People with a lifelong condition like multiple sclerosis (MS) are always on the lookout for a new treatment that might improve, or even cure, their disease. In the last few years, there's been a lot of buzz about a vein condition called CCSVI and its possible connection to MS.
However, this connection is very controversial. Some researchers say treating CCSVI can relieve MS symptoms. Others say CCSVI isn't even real. They compare it to the snake venom, bee stings, and other dubious "cures" that have been proposed to treat MS over the years.
So what is CCSVI? Could it be the next big breakthrough in MS research? Or is it just a false theory with a potentially dangerous treatment?
CCSVI stands for chronic cerebrospinal venous insufficiency. It's a narrowing of veins in the neck and chest that carry blood away from the brain and spinal cord. The theory is that when blood flow is slowed, it backs up into the brain and spinal cord and leads to oxygen loss and iron deposits in the brain.
In 2009, Italian researcher Paolo Zamboni, MD, first introduced the idea that CCSVI might cause MS, or make its symptoms worse. When he used ultrasound to compare the blood vessels of people with and without MS, he found abnormal blood flow in 100% of the people with MS, but in 0% of people without MS.
Does CCSVI Really Exist?
Zamboni's findings sound impressive. But when other researchers have tried to copy his research, they haven't gotten the same results.
- Some studies have found that CCSVI is more common in people with MS than in healthy people -- but not nearly as common as Zamboni found.
- Other studies have reported CCSVI in almost exactly the same number of healthy people as in people with MS.
- Some researchers have also found CCSVI in people with other nervous system conditions.
These differences in results raise questions about whether CCSVI is a real condition and how it relates to MS. "When something is true, it is replicated. This is how science works," says David A. Hafler, MD, chairman of the Yale School of Medicine department of neurology.
Why have researchers gotten such different results? One reason is that research teams use different criteria to evaluate CCSVI.
"The way the ultrasound is conducted is not yet standardized," says Robert Fox, MD, staff neurologist and medical director at the Cleveland Clinic Mellen Center for MS. "It's not like getting a blood count." He found that when people were examined with different types of scans, the number of CCSVI cases changed.
The difference in results could also have to do with something as basic as how much water study participants had to drink before their scans. "If you don't have a lot of volume in the veins they're going to collapse down," Fox says. When he had study participants drink Gatorade before their ultrasound, many of them no longer had signs of CCSVI. "Once you fill up the veins, you have much more blood flowing through them, and they're much more plump."
Even though researchers are still divided on whether CCSVI exists, some studies have started looking at the effects of treating it with surgery.
Zamboni and other researchers have been studying whether treating CCSVI by opening up blocked veins can improve symptoms of MS. The treatment for CCSVI is called endovascular surgery, or sometimes "liberation therapy" or the "liberation procedure." It involves placing a tiny balloon or tube called a stent inside a blocked vein to open it and restore blood flow out of the brain and spinal cord.
When Zamboni studied this surgery in a group of MS patients, he found that it did reduce relapses and the number of new brain lesions. Other studies have not found the same improvement. Some people with MS who've had the endovascular procedure claimed they felt better afterward, but researchers say this may be due to people's high hopes about the surgery outcome.
Should You Be Treated for CCSVI?
CCSVI is treated with surgery, and any type of surgery can have risks. "There have been some patients who have been seriously injured or have died as a result of this surgery," Fox says. Risks involved with endovascular surgery include:
- Movement of the stent
- Damage to the blood vessel, which could lead to clots
- Bleeding from the blood thinners prescribed after surgery
- Re-closing of the vein after surgery--called restenosis
In May 2012, the FDA released a statement warning people with MS about the risks of surgery used to treat CCSVI. The statement cautions that these procedures have not been FDA-approved or proven safe and effective for treating MS.
"We need to stop this use of treatment when we don't know if it's useful or not," says Robert Zivadinov, MD, PhD, professor of neurology at the University at Buffalo. He says endovascular surgery needs to be proven in carefully controlled studies before it can safely be used on people with MS.
The Future of CCSVI Research
So is CCSVI real? And can its treatment change the course for people with MS? The answer depends on which expert you ask.
"I think in many people's minds the issue has been sorted out," Fox says. He says his team is in the process of completing its studies, "but there does not seem like there is evidence in support of CCSVI. I think for many people this hypothesis of MS is winding down."
But Zivadinov says researchers who claim CCSVI doesn't exist are not interpreting the diagnostic criteria correctly. "Our studies are demonstrating that clearly there is this condition, and it's present in about 30% to 50% of the subjects," he says.
"Although this is a very controversial field, I am very certain that research should proceed," Zivadinov adds. He says it's important to keep studying CCSVI, to understand what it means for people with MS and other nervous system conditions.
Several studies are under way to learn more about CCSVI -- whether it is a real condition, and, if so, what its relationship to MS is. In Canada, a group of researchers is launching a study to investigate the safety and effectiveness of surgery on about 100 people with MS. What they and other research teams discover may answer many of the remaining questions about CCSVI and its treatment.
What You Can Do Today
It's natural to get excited about a new treatment that might improve MS. Yet our experts say it's important to be sure that any new treatment is well-tested in clinical trials to make sure it works, and it's safe, before trying it.
What can you do right now?
- Learn as much as you can about MS.
- Ask your doctor about new, well-researched treatments for MS.
- Find out if any new treatments are being studied in clinical trials and whether you can participate.