New York: A common treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure reveal.
Pain and disability were virtually the same up to six months later, whether patients had a real treatment or a fake one.
Tens of thousands of Americans each year are treated with bone cement, especially older women with osteoporosis, some of them stooped and unable to stand up straight. The treatment is so widely believed to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing.
"All of us who do the procedure have seen apparently miraculous cures," said Dr. David F. Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also "miraculous cures" among those who got the fake treatments.
The researchers said it is yet another example of a medical procedure coming into wide use before good studies are done to show that it is safe and effective. Medicare pays $1,500 to $2,100 for the outpatient procedure.
Bone cement has long been approved for many medical uses, but this particular use had not been tested against a placebo procedure until now.
The findings, published in Thursday`s New England Journal of Medicine, mean patients and doctors need to review the options together, wrote Dr. James N. Weinstein of Dartmouth Medical School in an accompanying editorial. "When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential," he said.
About 750,000 Americans suffer painful compression fractures in the bones of the spine each year. Bone-thinning osteoporosis is the most common cause. The weakened bone collapses or cracks, sometimes causing debilitating pain, limiting mobility and resulting in a loss of height or a stooped posture.
Doctors usually try bed rest, painkillers and back braces before turning to vertebroplasty (pronounced vur-TEE-broh-plas-tee). During the procedure, hot bone cement is injected into the collapsed or cracked vertebra. The cement is thought to shore up or stabilize the compressed bone. There can be complications, including infection and leakage of the cement.
Bone cement was first used for spinal fractures in the U.S. in the 1990s, and Kallmes said it quickly became routine because there were few good options. The rate of Medicare-paid procedures nearly doubled from 2001 to 2005. Now there are about 80,000 procedures done in the United States each year, Kallmes said.
The Mayo-led study involved 131 patients at medical centers in the U.S., Britain and Australia. The second study enrolled 78 patients in Australia. The patients, mostly women with fractures from osteoporosis, were randomly assigned to get the cement injection or a fake treatment. On average, they were in their mid-70s.
Neither the patient nor the person who evaluated them knew which treatment they got.
All participants first got local anesthesia to numb their backs. For the fake treatment, doctors simulated the cement injection by pressing the back, tapping instruments and having the strong-smelling cement on hand.
The patients were questioned periodically afterward about their pain, mobility and other measures — up to six months in the Australian study and one month for the Mayo-led study. The results were similar in both tests.
"Both treatment groups improved, it`s just that they improved by about the same amount," said study leader Dr. Rachelle Buchbinder of Cabrini Hospital in Melbourne, Australia.
The researchers do not know why people felt better, but suggest it could be due to the anesthesia, the placebo effect or that the fractures healed on their own over time. Kallmes said the procedure may work in a few patients, and that more research is needed to figure out who might benefit.
Kallmes, who`s been doing the procedure for 15 years, said he has revamped his practice so that most patients are enrolled in new studies of the procedure. Buchbinder, who treats patients with back pain, said she no longer recommends it.
The Mayo-led study was funded by the National Institutes of Health; some of the researchers have received fees or grants from drug makers and medical equipment companies. The Australian study was also mostly government funded; a medical cement maker provided the cement and some funding.