More than a touch of bias

Just got wind of a 3-year Stanford University clinical trial that's underway to study the efficacy of Healing Touch (HT) [1]. What is HT? It's very much akin to Therapeutic Touch (TT). Duh! Ok, ok. It's basically a laying of hands on the sick. In TT the hands don't actually touch the person. In HT, the hands can be in physical contact. Both techniques are said to be based on the manipulation of some human "energy field." Here's how one of the researchers of the Stanford study describes the basis of HT.

"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," [Kathy] 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.

And here's how HT is performed.

People remain fully clothed. A lot of it is actual touching, but if someone has just had surgery, the healer can work above the person's body. Healing Touch International Inc. runs a certification program across the country that many nurses take, but it's open to everyone.

[Anne] Broderick, a former corporate executive turned psychotherapist, provides Healing Touch to Lydia Li every week. Both survived breast cancer and took part in Healing Partners at Stanford.

Earlier this month, Li arrived at Broderick's Palo Alto office with shoulder pain and a headache. She lay on a massage table, and Broderick covered her fully clothed body with a white sheet. Broderick, 69, then silently told herself, "I set my intention for the highest good," and began methodically touching Li to the sounds of running water and quiet music, occasionally sweeping her hands above her. At times, she firmly held a foot, knee or wrist. At others, she seemed to play an imaginary piano on Li's back.

Often, Broderick begins sessions by holding a crystal (although she said a "lifesaver on a string" would work just as well) 4 inches above Li and watches it circle over the seven chakras - energy vortices - that run along the length of the body. Clockwise is a good sign. No movement or one that's counterclockwise means the person could use some help getting healthy energy flow, she says.

To most people, a scientific study is a scientific study. And once a study has shown that there is evidence therapy X is effective you'd think that's that; X does work. Well, as with cars, not all studies are of equal quality. You'd of course trust a Rolls and a Ferrari over the China-made Chery. So it should be with clinical trials. And guess what? The Stanford trial is a poorly designed study. It has two major flaws even at the outset. Participants are not randomly assigned to the experimental and control groups, i.e., there is either self-selection--the patients choose in which group they want to be in--or the researchers get to determine the group assignment [2]. Secondly it employs neither single nor double blinding (masking), i.e., the participants know whether they're receiving HT or not and the researchers know which patient is assigned to which group. What all this boils down to is massive propensity for bias and hence unreliability of the forthcoming results. Thus, even at this stage we already know that this clinical trial won't lead to any conclusive findings. In fact should the findings be positive it would be most suspect precisely because of the lack of blinding and randomization--two very crucial factors in any clinical trial that's able to guard against experimental biases.

Another potential problem lies in the control group. If a sham/faux HT procedure is possible then one group ought to be provided this "treatment," just as is in the case of tests of acupuncture where the control group is given sham needling. Therefore, a better designed trial would've involved actors who have no training in HT whatsoever perform the sham HT, with the participants blinded to this fact. If it turns out that patients in the sham HT group fare worse than those in the HT group then there would be good reason to say that there is favorable evidence for HT.

As we said both HT and TT claim the human body possesses an "energy field." Traditional Chinese Medicine likewise claims the body has an energy called qi (pronounced as chi). However, there is absolutely no evidence for this energy field or aura. And in a JAMA study conducted to evaluate TT, the practitioners (most if not all who practice TT are nurses) who claimed to be able to detect and exercise control over this energy field failed to even detect it. Given our knowledge of human anatomy, physiology, biochemistry, and given the experiments thus far conducted the plausibility of the theory of both TT and HT hovers around zero.

Be that as it may, the physical presence of someone who commiserates probably does have a psychological (and even detectable physiological) effect on patients. So does a loving touch--a friendly hand clasping the patient's for instance Or for that matter, embrace and companionship by the patient's loved ones. There's nothing controversial or implausible about these. In fact we would expect these behaviors and events to be helpful in some way, even if only to calm the patient and counteract the stressors s/he's experiencing. But let's dispense with all the energy field, chakra, and crystal poppycock.



Notes:

1. Learned of this study via Now What, Cat? a site that I think is owned by Cathy. I left a short and rough version of this blog entry as a comment. Moderation is active. Wonder if she'll post what I wrote. If not does that mean I'm persona non grata whatever the content of my comment?

2. The SFGate article made a booboo, describing the Stanford trial as randomized when in fact it isn't.