Saturday, 25 April 2015

AAN 2015: my take on the biotin the story

Is biotin a symptomatic therapy? #AAN2015 #MSBlog #MSResearch

"One of the MS highlights of the AAN 2015 meeting was the high-dose Biotin results in progressive MS trial. The following data sketch on the proportion of MSers in the trial with EDSS improvement confirmed at 2 study visits, sums up the results of the trial."


"The change in EDSS appears to occur very early in the course of the treatment, i.e. within the first 3 months. This strongly suggests that this is a symptomatic response and not a disease-modifying response. In addition, the changes are being driven by a very small number of responders (~10%), which means the majority of MSers in the trial did not have a confirmed improvement in disability as measure with the EDSS. The putative mode of action of Biotin is that it stimulates a large number of enzymes that increase the production of ATP or axonal energy. This local energy boost is what is hypothesised to overcome the energy deficits in vulnerable axons and presumably restore axonal conduction."
"The one proviso is that the early treatment response could be due to remyelination; from a biological perspective remyelination could occur early within the first 3 months of treatment. To sort this out the company will need to do a controlled withdrawal to see if the gains are reversible. If the gains persist (irreversible) it would support remyelination, however, if the gains are lost (reversible) it would suggest it is via an energy mechanism and hence a symptomatic therapy."

"I had informal talks with several pharma representatives at the meeting and it appears that several Big Pharma companies are doing due diligence on the product. If I worked for a Pharma company I would strongly recommend more work is done to sort out the symptomatic vs. remyelination issue. This could be done in animal models, for example Mouse Doc's chronic EAE model, in MSers using metabolic imaging (NMR spectroscopy, PET, SPECT), biomarkers (CSF studies), detailed conductions studies (evoked potentials and central motor conduction times) and a controlled withdrawal study in responders. Why is this important? The pricing model for symptomatic vs. disease-modifying therapies is very different; essentially symptomatic therapies are relatively cheap compared to disease-modifying therapies that are very expensive. A big pharma company will pay an order of magnitude more for the license of a putative disease-modifying therapy compared to a symptomatic therapy."

"On balance I think these results have been over-hyped by the media, and social media. The results are positive, but only weakly so, and it looks as if only a minority of MSers will be responders. The question about putative disease-modification remains open. Sorry to disappoint, but I don't want to set unrealistic expectations. I would, however, like to congratulate the academic team who have taken this product this far. Academic drug development is very, very difficult; well done. This study also places energy and metabolism centre stage when it comes to progressive MS."


OBJECTIVE: To evaluate the efficacy of Biotin 300 mg/day over placebo in patients with progressive multiple sclerosis (PMS).

BACKGROUND: Biotin is a water-soluble vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially key-enzyme in myelin synthesis. In one previous open-label pilot study involving 23 patients, it was found that high doses of biotin (100 to 600 mg/day) resulted in progressive and sustained improvement of disability in primary and secondary PMS patients.

DESIGN/METHODS: This is a randomized, double-blind, multicenter, placebo-controlled (2:1) trial of oral biotin 300 mg / day in patients with secondary or primary PMS with EDSS between 4.5 and 7 and evidence of EDSS progression within the past two years. Treatment duration was 48 weeks. The primary endpoint was the proportion of patients who improved at M9 and confirmed at M12, defined as decreased EDSS (by at least 1 point for EDSS ≤5.5 and .5 point for EDSS ≥6) or improved TW25 of at least 20%. Other endpoints included MSWS, CGI, % patients with stable or worsened EDSS, SF36, FIS, 9HPT.

RESULTS: The last patient is scheduled to complete the study January 2015. Baseline characteristics: 154 subjects from 16 sites across France were randomized; mean age 51.4; mean disease duration 16.6 years; 41% had PPMS and 59% had SPMS. The mean EDSS score was 6.1. The database will be locked by March 2015. Detailed results from primary and other outcomes will be presented.

CONCLUSIONS: This trial will evaluate the efficacy of Biotin 300 mg/d in a randomized, placebo-controlled trial. Effects of treatment with high doses of biotin in patients with PMS will be discussed in the context of future development of high doses of biotin as a novel potential treatment in PMS. 

