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Placebo effects

Posted 07 September 2011

I have pointed out in a number of posts how strong a placebo response can be, and asked whether some CAMS are only effective because of a strong placebo response and actually have no efficacy on their own.

Here is an interesting study that illustrates this very point.

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

"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."

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

Ted J. Kaptchuk1,2*, Elizabeth Friedlander1, John M. Kelley3,4, M. Norma Sanchez1, Efi Kokkotou1, Joyce P. Singer2, Magda Kowalczykowski1, Franklin G. Miller5, Irving Kirsch6, Anthony J. Lembo1

1 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America, 2 Osher Research Center, Harvard Medical School, Boston, Massachusetts, United States of America, 3 Psychology Department, Endicott College, Beverly, Massachusetts, United States of America, 4 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America, 5 Department of Bioethics, National Institutes of Health, Bethesda, Maryland, United States of America, 6 Department of Psychology, University of Hull, Hull, United Kingdom

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.

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0015591

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