December 27, 2010

YOU MEAN WE CAN'T JUST TELL THEM TO, "SUCK IT UP, BUTTERCUP"?

Meet the Ethical Placebo: A Story that Heals (Steve Silberman, December 22, 2010, PLOS)

For a complex and somewhat mysterious set of reasons, it is becoming increasingly difficult for experimental drugs to prove their superiority to sugar pills in RCTs, which was the subject of an in-depth article I published in Wired called “The Placebo Problem,” recipient of this year’s Kavli/AAAS Science Journalism of the Year award for a magazine feature.

Only in recent years, however, has it become obvious that the abatement of symptoms in control-group volunteers — the so-called placebo effect — is worthy of study outside the context of drug trials, and is in fact profoundly good news to anyone but investors in Pfizer, Roche, and GlaxoSmithKline. The emerging field of placebo research has revealed that the body’s repertoire of resilience contains a powerful self-healing network that can help reduce pain and inflammation, lower the production of stress chemicals like cortisol, and even tame high blood pressure and the tremors of Parkinson’s disease.

Jumpstarting this network requires nothing more or less than a belief that one is receiving effective treatment — in the form of a pill, a capsule, talk therapy, injection, IV, or acupuncture needle. The activation of this self-healing network is what we really mean when we talk about the placebo effect. Though inert in themselves, placebos act as passwords between the domain of the mind and the domain of the body, enabling the expectation of healing to be translated into cascades of neurotransmitters and altered patterns of brain activity that engender health.

That’s all well and good, but what does it mean in the real world of people getting sick? You can hardly expect the American Medical Association to issue a wink and a nod to doctors, encouraging them to prescribe sugar pills for seriously disabling conditions like chronic depression and Parkinson’s disease. Meanwhile, more and more studies each year — by researchers like Fabrizio Benedetti at the University of Turin, author of a superb new book called The Patient’s Brain, and neuroscientist Tor Wager at the University of Colorado — demonstrate that the placebo effect might be potentially useful in treating a wide range of ills. Then why aren’t doctors supposed to use it?

The medical establishment’s ethical problem with placebo treatment boils down to the notion that for fake drugs to be effective, doctors must lie to their patients. It has been widely assumed that if a patient discovers that he or she is taking a placebo, the mind/body password will no longer unlock the network, and the magic pills will cease to do their job.

Now, however, a group of leading placebo researchers — including Irving Kirsch at the University of Hull in England (who I interview at length below) and Ted Kaptchuk at Harvard — has produced a little bombshell of a study that makes these assumptions obsolete. For “Placebos Without Deception,” the researchers tracked the health of 80 volunteers with irritable bowel syndrome for three weeks as half of them took placebos and the other half didn’t. A painful, chronic gastrointestinal condition, IBS is serious business. It’s one of the top ten reasons why people seek medical care worldwide, accounting for millions of dollars a year in health care expenditures and lost work-hours.

In a previous study published in the British Medical Journal in 2008, Kaptchuk and Kirsch demonstrated that placebo treatment can be highly effective for alleviating the symptoms of IBS. This time, however, instead of the trial being “blinded,” it was “open.” That is, the volunteers in the placebo group knew that they were getting only inert pills — which they were instructed to take religiously, twice a day. They were also informed that, just as Ivan Pavlov trained his dogs to drool at the sound of a bell, the body could be trained to activate its own built-in healing network by the act of swallowing a pill.

In other words, in addition to the bogus medication, the volunteers were given a true story — the story of the placebo effect. They also received the care and attention of clinicians, which have been found in many other studies to be crucial for eliciting placebo effects. The combination of the story and a supportive clinical environment were enough to prevail over the knowledge that there was really nothing in the pills. People in the placebo arm of the trial got better — clinically, measurably, significantly better — on standard scales of symptom severity and overall quality of life. In fact, the volunteers in the placebo group experienced improvement comparable to patients taking a drug called alosetron, the standard of care for IBS.

Meet the ethical placebo: a powerfully effective faux medication that meets all the standards of informed consent.

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Posted by Orrin Judd at December 27, 2010 5:45 AM
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