Here is My Question:
I understand that a recent study suggests benefits from taking 300 mg of Biotin daily for individuals diagnosed with progressive forms of MS. What are your thoughts on the study? If so, do you have a preferred brand or compounding pharmacy?
French researcher’s did recently report preliminary phase III study results of a randomized, placebo controlled study of very high dose Biotin (labeled MD1003 this compound contains 300 mg Biotin per day) in people with secondary and primary progressive MS. The Biotin for this study is only made by the company that is funding this research for the purpose of obtaining regulatory approval for the treatment of people with progressive MS. The study results require confirmation but are quite hopeful.
Biotin is a B complex vitamin (vitamin H) that we normally receive from various food sources and require for carboxylase reactions involved in normal energy metabolism and myelination. It usually comes in microgram (not milligram) quantity supplements (the max size I found online was 10 mg or 10,000 micrograms), so we have little knowledge of the effect of 300 mg doses in either humans or animals.
In the French study, 154 patients were randomized to treatment with MD1003 (103 patients) or placebo (51 patients) for one year. All patients were required to demonstrate objective worsening on neurological exam in the prior 2 years and have an EDSS between 4.5 and 7. The study endpoint was the proportion of patients showing improvement on either the EDSS or the 25 foot walking time. 12.62 % of the patients randomized to MD1003 improved by the required amount by month 9 with sustained improvement continuing at the month 12 visit, whereas none of the placebo patients improved. Improvement began as early as 3 months after starting MD1003. Interestingly, MRI activity may have been high in the MD1003 group during the study although this did not reach statistical significance. Generally the MD1003 was well tolerated but does interfere with thyroid function testing, creating false positive test results in some people.
The authors warn about trying to start on high dose Biotin supplements before the company completes their regulatory studies. This warning is well founded for several reasons: 1) there is no current supplement of Biotin at this dose, 2) we know little about short term safety except from this study and nothing about long term safety, 3) the authors warn about use in pregnancy but give no reason at present for this concern
Stay tuned for more information.
Revere (Rip) Kinkel MD
Director of the Multiple Sclerosis Program
Professor of Clinical Neurosciences
University of California San Diego
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