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Old 11-21-2017, 06:02 PM
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Default CCSVI, aka Liberation Treatment, Officially Debunked -- By Scientist Who Started It

JAMA Neurol. 2017 Nov 18. doi: 10.1001/jamaneurol.2017.3825. [Epub ahead of print]

Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis: A Randomized Clinical Trial.

Zamboni P1, Tesio L2,3, Galimberti S4, Massacesi L5, Salvi F6, D'Alessandro R6, Cenni P7, Galeotti R8, Papini D9, D'Amico R10, Simi S11, Valsecchi MG4, Filippini G12; Brave Dreams Research Group.

Abstract

IMPORTANCE:
Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by restricted venous outflow from the brain and spinal cord. Whether this condition is associated with multiple sclerosis (MS) and whether venous percutaneous transluminal angioplasty (PTA) is beneficial in persons with MS and CCSVI is controversial.

OBJECTIVE:
To determine the efficacy and safety of venous PTA in patients with MS and CCSVI.
DESIGN, SETTING, AND PARTICIPANTS:
We analyzed 177 patients with relapsing-remitting MS; 62 were ineligible, including 47 (26.6%) who did not have CCSVI on color Doppler ultrasonography screening. A total of 115 patients were recruited in the study timeframe. All patients underwent a randomized, double-blind, sham-controlled, parallel-group trial in 6 MS centers in Italy. The trial began in August 2012 and concluded in March 2016; data were analyzed from April 2016 to September 2016. The analysis was intention to treat.

INTERVENTIONS:
Patients were randomly allocated (2:1) to either venous PTA or catheter venography without venous angioplasty (sham).

MAIN OUTCOMES AND MEASURES:
Two primary end points were assessed at 12 months: (1) a composite functional measure (ie, walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity) and (2) a measure of new combined brain lesions on magnetic resonance imaging, including the proportion of lesion-free patients. Combined lesions included T1 gadolinium-enhancing lesions plus new or enlarged T2 lesions.

RESULTS:
Of the included 115 patients with relapsing-remitting MS, 76 were allocated to the PTA group (45 female [59%]; mean [SD] age, 40.0 [10.3] years) and 39 to the sham group (29 female [74%]; mean [SD] age, 37.5 [10.6] years); 112 (97.4%) completed follow-up. No serious adverse events occurred. Flow restoration was achieved in 38 of 71 patients (54%) in the PTA group. The functional composite measure did not differ between the PTA and sham groups (41.7% vs 48.7%; odds ratio, 0.75; 95% CI, 0.34-1.68; P = .49). The mean (SD) number of combined lesions on magnetic resonance imaging at 6 to 12 months were 0.47 (1.19) in the PTA group vs 1.27 (2.65) in the sham group (mean ratio, 0.37; 95% CI, 0.15-0.91; P = .03: adjusted P = .09) and were 1.40 (4.21) in the PTA group vs 1.95 (3.73) in the sham group at 0 to 12 months (mean ratio, 0.72; 95% CI, 0.32-1.63; P = .45; adjusted P = .45). At follow-up after 6 to 12 months, 58 of 70 patients (83%) in the PTA group and 22 of 33 (67%) in the sham group were free of new lesions on magnetic resonance imaging (odds ratio, 2.64; 95% CI, 1.11-6.28; P = .03; adjusted P = .09). At 0 to 12 months, 46 of 73 patients (63.0%) in the PTA group and 18 of 37 (49%) in the sham group were free of new lesions on magnetic resonance imaging (odds ratio, 1.80; 95% CI, 0.81-4.01; P = .15; adjusted P = .30).

CONCLUSION AND RELEVANCE:
Venous PTA has proven to be a safe but largely ineffective technique; the treatment cannot be recommended in patients with MS.

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Old 12-17-2017, 09:27 PM
MSWhims MSWhims is offline
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Default Iíll Take the Fork

Well, we all know itís been proven safe, since the 70ís.

CCSVI is a condition in and of itself, so treatment for it may or may not improve MS, but it will improve symptoms of CCSVI, for some. Semantics? Maybe.

There are so many theories as to why MS affects us, and all differently. Vitamin D and magnesium deficiency? Venous malformations? Viruses? Autoimmune issue? Genetics? Environment? I subscribe to the theory that itís more than likely all of the above, and then some.

Whether venoplasty improves blood flow and ďbrain drainĒ, or the act of pressure on venous walls reboots the autonomic nervous system, we donít know.

And yes, for many, treatment was very disappointing, or only lasted a short time. My first treatment was miraculous, but lasted six months at best (until I found the right doctor).

As for the fork...so much anecdotal evidence exists as to itís efficacy that Iím not ready for that utensil.

Written by someone who has been treated three times, and continues to attribute reversal (yes, you read that right) of symptoms of severe (and rapid onset) PPMS to venoplasty. And please, MS gods and goddesses, if I need a fourth treatment, allow this patient to choose for HERSELF this particular safe treatment option.
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