Yesterday a friend called to say his mother, who suffered from osteoporosis, had suddenly experienced severe upper localized high back pain. He asked what he should do.
I suggested she might have a compression fracture of her vertebra. I referred him to a local primary care doctor. In a brief conversation I had with the doctor, he told me a pressurized injection of medical cement by an orthopedic surgeon into the fractured vertebra body often immediately relieved pain.
I also spoke to a medical internist friend who wife had vertebral fractures treated with similar procedures. He said his wife, who had multiple fractures, had mixed results, with quick relief in some instances and none in others, and with return of pain in some instances after initial relief.
Today I received the August 6 NEJM which, as luck would have it, contained two lengthy multicenter randomized, clinical trials on verterbroplasty with cement injection for painful spinal fractures. One study had 78 participants, the other 131.
Both trials had similar equivocal results between injected and control groups. The latter were given simulated injected. In other words, cement injection was no better than a placebo.
I tell this story because it vividly highlights the painful dilemma, or perhaps I should say “the dilemma with pain,” clinicians and payers will face in the future, namely, whether to inject the cement, and whether and how to pay for it?
Answering these questions are, after all, what comparative effectiveness trials are all about. Should doctors try to relieve pain in the short term, and should government and health plans pay? Annualized direct care expenditures for osteoporotic fractures in the United States in 2002 were $12 to $18 billion, roughly $2000 per patient. The number of verterbroplasty procedures has doubled in the last 6 years. In a procedure that may be no better than a placebo, who should decide who gets treated – the doctor, the payer, health plans, or government?
Is injecting cement into a fractured vertebra over-treatment or compassion to relieve pain? What are the financial consequences of giving injections to the 750,000 patients in whom these fractures occur each year? And given the increased use of this procedure, which is skyrocketing, and its limited benefits, and potential risk, should it be done at all? Should patients be informed of cost and consequences and given a choice? Like many treatments in medicine, there is no black and white, and shades of gray and mixes of Art and Science.
References
1. R. Buchbinder et al, “”A Randomized Trial of Vertebroplasty for Painful Osteoporotic Veterbral Fractures, “ NEJM, 662: 557-568, 2009; and Kalimes, D.A, “A Randomized Trial of Vertebroplasy for Osteoporotic Spinal Fractures, NEJM, 661: 569-579, 2009.
2. Weintstein, JA., “Balancing Science and Informed Choice in Decisions about Vertebroplasty, NEJM, 361:619-621, 2009.
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2 comments:
When poorly executed articles such as this get major press by being published in so-called 'prestigious journals'--such as JAMA, NEJM, BJM, and The Lancet--our corporate-run national media latches on to them and farms it out to everyone with a TV/internet. This, regrettably, is how the average medically unsophisticated person typically gets their information.
First, the suggestion that vertebroplasty (or, by inference, kyphoplasty) doesn't work is simple nonsense. However, let me define this in terms that the authors didn't. Vertebroplasty is highly effective at fixing acute pain from vertebral compression fractures (VCF). It doesn't treat any other kind of back pain. Second, patients who get VCFs tend to get additional fractures. VCF is not the only cause of midline/axial back pain. Another common cause is facet pathology that can be helped by blocking the median branch.
Major problems:
1. Not enough patients. Not only did the studies fail to their target number of patients, too many patients declined to enroll in the study. Translation: the patients who were more likely to benefit from vertebroplasty went on to have vertebroplasty anyway because they didn't want the risk of having to continue living with the pain.
2. Poor patient selection/Wrong patients. The patients that were actually in the study had relatively low pain ratings. Physicians who perform these procedures will tell you that their typical patient rates their pain from 8-10 on a scale from 1-10.
3. Flawed sham procedure. What the authors describe as a sham procedure actually amounts to a facet block. This is relatively effective procedure for one of the most common causes of midline axial back pain. Take this and the relatively low pain ratings, it is likely that many of the patients had facet mediated pain and the sham procedure was actually a treatment for that.
4. Crossover. Patients were allowed to crossover after one month. Of the control/sham patients, almost half of them chose to switch groups (have a vertebroplasty). Yet 88% of the vertebroplasty group patients chose not to crossover. This is consistent with previous studies showing efficacy of vertebroplasty around 85-95%.
5. Statistical significance. The authors state that there was no significant difference in pain levels after one month, but that the vertebroplasty group tended to have better pain relief at 3 months compared to the control/sham group. That is congruent with a positive result from a facet injection wearing off.
Summary
1. Patients who were more likely to benefit from vertebroplasty went on to have vertebroplasty anyway and weren't included in the study.
2. This was not a properly controlled-study; the sham procedure was essentially a facet block.
3. Almost half of the patients in the 'control' group eventually elected to have vertebroplasty.
4. 88% patients who had vertebroplasty were happy with the results.
Lastly, for those who have had patients who have undergone vertebroplasty or kyphoplasty, you know without a doubt how effective these procedures are. I find it almost farcical that this paper was published in NEJM. However, this type of so-called Evidence Based Medicine shouldn't surprise any of us as we are heading down a road toward increasing government interference in the doctor-patient relationship.
The other major aspect that must be part of the discussion is evaluating the serious consequences of vertebral osteoporosis beyond acute fracture pain. Vertebral fractures lead to kyphosis. Kyphosis shifts the center of gravity unnaturally forward, thus increasing axial load on the anterior column of nearby, already osteoporotic vertebrae. In short, kyphosis begets kyphosis. Patients with VCFs and kyphosis have markedly higher rates of pulmonary mortality than patients without them. Osteoporotic bone is, by definition, diseased. It doesn't remodel like healthy bone. When osteoporotic vertebral bodies fracture, they generally don't lose a great deal of height immediately. They, if untreated, progressively collapse over many months until finally "settling." Vertebroplasty/kyphoplasty not only provides immediate pain relief allowing elderly patients to quickly return to normal activities, it also prevents further progression of kyphotic deformity (related to that vertebral body).
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