Update on Biotin (Vitamin B7 (H)) for Multiple Sclerosis

[October 2021] 

At time of writing it has been around 18 months since MedDay announced the results on their last stage three (SPI2) trial which failed to meet the required results.

  So what has happened over the past months? Apart from Covid that is!

  Well, there have been three articles that I have found particularly interesting regarding Biotin.

  1. Data from all three Meday trials looking at walking was combined and re-analised. The finding was that Biotin does improve walking ability.
  2. Increased inflammation in MS patients taking high dose biotin (HDB)  found there was no correlation. Biotin does not increase inflammation in MS.
  3. Suggestions of a link between Biotin deficiency and MS and if MS patients experience benefits from HDB they should be tested for Biotinidase deficiency.

MedDay HDB Trials - a quick history

The last MedDay trial failed to meet its end points, of which there were two. These endpoints were: a reduction of at least 1.0 points on the Expanded Disability Status Scale (EDSS)  or improvement to the timed 20 foot walk (TW20) and a reduction in EDSS. This trial investigated the use of High Dose Biotin (HDB) as a treatment for Non-Active Progressive MS (NAPMS), that is, Progressive forms of MS that do not experience any Relapses but steadily deteriorate.

MedDay ran four trials in total. Three of which looked at improvements to EDSS and TW20. One looked at the effect Biotin has on eyesight. The first two trials, the Pilot and SPI, which were looking at disability and walking ability both revealed benefits. The pilot study looked at all MS patients including Relapsing Remitting. The first stage three trial (SPI) only looked at Progressive forms of MS and the third (SPI 2) only looked at patients with NAPMS. This trial did not deliver the results MedDay were looking for and as a result they have now ceased any further investment in Biotin. It seems to me that they were hoping for a treatment specifically for NAPMS because currently there are no treatments available. This would then have provided the greatest potential for a significant return on investment (ROI). The earlier trials, which looked at a wider range of the various types of MS, did reveal benefits. However it is understandable that MedDay were not interested in pursuing Biotin as a treatment for these other forms of MS. Other treatments already available are proving very effective and leave little room for MedDay to realise any significant ROI on Biotin. 

After MedDay published their results of SPI 2 we saw a lot of Neurologists advise their PMS patients that HDB didn't work and to stop taking it. We have seen customers cancel their subscription only to, several months later, start up again with comments that they felt better when taking Biotin.

Re-analysis of the MedDay Trials - Biotin Does Inprove Walking Ability in PMS Patients.

A recent review [5] published July 2021 in the Journal of MS and Related Disorders. This reviewed previous MedDay studies (Pilot, SPI and SPI2) involving MS and HDB. It combined the data from the 3 trials that looked at EDSS and TW25, then re-analysed it as combined data.

Key takeaways from the review:

A systematic review and meta-analyses were conducted on HDB for MS.
Three Random Controlled Trials (MedDay Pilot, SPI and SPI2) involving 889 patients with MS were combined and re-analysed.

HDB was beneficial in terms of TW25 among PMS (moderate certainty of evidence).
No evidence of Adverse Events (ED). (high certainty of evidence).
“Laboratory test interference” is increased in HDB (high certainty of evidence).

This reanalysis and review suggests a benefit in favour of HDB administered for 12 to 15 months in terms of the TW25 test in patients with PMS. Effect on RRMS was indeterminate due to the small number of candidates in the combined studies. It also reported the risk associated with inaccurate test results leading to misdiagnosis of other conditions. The Federal Drug Administration (FDA) in the United States of America issued a warning regarding this in 2017.  An unconscious patient admitted to an Emergency Department (ED) received false test results indicating a heart attack. The patient was administered heart medication for a non-existent heart attack and died from the medication administered. To this end, attending physicians must be made aware of a patient taking HDB.

As a result of this recommendation we advise customers to carry a card in your wallet or on person informing of the effect HDB has on test results and/or, getting a MedicAlert bracelet identifying that you take HDB.  Also make loved ones and your GP aware of the HDB you are taking.

    Why people stopped buying the pure 100mg/capsule Biotin products after MedDay made their SPI2 findings public is clear. But why many people take up Biotin a few months later is also clear.  It actually makes them feel a little better and more able to manage.

