Clinical trials Complementary and alternative medicine Medicine Quackery

A perfect storm of quackademic medicine and bad journalism

I sometimes wonder if the world is laughing at me.

Let me explain. A while ago I compiled a list of academic medical institutions that–shall we say?–are far more receptive to pseudoscientific and downright unscientific medicine in the form of so-called complementary and alternative medicine (CAM), otherwise known as “integrative medicine.” I dubbed this list my Academic Woo Aggregator, and lamented how big it was with much wailing and gnashing of skeptical teeth. Indeed, more than once I have reluctantly concluded that woo is fast becoming the future of American medicine. High up on the list of woo-friendly academic medical centers is the Stanford Center for Integrative Medicine. Reminding me of this have been three or four readers who sent me a link to an incredibly credulous article in SFGate about a clinical trial being done at Stanford, along with my seeing it on Skeptico.

This is some serious woo at what is a heavy-hitting big league academic medical institution that is apparently interested in being booted back to the minor leagues, dragged there by a bit of therapeutic touch:

Anne Broderick believes she can use her hands to alter the energy fields of others to help them heal, taking away fatigue, stress and nausea.

A clinical trial at Stanford University aims to prove it. The university is testing whether an energy therapy called Healing Touch can reduce the debilitating effects of chemotherapy on breast cancer patients.

It’s the juncture where touchy-feely New Age mysticism meets hard science.

No, it’s the juncture where academic physicians become so “open-minded” that their brains fall out and ooze on the ground at their feet. Skeptico is correct when he points out that when a believer aims to prove what she believes in it’s highly unlikely she’ll fail to do so. The reason is that a clinical trial should be designed such that it can falsify its hypothesis (more on that later). Naturally, this article includes what all good woo-friendly articles on CAM must include: Anecdotes! For example:

The results of Stanford’s three-year clinical trial won’t be known for two more years, but some who already have undergone the therapy at a Stanford medical program called Healing Partners say they know it works.

Of course they do. They always “know” it “works.” It doesn’t matter what “it” is; it could be acupuncture, homeopathy, reiki, or any other manner of woo. It’s practitioners don’t need no steekin’ science. They know it works. And how do they know? By the anecdote to follow, of course! Naturally, it’s an anecdote that tells us mean and nasty skeptics the believers’ favorite woo shows that that stodgy old materialistic world view that science is rooted in is just not enough to explain how they do their magic:

“It opened my mind up to the fact there are some things in this world that we can’t explain, and that doesn’t make them any less real,” said breast cancer survivor Catherine Palter, a trained geologist who typically prefers more scientific explanations.

It all started for Palter after doctors diagnosed her with the cancer in 2005. She began the full Western-style treatment plan: surgery, radiation, chemotherapy and hormone therapy.

But she craved the peace of mind of knowing she had tried everything. She heard Stanford had a program that used an “energy therapy” – Healing Touch. What could it hurt?

Someone worked with her weekly for six months to improve her energy flow by simply touching parts of her body such as legs, arms, back and head. The results were immediate and powerful, she said. The lethargy and fatigue of the chemotherapy disappeared. Her surgery wound rapidly healed. She could better cope with the fear of not being there for her two daughters.

The part about her surgery wound “rapidly healing” just comes across as silly. Most breast cancer surgery wounds heal pretty fast unless there is a problem. As for chemotherapy, the standard adjuvant chemotherapy regimens after breast cancer surgery generally last 12 weeks, usually four doses separated by three weeks. If there are positive lymph nodes, a second chemotherapeutic regimen is usually added, extending chemotherapy duration to 24 weeks. Depending on the timing of the therapeutic touch sessions and the doses of chemotherapy it would not be very difficult to produce the perception that the “therapy” is causing a lifting of the lethargy and fatique, particularly since it usually lifts over time anyway. Add the placebo effect and confirmation bias, and there are many reasons to suspect that any perceived improvement was likely unrelated to the therapy or due to the placebo effect and relaxation that the massage-like physical actions performed during therapeutic touch involve.

But, you say, what’s the harm in doing a clinical trial? Shouldn’t we figure out if there is anything to this whole therapeutic touch thing? After all, so many people give anecdotes like the one above, and so many nurses and other practitioners believe in it:

“It’s based on the belief that our bodies are surrounded by a field of energy and our bodies themselves are a denser form of energy,” Turner said. “The belief there is that once the body’s energy is cleared and balanced, our bodies have the innate capacity to heal themselves.”

The underlying technique is age-old, advocates say, and intends to balance and align people’s energy fields so they become “whole in body, mind, emotion and spirit” – although no one knows quite how it works.

Ah, yes, the fallacy of antiquity. If it’s old, it must be effective. Actually, therapeutic touch is neither. It’s definitely not old. It was created by a nurse on the faculty of New York University back in the 1970s, although I will grant that it appears to be based on 18th century science. Let’s put it this way: Unless large swaths of what we know about physics are spectacularly wrong, therapeutic touch can’t work. At least it can’t work by the mechanism its practitioners claim, namely the manipulation of a person’s qi or “life energy” by a practitioner of this “healing discipline.” Indeed, even a child was able to design an experiment that showed quite conclusively that therapeutic touch practitioners cannot even detect a human’s “energy field,” much less manipulate it. The entire concept behind therapeutic touch is not just incredibly scientifically improbable; it’s bogus. There’s already good evidence refuting it.

Curious, though, I looked over the patient page for the clinical trial at Stanford. Unfortunately, this clinical trial appears doomed to be useless from the start. How do I know? Just look at the study design. In particular, look at these two lines:

Allocation: Non-randomized

Masking: Open Label

In other words, the study is neither randomized nor blinded, much less double-blinded. This flaw alone makes this an utterly worthless experimental design for detecting a therapeutic effect above and beyond the placebo effect for any therapy, much less a therapy that relies so much on subjective impressions. It’s almost as though the study was purposely designed to produce a seemingly positive result. Indeed, the investigators might as well save money, not even bother, and just keep on doing therapeutic touch based on their “knowing that it works,” because their “knowledge” is probably as good as any results from this study–in other words, not very good at all. It boggles the mind that the Avon Foundation apparently funded this pointless study. Clearly, there is a problem with peer review of grant applications for the Avon Foundation to have utterly wasted its donors’ cash funding this study.

The odd thing about this study is that one of the investigators is a physician named Dr. Lynn Westphal in the Department of Obstrics and Gynecology and director of the fellowship in reproductive endocrinology and infertility at Stanford. Her CV shows a pretty solid, albeit not outstanding, publication record, and she’s had small grants from foundations and some pharmaceutical company funding, but no NIH grants. In other words, she appears to have a decent but not dazzling academic career in academic medicine. What she is doing as a co-investigator on this study I have no idea. She should know better. To me, that’s another truly pernicious effect of the infiltration of unscientific woo like therapeutic touch into academic medical centers. Besides giving an undeserved patina of respectability to pseudoscience, it sucks otherwise respectable investigators into its maw and turns them into de facto woo-meisters while soaking up funding that might better be used to do studies that are far more likely to answer a clinically relevant question than this useless waste of resources whose lax design affords it virtually no chance of answering the question its investigators claim it is designed to answer.

Maybe we need a nine-year-old girl to take over the study and rewrite its protocol.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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