84 comments:

  1. Thank you! Somewhat disappointing - but accurate information is always better than unrealistic expectations.

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  2. It was finding it "too early" to create expectations, even more important studies ... I find it very interesting not only are now looking to remyelination but also to the issue of energy and metabolism when speaking in progressive forms of MS .. . If I'm wrong please correct me but it seems that finally are listening to the "cry" of "Look at me" given by mitochondria Um ... and maybe could to become a future approach for the treatment of fatigue in MS?

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    1. I thin there are plenty of people looking at mitochondria and have been doing for some time

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  3. In the recent paper describing the results of Phase 2 trial (with some 20 patients), the authors reported worsening upon biotin termination, and improvements when the treatment was resumed. Symptomatic treatment?

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    1. Re: "...reported worsening upon biotin termination, and improvements when the treatment was resumed. Symptomatic treatment?"

      Yes, but this needs to confirmed in a blinded study. I would recommend taking say 50-60 responders and randomising them to blinded withdrawal (placebo or continuing on biotin) to answer this question.

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  4. Sounds good to me! just sounds like a very negative review to me! what evidence have you got that this is energy. So far this by far the most promising drug in pms I hope and pray yo god your wrong and this is a dmd.

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    1. It is a honest review, without seeing the data it didn't sound like a DMD, which we would expect it to sound like. When the paper is public

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  5. What was reported about side effects (or the lack thereof)?

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  6. Thank you for your comments, Dr. G. It is very much appreciated. First, I'd say that media is not solely responsible for "over-hype". Culpability rests with Medday, and AAN for scheduling this for the plenary session. One can arguably expect it from Medday as it is big pharma and so typically engages in puffery like a car salesman. AAN, however, should know better. That aside, can you comment further on the finding that 67% of participants of study had halt of disease progression? I suspect that is what you are aluding to when you stated that the DMT issue is still open. Thank you.

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    1. 67% is misleading - you need to understand that there were 4% worse off, I believe, and 11% not so the difference between 11 and 4 is 67% - it's typical stats speak - it seems huge if you don't read the text closely but is not significant.

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    2. It is not 67% it was the relative risk change between 4% and 13% of people progressing. The study was always too short to be measuring effects on progression. Before adding they need to work out what it is doing to find how to enrich such that the 10% who benefit become more. It is a start

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  7. first thank you prof G for the summary.

    second, bear in mind you all that a few months back we were getting only negative results for progressive ms in a few of the fat cat trials and now we have a cheap enzyme which seems to be midly positive!

    also, it's very important to see that there was no serious side-effects because you can be sure that many MSers will just buy it off the counter unless there is a proven drug which stop progression for good.

    yes, the results were over-hyped but not as much as was the case with many other pre-eliminary results in mice which we get every day as the new wonder drug.

    also, it is very reassuring to see how fast the guys were delievering results - and there is the on-going trial to deliver at the end of THIS year not in 100 years time.

    So my verdict - cheapeau!

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    1. Good point - these are results in HUMANS, not macaques, rodents, clams, geraniums or some other species.

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  8. Oh well
    It's not as if it's people's lives they are messing with? And people are sceptical about hsct !

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    1. I think people just need to learn not to count chickens before hatching - or in German, the saying "freu' dich nicht zu früh" would be applicable. Common sense is international. But the results are still very, very interesting, with the possibiity of it being a remyelination agent still standing. I personally will be taking a modest biotin supplement in the meantime given the remarkable effect that it has on my fatigue. And, in contrast to HSCT, it doesn't seem to be potentially lethal.

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    2. Exactly, that is my plan as well - Q10 and Biotin in low doses. And even modest gains in progression halt with this enzyme is better for me than dangerous drugs or some risky treatments.

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    3. Anyone noticed any benefit of coq10

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    4. (I'm Anon 10:42) I found no benefit from coenzyme Q10 at all. Biotin, on the other hand, at a low dose, seems to work wonders for me. But this is just one person's experience and it doesn't necessarily mean much. We need robust trials of these things, more studies to help address the massively detrimental impact that MS fatigue has.

