In 2012, the Ken Heaton Award for the Most Cited Paper was awarded to Ted J. Kaptchuck, OMD and Anthony J. Lembo, MD.
Title: Placebos without deception: a randomized controlled trial in irritable bowel syndrome.
Ted J Kaptchuk, Elizabeth Friedlander, John M Kelley, M Norma Sanchez, Efi Kokkotou, Joyce P Singer, Magda Kowalczykowski, Franklin G Miller, Irving Kirsch, Anthony J Lembo. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 2010;5(12):e15591.
Background: Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether openlabel placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS).
Findings: Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2±1.0 vs. 4.0±1.1, p<.001) and at 21-day endpoint (5.0±1.5 vs. 3.9±1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08).
Conclusions: Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.