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Placebo Effects

Placebo Effects

July 07, 2008 In the News

The "placebo effect" has been described as "mind over matter." Placebo is a "treatment" (of sorts) in which the authority knows no significant "cause and effect" therapeutic outcome from the treatment. Placebo may be presented to subjects and patients as sugar pills, oral or injected medicines, false surgeries, or even thoughts, ideas, and behavioral protocols with little or no outcomes-based value. In studies of placebo, the subject/patient is led to believe the placebo will help improve the situation or condition and quite often, placebo seems to have a positive impact on the situation at hand. Many placebos have been used and reported throughout science, psychology, medicine, and history. The "placebo effect" occurs when the subject or patient actually improves after administration of the placebo. Importantly, sometimes the placebo effect may not only be realized by the subject/patient, but sometimes professionals can be victims of placebo, too, without realizing our treatments, analysis or results may include a placebo-based factor.

Roland and colleagues (2004) published their "Randomized, Placebo-Controlled Evaluation of Cerumenex and Murine Earwax Removal Products" in 2004. Their study involved 74 subjects (mean age 45 years) randomly assigned to one of three treatment groups. Their article demonstrated that neither Cerumenex or Murine performed better than saline placebo as cerumenolytics. Subjective illnesses (irritable bowel syndrome, depression, chronic pain, perhaps tinnitus, headache etc) often report high placebo responses, as subjects/patients have an increased desire for the treatment protocol to successfully alleviate their symptoms. In audiology and hearing sciences, many studies have compared tinnitus treatments (i.e., Ginkgo) to placebo, yet no single treatment has outperformed placebo regarding tinnitus relief (DeBisschop, 2003).

Identifying and acknowledging placebo is an important part of modern cliinical science. Kaptchuk (2008) recently described the placebo effect as "...changes we detect in the placebo arm of a randomized controlled trial (RCT)." Kaptchuk argued that placebo wasn't appreciated until after RCTs occurred, because only after an RCT occurred, could we appreciate that subjects/patients improved using inert substances and treatments. Nonetheless, he also noted that placebo is not always clear cut and obvious — there are non-placebo intervening factors to consider; spontaneous remission, bias, regression to the mean, artifacts of measurement and natural fluctuations of the disorder/illness, all of which need to be considered. Interestingly, Kaptchuk noted many good pharmaceutical treatments don't succeed due to a high placebo effect. In other words, because the expectation of improvement is so high and because subjects/patients often improve secondary yo placebo, the actual pharmaceutical agent has to outperform elevated placebo effects, to demonstrate a statistically significant and efficacious RCT. Kaptchuk noted that well-controlled studies have shown that placebo does elicit changes in neurotransmitters, hormones, immune regulators and brain activity. In other words, placebo is not necessarily one particular thing, but may likely involve a spectrum of responses. Placebo is often so significant, Kaptchuk noted, that for any particular illness or condition, it may be unclear as to which intervention is responsible for change; the patient, practitioner, illness variability or the imprecision of the outcome measure.

For More Information, References and Recommendations:
DeBisschop, M (2003): Ginkgo Ineffective for Tinnitus. Journal of Family Practice. October 2003.

News and Analysis... An Audience with Ted Kaptchuk. www.nature.com/reviews/drugdisc Pg 554, July 2008, Vol 7. Associate Professor of Medicine, Harvard Medical School and National Advisory Counsel of the National Institutes of Health's National Center for Complementary and Alternative Medicine.

Roland, P.S., Eaton, D.A., Gross, R.D., Wall, G.M., Conroy, P.J., Garadi, R., LaFontaine, L., Potts, S and Hogg, G. (2004): Randomized, Placebo-Controlled Evaluation of Cerumenex and Murine Earwax Removal Products. Arch Otolaryngol Head Neck Surg. 2004;130:1175-1177.

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