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    5. As a person on Tysabri, I wonder if there is any contraindication with taking even low dose of Biotin? Any insight would be most welcome.

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    6. I started taking Tysabri 5 months ago. Evidently there is no contradictions between the two. My Neurologist actually told me of the Biotin XR 300 taken daily along with VIT D2 1.25 MG (50,000 UNIT) taken once a week. Both of these drugs, according to her are helping people with MS. She wrote me out a prescription for both last week. When I went to CVS I found out that both drugs are considered over the counter drugs. The Vitamin D was fairly cheap (less that $10.00) but the Biotin XR 300 has to be compounded and there is only one place in my area that can do that. I called them and was told the price was $250.00 for a 90 day supply, which is not covered by Insurance. I am now checking into what is the difference between this compound and Biotin that you can purchase at a local pharmacy. I can't afford $250.00 for a 90 day supply.

      If anyone knows anything about this, please let me know

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    7. If you cruise the various MS forums and blogs etc, many PwMS who are self treating with Biotin are simply buying the highest strength they can (up to 10mg caps are available) from some of the larger online vitamin suppliers/manufacturers. Some of those who post on the forums do acknowledge that what they are buying may not be quite the same grade as that used in the trial/s but it is still approved for human consumption. I have also seen some who have bought pharmaceutical grade biotin in bulk from wholesalers to try and reduce the costs. Whichever way you decide to go it is not going to be cheap as chips!

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  9. What about gnbac1 any news on this or your charcot project?

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  10. If 67% of patients in the trial did not progress, then I would happily take it ( is there anything better for progressive MSers)? Not as far as I know...

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    1. I follow a lot of LDN forums and facebook pages. Low Dose Naltrexone is one of the things being hailed as great along with the Biotin for MS.

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  11. I thought that benefits took 6+ months in the pilot trial?

    If biotin is a simply a safe anti-fatigue remedy, this is already a huge benefit. My neurologist had nothing to suggest for this terrible, unpredictable, debilitating systemic fatigue (a term I use to distinguish from fatigue of specific muscles from use). After taking just circa 1000 micrograms of d-biotin, I feel so much better.

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    1. I agreee a positive. 1mg works (i am happy) but maybe a placebo effect. Wwithout a trial it is hard to say

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    2. Yes, okay, I concede that it might be placebo. But then again, I had no more faith in biotin doing something for fatigue than many other things I've tried, and nothing has had the effect on me that this small dose of biotin has had. But, I know - the subconscious mind is incredibly complex and more "devious" than we consciously realise. For instance, maybe coenzyme Q10 didn't work on me as it is so expensive and so I didn't really want it to!

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    3. I'm taking 1mg of d-biotin a day. I am already taking Tecfidera for my RRMS so will see how it goes with the biotin. I feel I have progressive RRMS.

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    4. I've personally been taking 300mg of D-Biotin in tablet form of uncertain quality since April 1st. for a month, and then 300mg of USP grade D-Biotin powder since the beginning of May 2015. I am not expecting anything major for a few more months, because the mechanism seems to be fundamentally metabolic with Myelin rebuilding, ATP restoration, Mitochondria and Carboxylation pathways as key targets.
      In my opinion, this is 'One' of the most promising and viable options presented to us as pwMS (I am SPMS dx 2003) and I forever faithfully believe that just because an answer to MS hasn't been fully realised with a 100% success rate, it could always be the next one that is 'Hyped up' which is a breakthrough (at least in part) because I don't believe that MS is entirely of only one cause (this or that), but of several (these & those), so a cautious joyful acceptance of this realisation that Biotin, and in fact probably all of the B Vitamins & intestinal bacteria are involved in our dilemma, and not the blind view that DMD's & other potent drugs are the only option.

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  12. Just trying to put things into some perspective:
    From Avonex trials in RRMS:
    "People taking Avonex were 37% less likely to have increased physical disability at 2 years".
    going into the studies:
    35% patients progressed in the placebo group
    22% progressed in the Avonex group
    Absolute reduction is only 13%, but relative reduction 37%. This is how pharma sold us interferons for years ( when there wasn't anything better).

    So Biotin trial gives something like 4% of patients progressing in the Biotin group versus 13% in the placebo group - which gives absolute reduction of 9%, relative reduction of 67%.

