentially fatal, and causes severe harm if left unchecked - then I need to correct that. Another example is type 1 diabetes in children who can not produce insulin. Doctors are required to correct this deficit and have to administer insulin. Under such circumstances - if the patient has a metabolic problem, a deficiency or type of inherited resistance to a hormone or a vitamin - the doctor is ethically committed to intervene and correct it.
But when we talk about double-blind and randomized research, it means that I have a group of patients being treated with high doses of vitamin D, for example, and a group receiving a placebo who does not know either doctors or patients in this study, who gets the vitamin D and who gets the placebo.
Well, you could not do this kind of research with diabetic children. There has never been a randomized double-blind research that has proven that insulin is suitable for diabetic children! They were never made and they will never be made. The same goes for people with hyperthyroidism because we are forced to give treatment. There will never be a randomized, double-blind study where one group receives thyroid hormone and the other receives placebo. The same happens in the case of a lack of vitamin B12. A vitamin B12 deficiency can cause devastating neurological diseases that destroy the spinal cord, so you can not leave anyone with a B12 deficiency untreated, because that would be carelessness. So you can not just leave those people with treatable defects untreated. If I did a randomized, double-blind study, I would violate my duty to 50% of my patients. The placebo group would be the victim of a medical malpractice.
Yes, and this is a very important concept, because nowadays the medical community has been taught that all results published in the literature are negligible unless they are the result of a randomized double-blind study. This is a big mistake. Especially for nutrients and hormones. That's why we do not have double-blind randomized trials for our protocol, and we'll never let any patient under our care take part in it because it violates the two major principles in medicine that actually exist in all Western medical schools around the world Be taught world. The first principle is not to worsen the condition of the patient, not to act in such a way that the clinical condition deteriorates.
So, if I did not treat a patient with vitamin D deficiency or compensate for its vitamin D resistance - knowing that vitamin D is a great immunomodulator, probably the most potent immunomodulatory substance in all of nature - I violate my duty as a physician , Therefore, I will never conduct a randomized, double-blind study with vitamin D and placebo in individuals with autoimmune disease. Why? Because I would not do that with my daughter, not with my wife and therefore I will not do it with my patients!
Whenever a cause and effect relationship (such as vitamin D deficiency or resistance causes autoimmune disease), the cause must be eliminated or disease activity maintained.
We have thousands of documented cases that more than prove our concept. We have started to use vitamin D in autoimmune disease for the sake of the patient. Our goal was not research, was not to convince anyone, but simply followed the second principle of medical practice: to help the patient in an optimal way. Namely, if the patient has a deficiency of a powerful immune regulator, known and documented, we need to correct that deficiency. If he has resistance, we must increase the dose to compensate for this deficiency.
We have collected a lot of data, and we have experience with setting the dose for these patients. However, so far we have only been able to publish data on vitiligo and psoriasis, as these are the only diseases for which we have received research approval from the UNIFESP Ethics Committee (our university). (2) We would also like to have data published for other diseases, but unfortunately we did not get approval - for reasons we still do not understand. How can it be unethical to test a treatment that has such beneficial effects? We also could not understand how the ethical condition to correct a nutritional deficiency in a patient can not be given. I am unable to understand that
But even if we were not allowed to explore this too officially, that did not stop us from continuing to treat our patients for their interest, and we have gained a lot of experience and thousands of very well-documented cases. And we'll ask the ethics committee to evaluate these cases at least retrospectively - that's not research.
Because you need this permission for scientific publications: If I would like to submit a publication to a journal dealing with treating 2,500 patients with high doses of vitamin D, the journal will ask us for approval of the ethics committee - without this permission they will not publish anything. So now we have to apply to the ethics committee to approve at least a later revision of the medical records of these patients. With the approval of a revision of medical records, we could send an article to a medical journal. Let's hope that we will not have any problems this time.
On the one hand, this is understandable in order to prevent unethical research - in this case, it is unbelievable.
