Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome

By Ted J. Kaptchuk, Elizabeth A. Friedlander, John M. Kelley, M. Sanchez, E. Kokkotou, Joyce P. Singer, Magda Kowalczykowski, F. Miller, Irving Kirsch, A. Lembo. PLoS ONE, 2010

854 citations recorded by the source corpus.

Background Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label 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). Methods Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). 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). Conclusion 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. Trial Registration ClinicalTrials.gov NCT01010191

Subfields: Cognitive Neuroscience, Complementary and alternative medicine, Gastroenterology

View Paper: https://www.semanticscholar.org/paper/3d8aac4fba0e556c2d0898ad83cd3df11576e90c

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In Cognitive Neuroscience

Citations in the corpus

The placebo effect: From concepts to genes. (2015, positive): “Why else would patients expect improvement? A handful of open-label placebo studies where patients know a placebo is being administered challenge that conception (Park and Covi, 1965; Sandler and Bodfish, 2008; Kaptchuk et al., 2010; Kelley et al., 2012).”
Improving Methodological Standards in Behavioral Interventions for Cognitive Enhancement (2019, background): “…told that they are taking a placebo—and yet the benefits typically associated with placebos are nonetheless still observed, particularly when a prior conditioning mechanism is already in place (Carvalho et al. 2016; Kaptchuk et al. 2010; Kelley et al. 2012; Sandler and Bodfish 2008).”
RELIEVING PAIN IN AMERICA: A BLUEPRINT FOR TRANSFORMING PREVENTION, CARE, EDUCATION, AND RESEARCH (2012, background): “Because placebo use could undermine trust, Kaptchuk and colleagues (2010) told patients they were receiving a placebo, and the treatment still produced statistically significant improvements in terms of mean global improvement scores, reduced symptom severity, and adequate relief at both an 11-day m”