    High Dose Biotin Does Not increase Inflammation in MS Patients.

    In 2017 an independent trials result was banded around discrediting High Dose Biotin as a treatment for MS [3]. This prior to MedDays last SPI2 trial. It was due to present finding at the 2017 meeting of ECTRIMS reporting that HDB as a treatment for MS could result in an increase risk of inflammation and relapses. I can now find no evidence of this trial and it seems to have been removed from the ECTRIMS website.  

    A more recent study [3] in 2021 reported that "in conclusion, high-dose biotin therapy does not modify inflammatory activity in PMS".

    Another study [4] again published this year investigated increased inflammation in MS patients using High Dose Biotin and has also debunked these earlier claims reporting there was no link between taking High Dose Biotin and increased inflammation.

    It would appear earlier studies into HDB increasing inflammation and relapse rate only included MS Patients who were not taking a Disease Modifying Drug (DMD). So when comparing this group to the placebo group who were not taking HDB, but were often taking a DMD, results were skewed. 

    So an increase in Inflammation and relapses in MS patients taking HDB  has not been proven.

    Biotinidase Deficiency or Multiple Sclerosis?

    Biotinidase Deficiency is a rare disorder mostly confined to infants. However an article [1] published in the Journal of Multiple Sclerosis (JMS) in 2018 came to my attention recently. This article was based on a number of earlier Japanese studies looking at Biotin Deficiency in patients diagnosed with MS and in particular patients with MS whose symptoms improved when taking HDB. A doctor by the name of Barry Wolf, MD, PhD wrote the review. In it he discusses that Biotin Deficiency has similar symptoms to that of MS and theorised that Biotinase Deficiency could be misdiagnosed as MS. 

    A subsequent Letter [2] to the Editor of the JMS recommended that if a patient has been diagnosed with MS and experienced benefits when taking HDB they should be evaluated for Biotinidase Deficiency and that their symptoms may not actually be due to MS. 

    In 2020 B Wolf proposed a study investigating the possible link between MS and Biotinidase deficiencies [6] but I am not aware of anything further on this. 

     

    Take aways from this review for me:

    1. Biotin is still proving popular and we continue to get positive feed back regarding its use.
    2. If you do experience benefits when taking HDB then you may want to get tested for biotinase deficiency.
    3. Re-analysis of combined previous data (3 MedDay studies) shows improvements to walking in progressive MS.
    4. Increased inflammation shown not to be the case when taking HDB.
    5. If you do choose to take any higher than normal Biotin supplements let your medical providers and family members know. Have a medic alert bracelet that has this information.
    6. Biotin has proven to be safe with little to no side effects.

    We continue to offer a money back trial on our MS-Biotin Complex. Email me at info@MultipleSupplements.com if you would like to know more about this offer.

    Cheers
    Alan

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    References

      1. Wolf B. Biotinidase deficiency should be considered in individuals thought to have multiple sclerosis and related disorders. Mult Scler Relat Disord 2018; 28: 26–30. [PubMed[]
      2. Wolf B. Any individual with MS who markedly improves neurologically with high doses of Biotin should be evaluated for Biotinidase deficiency. Multiple Sclerosis Journal— Experimental, Translational and Clinical April–June 2020, 1–2; DOI: 10.1177/ 2055217320923131 Nuerotherapeutics (2020) 17 : 989-993
      3. Sophie Mathais, Xavier Moisset, Bruno Pereira, Frederic Taithe, Jonathan Ciron, et al.. Relapses in Patients Treated with High-Dose Biotin for Progressive Multiple Sclerosis. Neurotherapeutics, Springer Verlag, 2020, 10.1007/s13311-020-00926-2 . hal-02995967
      4. Branger, P., Parienti, JJ., Derache, N. et al. Relapses During High-Dose Biotin Treatment in Progressive Multiple Sclerosis: a Case-Crossover and Propensity Score-Adjusted Prospective Cohort. Neurotherapeutics 17, 989–993 (2020). https://doi.org/10.1007/s13311-020-00880-z
      5. Adriad I. Espiritu, Patricia Pauline M. Remalante-Rayco. High-dose biotin for multiple sclerosis: A systemetic review and meta-analysis of randomized controlled trials. MS and Related Disorders 55 (2021) 103159
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