Bone Cement For Backs No Better Than Placebo

This discussion is excerpted from an Associated Press article by Stephanie Nano on August 05, 2009:

http://my.earthlink.net/article/hea?guid=20090805/4a7911d0_3426_13350200908 0544664756

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 placebo-controlled studies reveal.

Pain and disability were virtually the same up to six months later, whether patients had a real vertebroplasty or a fake one.

About 750,000 Americans suffer painful compression fractures in the bones of the spine each year. 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. 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.

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.

On the Net:

New England Journal: http://www.nejm.org