We're used to medications being regulated to the highest standards. Pharmaceutical companies have to provide reams of data from scientific studies before gaining a license to market a drug.
But what about surgery? Strangely, for something that has the potential to cause such harm, surgery is not regulated in the same way as medications. Because of this, there's less research looking at how well different types of surgery work, compared to the evidence for drugs. This can mean a surgical technique becomes quite widely used before its effectiveness is established.
One type of surgery that's become popular over the last decade or two is vertebroplasty. In vertebroplasty, a type of cement is injected into the vertebrae of the spine. The procedure is done to treat compression fractures of the spine, usually caused by osteoporosis. These fractures can cause disability and pain. Vertebroplasty is intended to strengthen the spine, relieve pain, and reduce disability.
Yet, despite the popularity of the procedure, the American Academy of Orthopedic Surgeons has just released a guideline saying it doesn't work, and shouldn't be used.
They reviewed all the literature about the procedure, and found two good-quality studies (randomized controlled trials) that show vertebroplasty works no better than a fake (placebo) procedure. There were no clinically significant differences in pain or disability, they say.
In this case, it probably comes down to what you mean by significant pain relief. The US surgeons set a strict definition—hey said a difference in pain relief of less than 2 points on a 10-point scale was not meaningful for patients. Smaller differences in pain relief were recorded in the studies, but, say the surgeons, they were not big enough to make a real difference.
The surgeons say the evidence against vertebroplasty is strong, and they don’t expect future studies to overturn their recommendations. It seems odd that such widely used techniques are not subjected to more rigorous research before becoming standard operating procedure.
What you need to know. If you're considering any type of surgery, ask your surgeon to show you data about how likely it is to solve your problem. A surprising number of operations are done without clear evidence that they benefit the patient.
—Anna Sayburn, patient editor, BMJ Group
ConsumerReportsHealth.org has partnered with The BMJ Group to monitor the latest medical research and assess the evidence to help you decide which news you should use.
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