Read below to find out why they have not used it with MS. At the moment many practitioners may be hesitant, as no clinical RCTs with your protocol have been conducted – why is that the case?
This question is very important because physicians can't randomize metabolic alterations that cause disease: they are obliged to correct them. If there's one person who has a metabolic disorder diagnosed through laboratory - for example a person with hypothyroidism: a deficiency in thyroid hormones that is potentially lethal and can cause damages to someone's health, if it is not adjusted. I have to correct it. Another example is that of type 1 diabetes, in children that can't produce insulin. Physicians are obliged to correct this deficit and have to administer insulin. So, in those circumstances, when the patient has a metabolic problem, a deficiency, a sort of resistance inherited, in relation to a hormone or a vitamin, the caring physician is ethically obliged to intervene to adjust it. Doing otherwise could be regarded as negligence. So, if you are talking of a double-blind and randomized research, you are teling me that I will have one group of patients that will treat for example with high doses of vitamin D and a group of patients who will receive placebo; and both doctors and patients involved in this research don't know who are the patients receiving vitamin D and who are receiving placebo. Well, one couldn't do this kind of research with diabetic children, for example. We have never done a randomized double-blind research to know if insulin is suitable for diabetic children!
We have never done and will never do. The same happens with people with hyperthyroidism, since we are forced to give a treatment. A randomized double-blind study will never be done, where a group receives thyroid hormones and the other receives placebo. The same happens in case of a deficiency of vitamin B12. A vitamin B12 deficiency can cause a devastating neurologic disease destroying the spinal cord, so you can't leave a person that suffers from a deficiency of vitamin B12 without treatment, because that would be negligence. You can't leave a person that suffers of pellagra, with a deficiency of niacin (vitamin B3) without treatment, because this can cause diarrhea, dermatitis and even death. So, you can't leave these persons with treatable deficiencies. If I make a randomized double-blind study, I will be negligent with 50% of my patients. The placebo group will be victim of medical negligence. This is a very important concept because nowadays the medical community has been taught that all the results published in the literature are not to be considered if they aren't the result of a randomized double-blind study. This is a big mistake. Especially for nutrients and hormones. So we don't have any randomized double-blind study and we will never do one with any of the patients under our care because of the two great basic principles in medicine, that are taught in all western medical schools around the world. The first principle says not to worsen the state, not to hurt, not to act on your patient in such a way that worsens his clinical state. And the second principle says that the patient has to receive all the possible benefits. Then, if I left a patient with uncorrected vitamin D deficiency (or uncompensated vitamin D resistance) – although aware that vitamin D is a great immunomodulator, probably the most powerful immunomodulator substance existing in nature - a patient with an autoimmune disease who has an unregulated immune system producing aberrant TH17-immunological reaction, if I leave this patient with deficient levels of the only substance that, selectively and powerfully, is able to inhibit this TH17 reaction and induce the proliferation of regulatory lymphocytes, I will be negligent toward this person. So, I will never do a randomized double-blind study using vitamin D and placebo with persons having autoimmune disease. Why? Because I wouldn’t do this sort of things with my daughter, my wife and I won't do it with my patients. Whenever there is a cause-effect relationship (like vitamin D deficiency or resistance causing autoimmune diseases), the cause has to be removed, or disease activity would be sustained. We have thousands of documented cases that more than demonstrate our concept. A fundamental issue regarding RCTs is that the therapeutic efficiency of our protocol cannot be tested that way. RCTs require giving the same daily dose of vitamin D to all individuals involved in the experimental group, and the research physician who is supposed to administer the substances has to be blind to what he is giving each patient (placebo or testing substance). In our protocol the caring physician has to calculate (from laboratory data) the daily dose of vitamin D to be given. The result is a wide range of daily doses, each one tailored to the needs of each specific patient as to compensate for his / her individual needs (his / her specific level of resistance to vitamin D). So the caring physician cannot be blind to what the patient is taking. Another fundamental issue is that there is at least one RCT available where Finish researchers have used 20,000 IU of vitamin D weekly. That is equivalent to less than 3,000 IU per day – much less than the minimal dose of 7,000 IU per day, which is now recognized to be the minimal dose to correct vitamin D deficiency or insufficiency. Nevertheless, they have shown a reduced number of active lesions on the MRI after one year of treatment compared to the placebo group.
We started using vitamin D to treat autoimmune disease for the patients’ sake. Our objective wasn't the research, wasn't to convince anyone but was simply satisfying the second principle of the medical practice: to benefit the patient in the most optimal way. Namely, if the patient has a deficiency of a powerful immunoregulator, known and documented, we have to correct this deficiency. If he has a resistance, we have to increase the dose in such a way that this deficiency is compensated. We have gathered a lot of data during this period, and we got experience with the adjustment of the dose for these patients. We have published preliminary data about vitiligo and psoriasis, as these are the only diseases that we were able to get an approval by the ethical-medical committee of the UNIFESP (our university) to do any research on. We would like it done also for other diseases, but, unfortunately we do not get approval for reasons that many times we don't understand – how can it be unethical to find a treatment that could benefit, in the same way we don't understand how the ethical condition to correct a nutrient-deficiency in a patient could be denied. I am not able to understand this, however the answer has been negative for many diseases. But even if we are not allowed to research, this hasn't stopped us from continuing to treat our patients according to their interest and we have accumulated great experience and thousands of very well documented cases. And when we will have the possibility, we will solicit an ethical committee to allow us to evaluate these cases retrospectively. Because you need this approval for scientific publications: If I want to submit a publication to a journal with 2,500 patients treated with high doses of vitamin D, the journal editor will ask us for the approval of the ethical committee - otherwise they will not be able to publish. So first we have to request the ethical committee to approve a revision of the medical records of these patients. With the revision of the medical records we could send the material to a medical journal. Let's hope we don't get problems.
Dr. Cicero Coimbra, MD, PhD (excerpt from German interview)