Vertebroplasty isn’t any better than a placebo

Injections of bone cement into fractured vertebrae fail to relieve pain any more than a placebo does, researchers found.

Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn’t Helping (by Gina Kolata at the New York Times)

Scientists warned osteoporosis patients on Thursday to avoid two common procedures used to shore up painful fractures in crumbling spines.

The treatments, which involve injecting bone cement into broken vertebrae, relieve pain no better than a placebo does, according to an expert task force convened by the American Society for Bone and Mineral Research.

The task force noted that the pain goes away or diminishes within six weeks without the procedure. Patients should take painkillers instead, the experts said, and maybe try back braces and physical therapy.

Patients also should take osteoporosis drugs to slow bone loss, said Dr. Peter Ebeling, head of the department of medicine at Monash University in Australia and lead author of the new report, which was published in the Journal of Bone and Mineral Research.

A patient who has had a spine fracture and does not take the drugs has a one-in-five chance of developing another fracture in the next year. With the medications, the odds are one in 20.

The new advice may not sit well with many doctors and patients. For chronic pain caused by fractured vertebrae, there are few good treatments. And many patients believe the procedures eased their pain and increased their mobility.

“That’s why people don’t want to let go of this,” said Dr. Alan S. Hilibrand, a professor of neurological surgery at Jefferson University and a spokesman for the American Academy of Orthopaedic Surgeons.

Surgeons use two methods to deliver the bone cement. In one operation, vertebroplasty, the cement is injected directly into the injured vertebra. In a newer procedure, kyphoplasty, doctors inflate a balloon to elevate the broken bone into position, and then inject the cement.

The treatments are widely advertised and promoted by companies that make surgical devices and bone cement, as well as groups such as the National Osteoporosis Foundation.

Insurers generally cover the treatments. Medicare pays about $2,400 to $3,000 for vertebroplasty, and $6,500 to $10,000 for kyphoplasty, depending on where the procedure is performed.

To assess the effectiveness of the two methods, the task force reviewed previously published data.

Vertebroplasty was tested in five rigorous trials with placebo controls, the task force found. Subjects who received sham procedures reported just as much pain relief.

Moreover, for those who had the treatment, pain relief did not last, said Dr. Bart Clarke, president of the A.S.B.M.R., who wrote a perspectiveaccompanying the task force report.

After a month, pain among these patients was no less than it was among patients who did not have cement injections.

Kyphoplasty has not been subjected to such rigorous evaluations, but it has been compared with vertebroplasty in a few small trials. In terms of pain relief, the two procedures were roughly equivalent.

“If one of these procedures is going to be offered, the patient should be informed that there is a minimal chance it will help,” said Dr. Ebeling, who conducted one of the first randomized trials of vertebroplasty.

“The natural history is that pain will get better over the next four to six weeks,” he added. “That’s what I tell my patients.”

Australia’s health care system stopped paying for the procedures in 2010, after two placebo-controlled trials failed to find a significant effect, and their use dropped by about 70 percent, Dr. Ebeling said.

The problem for doctors and patients is that even if the pain diminishes with time, patients may be desperate for relief in the short term. The cement injections can seem to offer that.

Suppose a patient is incapacitated by pain from a broken vertebra, said Dr. Joshua A. Hirsch, a back-pain specialist at Massachusetts General Hospital. Is it so bad to offer bone cement?

“You have a choice,” said Dr. Hirsch. “Opiates and lying in bed with diminished activity, or a procedure that can mobilize patients and improve them.”

Then there are the difficult patients, perhaps 10 percent of the total, whose severe pain lingers for months.

Dr. Hilibrand said he agrees with the task force’s findings, but if patients “still have recalcitrant pain one to three months after the fracture, this is an option. Do you withhold treatment and have them continue to suffer?”

Dr. David Kallmes, a radiologist at the Mayo Clinic and one of the first doctors to cast doubt on vertebroplasty, said he understands the appeal.

“I have seen miracles with vertebroplasty,” he said. “But the data are the data.”

He tries to talk patients out of the treatment, describing the risks, which are small but real, including bleeding, infections, leakage of the cement, and new fractures from the procedures.

He explains the lack of benefit. But if a patient insists, he sometimes performs the procedure anyway.

“If it’s not done by me, it will get done by Joe down the road,” he said.

Gina Kolata writes about science and medicine. She has twice been a Pulitzer Prize finalist and is the author of six books, including “Mercies in Disguise: A Story of Hope, a Family’s Genetic Destiny, and The Science That Saved Them.” @ginakolata • Facebook