Wednesday, March 20, 2013

Daily Dispatch - The power of "placebo"



From: Marc Micozzi, MD
Date Mon, Mar 18, 2013 Daily Dispatch - The power of "placebo"



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The power of "placebo"
Dear Reader,

Dr. Micozzi's Insiders' Health Harvard researchers conducted a study about 10 years ago that may have you questioning St. John's wort (SJW). This herb is one of the best, proven ways to combat mild to moderate depression. And it's natural. But the Harvard study concluded that SJW isn't any more effective than a placebo for treating depression.

Of course, everyone believed the study. It was Harvard, after all. And they don't mess up studies.

Or do they?

The truth is, even Harvard researchers can get it wrong. In fact, this study shows all that can go wrong when a high-powered mainstream medical research team conducts research on traditional, natural therapies that they do not understand.

There were so many ethical, scientific and theoretical problems with the Harvard research that I use it as a case study to teach my medical students at Georgetown and Penn. You can also find all the details in Chapter 2 of my textbook, "Fundamentals of Complementary & Alternative Medicine," now going into its 5th edition.

Everyone heard about this Harvard study. But the mainstream press missed several key details.

First off, the study didn't just compare SJW with a placebo for depression. The study actually compared three treatments: a popular SSRI antidepressant drug, SJW, and a placebo.

And, yes, the results showed that SJW did not appear effective for depression compared to the placebo.

However, you probably didn't hear this key point about the study...

The SSRI also did not appear effective for depression compared to the placebo. And it wouldn't have taken much for an SSRI to be considered effective. According to the FDA, if a drug shows just a 20 percent improvement over the placebo, that's good enough. But the SSRI didn't even do that.

And there's a reason why: The placebo group wasn't a true placebo group.

For this study, Harvard researchers couldn't just give the placebo group a sugar pill and send them on their unhappy way. It would be unethical. And similar to how they treated depression in the 19th century. Back then, they threw the mentally ill in a cell and fed them bread and water.

But this is the 21st century! Even Harvard has its standards.

So everyone in the study--participants in all three treatment groups--received 16 hours of intensive therapy from a highly trained Harvard mental health professional. And then they took an SSRI, SJW or a placebo.

And the results showed that participants in all three groups experienced a small boost in mood. But the SSRI and SJW groups simply didn't experience greater improvements than the placebo group.

But that's because the intensive talk therapy was the key factor. It was so effective, it washed out the effects of any pill.

So what this Harvard study really proved is that personal interaction with a human being in a therapeutic context is so effective that it washes out the effects of any pill-- whether an SSRI or SJW.

Surprised? You shouldn't be.

Here's a lesson we can learn from this flawed study...
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In an era of modern drugs and modern medicine, we should not forget the value of old-fashioned behavioral and talk therapies.

To be sure, we've come a long way in treating mental illness. During the 18th and 19th centuries, the mentally ill were treated like criminals. Or worse. They were confined, incarcerated and abused.

But before that--during ancient times and the Middle Ages--the mentally ill or mentally deficient were usually given some kind of role in the community. Either tolerated as the "village idiot." Or sent out to tend sheep in the pastures and the mountainsides. This practice is still common among some traditional peoples of the Mediterranean, for example.

Without meaning to offend modern sensibilities, the "village idiot" was a very well known figure in earlier times. In the 16th century, Shakespeare used the term in his famous quote: "like a tale told by the village idiot; full of sound and fury, yet signifying nothing."

This in turn gave William Faulkner the words for his 20th-century masterpiece, "The Sound and the Fury" about mentally disturbed people in the South.

Moral reformers took notice of the mentally ill in the 19th century. Their treatment for mental illness was simply known as "moral therapy." This treatment resembles what the ancients knew about keeping the mentally ill within the community. The reformers of the 19th century also placed the mentally ill within the community. In boarding homes or rooming houses.

Living within the community, the mentally ill experienced the "normal" behaviors and practices of people going about their daily lives. They weren't confined to "looney bins." They didn't see just other "crazy" behavior--and the doctors and nurses who ministered to it. Instead, they developed a fund of normative experiences. And they were reinforced for sane behavior. And they were consistently discouraged against inappropriate behaviors.

This is very much what behavioral therapists talked about in the 20th century. They reinforced the desired behaviors. And discouraged the inappropriate behaviors. Too bad in the 21st century, these behavioral therapy approaches appear to be few and far between.

In the meantime, if you suffer from mild to moderate depression, don't overlook St. John's wort. And don't base your opinion about SJW on this flawed Harvard study, in any case.

It may take a few weeks before you feel a boost from SJW, but this is true of SSRIs as well. And SSRIs are far more dangerous, as I've discussed in recent Daily Dispatches and in the upcoming April Insiders' Cures newsletter. And you may want to consider finding a good behavioral therapist. There are even some great ones at Harvard.

Always on the side of science,

Marc S. Micozzi, M.D., Ph.D.

Source:
1. JAMA. 2002 Apr 10;287(14):1807-14.

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