“The line between treatment and placebo is blurrier than ever.”
—Neurologist M. Okun in “Mind Over Matter,” National Geographic, December 2016.
A placebo is the strangest treatment of them all. The moment a patient discovers its method of action, it stops working. A placebo is a treatment recognized as having no clear medical benefit — other than the patient’s satisfaction at having received a concrete form of attention.
The word placebo comes from the Latin, meaning “I please you.” The implication is that the treatment does nothing but satisfy the patient’s need for medical attention. Remarkably, sometimes that’s all it takes to make the problem go away! Therefore, it really is a treatment. Placebo is sometimes used synonymously with “doesn’t work, it’s just there to fool you,” and that is simply not correct. Well, not completely correct. It does indeed fool you, but it can be effective.
Here’s the a placebo mechanism: the mere fact that a person believes in a treatment somehow makes it effective. You gotta believe. “Mind over matter” you might say. Naturally, the more a person believes, the better the placebo effect.
At jury duty a while back, the officer who was reviewing policies and procedures to the huddled masses in front of him made the following announcement: “The water fountain has a foot pedal and a button. Ignore the pedal. It’s just a placebo. It doesn’t work.” Everybody laughed, but that pedal was no placebo. Had the pedal truly been a placebo, one-third of prospective jurors would have found that pushing that pedal had quenched their thirst!
Fully one-third of people will get pain relief from any pill. There are many ways to look at this: it’s wonderful that an inexpensive tablet can help so many patients. On the other hand, look at the amount of money spent on medications that are no more effective than a placebo.
And we haven’t talked about risks yet.
“My friend Mary takes Pain-Go-Away for her knee and she thinks it’s terrific. Stopped her pain like that!” So starts many a conversation. Patients not uncommonly come to the office hoping that I will prescribe the same medication their friend has. It’s not necessarily unreasonable. The fact that Mary feels great with Pain-Go-Away only predisposes my patient that much more toward getting a placebo benefit. On the other hand, if there are medications that are more effective than Pain-Go-Away, it’s unreasonable not to take the better medication.
One of the remarkable findings is that aggressive, invasive treatments such as surgery also have a placebo effect. This is especially true of certain operations designed to alleviate pain, and it applies particularly to the knee. In a very limited study (not involving any of my patients) patients with knee pain underwent a sham arthroscopy. (For this procedure, small holes [portals] are made at the front of the knee. Pencil-like instruments are placed into the knee through the portals, and these instruments are used to address whatever perceived problems exist in the knee.) For the purposes of this study, surgeons only made the two little portals. No instruments were inserted into the knee. I think anyone would agree that making two holes in the knee has no medicinal effect unless we’re back to releasing evil humors. Yet, behold: some of the subjects reported feeling better! It is hard to know what aspect of the treatment provided the placebo effect. Being wheeled into the operating room? The intravenous in the arm? The anesthesia? The surgical pain from the two incisions? The confidence in the surgeon? The relief of really being taken seriously? Or maybe it’s the whole package. As surprising as this finding might be, it really isn’t so astonishing if you consider again how a placebo works: the subject needs to be impressed and to believe. The bigger the treatment, the more expensive the pill, the more well-known the doctor, the more impressionable the patient, the greater becomes the placebo effect. What bigger treatment is there than surgery?
Great Expectations
Once upon a time doctors knew nothing, yet they sounded as though they knew everything. There was a great deal of gentle deception. Not only was this socially acceptable, it was expected. Everybody suspected the doctors’ very limited knowledge. It wasn’t so long ago that doctors didn’t know the difference between veins and arteries. In the days of Shakespeare, doctors had no clue as to why blood could be either dark red or bright red. The term “blood pressure” did not exist. As recently as 1860, Oliver Wendell Holmes is reported to have noted that if all medications “could be sunk to the bottom of the sea, it would be all the better for mankind — and all the worse for the fishes.” Nevertheless, the know-it-all attitude of doctors was critical to the placebo effect — the only effect that could be expected. Nowadays, doctors still don’t come close to knowing everything, but they really do have a great deal of scientific, evidence-based medical information. Because of this new knowledge patients expect a cure every time. In the absence of mystery, patients want to be part of the decision making process. They want to be informed of choices and options. Whereas failure used to be the norm, success is now so common that failure has become unacceptable. Hence the lawsuits and the “I had no idea things could turn out so bad” frame of mind.
