Osteoporosis Treatment No More Effective Than Placebo, Two Studies Show
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Vertebroplasty was once one of the most revered treatments for easing the pain caused by osteoporosis. During the treatment, acrylic cement is injected into cracks in the spinal column. Doctors began performing the procedure in the 1990s and many patients reported instantaneous relief from their terrible pain. The only problem was that no clinical trials were ever performed to see whether the treatment really worked, or if could potentially cause worse problems in the future. In fact, the procedure does have risks—while rare, complications can be serious, including damage to the heart and lungs and even death if the cement leaked into surrounding blood vessels. Moreover, there are also unresolved questions about whether cementing one cracked vertebrae can caused stress on other vertebrae and lead to more breaks in the future. If vertebroplasty is not as effective as it claims to be, then the risks are not justified if there is no real benefit.
Indeed, two new studies cast serious doubt on the effectiveness of the treatment. Studies began several years ago at medical centers in the U.S. and in Australia. Working independently of on another, the two research teams randomly selected patients to either receive the real injection or a placebo. The American team assessed the patients one month after the procedure and the Australian team assessed their patients at one week and then at one, three and six months after the procedure. The results of the study showed that vertebroplasty failed to dramatically improve patients’ pain any better than the placebo.
One of the researchers in the American team, Dr. Kallmes, helped develop vertebroplasty and has been performing the treatment for 15 years. He says he is “shocked at the results”, but knows that other doctors will not be so quick to stop performing the procedure. Specifically, he stated: “the only way medical practice would change would be if Medicare and other insurers were to stop covering vertebroplasty or to cover it only when it was part of a study.” Other doctors, such as Dr. Robert R. Recker of the National Osteoporosis Foundation, said that there needs to be more studies before his foundation abandons vertebroplasty as a viable treatment option. Moreover, Dr. Marcel E. Salive, a director in the Medicare division said Medicare has no national policy on vertebroplasty and has been letting the states decide whether or not cover the treatment—most states have. Dr. Salive also said there are a lack of randomized, controlled studies to provide enough evidence to affect Medicare coverage.
The new studies are indicative of the type of research that health policy experts and President Obama have been calling for, to find out if the nation is spending its health care dollars wisely, on treatments that actually work. A bill passed by Congress this year provides $1.1 billion for effectiveness research.