Doctors trust placebos while facing a dilemma.

It appears that physicians intuitively know that placebos work. At least they act in a way that is consistent with this belief. A national survey of medical internists and rheumatology specialists in the US (Tilburt, 2008) showed that about half of these professionals prescribe medications as placebos on a regular basis. Most physicians (62%) believed this practice to be ethical. Yet, only 5% tell their patients they are receiving a placebo. They typically describe the placebo treatment to be “potentially beneficial” or “not typically used for their condition” (68%).

Medications used as placebo were, in order of popularity: Painkillers (41%), Vitamins (38%), Saline Solution Injections or Infusions (18%), Antibiotics (13%), Tranquilizers (13%), and Sugar pills (12%).

A meta-analysis review of 22 studies conducted in 12 countries supported these findings and found that the use of placebos outside of clinical trials is considerable (Fässler, 2010).

This poses an ethical dilemma: The American Medical Association (AMA) advocates against the use of placebos without the patient’s knowledge.

Trust and transparency in a collaborative care model

If we want to empower care teams we need to build on trust and transparency. Keeping the patient somewhat in the unknown may be beneficial in an authoritative care model, but for more active patients who are competent partners in their own care we need to be more transparent. This includes how we use placebos as well.

When a pure placebo, such as a sugar pill, is administered in a deceptive way, that’s a violation of the patient’s trust.

When an active drug, such as an antibiotic, is given as a placebo that’s a violation of trust and of the “First do no harm” principle.

The exposure to the potential side-effects from active ingredients in painkillers, antibiotics, or tranquilizers poses a real health risk for some patients. In addition, prescribing antibiotics as placebo adds to overuse and increases population-wide antibiotic-resistance.

We have a significant problem: strong demand (for placebos) matched with a lousy solution (prescribe drugs as placebo).

This is a great opportunity for those who can solve it. A good solution will deliver placebo benefits without deception and avoid side-effects from active ingredients. Well, there is good news.

News: Placebo without deception enhanced treatment.

In a break-through study, Ted Kaptchuck at Harvard Medical School’s Osher Research Center and Beth Israel Deaconess Medical Center (Kaptchuk, 2010) tested the effects of honest placebo in patients with Irritable Bowel Syndrome (IBS). In this study the patients knew what they were getting:

a) placebo + standard treatment

b) standard treatment alone

80 patients with IBS were randomly assigned to both groups. Patients in the placebo group took their placebo pills twice a day from a bottle clearly labeled ‘Placebo’. Patient-provider interaction was maintained in both groups. The participants were given some points to remember. They were told that even though the placebo pills contained no active ingredients, placebos used in clinical trials had shown to be somewhat beneficial. Those who did not receive a placebo were assured that their participation was essential for the study.

Patients who participated in the study answered questionnaires at study start and at days 11 and 21. Their health outcomes were measured using the IBS Global Improvement Scale, the IBS Symptom Severity Scale, IBS Adequate Relief, and the IBS Quality of Life scales.

The patients who received the honest placebo in addition to standard treatment did a lot better than the patients who received standard treatment alone.

The difference was statistically significant and clinically meaningful. In other words:

a) Researchers using statistical methods were highly confident that the differences between both groups were real.
b) Clinicians and patients found that the size of this difference really mattered in the life of a patient with IBS.

Kaptchuk’s study was a real break-through in several ways:

  • the major first investigation of open placebo use
  • offered a practical approach for the administration of honest placebo use in clinical care
  • delivered a solution that uses pure placebo
  • potential to increase acceptance for honest placebo use
  • shows a path for more placebo research to come

Since open placebo studies are only a recent concept, most studies covered in this book had a design of either keeping the patient in the unknown or coerce the patient into believing they are received an active drug. Let’s just keep in mind that these studies are basically Placebo 2.0 studies. We can still learn a lot from these. Would we find similar results if these studies were done with open placebo? I believe in most cases we would. Ted Kaptchuk, with his break through study of honest placebos, ignited research to confirm that Placebo 2.0 effects also apply to Placebo 3.0.

In the meantime, while more research results are coming in, consumers, patients, and doctors can start designing pure and honest placebo-experiences that complement standard care in a personalized, safe and ethical way.