*Sham surgery just as effective as real procedure
*Doctors doubt future of vertebroplasty
By Gene Emery
BOSTON, Aug 5 A common spine operation for relieving back pain is no more effective than make-believe surgery, two teams reported in the New England Journal of Medicine.
The technique, called vertebroplasty, involves injecting medical cement into a fractured spine bone to strengthen it. More than 38,000 such procedures are done in the United States every year and the number has been increasingly rapidly, nearly doubling from 2001 to 2005.
"We had hoped this treatment might get the pain better quicker, but we couldn't demonstrate that," said Rachelle Buchbinder of Monash University in Malvern, Australia, whose group found that 36 volunteers who received sham surgery did just as well as 35 who got the real operation.
A separate test, of 131 people at 11 medical centers and led by Dr. David Kallmes of the Mayo Clinic in Rochester, Minnesota, also found that sham surgery produced a comparable degree of pain reduction and movement.
"We aren't saying the vertebroplasty doesn't work, because it somehow does," Kallmes said in a statement.
"But both sets of patients experienced significant improvements in pain and function a month following the procedure. Improvements may be the result of local anesthesia, sedation, patient expectations, or other factors," he said.
Buchbinder disagreed. "I don't think there's any place for vertebroplasty at the moment," she said in a telephone interview.
"The results may change vertebroplasty from a procedure that is virtually always considered to be successful to one that is considered no better than placebo," Dr. James Weinstein of Dartmouth Medical School in New Hampshire wrote in a commentary.
The findings may seem to be bad news for patients looking for faster relief, said Buchbinder.
"The important thing to note is that both treatment groups improved over time. I tell my patients, 'Yes it's terrible pain, but the pain does improve with time.' People can get better relatively quickly or it may take many months, but eventually the pain does get better whatever you do," she said.
Compression fractures are a significant health problem, particularly among older people. About 1.4 million people worldwide have been diagnosed with at least one, more than half of them in the United States. The cost of treating them was as high as $18 billion in the United States in 2002.
Another variant of the procedure, called kyphoplasty, involves inflating a balloon in the vertebra to reopen the bone before the cement is injected. Buchbinder speculated that if that surgery were subjected to a similar test, "I suspect the result would probably be the same."
To mimic the effects of the operation without actually injecting the cement, the Australian researchers tapped against the spine to mimic the sound and feel of the needle going in. They also released the odor of the cement used in the procedure.
"There are two things people remember even though they're a little bit sedated. They remember the tapping and they remember the scent. So in addition to the tapping, we wafted cement in the room because it's got a really pungent odor," said Buchbinder. (Editing by Maggie Fox and Phil Stewart)