Studies dash hopes for MS procedure
When an Italian physician, Paolo Zamboni, announced a new treatment for multiple sclerosis in 2008, the news spread across Canada like wildfire.
Canada has more MS sufferers, per capita, than any country in the world, and the Prairies have the highest incidence in Canada. This latter fact led the government of Saskatchewan to offer $2.2 million for a clinical trial of Zamboni’s procedure.
Liberation therapy, as the procedure is known, involves expanding neck veins by temporarily inserting a small balloon and inflating it. Zamboni’s theory was that MS is triggered, in part, by an inadequate flow of blood to the brain.
Since the initial announcement, unfortunately, liberation therapy has lost much of its credibility. First, the Saskatchewan study collapsed when not enough patients came forward.
Next, several clinics in the U.S. and elsewhere failed to replicate Zamboni’s results.
Then serious questions were asked about his methodology, and his failure to disclose commercial interests that are normally declared by proponents of new medical procedures.
But what might be the final nails in the coffin were hammered home this year by a pair of studies at the University of British Columbia. The first involved 102 MS patients who had gone abroad for the procedure, then returned to B.C.
Each was asked a series of standardized questions about symptoms associated with the disease — loss of mobility, dizziness, depression and so on. Over periods of six, 12 and 24 months, whatever improvements they initially reported progressively disappeared.
Moreover, physicians who examined them were often unable to confirm any benefits at all. Wishful thinking on the part of patients might have played a part — the so-called placebo effect. But MS sometimes goes into spontaneous remission for a time, which could also account for some of the temporary “improvements.”
Against this, serious side-effects were noticed, including blood clots, bleeding at the site where the balloon was inserted and heightened blood pressure requiring hospitalization.
The study authors concluded “patient and/or physician perceptions of positive impact … were not sustained over time.”
The second investigation was a clinical trial designed to satisfy the highest research standards. Called a “double blind” trial, the study involved giving 49 patients the real procedure, and 55 a fake version. Neither the patients nor the clinicians who followed their progress knew who had the actual procedure.
A year later, there was no difference in the progress of symptoms between the two groups, as measured by brain imaging, physician observations and the patients’ own self-assessments.
Is this the end of liberation therapy? It should be, but it probably won’t be. The Internet is awash in testimonials from patients who have had the procedure.
We’ve seen this sort of thing before. During the 1970s and ’80s, an experimental drug called laetrile burst onto the scene, capable of curing cancer, or so it was claimed. The actor Steve McQueen went to Mexico for this treatment, but he died shortly thereafter.
Pressed by public clamour, the U.S. National Cancer Institute eventually undertook a clinical trial of the drug. But the patients either died or their tumours increased in size. Laetrile was a bust.
There is a pattern here. A new miracle treatment is announced for patients with irreversible ailments that mainstream medicine cannot cure.
Typically, the evidence is weak or non-existent, and the science doesn’t add up. But people who believe they have nothing to lose are willing to try it, and some are sufficiently impressed to swear by it.
That’s basically what happened with liberation therapy.
Though it still has highly committed supporters, the burden of proof has not been met, despite numerous trials.
It’s time to close the book on this controversial procedure. Sadly, it just doesn’t work.