RE MEDDAY'S MD1003 HITS AMBITIOUS END POINTS IN ITS MS PASE3

Biotin is an emerging therapy for the treatment of secondary progressive MS.

RE MEDDAY'S MD1003 HITS AMBITIOUS END POINTS IN ITS MS PASE3

Postby seeva » Sat Sep 26, 2015 3:19 pm

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Re: RE MEDDAY'S MD1003 HITS AMBITIOUS END POINTS IN ITS MS P

Postby zen2010 » Sat Sep 26, 2015 10:10 pm

Thks Seeva,

I am confused...
There are two different data from two official reports:


http://www.msard-journal.com/article/S2 ... 0006-1/pdf
" Overall, the EDSS score significantly improved
in 4/23 patients (22%) with a decrease of at least 1 point
(for initial EDSS between 4 and 5.5) or of at least 0.5 (for
initial EDSS between 6 and 8.5)."

http://www.bioworld.com/content/meddays ... -iii-trial
"Overall, the mean change in EDSS in the active arm was -0.03 at 12 months"
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Re: RE MEDDAY'S MD1003 HITS AMBITIOUS END POINTS IN ITS MS P

Postby DrGeoff » Sun Sep 27, 2015 6:09 am

Quite apart from the fact that this is old news (and I can understand why the researchers would want the results in as many journals as possible) the original words - along with a mass of data can be found at:
http://dx.doi.org/10.1016/j.msard.2015.01.005
As for the apparent disparity in figures, I assume that as the EDSS is a scale from 0 to 10 a negative value is a reduction. Thus the -0.03 quoted as a mean change, is the mean reduction across the original EDSS scores for the whole group.
Two things come out from this:
- There is one case of a reduction in EDSS from 6.5 to 6. Now EDSS 6.5 is very clear - the patient needs two canes or other support that need both hands (bilateral assistance). The quoted reduction can only mean the the patient was able to dispense with one cane.
- What I have not seen (anywhere) is any evidence that the EDSS is an equal interval scale. Kurtzke's "expansion" was the introduction (to his original scale) of the 0.5 point markers which give the x.5 steps in values. Thus, you can be EDSS 6 (with one cane) and progress to EDSS 6.5 (when you need two).
It is somewhat bizarre that I was EDSS 1.5 with one cane, and immediately jumped to EDSS6.5 when I added a second cane. This was with no other change in my condition, no MRI, no VEP, just the observation of a neurologist.
The best thing about the EDSS is that it is used worldwide, and does lead to consistency of judgement. It does a job that needs doing.
Having said that, if (as looks probable) Biotin does actually slow progression, that looks to me to be a good reason to continue taking 300 mg daily.
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