This brings up a tricky issue: informed consent. Patients in the United States want to be fully informed. And I agree with this completely. I certainly want to be fully informed before I agree to a procedure, medication, or treatment of any kind for that matter. Having said that, by the time a surgeon finishes talking about all the risks and all the potential complications, he’s pretty much ruined any placebo effect he might have been counting on. In fact, now you’ve got a scared patient. Your patient is at risk for the reverse placebo effect! The subject is so frightened by the thought of a complication that recovery is compromised. If the placebo effect exists for the better, you have to believe that it can occur for the worse.
Given all this, how then does the surgeon explain a procedure to a patient? The surgeon is supposed to inform the patient of reasonable risks but it is up to the surgeon to decide what constitutes reasonable. There is no official catalogue of reasonable risks. I think you have to inform patients of any factor that could lead them to change their mind—but that can vary from patient to patient. Moreover, it’s not just what the surgeon tells you it’s how he tells you. He can rapidly go through the risks in a dismissive tone of voice or he can spell each one out in exquisite detail. In the former case, the surgeon is leading the patient down a falsely rosy path and in the latter he is sabotaging his own practice. Who wants to be operated on by a surgeon who spends so much time talking about complications? He must have a lot of complications to be dwelling on them so much. I’ve seen people leave their surgeon “because he’s such a downer.” But if there isn’t enough preoperative explaining (or perceived explaining), a patient can say she wasn’t adequately informed. Obviously, there is a happy medium, but you can see how tricky a balancing act it is. There is a fine line between being reassuring and being dismissive. The better doctors know how to walk that line.
Making things more complicated is the fact that some patients don’t want to hear about complications. They know they will probably benefit from the planned procedure and don’t want to hear anything negative. To an extent, this is understandable. This attitude keeps patients in a positive frame of mind. They recognize that they are impressionable and subconsciously don’t want to be subject to the reverse placebo effect. Unfortunately, in today’s legal climate it is impossible not to discuss potential complications.
Do you know why hospitals pay large sums of money to have one of their doctors anointed team doctor for a professional team? Placebo. Patients want to be treated by the doctor who treats their favorite athletes. That doctor has to be good, right? The patient now has just one degree of separation from their athletic hero! Their chest swells with pride at the mere thought of this association. They’re psyched! Their knee has to get better. And the fact is, it often does. Then, they refer their friends.
The down side
So why do placebos get such a bad rap? Money, risks, and diversion.
Diversion. Effective treatments exist for many conditions. For example, if you’ve just had an outpatient knee operation, we know that certain medications will control the pain. If instead, someone offers you a placebo that by definition may or may not work, they are diverting you away from a sure thing.
This may not be serious when we are only dealing with pain. After all, you can always switch back to a proven pain medication. But it is certainly serious if you are treating an infection, a heart attack, cancer, or any other condition where time is critical. Serious harm can befall you if you waste precious time on a placebo. (This seems to have been an issue with Steve Jobs.)
Risks. It’s one thing if a placebo is harmless, it’s quite another if there are significant risks associated with its use. The Hippocratic oath taken by every medical student states, “And first do no harm.” A little starch pill won’t do you any harm nor will water with a small amount of FDA-approved coloring in it. But a pill that can affect your kidney or a treatment associated with surgical complications, these are quite another story. ALL medications have potential side effects, as of course does surgery. It’s one thing to take a chance on a treatment that has a very good chance of working, it’s another to take that same chance on a treatment with a much lower success rate.
Money. Somebody’s paying for your treatment. It may even be you. In fact, it’s definitely you. It’s just a question of whether you are paying directly or via premiums to an insurance company or via taxes. No one minds paying for safe and effective treatments. Placebos, though, aren’t predictable in their effectiveness. No insurance (including the government) wants to shell out money for those kinds of odds. Too bad in a way, because an expensive medication is going to have a better placebo effect than an inexpensive one! Think about it: What makes you feel better about your visit to the doctor? A prescription for “Naproxen 250 mg bid sig#30” on the doctor’s formal prescription pad or a simple recommendation to take over-the-counter Aleve® twice a day? Yet the two are essentially the same.
Reality
The FDA does not give its seal of approval to pain medications that are recognized to be placebos. Why not? Easy: If you tell people that you are selling a placebo, the placebo effect will be lost! People have to believe it’s real medication. And if you don’t tell people it’s a placebo, then you’re guilty of deception. The government is not into that—at least not at this level.