    Dear prof G., I would not downplay it, it seems to me that Biotin is worth the trouble.

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    1. I think the first line injectables were approved based on reduction in relapse rate over placebo which is around 30%. They were not approved based an their effect on progression.

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    2. I like your perspective; partly because it is a fair point and partly because I, like so many others, are desparate for some concrete good news on the spms front.

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    3. End point for RRMS drugs is gad enhancing lesion reduction over 2 year period. Controling inflammation is presumed to delay disability progression.

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    4. The efficacy of interferons for relapses is also calculated and quoted as a relative risk reduction in %. For Betaseron: 0.29 yearly relapses in treatment group, 0.47 in placebo group. That gives absolute change of 0.18 fewer relapses per year on interferon compared to placebo. That would give like 1 less relapse on interferon every 5 years in a treated patient compared to placebo.
      But it sounds better when given as a percentage... 35-40 % reduction in annualized relapse rate quoted for most interferon studies.

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  13. Maybe we now need a combination therapy trial - biotin + simvastatin + sodium channel blocker (?oxcarbazepine) over 2 years. Then work backwards from there, removing components with further trials.

    I'm being a bit facetious here, and perhaps there could be interactions that decrease the activity of one or more of the drugs, but it would be interesting to see how the combination would fare when progression, atrophy etc were measured.

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  14. Prof G - would you care to give us your top 5 from AAN? Given so many results in the past weeks, some good & som bad I can't see the forest for the trees.

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    1. No. 1 the work of TeamG and UCLP.... easy peasy lemon squeezy

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  15. Biotin is a cheap, over-the-counter supplement. MSers take vit D supplements without data showing benefit. Might as well give biotin a chance.

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  16. l have had PPMS for 33yrs. Never been offered any treatment for it. l have taken LDN for the last 7yrs -with many benefits and now l am taking a high dose of Biotin. Straightaway l noticed more energy - and l am hoping to increase the amount. The Biotin l have bought contains calcium - so l am wary of how that will effect me in higher doses. So l am taking Vitamin K - which is supposed to help. Until l can source a pure Biotin powder l will stay at the amount l am taking now which is 10 x 10.000mcg. daily with food - otherwise it can make you feel nauseous. Many of us with PPMS have joined a facebook group Biotin for Progressive MS. All like minded people who feel that this is a chance to do something to help their condition. What have we got to lose.

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    1. Hi Frances
      How do you feel ldn has benefited?

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    2. I am finding just a modest dose of d-biotin beneficial (1mg per day) for fatigue, but I don't think the scientific evidence presented so far is enough to merit taking massive doses of over-the-counter biotin. I have PPMS, but the way I see things is that I have _everything_ to lose. I don't want to take high doses of something when it may - at best - do no good. Science will find the answer; no amount of wishing and willing will make a remedy which doesn't work effective.

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  17. Please note that OTC (over-the-counter) biotin is not the same as the high-dose, ultrapure, MD1003 formulation. Representatives of the company, developing the drug, have informed me that most OTC vitamin preparations have very little bioactive biotin in them. This is why I would not recommend using OTC formulations unless they are tested and certified to have bioactive biotin in them.

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    1. Doing some Googling, the best guess of what MedDay mean by 'bioactive biotin' is d-biotin, one of 8 stereoisomers of Biotin, and the only one to be biologically active (https://books.google.co.uk/books?id=iX3Bm85KQVAC&pg=PA105)

      It seems to me that the question is therefore whether a given OTC formulation contain d-biotin or other isomers too.

      From further Googling, some of the OTC suppliers/manufacturers claim that their product is d-biotin:
      http://www.privatelabelnutra.com/biotin-10000-mcg-p-832.html
      http://www.swansonvitamins.com/swanson-premium-biotin-5-mg-100-caps
      http://www.toxinless.com/biotin

      Though the nutraceutical industry has a history of not being accurate in their labelling (http://gizmodo.com/most-store-brand-herbal-supplements-dont-even-contain-t-1683515706) and without analysis I wouldn't be sure that they contain the stated amount of d-biotin.

