Mind over matter

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Do placebos have a role to play in treating patients?

Modern physicians practice evidence-based medicine. Whenever possible, they use the latest scientific studies to plan their tests and guide their treatments. Even so, medicine is an art as well as a science.

Trust, confidence, and belief are important parts of the therapeutic relationship, and they can have a powerful effect on healing.

Scientists understand the importance of expectations and beliefs. They know that some patients feel better after they take a medication, even if the drug turns out to be entirely ineffective.

Doctors call it the "placebo effect." It's well-named, since the term is derived from the Latin placere, or "to please."

When researchers want to find out if a new medication is safe and effective, they test it against a placebo, an inert, inactive "dummy" pill that looks, tastes, and smells exactly like the test medication.

In the best experiments, the patients are randomly assigned to take either the placebo or the test pill, and neither the volunteers nor their doctors know which is which until the study is over.

In medical lingo, these studies are called placebo-controlled, double-blind randomized clinical trials.

Science is important, but so are ethics. Randomized clinical trials must be carefully planned, with safety as the top priority.

Before they go forward, they are cleared by the agency that is funding the research and by institutional review boards, which function as "ethics czars" at participating medical centers.

In addition, the studies are monitored by safety officers as they proceed. Above all, the patients must be true volunteers who are fully informed about the risks and benefits of the study and are free to decline or withdraw without prejudicing their care.

Randomized clinical trials are complex, slow, and expensive - but they are essential. And two studies show just how potent placebos can be.

The placebo effect

Heart failure (HF) develops when the heart muscle is weakened and is unable to pump blood to the body's tissues with its normal efficiency. Typical symptoms include fatigue, weakness, shortness of breath, and fluid accumulation in the legs, abdomen, and lungs.

Heart failure is both common and serious. Fortunately, randomized clinical trials have taught doctors to use combinations of up to five drugs to treat HF, with dramatic relief of symptoms and equally impressive improvements in survival.

The CHARM study tested candesartan (Atacand) against a placebo in 7,599 patients with HF. The drug, an angiotensin-receptor blocker widely used for high blood pressure, was effective, reducing the overall mortality rate by 10%.

The results were expected, since similar medications are also effective in HF. In addition, researchers found that patients who took candesartan as directed, consuming at least 80% of the prescribed doses, had a 34% lower death rate than patients who did not take the drug faithfully. That finding was also expected.

In a new report, the scientists went one step further by studying the placebo group in detail. And this time, the results raised more than a few eyebrows: the patients who took the placebo as directed had much better results than those who missed over 20% of their doses.

In fact, people who took the placebo faithfully had a 36% lower death rate than patients who missed more than 20% of their doses - an improvement that was on par with the participants who faithfully took the real drug.

The placebo used in the CHARM study was a true dummy pill, entirely inert and devoid of biological activity. Even so, taking it regularly was associated with just as much benefit as taking candesartan regularly. That's a powerful placebo indeed.

What explains these surprising results? The CHARM investigators themselves were unsure, but several possibilities come to mind.

First, the patients who did not take their pills regularly may have been sicker than the compliant patients, perhaps too ill to follow instructions. But the scientists excluded this explanation; the patients in both groups had the same degree of HF and severity of illness.

A second explanation is more likely. Treating HF is very complex. It involves up to five medications, strict dietary salt restriction, appropriate exercise, and diligent monitoring.

Patients who skipped their pills - be they active or placebo - may have cut corners on these other measures as well, with unfortunate results.

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