Surgery, ‘Sham’ Equal in Treating Compression Fracture PainLast Updated: August 05, 2009. Injecting cement into spine no better than placebo procedure, study finds.
By Amanda Gardner
WEDNESDAY, Aug. 5 (HealthDay News) -- Two new studies suggest that vertebroplasty, a widely used surgery to help heal compression fractures, is no better than "sham" surgery when it comes to relieving pain and improving daily function.
But both procedures resulted in a significant decline in pain, so this is unlikely to signal the death knell for this widely performed surgery, experts noted.
"From a clinician's standpoint, it's important to read this data and be aware of it," said Dr. L. Gerard Toussaint III, an assistant professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine and a neurosurgeon at Texas Brain and Spine Institute in Bryan.
Vertebroplasty involves injecting a type of "cement" into the spine to stabilize it, thereby relieving pain and reducing disability in people who have had osteoporotic fractures.
The procedure is minimally invasive and often performed under local anesthetic, with the patient going home the same day, Toussaint said.
In the United States alone, some 750,000 people have vertebral compression fractures each year. According to an editorial that accompanies the studies, all appearing in the Aug. 6 issue of the New England Journal of Medicine, the number of vertebroplasty procedures performed in the United States has doubled in the past six years, from 4.3 to 8.9 per 1,000 people.
Several studies have found great benefit from the procedure, but none of those were placebo-controlled.
Experts also worry that there may be a downside, with the surgery putting patients at higher risk for future fractures.
One trial, from Mayo Clinic researchers, randomly assigned 131 patients who had had one-to-three osteoporotic vertebral compression fractures to receive either vertebroplasty or a "sham" surgery without cement.
Those in the placebo arm went through the motions of surgery, including being brought into the procedure room and being sedated before surgeons put novocaine in the skin and over the bone, said study author Dr. David F. Kallmes, a professor of radiology at the Mayo Clinic in Rochester, Minn.
After one month, both groups had experienced a similar, and significant, reduction in pain.
"Like every other trial, patients with vertebroplasty gained substantial benefit. Pain was cut almost in half," Kallmes said. "To our shock and amazement, however, there was no difference in pain relief, function or quality of life between the groups."
The second study, done in Australia, used essentially the same methodology with 78 participants.
Again, there were significant and similar declines in pain and other measurements in both groups six months after surgery.
"We conclude that the procedure seems to work but not apparently because of the cement," Kallmes said.
It could be the placebo effect or something as simple as the effect of the novocaine on the bone, breaking the cycle of pain, he added. Kallmes is currently enrolling patients in a trial to see if novocaine on the bone gives the same benefit as vertebroplasty.
But even now, many physicians do not favor vertebroplasty as the first-line treatment.
"I think we should take the middle road," Kallmes said. "We should discuss with the patient in a completely informed manner what the options are, and I think we have options. I still counsel patients that they should try ongoing medical therapy but I don't think it's unethical to do the procedure at this point. I think it's suboptimal."
"I always try bracing and analgesics and physical therapy to try to get the patients to feel better without any intervention at all," Toussaint added. "But if those measures don't work, I still think it is an option."
Also, Toussaint noted, "a lot of patients can't get their insurance companies to pay for medications that are more effective for osteoporosis treatment because they're expensive and new, but they will pay for the surgery."
The Radiological Society of North America has more on vertebroplasty.
SOURCES: David F. Kallmes, M.D., professor, radiology, Mayo Clinic, Rochester, Minn.; L. Gerard Toussaint III, M.D., assistant professor, neuroscience and experimental therapeutics, Texas A&M Health Science Center College of Medicine, and neurosurgeon, Texas Brain and Spine Institute, Bryan, Texas; Aug. 6, 2009, New England Journal of Medicine
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