Two studies and an editorial in the New England Journal of Medicine report on a widespread treatment for painful vertebral fractures. (NEJM Article) (NEJM Article) (NEJM Editorial) The treatment involves injection of a bone cement. In both studies, treatment with the cement was compared to a sham treatment. Primary and secondary outcomes were pain scores and functional status assessment. Both studies showed little, if any, difference in outcomes between the real and sham treatment. All patient groups showed significant improvement. The results are likely due in part to the placebo effect, to the fact that the condition would naturally improve over time no matter what and tendencies for patients to regress to the mean over time.
The results are notable in several respects. One is that this has become a relatively widespread treatment which costs thousands of dollars. If there is truly no overall benefit compared to a sham treatment, it appears to be a significant waste of money. Another is that like any medical care, particularly invasive procedures, there are associated risks and adverse events which can engender further spending. This procedure had been the subject of earlier, non-randomized trials which showed favorable results. The current studies show the danger of relying on such trials, whose results may often overestimate treatment effects. Finally, this is an example of the value of rigorous comparative effectiveness research. These studies can be used to inform physician and patient decision-making, which in this case should mean far less use of the procedure, saving money and avoiding potential adverse events.
