Tuesday, May 3, 2016

This Procedure Works Great! Oh Wait, This Procedure Doesn’t Work at All!

I recently read a thought provoking book, Cure: A Journey into The Science of Mind Over Body, by Jo Marchant, and I would recommend adding it to your reading list. A chapter in the book is about vertebroplasties, which are procedures done for vertebral compression fractures. Fractures of this sort can be miserable. Vertebral fractures occur when the bones of the spine become compressed; they are usually caused by trauma. They are most likely to happen in elderly patients with osteoporosis. They are painful and can severely limit mobility.

I am an anesthesiologist and have done anesthesia for kyphoplasties, which are very similar procedures to vertebroplasties. A kyphoplasty is where a tube is placed into the vertebral body, a balloon is inserted and filled with cement. This elevates the fracture and stabilizes the bone with the goal being pain relief for the patient. In fact, I vividly remember doing anesthesia for two patients undergoing these procedures. Both patients had significant pain pre-operatively. They were both looking forward to the procedure and were expecting good results.

When I saw them the day after their kyphoplasties, one of the patients had a lot less pain and felt great. The other patient still had some pain, but said it was decreased, and felt pretty good about having the procedure.

This seems like a rather satisfying result. The book I had read got me thinking about what the Treatments Score would be for this procedure. It seems there is a pretty significant decrease in pain levels post procedure usually in the range of a 30-40% decrease in the first few days. There is also an increase in functionality, but there are also some potential significant side effects, and the studies aren’t perfect, so something has to be subtracted to get a Treatment Score. I gave this procedure an initial Treatment Score of 30 for decreasing pain. My Treatment Score Calculator™ looks like this:


This is all well and good except that when two randomized controlled studies were done comparing vertebroplasties vs. sham surgeries, they found that the sham surgeries worked just as well. (Studies have shown similar outcomes when comparing vertebroplasties to kyphoplasties.) If we do a Treatment Score on sham surgery for compression fractures, the score turns out to be almost identical to the score for vertebroplasty as you can see from the Treatment Score Calculator™ below. It should be pointed out that these treatment Scores are in the immediate few days after the procedure. Over a longer time period, such as one year, there is no difference between having the procedure or medical management.


Now being an anesthesiologist, I don’t get to decide who gets what procedure. That decision has already been made by the time the patient reaches me. My job is to get them through the procedure as safely as possible. Having a procedure that doesn’t work any better than a sham surgery raises a lot of questions. Should we even be doing these procedures? Most of the patients with these fractures have osteoporosis and are elderly with significant medical problems. From my point of view, they can have significant anesthetic risks. As mentioned, there are several side effects to these procedures. For instance, there may be a higher risk of compression fractures at other levels, there may be some “sintering of bone” leading to spinal stenosis. I have even heard of a case at another hospital where a patient woke up paralyzed and died a couple of months later. Should I have made my Treatment Score a 0 (zero) since any side effect is not tolerable for a procedure that works no better than a sham surgery?

Why would anyone do a procedure that works no better than a sham procedure? Look at it this way, we have a patient who is in severe pain, unable to function, and all they want is to get better. Most of these patients will get better after this procedure. Medical management like braces and pain killers do not work as well. Do we need to tell patients that the procedure is no better than placebo knowing this will probably decrease the chance of them having a positive result? Some doctors can do these procedures in 15 or 20 minutes and others an hour and a half. Do we need to abandon the procedure if it is taking too long knowing the patient will probably get better anyway?

There are a lot of issues here and a lot of questions. As most of you know all too well, this is very common in medicine. I am not going to be able to answer these questions here and that is not really what Treatment Scores are about. Treatment Scores allow us to know what is already known and it seems apparent that the sham procedure works just as well as the surgical procedure for the patients in the studies I looked at.

It appears to me what we really need is a treatment that works just as well as the sham surgery and has less side effects. Maybe it will involve injection of stem cells or growth factors near the vertebral body. Who knows? I’m just speculating. However, I don’t know if anyone is really looking at the problem in that way and I think that will be another advantage of Treatment Scores. They will give us the ability to find out what is already known, and will make it more clearly apparent what is not known and what we need to find out.

Treatment Scores will also help us to determine what we need to know better. The first studies of vertebroplasties were comparing the vertebroplasty group against patients getting medications and braces, but not surgery. Some of these were randomized and some were cohort studies. The Treatment Score would need to be lowered since the studies were not controlled against a sham surgical procedure. They were not truly controlled studies. With Treatment Scores this would be apparent and at least it would be possible to recognize up front some of the limitations of this treatment. We need to know what we know, know what we don’t know, and we need to know what we need to find out. Treatment Scores can do this. Join us, support us, and let’s keep the TREATMENT TRANSPARENCY movement going.

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1 comment:

  1. Excellent article. The "placebo" effect can greatly affect outcomes. Because the actual surgeries purported to cure the problem, and the patient believed that, they had good outcomes. Makes one wonder how many medical procedures could be eliminated by teaching patients the power of their minds.

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