      On the other hand ... it seems to me that risk/reward is very much in favour of giving the OTC a go - while reward may be uncertain, the downsides - the cost and risk of side-effects - are very low.

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    2. I don't think stereochemistry is the major issue in biotin supplements - after all, I would not worry about D-aminoacid content in any biological supplements which are supposed to contain L-aminoacids; biosynthesis is stereospecific in most cases. However, the actual total biotin content may be lower than claimed

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  18. Company representatives will always claim their product is better ( they get paid for it after all), but the truth is that in every market, even in biologics, there are good copies. We use Remsima in the clinic now ( that is what the hospital purchases) at a fraction of the original cost of Remicade, with the same effect. Pharma reps are not happy, but we are not here to keep pharma reps happy, are we?
    I would not buy "biotin" on the internet, though.

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    1. D-Biotin is roughly $28USD/100 mg which is not a trivial amount since the study was 100-300 mg q.d.

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  19. There's ALOT of olaces who have sold out of biotin
    Oddering d biotin in the UK costs around £12 for 50 10,000mcg tables so 100mg would cost £2.40 a day I think? A Big Mac? If it works it'll be worth it

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  20. MouseDoc - I've got a question about a drug I have been treated with in the past - I have read it's an old kind of a sodium AND calium blocker (C13H20N2O2) called procain.

    Can you tell me something about its mode of action in the body? Is it combarable to phynotein?

    I'm asking because during treatment I was completely relapse free and well - in fact, it was the only time I felt so.

    Having read about the renaissance of sodium blockers I am thinking of giving it a second go.

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    1. I know there's procaine in a supplement called gh7 which some people take for Ms
      Not sure how or if it works

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    2. What I am interested in is if procaine actually is able to cross the BBB or not -

      the treatment was procaine injections I had and was expensive and I wouldn't like to spend so much money only to find out that it blocks sodium channels all over my body except the brain.

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    3. MD2 - can you help me with this one? I did search on the net but I can't find anything about procaine?

      I don't have the background to understand if they mean neuronal sodium channels or others that they block.

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    4. http://en.wikipedia.org/wiki/Procaine
      This is also known as Novocaine....an anasethetic then there is lidocaine. This is a Nav1.8 sodium channel blocker, there are many different sodium channels and they occur in many different states so this is complex . The ones in MS of more interest are Nav1.6 and Nav1.2, so procaine will be different from phenytonin. However the waxman group have just had some interesting stuff published on nav1.8 and symptom control. This channel is not normally expressed in the brain and spinal cord but is found in dorsal root ganglia which is where peherial nerve cell bodies are found. In MS Nav1.8 gets up regulated in the cerebellum where it may cause movement problems

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    5. " In MS Nav1.8 gets up regulated in the cerebellum where it may cause movement problems" - does that mean that getting procaine injections they would down regulated sodium channels in the cerebellum and thus improving MS symptoms?

      what about inflammation? could they stop inflammation in the brain? they seemed to have done that to me....

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    6. Possible but there is no evidence and as to anti inflammation there is no evidence that I flammatory cells in ms express nav1.8 so I doubt it

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    7. Possible but there is no evidence and as to anti inflammation there is no evidence that I flammatory cells in ms express nav1.8 so I doubt it

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    8. Thank you very much all for your explanations and time.

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  21. I started taking D biotin at 300mg from august 2014 honest improvements I have never felt before

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    1. Was it easy to get that amount?

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  22. No super expensive that's why medday are on to a winner.

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    1. 2,100 euros per 28 days approx? On page 6.
      http://www.hsc.nihr.ac.uk/files/downloads/2529/2765.4c3b2cf1.Biotin_disabilityassociatedwithMSrelapses_Mar15.pdf

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    2. Here's the link to the PDF for the briefing of the primary and secondary progressive biotin trial.
      http://www.hsc.nihr.ac.uk/files/downloads/2528/2764.3b2370da.Biotin_primaryandsecondaryprogressiveMS_Mar15.pdf
      The link in the comment above is for the relapsing MS biotin trial.



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  23. I have spoken to a few colleagues of mine who are chemists and scientific researchers and they have read all all the papers on md1003 and they have told me that over all looks promising. And could well be remylation.

