title: Placebos without deception: a randomized controlled trial in irritable bowel syndrome.
abstract: 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).
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01010191.
authors.affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Ted J
authors.initials: TJ
authors.lastname: Kaptchuk
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Friedlander
authors.forename: John M
authors.initials: JM
authors.lastname: Kelley
authors.forename: M Norma
authors.initials: MN
authors.lastname: Sanchez
authors.forename: Efi
authors.initials: E
authors.lastname: Kokkotou
authors.forename: Joyce P
authors.initials: JP
authors.lastname: Singer
authors.forename: Magda
authors.initials: M
authors.lastname: Kowalczykowski
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
authors.forename: Irving
authors.initials: I
authors.lastname: Kirsch
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Lembo
mesh_terms: D000328:Adult; D008192:Deception; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010919:Placebos; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010919:Placebos