"The question can't be answered without a sham procedure."
Dr. Aaron Miller, director of clinician affairs at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mt. Sinai Hospital in New York, was speaking to me in his cramped office on East 98th St. one night late in 2011. I was researching my article for the magazine, "The Zamboni Effect," which was published last October.
The "question" was whether there was any truth to the theory put forth by Dr. Paolo Zamboni, an Italian vascular surgeon who'd begun researching multiple sclerosis after his wife was contracted it: that M.S. isn't an immune-mediated process, as neurologists like Miller have believed — and gathered substantial evidence to support — for decades, but is instead related to blockages of the main veins draining the neck. Zamboni called it chronic cerebrospinal venous insufficiency, or CCSVI, and much of the M.S. patient community has been excited by the news. The month before interviewing Miller, at a meeting of the world's M.S. researchers and clinicians in Amsterdam, I saw him make a presentation on the spread of positive reports from CCSVI patients. Some travel far and wide and pay as much as $11,000 for surgery in hopes of correcting the condition and improving their M.S., one of the most damning diseases to strike patients, and one of the most vexing to researchers.
"There's too much variability in M.S.," Miller would tell me later, "and too much potential for a placebo response in important areas for which there are little objective measures, such as pain and fatigue," to know whether patients were really being helped by the surgery or whether they were subject to, well, the Zamboni effect. The sham procedure, the surgical equivalent of a placebo drug, was the only way to answer the question.
Today at the American Academy of Neurology's annual conference in San Diego, patients will get an answer. Dr. Robert Zivadinov of the University of Buffalo, who has published studies indicating CCSVI is real but not M.S.-specific, will present results of the first of several studies on CCSVI surgery at the highest level of evidence: comparing outcomes in patients who had the procedure recommended by Zamboni, and the "sham procedure" Miller referred to. (Zivadinov and I also met in Amsterdam.)
His results? According to the randomized, double-blind control trial — some subjects had the real surgery, others went under the knife but didn't get the operation, and neither the patients nor the scientists evaluating the results knew who got which — the procedure "failed to provide any sustained improvement," Zivadinov and his colleagues write.
"We were disappointed and surprised," Zivadinov told me over the phone on Friday. "It's very discouraging. We thought it would go the other way, or else we wouldn't do the study — you do the study to try and help the patient."
Zivadinov cautioned that the study was small, and looked at patients just six months after the operation. (Patients I spoke to in the course of my research said they'd felt better the next day, so it seems unlikely the 12-month follow-up Zivadinov and Siddiqui intend to perform will show improvements.) Even self-reported, subjective measures showed no improvement. The study has not been published because it's so recent.
Oddly, not only did the procedure not help but there was also increased disease activity in patients whose veins were opened the most. Zivadinov enrolled in the study patients with high disease activity; he said that could be a factor in this puzzling result. "Or," he told me, "it could be that reopening the veins is exacerbating" their M.S. — the opposite of what Zamboni posited. Given the small size of the sample, this could just be a random quirk. "However, one thing is clear," Zivadinov told me. "Patients should not have this type of treatment outside of controlled, blinded, carefully done clinical trials."
Adam Gottschalk, the CCSVI patient profiled in the article, said to me via Internet chat that his feelings about the Zamboni treatment "have not changed one bit. I still have all the great benefits. I don't know about others, but these improvements are demonstrable and definite."
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