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    1. Or a symptom modifier. It is promising but we mustn't get too carried away yet.

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    2. MD2 - in my book even as symptomatic drug that would be hot stuff to have for progressive MS to boost one's energy.

      I mean, given my fatigue, that would be 100 times better than nothing, it's cheap and has no dangerous side-effects.

      IF they were to find out by the end of this year that on top of that it still remyelinates then it's a veritable miracle

      (hopefully one of many to come!).

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    3. I'm with you there, I hope it's as good as suggested.

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    4. "Read all the papers on MSD1003". There only is one?

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  24. It'll be the optic neuritis trial that will tell us whether its a remyelination product surely?
    And haven't there been studies done already showing visual acuity improvements?

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  25. The report has to be bought ($2800 US) - Can you get the report and summarize it for us? Perhaps we could crowdsource the purchase for you

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    1. No it is not worth spending $2800 is is a business report of no therapeutic value

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  26. I agree:) what do you think MD2?

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  27. fyi

    MD 1003 Clinical Trials underway

    MD 1003 - Optic neuritis study - PIII - start date Oct 2013 - end date approx June 2015 - n = 105
    https://clinicaltrials.gov/ct2/show/record/NCT02220244?term=md+1003&rank=2

    Effect of MD1003 in Spinal Progressive Multiple Sclerosis (MS-SPI) - PIII - start date Oct 2013 - end date Jan 2016 - n=144
    https://clinicaltrials.gov/ct2/show/NCT02220933?term=md+1003&rank=1

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  28. The Ms spi trial is the one they reported on

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  29. Team G, What about a trial of combined treatment of high dose biotin and vitamin B1 for MS?

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    1. Running before walking we need to see how biotin fairs, but I suspect that getting a vitamin B trial will be hard who will pay for it

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    2. Thanks for your reply MD.
      I read a post on this blog about MSers may have a mild vit B1 deficiency, a small study showed and high dose vit B1 helped with fatigue.
      If MSers are deficient in vit B1 and biotin then a combined study could give even better results.

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  30. Are the participant MSers biotin levels being monitored during these two trials? If this is by blood test is there a normal range before starting the biotin And ideal range while during the trial?

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  31. I thought this article was interesting Team G regarding MS and biotin
    http://www.ncbi.nlm.nih.gov/pubmed/10577274
    Cerebrospinal fluid levels of biotin in various neurological disorders.
    Acta Neurol Scand. 1999 Jun;99(6):387-92.

    Conclusion:
    There is a significant reduction in cerebrospinal fluid biotin in epileptics and patients with multiple sclerosis compared to controls. In epileptics this may be related to competition between biotin and anticonvulsants bearing carbamide ring for absorption. Reduction of biotin levels in patients with multiple sclerosis could be attributed to intestinal malabsorption caused by the underlying disease or a biotin-binding immunoglobulin which may be involved in multiple sclerosis pathogenesis.

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    1. MSers could be biotin deficient this article is suggesting??

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    2. That's what it suggests i.e. low biotin levels

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    3. So wouldn't it be wise MSers biotin levels are monitored like vit D and take a biotin supplement, perhaps 5 or 10 mg biotin daily?

      http://www.ncbi.nlm.nih.gov/books/NBK1322/
      Biotinidase Deficiency
      Management
      Treatment of manifestations: All symptomatic children with profound biotinidase deficiency improve when treated with 5-10 mg of oral biotin per day. All individuals with profound biotinidase deficiency, even those who have some residual enzymatic activity, should have lifelong treatment with biotin.

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    4. Prof G and Neuro Doc G, Mouse Doc when patients have a LP for MS diagnosis would it be an idea to start testing biotin levels in spinal fluid? Also in confirmed MSers and others having an LP for other reason. It could be valuable information to confirm findings in this 1999 article.
      I would like to know if I am biotin deficient.
      Thanks.

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  32. My neuro told me if he had ms he would certainly give it a go! I did start 300 pure powder last year but I did stop until now. I do believe biotin is also an antifungal killing off candida so die off could explain those who progressed as that can worsen symptom. I think it is worth a try so will continue until I run out

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