Justine E Owens1, Martha Menard. 1. Department of Medicine, Division of General Medicine, Geriatrics and Palliative Care, Health Sciences Center, University of Virginia, Charlottesville, VA, USA. owens@virginia.edu
Abstract
OBJECTIVES: The objective of this study was to test a model of placebo effects in the context of a general model of health care outcomes. DESIGN: The design of this study was a multisite, double-blind, placebo-controlled crossover trial. SETTINGS: The study was conducted at The University of Washington Hospital, Seattle, Washington, Cooper Hospital/University Medical Center, Camden, New Jersey, and at the Neurology Center of Fairfax, Fairfax, Virginia. SUBJECTS:One hundred and seventeen (117) patients diagnosed with Multiple Sclerosis were enrolled in the study. INTERVENTION: Subjects had daily exposure to a pulsing electromagnetic generator. OUTCOME MEASURES: The outcome measures were the average score of three quality-of-life indices: the Modified Fatigue Impact Scale, the Medical Outcomes Study Pain Effects Scale, and the Spasticity Effects Scale. RESULTS:Placebo responders scored higher in the personality trait of Absorption compared with nonresponders (p<0.01). Placebo responders were more confident that the sham device was active compared to placebo nonresponders (p<0.009). The two factors of confidence in the treatment and Absorption accurately identified 80% of placebo responders in a discriminant analysis (p<0.0004). CONCLUSIONS:Placebo effects are best understood when integrated in a general model of health care outcomes.
RCT Entities:
OBJECTIVES: The objective of this study was to test a model of placebo effects in the context of a general model of health care outcomes. DESIGN: The design of this study was a multisite, double-blind, placebo-controlled crossover trial. SETTINGS: The study was conducted at The University of Washington Hospital, Seattle, Washington, Cooper Hospital/University Medical Center, Camden, New Jersey, and at the Neurology Center of Fairfax, Fairfax, Virginia. SUBJECTS: One hundred and seventeen (117) patients diagnosed with Multiple Sclerosis were enrolled in the study. INTERVENTION: Subjects had daily exposure to a pulsing electromagnetic generator. OUTCOME MEASURES: The outcome measures were the average score of three quality-of-life indices: the Modified Fatigue Impact Scale, the Medical Outcomes Study Pain Effects Scale, and the Spasticity Effects Scale. RESULTS: Placebo responders scored higher in the personality trait of Absorption compared with nonresponders (p<0.01). Placebo responders were more confident that the sham device was active compared to placebo nonresponders (p<0.009). The two factors of confidence in the treatment and Absorption accurately identified 80% of placebo responders in a discriminant analysis (p<0.0004). CONCLUSIONS: Placebo effects are best understood when integrated in a general model of health care outcomes.
Authors: Ted J Kaptchuk; John M Kelley; Aaron Deykin; Peter M Wayne; Louis C Lasagna; Ingrid O Epstein; Irving Kirsch; Michael E Wechsler Journal: Contemp Clin Trials Date: 2008-02-23 Impact factor: 2.226