The North American Spine Society and the Society of Interventional Radiology have pointed to flaws in both studies. And earlier studies, published over 15 years, found major benefits to kyphoplasty and a related procedure called vertebroplasty.
"We're missing opportunities for patients to receive a safe and effective treatment that can significantly reduce their pain and disability," said Malamis, an interventional radiologist.
The procedures are used to treat vertebral compression fractures in patients with osteoporosis and other conditions that result in brittle bones. In a vertebroplasty, an acrylic cement is injected into a fractured vertebra. In a kyphoplasty, a balloon-tipped catheter first is inserted into the fracture. The balloon is inflated to restore the height and shape of the vertebra before the cement is injected.
Neva Nelson, 74, of Naperville, Ill., said a kyphoplasty that Malamis performed in October, 2009, has greatly reduced her pain in a vertebra in her lower back that she fractured after falling on ice. Before her kyphoplasty, Nelson had to sit on cushions. Walking, and especially standing, were painful. "I had to do something," she said. "I could not go on like that."
Nelson said that since undergoing her kyphoplasty, "I don't have to worry about my back any more."
In the controversial studies, patients were randomly assigned to receive a vertebroplasty or a placebo-like "sham" procedure. In the sham procedure, patients received an injection of anesthetic, but no cement.
However, patients in severe pain are reluctant to enroll in a trial where there's a 50 percent chance of receiving a sham treatment. In one of the studies, researchers had to screen 1,813 patients to enroll just 131 subjects. In the other study, only 78 of 219 eligible patients were enrolled. This low enrollment rate raises the possibility that the patients who did enroll were not representative.
Patients experience the greatest pain during the first three months after a compression fracture. Thereafter, pain gradually subsides. Thus, a vertebroplasty or kyphoplasty provides the greatest benefit when performed within a week or two of the fracture. But the studies enrolled patients up to 12 months after fractures.
In addition to reducing pain and disability, a kyphoplasty can reduce the risk of subsequent fractures by improving the angle and height of the spine. The studies evaluated vertebroplasty alone, and did not include the more innovative and very different kyphoplasty procedure.
Malamis suggests the medical community wait for the results of additional studies now underway before passing final judgment on vertebroplasty or kyphoplasty. In the mean time, he notes that Medicare still covers the procedures.
thinkahol * on 02 Jan 11December 9th, 02005 - Sam Harris"The View From The End Of The World"This is an audio only presentation. This talk took place in the Conference Center Golden Gate Room, San Francisco. Quote: With gentle demeanor and tight argument, Sam Harris carried an overflow audience into the core of one of the crucial issues of our time: What makes some religions lethal? How do they employ aggressive irrationality to justify threatening and controlling non-believers as well as believers? What should be our response? Harris began with Christianity. In the US, Christians use irrational arguments about a soul in the 150 cells of a 3-day old human embryo to block stem cell research that might alleviate the suffering of millions. In Africa, Catholic doctrine uses tortured logic to actively discourage the use of condoms in countries ravaged by AIDS. "This is genocidal stupidity," Harris said. Faith trumps rational argument. Common-sense ethical intuition is blinded by religious metaphysics. In the US, 22% of the population are CERTAIN that Jesus is coming back in the next 50 years, and another 22% think that it's likely. The good news of Christ's return, though, can only occur following desperately bad news. Mushroom clouds would be welcomed. "End time thinking," Harris said, "is fundamentally hostile to creating a sustainable future." Harris was particularly critical of religious moderates who give cover to the fundamentalists by not challenging them. The moderates say that all is justified because religion gives people meaning in their life. "But what would they say to a guy who believes there's a diamond the size of a refrigerator buried in his backyard? The guy digs out there every Sunday with his family, cherishing the meaningthe quest gives them." "I've read the books," Harris said. "God is not a moderate." The Bible gives strict instructions to kill various kinds of sinners, and their relatives, and on occasion their entire towns. Yet slavery is challenged nowhere in the New or
