An internationally-hyped multiple sclerosis treatment is ineffective, its inventor has finally admitted.
Dr Paolo Zamboni’s so-called ‘liberation treatment’ claimed to alleviate pain and restore mobility for MS patients through an invasive procedure to reopen collapsed blood vessels.
This month, he published the disappointing results of a standardized trial, proving finally that the technique is ‘largely ineffective.’
MS sufferers flocked to the treatment when Dr Zamboni introduced it, but other doctors have long been skeptical of it.
Dr Paolo Zamboni (pictured) has finally admitted that the MS treatment he pioneered is ineffective, dashing the hopes of patients and confirming years’ of doctors’ doubts
In multiple sclerosis, the immune system turns against and attacks myelin, the covering that protects nerve tissue.
Scar tissue forms in place of the damaged myelin, but the new material interferes with signals sent from the brain through the spinal cord, leading to weakness, pain and loss of motor control.
The disease typically begins with a single episode when people are between 20 and 40, and gets progressively worse.
There is no cure, and no clear, exact cause for MS.
The ‘liberation treatment’ has an origin story that would make anyone believe in it.
Dr Zamboni, a medical professor at the University of Ferrara, became determined to the disease’s root when his wife, Elena, was diagnosed.
As he dove head first into MS research, Dr Zamboni made a connection between the symptoms of MS and a condition in which blockages prevent blood from properly draining from the brain to the spine.
As it happened, 90 percent of the MS patients – including his own wife – that he examined to find proof of his theory did in fact have the blood drainage abnormality, which he dubbed chronic cerebro-spinal venous insufficiency (CCSVI).
So Dr Zamboni suggested a novel treatment: He thought that he could insert surgical balloons, called stents, into patients’ neck blood vessels to open their blockages, improve the flow of blood from their brains to their spines and – maybe, hopefully – cure MS.
He tried the procedure in a total 65 patients in 2009, including his wife, and reported that the stents did indeed improve blood flow and ‘positively influenced’ MS symptoms in all the patients.
POSSIBLE MS CAUSES
No one knows for sure why people get MS. It’s likely to be due to a mix of genetics and environmental and lifestyle factors.
Some of the factors that have been suggested as possible causes include:
MS isn’t directly inherited, but people who are related to someone with the condition are more likely to develop it; the chance of a sibling or child of someone with MS also developing it is estimated to be around 2-3%.
Lack of sunlight and vitamin D
MS is more common in countries far from the equator, which could mean that a lack of sunlight and low vitamin D levels may play a role in the condition, although it’s not clear whether vitamin D supplements can help prevent MS
People who smoke are about twice as likely to develop MS compared to those who don’t smoke.
It has been suggested that infections, particularly those caused by Epstein-Barr virus (responsible for glandular fever), might trigger the immune system, leading to MS in some people.
Source: NHS Choices
But all patients should not have shown improvement. If Dr Zamboni had done the trial by the highest medical standards, only half of the patients – not all – would have even been given the treatment.
So there were no controls, and everyone involved knew exactly who was getting what treatment.
Doctors were skeptical of the methodology, but around the world, the results inspired new hope for 2.5 million people suffering from MS, which is typically managed with immunosuppressant drugs and physical therapy.
Even with these interventions, nothing had been shown to stop the disease’s progress. It is rarely fatal, but often debilitating.
Even the name – the ‘liberation treatment’ – inspired a sense of immediacy.
Caught up in the excitement, patients flocked to Italy, and charities like the National Multiple Sclerosis Society poured millions of dollars into funding Dr Zamboni’s research.
It is unclear exactly how many people have undergone the controversial procedure, but patients report travelling from Canada and the US overseas to places like Italy and India to have it performed.
Earlier this year, the University of British Columbia tried to replicate the results of Dr Zamboni’s study, and found that it was not the miracle cure it had purported it to be.
Finally, on November 18 Dr Zamboni published his own randomized, double-blind study of 115 patients in JAMA Neurology, and acknowledged that the treatment ‘has proven to be a safe but largely ineffective technique; the treatment cannot be recommended in patients with MS.’
Recent studies show that stem cell treatment could help people with MS, but the therapy is still being tested.