A controversial vein-widening treatment for multiple sclerosis (MS) is "largely ineffective," "cannot be recommended" to patients, and does not merit more clinical trials.
That's the conclusion of a rigorous controlled trial led by Paolo Zamboni, the Italian vascular specialist who developed the unorthodox procedure.
But it is not likely to be the end of his "liberation therapy."
The study, published recently in JAMA Neurology, includes a seemingly contradictory coda: Vein angioplasty may benefit a subgroup of MS patients, and "this should be further analyzed and investigated."
Janet Grieco, 61, of Chalfont, is among patients around the world who swear by the procedure, no matter how many studies debunk it or how much it is frowned on by neurologists, the specialists who normally treat MS.
"I'm still doing incredibly better than before the procedures," Grieco, who has had seven vein angioplasties, said Thursday. "I stand by the fact that it helped me."
Zamboni, a physician at Italy's University of Ferrara, did not respond to an email seeking comment. However, a recent public presentation suggests he has not disavowed his theory that in some MS patients, constricted or twisted veins cause what he dubbed "chronic cerebrospinal venous insufficiency" (CCSVI). The idea is that slow-flowing blood backs up in the brain, leaving behind iron that irritates delicate tissue, thereby signaling immune cells to mop up the toxins.
Zamboni's speculative work offered an explanation for the central mystery of MS — why immune cells attack nerves, causing progressive disabling symptoms that include weakness, numbness, loss of vision, and paralysis. An estimated 2.3 million people worldwide, including 400,000 in the United States, are living with the varied and unpredictable illness. Approved drugs reduce the frequency and severity of clinical attacks, but "don't generally make a person feel better," according to the National MS Society.
In the eight years since Zamboni offered the CCSVI concept — rooted in his efforts to help his wife's MS — researchers around the world have poked holes in it. Poor vein drainage has been found in healthy people as well as those with neurological conditions other than MS. It doesn't bother everyone who has it, and not all MS patients get better with the $8,000 vein-dilation procedure.
In March, Canadian researchers presented results from a randomized and blinded clinical trial — the gold standard of medical research. The trial found vein angioplasty was no better than a sham procedure for relieving MS symptoms. (For the sham, a tube was threaded into patients' veins but the tip was not inflated to dilate the vessels.)
The co-leader of that study, University of British Columbia neurologist Anthony Traboulsee, said, "We've got this tension between science and social media, where people will put these compelling stories, saying, 'I've had this treatment, and I feel dramatically better.' I hope these findings …will persuade people with MS not to pursue liberation therapy, which is an invasive procedure that carries the risk of complications, as well as significant financial costs."
The new trial in JAMA Neurology was accompanied by a scathing editorial written by three MS neurologists. The title said it all: "Combatting the Spread of Ineffective Medical Procedures. A Lesson Learned From Multiple Sclerosis."
In contrast, the National MS Society issued a mild statement that said the Canadian and Italian trials found venous angioplasty "did not provide a clear benefit." The statement did not recommend that patients steer clear of the treatment.
The Italian trial, which enrolled 115 patients at six MS centers in that country, reflected the tensions underlying CCSVI research, with a number of critics suggesting that conducting the study was unethical and a waste of resources.
Like the Canadian patients, the Italian patients were randomly assigned to undergo angioplasty or a sham procedure.
Vein-widening, while safe, did not improve the patients' function, nor did it reduce the average number of new brain lesions seen on MRIs at 12 months, the study concluded.
And then came the contradiction: "However, there was a tendency for more patients to become free of new lesions after venous angioplasty mainly because of a reduction in new lesions appearing six to 12 months after randomization."