Wednesday, May 12, 2010

Vertebroplasty No Better Than Sham For Painful Osteoperotic Fractures

At least that's what the New England Journal Of Medicine is reporting. This randomized double blind, placebo controlled study took participants with one or two painful osteoperotic fractures unhealed and less than 12 months old by MRI and randomized them to either vertebroplasty or sham.

For the nonmedical types out there, vertebroplasty and kyphoplasty involves the injection or balloon expansion of a compressed vertebrae, the theory being that this action will decrease the back pain associated with fractures. The only indication to have one, that I'm aware of, is to treat uncontrolled pain.

Interestingly, 5 years ago we didn't have such a procedure. Patients with compression fractures got pain meds and Miacalcin and told to wait it out. They were told that as the bone healed the pain would improve. We would use moist heat and ultrasound to hasten the healing, then soft tissue adjustments.

Today, just about every acute compression fracture with associated pain gets an MRI and then gets evaluated by either an interventional radiologist or an orthopedic spinal surgeon for evaluation for vertebroplasty or kyphoplasty.

In the study above the primary outcome being measure was pain. Using the primary outcome of pain at 1 month, 3 months and 6 months the study showed no difference between the treatment group and the sham (placebo) group.

This is huge. HUGE. Granted, the study was small, but it appears to be well designed.

This is the second clinical study showing that vertebroplasties are worthless. And the studies were performed by spinal surgeons themselves!

People believe that invasive means better. It's engrained in the American culture where you have to be a specialist that does something to be worth your time and money. Why get pain medication or chiropactic care when you can get needles and cement at 1000 times the cost..... that must work.

This study is a fascinating example of the power of special interest groups infiltrated into clinical medicine. Early studies indicated the vertobroplaties and kyphoplasties may have clinical benefit. The key word is "may". They get approved by the Medicare National Bank as showing benefit over placebo and then everything gets paid for at enourmous cost to the MNB.

I would like to know how these procedures ever made it into mainstream medicine without strong scientific evidence to its efficacy, especially considering their cost to the public Treasury. Chiropractors are constantly ridiculed as being "unscientific", yet we have more clinical studies that show what we do works than most surgical procedures do!

Situations like this tend to weaken the standards of Western medicine which are supposed to be science based, but are looking more and more like they are financial based. Get a bunch of device manufacturers to back a less than optimal study design, gain favor from the radiological and orthopedic societies, which have direct finanical interests in the matter, and spread your position statements out to the world. And make it the gold standard.

Medicine is killing us....and you are paying for it!

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