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Sun 13 Jul 2008 04:00 AM

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Mind over matter

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

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.

Trust, confidence, and belief are important parts of the therapeutic relationship.

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.A final possibility is harder to measure, but no less intriguing. It's the placebo effect itself. The mind is as powerful as any organ in the body. People who took their placebo faithfully in the belief it would help may actually have gotten real help.

In fact, the modern treatment of HF includes medications that counter the effects of the stress hormone adrenaline along with additional measures to lower the blood pressure and slow the heart rate.

Medicine is a science, and healing is an art.

It's not much of a stretch to suppose that confidence and belief in a pill can exert similar effects, even if the pill itself is inert. Placebos can be powerful assets - but there can sometimes be a dark side to the placebo effect.

Pricey placebos

In our consumer society, many people believe "you get what you pay for." For example, when a single bottle of wine is split into two portions, tasters typically prefer the sample labeled as expensive over the identical one labeled as "bargain brand."

Wine has a certain snob appeal - but could the same bias apply to medication, or even placebos?

In a 2008 study, researchers at the Massachusetts Institute of Technology tested the ability of placebos to reduce the pain of electric shocks in 82 healthy volunteers.

The scientists administered identical placebos that were touted as painkillers; one was "priced" at $2.50 a pill, the other at $0.10. Both placebos were reported to reduce pain, but the "expensive" one was consistently more effective.

It's only one small study, but it may help explain why some patients prefer brand-name drugs to generic equivalents. Since the volunteers were each paid $30 to participate in this shocking experiment, they may have been particularly price-conscious folks.

The notorious nocebo

Faith in a medication can boost its effectiveness - but fear of a medication can magnify its toxicities. In today's world, everyone knows that medications can produce side effects.

And placebos can, too. In every placebo-controlled trial, some volunteers report ill effects from their placebo, sometimes even unpleasant enough to force discontinuation of the pills. Doctors have a name for this, too: the nocebo effect.

A recent trial is a case in point. The volunteers were 225 men with moderate to severe symptoms of benign prostatic hyperplasia (BPH).

The men were randomly assigned to take saw palmetto or a placebo for one year. At the end of the trial, there was no difference in the men's symptoms or in their urine flow rates, bladder emptying, prostate size, or PSA (prostate-specific antigen) levels.

The results conflict with earlier, briefer trials that found benefit from saw palmetto. Like all "dietary supplements," saw palmetto is not regulated by the FDA, so preparations may vary in potency.

More research is needed to find out if saw palmetto can reduce symptoms of BPH, which preparations are best, and which men are candidates for the herb. If nothing else, though, the current study showed that saw palmetto was safe.

Only 8 of 112 men who took it experienced a serious adverse event during the one-year study. That compares favorably to the placebo: 18 of the 113 men who took the inert pill experienced a serious adverse event. And less important side effects were equally common in the two groups.

The mind matters

The placebo effect is an old story, the nocebo response a newer one. Both reflect the power of belief. At one time, doctors attempted to harness that power by administering inert tablets or injections to people with distressing symptoms that defied diagnosis and treatment with conventional methods.

Although the practice is no longer recommended, a 2008 study found that 45% of clinicians surveyed reported prescribing placebos. And even without resorting to a placebo, a trusting, positive therapeutic relationship between doctor and patient is as important as ever.

It's sadly threatened by the fast pace of today's technologically oriented, evidence-based style of medical practice, but it can never be allowed to vanish. Medicine is a science, and healing is an art.

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