You also have to keep in mind that MS is a billion dollar market. The market for multiple sclerosis therapeutics is expected to reach around $ 17 billion by 2017 and $ 25 billion in 2024. And that's just one autoimmune disease! Vitamin D on the other hand is extremely cheap and not patentable.
In the background, the pharmaceutical industry is already testing tens of thousands of modified and therefore patentable chemical analogs of vitamin D under the pretext of developing a drug that would not cause the side effects of high doses of vitamin D such as hypercalcaemia. In fact, we could simply use high doses of Vitamin D, also without such side effects, by controlling the amount of calcium, diet, increased hydration and monitoring of PTH levels.
Due to the large amount of money involved in drug marketing, the dissemination of knowledge within the medical community is one of the most rigorously controlled systems of our time. There is a very good article entitled " Key opinion leaders: discrete experts or drug representatives in disguise? ". It was published in the British Medical Journal (BMJ) in 2008. (3) It is also interesting to read all the letters the editor has received from various doctors on this article - and I also recommend the video interview with Kimberly Elliot, who has worked for a pharmaceutical company for many years.
One of the most commonly used tools to control medical knowledge is the consistent dissemination of the false concept that only RCTs (especially multicenter RTCs) should be considered as "truly evidence-based medicine". Especially when deciding how best to treat patients. Interestingly, most, if not all, of these multicenter RTCs can only be implemented if financially supported by pharmaceutical companies. The concept is fundamentally wrong. An open-label study, where both the researchers and the subjects know which treatment is given, is just as valid,
Yes, this topic has been discussed for some time, for example by Paul Glasziou and colleagues from Oxford University in their article entitled "When are randomized trials unnecessary?" Picking signal from noise ", published in the BMJ in 2007. (4) In this, the authors provided a list of examples of therapies that have been included in the medical practice without RCTs, precisely because of the dramatic difference that can be seen with these therapies. For example, insulin in diabetes and sulphanilimide for puerperal sepsis.
Actually, it's the other way around: if the difference is dramatic, RCTs become unethical!
Another misconception is that once the therapeutic value of a substance has been confirmed by RCTs from several independent research groups, it would automatically be integrated into clinical practice. In fact, it probably will not, if the therapeutic agent is too cheap and has the potential to drive out expensive drugs from the market. An example is the use of high doses of riboflavin (vitamin B2) for the prevention of migraine: effective, inexpensive and without side effects. Yet almost never prescribed.
One last question. They work therapeutically with very high doses. But what doses do you recommend for prevention in healthy adults?
For healthy people, we do not recommend high-dose vitamin D, but only normal doses of up to 10,000 IU per day. This is a completely safe dose because you can get that amount easily from sun exposure. Children can receive up to 200 IU per kilogram of body weight per day.
Thank you for this fascinating interview!
- Soilu-Hänninen M, Aivo J, Lindström BM, Elovaara I, Sumelahti ML, Färkkilä M, Tienari P, Atula S, Sarasoja T, Herrala L, Keskinarkaus I, Kruger J, Kallio T, Rocca MA, Filippi M. A randomized, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon ß-1b in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 May; 83 (5): 565-71.
- Finamor, DC, Sinigaglia-Coimbra, R., Neves, LC, Gutierrez, M., Silva, JJ, Torres, LD, ... & Lopes, AC (2013). A pilot study evaluating the effect of prolonged administration of high daily doses of vitamin D on the clinical course of vitiligo and psoriasis. Dermato-endocrinology, 5 (1), 222-234.
- Moynihan, R. (2008). Key opinion leaders: independent experts or drug representatives in disguise? | NOVA. The University of Newcastle Digital Repository.
- Glasziou, P., Chalmers, I., Rawlins, M., & McCulloch, P. (2007). When are randomized trials unnecessary? Picking signal from noise. BMJ: British Medical Journal, 334 (7589), 349.