The Quantification of Placebo Effects Within a General Model of Health Care Outcomes

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.

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