Alberta Health and Wellness will fund an observational study to determine the benefits, risks and possible complications for multiple sclerosis (MS) patients who have undergone liberation therapy, also known as the Zamboni treatment.
The procedure is based on Italian doctor Paolo Zamboni’s theory that MS causes blood flow to the brain and spine to be slowed, a condition known as chronic cerebrospinal venous insufficiency (CCSVI).
The controversial treatment involves inserting either a balloon-type device, a procedure called an angioplasty, or a stent to open up the vein.
“Alberta Health and Wellness is committing up to $1 million dollars to fund an observational study to help determine the safety and the ultimate impact of venous procedures for people with multiple sclerosis,” said Health Minister Gene Zwozdesky, during a press conference on Thursday.
“This will be an observational study and it’s a very logical first step to what will surely be additional steps thereafter.”
The purpose of the study is to determine the safety and patient-reported impact of the procedure.
“The observational study will use first-hand accounts of people who have MS, it will be led by very credible researchers and neurologists at the University of Calgary and the University of Alberta and it will include other experts as well,” Zwozdesky said.
Information obtained through the observational study will be part of the broader information pool required to help determine whether to move forward with future studies, including clinical studies, said Zwozdesky.
“This study will also help determine what complications, if any, Albertans may have experienced after the so-called Zamboni treatment or CCSVI or what their follow-up care needs might be,” he said.
The three-year observational study will begin early next year. In conjunction with the study, a secure MS research website and database will be developed.
Darrel Gregory, director of communications with the MS Society of Canada, Alberta Division, said the organization is pleased with the news.
“We hope it will lead to a clinical trial and get us to a position where we can have this treatment available for people right here in the province,” he told the Gazette Thursday.
Gregory said he’s spoken to many Albertans who have undergone the Zamboni treatment abroad and said their experiences vary widely.
“For some people, it’s extremely positive and other people haven’t had the same positive results. Some people have even been worse off. That’s why something like an observational study is important,” he said.
At present, the procedure is not performed in Canada and many Albertans have travelled to places like Poland or Mexico to have the surgery.
“Why should we have to go out of town?” asked Connie Beaudette, a 54-year old MS sufferer from St. Albert who travelled to Mexico last summer to undergo the procedure.
Since having the procedure done, Beaudette said her symptoms have greatly improved.
“My husband said I was going downhill fast. I didn’t even know but he said my head was bobbing and it’s my balance that it had affected,” said Beaudette of her symptoms before she had the surgery.
Beaudette said her balance was so bad that in May she fell and broke her humerus in three places. The fall also caused a herniated disc in her back.
“The thing with MS is when you’re falling, you don’t even try to stop yourself,” she said.
One year after being diagnosed with MS, Beaudette said she began having trouble sleeping and eventually had to take sleeping pills each night to fall asleep.
“I’m a size three. I was taking four a night to go to sleep,” Beaudette said.
The surgery took two and a half hours and Beaudette, who was awake for the procedure, said doctors made a tiny incision in her groin.
Immediately after surgery, she said she was able to fall asleep and was left with no side effects.
She called the government’s announcement “wonderful.”
“Have it done. It’s worth it,” she said of the procedure.
“I water skied five years ago, I took the stairs in my house two at a time, I wore four-inch heels,” she said.
“I have energy now, which I didn’t have before. I’m sleeping without sleeping pills. I don’t shake, and if I didn’t have a herniated disc, I’m sure I could wear heels.”
