A widely used surgical procedure in which cement is used to fortify cracks in the spine is no better than a sham operation, two groups of researchers independently reported Wednesday in the New England Journal of Medicine.
The findings shocked clinicians because the procedure, first introduced in the early 1990s, is now widely accepted and assumed to be effective at relieving pain and improving mobility. About 80,000 such procedures, called vertebroplasties, are performed in the United States each year, primarily in the elderly.
The spinal cracks typically are a result of thinning of the bones caused by osteoporosis. The operation typically costs as much as $3,000, although Medicare pays only about two-thirds of that amount.
The procedure is so widely accepted that researchers had a hard time enrolling patients in the clinical trial because patients feared being placed into the placebo group.
The findings should provide powerful support for increased testing, wrote Dr. James Weinstein of the Dartmouth Medical School in Hanover, N.H., in an editorial accompanying the reports..
In one of the new studies, supported primarily by the National Institutes of Health, Dr. David Kallmes of the Mayo Clinic and his colleagues enrolled 131 patients; 68 received a vertebroplasty and 63 received a sham procedure in which the back was numbed, surgeons pressed on it as if they were injecting cement, and the patients were exposed to the distinctive odor of the cement.
Both groups of patients reported a significant reduction in pain and improvements in quality of life during the follow-up period.
In the second study, epidemiologist Rachelle Buchbinder of Monash University in Australia and her colleagues performed a similar study on 71 patients, with identical results. Kallmes suspects that the improvement in pain reduction may have come from prolonged effects from the drugs that were used to numb the back in both groups. He is now beginning a second trial to test the benefits of such numbing.
It is also possible that many or all of the benefits derive from a placebo effect — simply from patients’ perceptions that something is being done for them.
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