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

Donald Steiny Blog, Health, Science Leave a Comment

Though our mind can only affect certain body processes it can have a lot more to do with healing than we have been able to identify until recently. Evidence based medicine and the idea that the mind has effect on healing are not at odds at all.  This article is a good example of how evidence based practices can be used to examine the mind’s effect on healing.

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 NCT01010191

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