Manufacturers of nutritional supplements don’t have those qualms. A nutritional supplement is often a product found in nature. It hasn’t been created by mankind. It is something you might ingest in common food products. These nutritional supplements generally fall outside the purview of the FDA. Manufacturers make many claims pertaining to these products. Some of these are true, some are not. Some are impossible to prove or disprove at this point. For example, if someone claims that a certain product will make us live longer, who’s going to know if that’s true or not until we’re all gone? Some supplements work because of a specific scientific principle, some work purely on a placebo effect, and in some cases it isn’t clear at all. Glucosamine and chondroitin sulfate fall into this latter category. In any case, people buy nutritional supplements in huge quantities; they buy them out of their own pocket (no insurance pays for this), and if they feel better from the placebo effect, so be it.
Real medicine versus placebos
How does the FDA protect us from placebos? It demands controlled clinical trials. One group of patients gets the new medication while another group gets a pill that looks the same but made of a (presumably) inert substance. Ideally, the study is double blind: neither the doctor nor the patient knows whether he or she is getting the medication or the placebo. They just know it as A or B. After a period of time, the code is revealed. Everyone then knows who got what, and the effectiveness of the medication can be compared to that of the placebo. In fact, that’s how people discovered that placebos work! Because even in the placebo group people got better!
In order for a medication to be approved by the FDA it has to be deemed safe (though no medication is 100 percent safe) and it has to work better than a placebo. Is a 30 percent success rate good enough for the FDA? If a placebo works on 2 percent of subjects, the answer is yes. If, however, a placebo was found to work on 29 percent of patients tested the answer is no! When it comes to pain, that’s the success rate that we’re talking about. So if 30 percent of your friends who’ve tried this new natural pain medication tell you they love it, they’re just getting a placebo effect. But don’t tell them, you’ll ruin it for them.
Placebos über alles?
It is not terribly surprising to find that a placebo alleviates pain. Pain is not a monolithic entity. It’s more like a layered cake. There’s the actual pain and there is the anxiety associated with it. In some cases the anxiety component is by far the major factor, and it’s easy to see how the power of suggestion could address this. I find this all the time when giving injections. Some people clench their fists, break out into a sweat, and cry for their mother at the mere mention of an injection, while others coolly file their nails.
It is harder to imagine how a placebo affects conditions seemingly unrelated to anxiety. The chest pain you get from shoveling snow is due to a lack of oxygen to your heart and is called angina. Parkinson’s is a degenerative condition of certain brain cells that can lead to stiffness and tremors. Colitis is an inflammation of the colon. Asthma is a constriction of the air ducts in the lungs. Warts are nasty growths. None of these conditions should be amenable to a placebo, yet all have been found to be (albeit to a certain extent). Where does it end?
Unfortunately, people still get sick and die even when they fervently believe. Cancer is an area that has not been vanquished by placebos. It is therefore a dangerous area to fool around in. The same holds for bacterial infections. People used to die from what today would be called simple infections. Appendicitis was a killer. (Even Houdini could not escape.) If you develop a bacterial infection you want an evidence-based medication.
A little respect
What then should be organized medicine’s stand on placebos? Once upon a time, placebos, these “lies that heal,” were just about the only form of treatment available. Though they could not cure cancer nor arrows through the heart, they helped a large number of patients afflicted with a remarkable array of conditions. No one questioned the doctor about his treatment. He was above reproach (there were no shes then). Everyone knew that the doctor’s cure rate was limited, but any chance of success lay greatly in belief.
Society has now turned 180 degrees. We expect victory and want no part of any phoney-baloney. The doctor has been stripped of mystery and magic. Instead of the haughty, paternalistic physician who looks down his nose through those little glasses and tells you you’ll get better, you have the kinder, gentler doctor who tells you about all the terrible things than can go wrong. We are winning the battle over conditions that require science and losing out on those that just need a little placebo. Doctors no longer dare be paternalistic. Society does not accept this.
If a treatment is no better than a placebo, it is reasonable to abandon the treatment, especially if it is expensive or risky. But how about adopting the placebo as the formal treatment? We have arrived at an interesting point in our medical advances: we understand that diseases all have a scientific basis and we have developed scientific treatments for many of these conditions. Many, not all.
Maybe we should take a more scientific look at placebos.
The Reverse Placebo
As noted above, a patient who overly worries about failure and complications is setting him/herself up for a poor result.
On a related note, patients given a diagnosis of a herniated disc, a torn rotator cuff, a torn ligament, a torn meniscus, a torn anything will think of themselves as wounded. This messes with their mind: they baby themselves; they can’t do this; they can’t do that. This protective behavior can on occasion be appropriate; but when the tear or herniation is but an MRI finding with no clinical relevance, the MRI report without appropriate counseling has been harmful to the patient.
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