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Effectiveness of CCSVI Treatment
CCSVI is undoubtedly one of the major discoveries in medicine this century. To actually define a new medical condition with anatomical abnormalities is a breathtaking development.
It is no surprise that it has created considerable controversy in the medical world. How could we have missed something so important and indeed there are some published papers which cast doubt on the very existence of CCSVI? Having observed the lesions on Doppler ultrasound, venogram and with intravascular ultrasound, it is clear that this is a real condition and in time all doubts will be cast aside.
The area where there is still some doubt however is whether treating these lesions produces a worthwhile clinical benefit.
CCSVI is a great discovery but is it a breakthrough in treatment for patients with MS and other neurovascular conditions?
The Bologna conference in March 2011, from the International Society of Neurovascular Disease (ISNVD), was a great platform for the presentation of new research into CCSVI. It was also a good forum for introducing the next generation of studies which are aimed at investigating the effectiveness of CCSVI treatment.
The current president of ISNVD is Professor Robert Zivadinov; a consultant neurologist from Buffalo University in New York. His background is in Multiple Sclerosis research mainly into pharmaceutical treatments for the disease. It was very clear from his conference presentations, and in conversation, that he is an academic heavyweight who has concluded that CCSVI is a very important area requiring clinical investigation. He is involved in one of the three randomised controlled trials into CCSVI treatment and has a strong association with Paulo Zamboni and the University of Ferrara.
This combined team from these two Universities, Buffalo and Ferrara, have published an early trial on the effectiveness of treatment in the European Journal of Vascular and Endovascular Surgery (1).
Although the number of patients was small, fifteen in total, the results are suggestive of a positive effect from CCSVI treatment. There was no control group in the study but the angioplasty treatment was staggered with a group of eight patients treated initially and the other seven treated after a six month delay.
One of the traditional study endpoints in MS is the frequency of relapses which was reduced in the early treatment group. Two of the initial group had a relapse in the next six months as opposed to five from the seven who were in the delayed group (had not been treated at that point). Of even greater significance was the fact that the brain volume of the treated group was reduced compared to the untreated group. This would suggest that treatment of the venous outflow from the brain, reduces swelling and inflammation. As Prof Zivadinov suggests, the numbers are too small to make any firm conclusions but the positive outcomes give great encouragement for future research.
As part of our ongoing investigative approach to CCSVI treatment in Scotland, we are collecting a large amount of data
including an independent assessment of neurological function. Early indications are that our results are very similar to those being published and presented at International conferences. It will be some time before we have the data fully analysed but we are very encouraged by the objective improvements reported both here in the UK and abroad,
The largest randomised controlled trial is due to start in Italy , BRAVE DREAMS, is looking at several hundred patients and will hopefully be of a size that can allow more concrete conclusions to be drawn.
Another New York based study at Albany University, under the direction of Dr Manish Mehta, is a prospective randomised double blind trial which aims to recruit 600 patients. Initial results were presented at the Second CCSVI Conference in New York in July 2011. 48 patients who had undergone angioplasty treatment were assessed after 4.5 months using the Expanded Disability Severity Score (EDSS). The EDSS is a very difficult score to improve but in these patients there was a statistical improvement in those with relapsing remitting MS and secondary progressive MS. The patients with primary progressive did not improve on EDSS. 79 patients were evaluated with a timed 25 foot walk which showed significant improvements. He also reported that there were improvements in fatigue and quality of life indices for those who had undergone treatment.
While these results are far from conclusive, in combination with the excellent safety data which has recently been published, they are very encouraging and suggest that CCSVI is not just a major discovery but may also have opened the way for improved treatments for MS.