The “placebo effect”– i.e. the extent to which a person’s belief in the efficacy of a substance or therapy influences both the physiological and psychological effects thereof – is mainly familiar because of its use in clinical trials. Rigorous science often requires triple-blind studies, where the patients receiving treatment, the providers giving it, and the analysts evaluating it are not “biased” by knowledge of whether or not the treatment is a placebo, i.e. inert substance or sham treatment.

But there have been increasing arguments against thinking of the placebo effect as merely a “false” result. It clearly demonstrates the “mind-body” effect, i.e. the ability of the mind to influence the body’s responses, which accounts for both the negative and positive effects of stress, as well as the positive placebo and negative “nocebo” effects of treatment (where belief that the treatment will do harm produces harm even when the treatment is inert).

Many have argued that the placebo effect, and the nocebo effect for that matter, are both reflections of “enlisting the mind” in the pursuit of healing. Given the ability of this effect to add to as well as detract from the effects of substances and therapies, the effect, when positive, should include the total mind-body response to either, rather than discounting the effect as merely “humoring” patients into believing they are getting treatment when they really need none.

Since the placebo effect is often as much as or even above 50% of patient response noted, the acceptance or rejection of the effect can make a huge difference to the measured efficacy of a given treatment. In a recent book on the positive as well as negative effects of the mind on the body, its author made a strong case for recognizing the importance and value of the mind-body connection, which has been demonstrated in terms of objective physiological responses through the hypothalamus-pituitary-adrenal glands connection. [E. Sternberg The Balance Within: The Science Connecting Health and Emotions W.H. Freeman 2001]

The placebo effect seems to be particularly strong with respect to pain perceptions by people being treated – with almost anything. Since pain is primarily a subjective perception, rather than an objective metric, people who believe in the efficacy of a drug, herb, or therapy often report as much relief from the placebo as from what is supposed to be an “active” intervention. Sham acupuncture has yielded as much pain reduction as the real thing, for example.

The trouble is that the placebo effect can also be the foundation for immense profits by manufacturers and retailers of substances, and providers of therapies, that have no physiological effects at all, that may be dangerous to patients in either or both of two serious ways. They may cause damage, by being inherently inimical to health – or they may prevent or delay people from seeking and getting truly effective alternatives. They may even cause people to avoid or negatively affect what are proven treatments if people “tar them with the same brush” because of their similarity to unproven or proven-to-be-useless/harmful alternatives.

The general system of homeopathy, for example, has been under attack in the U.K. [B. Goldacre “The End of Homeopathy?” The Guardian Nov 16, 2007 (www.badscience.net)] People still swear by its remedies, because they say homeopathic pills make them feel better. But what if the entire impact of homeopathic medicine is “in the mind”, i.e. the placebo effect? A review of 110 homeopathic and 110 matched conventional medicine trials were compared, with both finding that smaller and lower-quality trials tended to find more benefit than did larger and higher quality, but the overall findings were compatible with the notion that homeopathic clinical effects were due to the placebo effect. [A. Shang, et al. “Are the Clinical Effects of Homeopathy Placebo Effects? The Lancet 366 2005 726-732]

In a recent series of stories, the major newspaper where I live describes a wide range of medical devices being manufactured, sold, and used as “energy” treatments. These machines relied on light, radio, electricity, or electromagnetic forces to “cure” diseases as serious as cancer. While such forces have been proven to have positive effects in a number of medical applications, the machines described in the reports had no demonstrable physiological effect, and certainly did not eliminate the conditions that their users claimed would be cured by them.

In most cases, these devices were used by untrained laypersons, though some physicians, chiropractors, and other health professionals, and at least one hospital also used them. [C. Willmsen & M. Berens “Miracle Machines: The 21st Century Snake Oil” Seattle Times Nov 18, 2007 A1, A10-13; “Public Never Warned About Dangerous Devices” Nov 19, 2007 A1, A8; and “A Patient’s Plea: Please God, No More” Nov 20, 2007 A1, A10] One example involved drawing a patient’s blood, treating it with “photo luminescence” light waves (ultraviolet light), then injecting the treated blood back into the patient. Infections at the injection site occurred, but cures did not. The provider was arrested for practicing medicine without a license, while the patient died the day after treatment. While claiming to be a naturopathic physician, the provider had no training, merely a degree from an unaccredited “diploma mill”.

Another device claimed to cure AIDS, cancer, and other life-threatening conditions with electromagnetic waves, and was being used in five states, including Washington, despite the foundation for its efficacy that “…goes beyond human knowledge” according to its inventor. It got around FDA regulations by claiming it was only being used in “clinical trials”, though providers profited from its use, which was not allowed in such trials. Machines had been sold to physicians, chiropractors, acupuncturists , naturopaths, and massage therapists, as well as people with no training at all, and used for desperately ill patients who feared or had already experiences severe side effects from conventional treatment of cancer, heart disease, ulcers, etc.

An out-of-work former mathematics instructor built a radiofrequency wave machine claimed to diagnose and treat everything from allergies to cancer, was forced by the FDA to leave the US, and now operates from Hungary. He has apparently sold over 10,000 of his devices in the U.S. alone. The idea of electric, light, sound, radio and microwaves being used to treat disease is over 100 years old, and has many proven applications, but probably far more unproven ones, with many dangerous, such as the use of electricity or electromagnetic waves in patients with implanted pacemakers, or simply dangerous machines.

Thanks to the placebo effect, almost any machine, nostrum, herb, or therapy may easily find dozens, hundreds, even thousands of patients who report being cured, or at least having pain diminished or disappeared. And these can be powerful testimonials in media advertising or word-of-mouth, viral and “buzz” marketing. Moreover, the placebo effects are real in many cases, though rarely as reliable or complete as truly efficacious alternatives. And given the profit motive, that can drive both professional clinicians and laypeople to purchase and use such machines, as well as sell them to patients, there are strong financial motivations, as well as gullibility that can drive widespread use.

Americans have not only the most expensive healthcare system in the world, but one of the most promising for quacks and charlatans, as well as misguided, well-meaning practitioners and marketers. The FDA has been criticized for years, charged with inadequate and biased regulation of medical treatments and prescription drugs. It has done far worse in the case of unproven (even as to causing harm) alternatives to these, and thousands of people suffer as a result.

At a minimum people who rely on the placebo effect alone are wasting their money where it could be better spent elsewhere, and at worst, they are delaying or avoiding proven alternatives, and dying as a result. The placebo effect is certainly valuable for those who experience it, but when there are alternatives with proven records for positive clinical effect as well, it a dangerous basis for patient choice, and an inadequate basis for generating profits.