CCSVI – Don’t throw the book out yet!
A recent study led by Dr Anthony Traboulsee at the Univeristy of British Columbia was presented at the 2017 Society of International Radiology annual scientific meeting in Washington D.C. The study comprised of 104 people with Multiple Sclerosis who were found to have Chronic Cerebrospinal Venous Insufficiency (CCSVI) and were randomised into either a treatment or a sham group. Half of the participants received venoplasty to open narrowings in jugular veins of the neck and/or azygos veins in the chest. Both patients and evaluating doctors were unaware of who received the treatment and who received placebo.
Vascular experts, Neurologists and people with MS/CCSVI have raised concerns about this study and they fall into three main areas:
- The participant selection included patients least likely to respond to treatment
- There was no evidence provided that venous abnormalities were corrected by the procedure or that restenosis did not occur during the 48 week observation period
- 48 weeks is not a long enough study to draw the conclusion that further research should be discouraged.
According to the UBC presentation slides, of those in the treatment group, the age of participants varied from 35-63 years (average 51) and average disease duration was 18.1 years. This is a relatively old cohort compared to MS drug trials which tend to recruit younger participants with early MS. We know that on average, people who have been diagnosed with MS for 18 years are likely to have significant neurological damage and restoring blood flow does not repair permanent damage done to the nerves. Additionally 39% of people in the treatment group had a progressive form of MS. Whilst anecdotally, people with progressive MS have reported improvement in symptoms such as fatigue and heat tolerance, they are unlikely to show improvements in disability scales or MRI according to Zamboni’s preliminary studies (CTV News 2017).
Interventional Radiologist, Dr Salvatore Sclafani, has been treating CCSVI since 2009. He questions the appropriateness of the patient selection. Further he is concerned that the that the balloons used were not of a high enough pressure, that veins were likely under-treated and that there was no report of whether veins had renarrowed during the 48 week observation period. Dr Sclanfani concluded that the UBC study did not provide results that would stop him treating CCSVI (CTV News 2017).
Lynne Harris, a person living with MS since 2001, is also undeterred.
I have approached MS with a wholistic lifestyle, daily exercise and vitamin supplements. I now deal with the effects of Osteoporsis as a result of Copaxone. While searching for a drug-free alternative I found an article by Dr Paolo Zamboni about CCSVI and undertook extensive research to understand the theory. I since enrolled in The Alfred CCSVI study in Melbourne. If my jugular veins are found to be blocked, limiting blood flow from the brain, they will be treated by angioplasty which is a day procedure without general anaesthetic. I am extremely interested in participating in this trial as people have had wonderful results without MS medication. My only hope is I will have as much success as so many. I feel lucky that I found CCSVI Australia’s website and the information I needed to make this decision.
Finally it is premature to make the claim after 48 weeks observation, as Trouboulsee has, that “dialating the veins in the neck does not improve the symptoms of Multiple Sclerosis.” He claims that both the placebo and treatment group reported improvements but that there was no significant difference and therefore no justification “to go forward with a larger, confirmatory study. It is done.” But this is not how science works, there is debate and a comparison studies to validate evidence. As Dr Sclafani states, “there are other trials nearing completion that are also double blinded with larger volumes of patients so we shouldn’t close the door before we have all the players in the room.” He also says that we haven’t seen the UBC paper published yet so that we cannot assess how they defined stenosis, whether the treatments were adequate and what other factors may have affected the results (CTV News 2017).
Neurologist Alireza Minagar adds that this is an enormously complicated subject, there is a lack of unified methodology to investigate this concept and that more studies must be done to determine how to investigate CCSVI (CTV News 2017). He encourages “collaboration not confrontation.” And it is precisely this kind of collaboration that will be underway in May at the Annual Scientific Meeting of the International Society of Neurovascular Disease. The much awaited published results of the Brave Dreams CCSVI trial in Italy is expected to contradict the UBC study and there will be an update from Australia’s CCSVI trial presented.
Don’t close the book on CCSVI yet – there are still many pages to be read!
Special thanks to CTV Canada for video interviews. Full interviews can be viewed via link below.
CTV News 2017, “Study finds MS vein therapy ineffective, questions remain”, 8th March 2017, http://www.ctvnews.ca/health/study-finds-ms-vein-therapy-ineffective-questions-remain-1.3315927