In order for a drug to be approved by the FDA, it must show itself better than a placebo, or a fake drug. This is because of the placebo effect, which we discussed last week, where patients often improve just because they think they're being treated with something. If we don't have a placebo, or fake therapy, then the benefits seen by a new drug may be nothing more than wishful thinking.

But when it comes to medical devices in surgery, the requirements aren't the same. Placebos aren't required. That's likely a mistake. On the other hand, how might placebos work in surgery? It actually turns out that fake, or sham, procedures have been around for quite some time. And they're important. Surgical placebos are the topic of this week's Healthcare Triage.

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At the turn of this century, arthroscopic  surgery for osteoarthritis in the knee was common. Basically, surgeons would clean out the knee using arthroscopic  devices. They'd make small incisions, and then insert tools to do the job.

Another common procedure for the issue was lavage, where a needle would inject saline into the knee to irrigate it. The thought was that these procedures likely removed fragments of cartilage and calcium phosphate crystals that were causing inflammation. A number of studies have shown that people who underwent both of these procedures improved more than people who didn't.
However: a growing number of people were concerned that this was really no more than placebo effect, and in 2002, a study was published that proved it.

One hundred and eighty patients who had osteoarthritis of the knee were randomly assigned to one of three groups. The first had a standard arthroscopic procedure, and the second had lavage. The third, however, had sham surgery.

They had an incision, and then a procedure was faked so that they didn't know that they actually had nothing done. Then the incision was closed. The results were stunning: those who had the actual procedures did not better than those who had the sham surgery. They all improved the same amount. The results were all in people's head.

Many were angry that this study occurred. They thought it was unethical that people underwent an incision and likely got a scar for no benefit. But, of course, the same was actually true for the people who had arthroscopy or lavage. They received no benefit either.
Moreover, the results did not make the procedure scarce. Years later, more than a half million Americans underwent arthroscopic surgery for osteoarthritis in the knee. They spent about three billion dollars a year for a procedure that was no better than placebo.
Sham procedures for research aren't new. As far back as 1959, the medical literature was reporting on small studies that showed that procedures like internal mammary artery ligation were no better than fake incision for angina.

And yet, in 2005, a study was published in the Journal of the American College of Cardiology, proving that percutaneous laser myocardial revascularization didn't improve angina better than placebo either. We continue to work backwards and use placebo controlled research to try and convince people not to do procedures, rather than use it to prove conclusively that they work in the first place.

A study published in 2003, without a sham placebo control, showed that vertebroplasty, or cement, worked better than no procedure at all. From 2001 through 2005, the number of Medicare beneficiaries who underwent vertebroplasty each year almost doubled, from 45 to 87 per 100,000. 

Some of them had the procedure performed more than once, because they failed to achieve relief, but in 2009, not one but two different placebo-controlled studies were published, proving that vertebroplasty for osteoporotic vertebral fractures worked on better than faking the procedure.

Over time, after the 2002 study showing that arthroscopic surgery didn't work for osteoarthritis in the knee, the number of arthroscopic procedures performed for this indication did begin to go down, but at the same time, the number of arthroscopic procedures for meniscal tears began to go up fast. Soon, about 700,000 of them were being performed each year, with direct costs of about 4 billion dollars. Ironically, less than a year ago, many were shocked when arthroscopic surgery for meniscal tears in the knee performed no better than sham surgery. This procedure was the most common orthopedic procedure performed in the United States.

The ethical issues aren't easily dismissed. Theoretically, a sugar pill carries no risk, and a sham procedure does. This is especially true if the procedure requires anesthesia. The surgeon must go out of his or her way to fool the patient. Many have difficulty doing that. But we continue to ignore the real potential that many of our surgical procedures and medical devices aren't doing much good.

Rit Redbergs, in a recent New England Journal of Medicine Perspectives article on sham controls in medical device trials, noted that in a recent systematic review of migraine prophylaxis, while 22% of patients had a positive response to placebo medications, and 38% had a positive response to placebo acupuncture, 58% had a positive response to placebo surgery. The placebo effect of procedures is not to be ignored.

Earlier this year, researchers published a systematic review of placebo controls in surgery. They searched the medical literature from its inception all the way through 2013, and in all that time, they could find only 53 randomized controlled trials that included placebo surgical arms. In more than half of them, though, the effect of sham surgery was equivalent to that of the actual procedure.
The authors noted, though, that with the exception of the studies of osteoarthritis in the knee and internal mammary artery ligation that I already talked about, and I'm quoting, "most of the trials did not result in a major change in practice."

We have known about the dangers of ignoring the need for placebo controls and research on surgical procedures for some time. When the few studies that are performed get published, we ignore the result and their implications. Too often, this is costing us many, many billions of dollars a year and potentially harming patients for no apparent gain.

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