Thursday, July 24, 2014

Death by Neurologist

NY Neurologists and insurance companies will guarantee you an expensive death with holes in your head/brain while Italy laughs at the folly of New Yorkers and wishes them a grisly death or a visit to Ristori in Italy.

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2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.

Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.

Ristori G¹, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P, Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M, Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti M.

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Abstract

OBJECTIVE:

To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).

METHODS:

In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.

RESULTS:

Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence interval [CI] 0.308-0.956; p = 0.03) for gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI 0.207-0.639; p = 0.001) for new and enlarging T2-hyperintense lesions, and 0.149 (95% CI 0.046-0.416; p = 0.001) for new T1-hypointense lesions. The number of total T1-hypointense lesions was lower in the BCG group at months 6, 12, and 18: mean changes from baseline were -0.09 ± 0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08), and -0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27-0.99; p < 0.05), and more vaccinated people remained DMT-free (odds ratio = 0.20, 95% CI 0.04-0.93; p = 0.04).

CONCLUSIONS:

Early BCG may benefit CIS and affect its long-term course.

CLASSIFICATION OF EVIDENCE:

BCG, as compared to placebo, was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy (Class I evidence).

Comment in

BCG vaccine for clinically isolated syndrome and MS: infections and protective immunity. [Neurology. 2014]
Multiple sclerosis: disease activity is reduced in CIS after BCG vaccination. [Nat Rev Neurol. 2014]

PMID:: 24306002; [PubMed - indexed for MEDLINE]
PMCID:: PMC3873620; [Available on 2015/1/7]

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