Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

We found that the results of placebo interventions did not differ from those of the no-intervention control when an objective measure of airflow was used

Michael E. Wechsler; John M. Kelley; Ingrid O.E. Boyd; Stefanie Dutile; Gautham Marigowda; Irving Kirsch; Elliot Israel; Ted J. Kaptchuk

2011

Scholarcy highlights

  • In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention
  • Among the 39 patients who completed the study, albuterol resulted in a 20% increase in forced expiratory volume in 1 second, as compared with approximately 7% with each of the other three interventions
  • It is unclear whether placebo effects observed in clinical trials influence both objective and subjective outcomes and whether placebo effects differ from the natural course of disease or regression to the mean
  • The placebo effects were equivalent to the drug effect, and all were greater than the no-intervention effect
  • The two placebo interventions had a strong effect on the patient-reported outcome but had no effect on the objective outcome; the active drug had a strong effect on the objective outcome but had no incremental benefit with respect to the subjective outcome
  • Improvement in objective measures of lung function would be expected to correlate with subjective measures, our study suggests that in clinical trials, reliance solely on subjective outcomes may be inherently unreliable, since they may be significantly influenced by placebo effects
  • Placebo effects are reported to improve signs and symptoms of many diseases in clinical trials and in clinical practice. On this basis, the accepted standards for clinical-trial design specify that the effects of active treatment should ideally be compared with the effects of placebo. Despite this common practice, it is unclear whether placebo effects observed in clinical trials influence both objective and subjective outcomes and whether placebo effects differ from the natural course of disease or regression to the mean

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