A study by Harvard researchers published in the New England Journal of Medicine found that patients reported similar relief of symptoms from use of a placebo inhaler compared to use of an albuterol inhaler. Although the albuterol inhaler resulted in significantly greater increase in FEV1 (20% vs. 7% for the placebo), the albuterol inhaler showed no significantly greater benefit in patient-reported outcomes, with patients claiming a 45% improvement in symptoms for the placebo compared to 50% for the active treatment.
The double-blind study involved treatment with either an albuterol inhaler, a placebo inhaler, sham acupuncture, or no treatment at all. Out of 46 patients initially enrolled, 39 completed the study, which took place over a total of 12 visits. Sham acupuncture produced similar results to the placebo inhaler, with a 7% increase in FEV1 and 46% reported improvement in symptoms. Patients receiving no treatment reported a 21% improvement in symptoms.
Senior author Ted Kaptchuk commented, “We chose to study patients with asthma because earlier evidence had suggested that placebos would change the underlying medical problem. While I was initially surprised that there was no placebo effect in this experiment [after looking at the objective air flow measures] once I saw patients’ subjective descriptions of how they felt following both the active treatment and the placebo treatments, it was apparent that the placebos were as effective as the active drug in helping people feel better.”
Lead author Michael Wechsler points out that “while placebos remain an essential component of clinical trials to validate objective findings, assessment of natural history is essential in the final assessment of patient-reported outcomes.” He suggests that trials may require a “placebo for the placebo” in order to make that assessment.
Read the NEJM abstract.
Read a Harvard Beth Israel Deaconess Medical Center press release.
