Ibudilast to save nerves maybe


As COIVD-19 vaccines approaches a reality, the anti-VAXers are out, giving us a conspiracy theory. The Government is going to force you to be vaccinated….but lets face it they don’t have enough vaccine to treat everybody…Do you really thing that this force going to happen. Think stop talking SH1.

Next up there will be reasons why you shouldn’t vaccinate such as vaccine RNA stops your DNA from fighting a virus….Yep this was said yesterday on this blog.

So first I say… put-up or shut up!. Give us the source of this information and getting a comment from your granny on snap numpty and tweetbook is not a source of information. Where is the science and not the rhetoric.

Do not accept hearsay, because if you do, you won’t be able to make a sensible choice….Because at some point you will indeed be given the choice to vaccinate

Scientists are not incapable of streching the truth and so we have to apply the same rigour to their arguments too. If you do not, we would all be eating 5kg of tumeric a day, spending all our money on supplements and washing it down with a litre of red wine to get the resveratrol. Yep there may be an element of truth but we have to peel it away from fantasy

So here we have a report on benefit from Ibudilast in terms of neuroprotection and here they look at the retinal changes as a surrogate for brain atrophy. If you are a glass half full person you say it may of had an affect but if you are half empty then it didn’t really. Although it looks like the thickness of the top layer of the retina that contains the nerve heads of the optic nerves didnt drop compared to placebo it wasnt significant…maybe some people responded and others didnt. The macular is where there is the greatest area of visial acquity in the eye and here the volume of loss was different but only if you used a Heidelberg scientific spectralis machine not is you used a machine from Cirrus. So this makes you think whatever the effect if real is small. Being hard nosed you have to say sorry it failed and if you want to make me believe it then you have to do it again…using the spectralis machins and show it was not a fluke of data analysis.

Optical coherence tomography outcomes from SPRINTMS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.Bermel RA, Fedler JK, Kaiser P, Novalis C, Schneebaum J, Klingner EA, Williams D, Yankey JW, Ecklund DJ, Chase M, Naismith RT, Klawiter EC, Goodman AD, Coffey CS, Fox RJ.Mult Scler. 2020 Oct 15:1352458520964409. doi: 10.1177/1352458520964409.

Background: The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants.

Objective: Report the OCT results of the SPRINT-MS trial.

Methods: OCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models.

Results: Change in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): -0.3091 to 0.3939) for ibudilast versus -0.2630 uM (95% CI: -0.5973 to 0.0714) for placebo (n = 244, p = 0.22 =NO EFFECT). Macular volume change was -0.00503 mm3/year (-0.02693 to 0.01688) with ibudilast versus -0.03659 mm3/year (-0.05824 to -0.01494) for placebo in the Spectralis cohort (n = 61, p = 0.044) = MARGINAL EFFECT. For the Cirrus cohort, macular volume change was -0.00040 mm3/year (-0.02167, 0.020866) with ibudilast compared to -0.02083 mm3/year (-0.04134 to -0.00033) for placebo (n = 183, p = 0.1734 = NOT EVEN CLOSE EFFECT). Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was -0.4893 uM/year (-0.9132, -0.0654) with ibudilast versus -0.9587 uM/year (-1.3677, -0.5498) with placebo (n = 183, p = 0.12 = NO EFFECT).

Conclusion: Retinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect.

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  • As one who applies statistics and data science regularly in my professional and personal life, it seems with the wide variance in outcomes relative to the sample size it is no surprise that the p-values are what they are. The confidence intervals -er- the shift in them, is actually interesting. The intervals are already such that a profound affect would be required to generate a large enough difference in said confidence intervals to produce a p-value that says “statistically significant at alpha .05, or .01”. This is a shame as this could have been known before the study ever started. Some statistical inference and bootstrap resampling would probably show a much more solid outcome. I assume medical science doesn’t use such methods in reporting, but as far as statistical science and significance goes, such methods should be a regular item in a statistical appendix. I fear a promising drug may not meet some arbitrary p-value and be rejected.

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