Study casts doubt on MS treatment
A clinical trial into CCSVI intervention for multiple sclerosis patients suggests it does not improve symptoms
18th March 2013 – The first controlled clinical trial to test the safety and effectiveness of angioplasty to treat patients with multiple sclerosis (MS) has found that the treatment does not improve their health and, in a few cases, made symptoms worse.
Researchers from the University of Buffalo in the US are due to present details of their research later this week but have already released some of their initial findings as well as discussing the results online.
Improving blood flow
The surgical technique known as called percutaneous venoplasty aims to improve blood flow from the brain by using inflatable balloons to widen narrow veins in the neck. This can improve the drainage of oxygen-depleted blood from the brain. It has been suggested that there could be a link between these narrowed veins (called chronic cerebrospinal venous insufficiency, or CCSVI) and the progression of MS.
The link between CCSVI and MS was first put forward by an Italian doctor called Paolo Zamboni whose wife had MS. He suggested that MS can be caused by blockages in the veins draining blood from the brain and that, by clearing these blockages, symptoms of the disease could be eased.
Since 2009, approximately 30,000 MS patients worldwide have undergone the procedure that opens blockages in veins that drain blood from the brain. The vast majority of these procedures were done on a fee-for-service basis, and not as part of clinical trials.
'No improvement' for patients
The key finding by the Buffalo researchers is that, while the treatment is safe and not associated with serious adverse events, it does not provide sustained improvement in MS patients.
The Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial is believed to be the first prospective randomised double-blinded, controlled study into the treatment. A total of 30 MS patients, mostly from New York, were studied over three years in six month phases. Phase I was a safety trial, involving 10 MS patients and Phase II involved a total of 20 MS patients, who were randomised to receive either the angioplasty treatment or a sham intervention.
Dr Adnan Siddiqui, associate professor of neurosurgery at Buffalo, says in a video posted on YouTube: "When we looked at these patients' disease activity, what we found there was rather surprising and unexpected and quite to the opposite of what we had originally premised, which was increased disease activity in patients who were treated as compared to the other group."
Larger scale trials needed
The researchers caution that their study was small and further larger scale trials are needed to substantiate their preliminary findings.
However, Dr Siddiqui says: "Our recommendation to patients and to practitioners who have in earnest been seeking betterment for their disease and a cure for MS – they should instead consider enrolling in trials rather than undergoing these procedures on a fee-for-service basis."