American Lung Association Study to be Designated as an Editor’s Choice Article in Next Edition of the “Journal of Allergy and Clinical Immunology”

Study Investigates Whether the Response to Placebo or Active Treatment can be Augmented by Increasing the Patients’ Expectations of Clinical Benefit

Washington, DC (September 7, 2009)

The American Lung Association's Asthma Clinical Research Centers(ACRC) completed the largest and most comprehensive study to evaluate placebo effects in patients with asthma. This new study investigated whether it is possible to enhance the effectiveness of treatment for poorly controlled asthma by increasing patients' expectations of the health benefit prescription drug therapy will provide.

The results of this study, which were published today in the Journal of Allergy and Immunology, showed that neither the presence of a placebo nor enhancing patients' expectancy about the effectiveness of a drug had an affect on lung function. However, study participants in the placebo with enhanced messages group reported an improvement in their asthma symptoms despite no improvement in lung function.

The 601 patients with poorly controlled asthma that participated in this ACRC directed study were randomly assigned to one of five treatment groups: placebo with enhanced messages; placebo with neutral messages; montelukast with enhanced messages; montelukast with neutral messages or usual care.

"This study is significant, because it reveals how the 'placebo effect' is affected by doctor-patient communication," said Norman H. Edelman, MD, American Lung Association Chief Medical Officer. "While the study investigates this well documented phenomenon among patients with poorly controlled asthma, the framework can be replicated to shed light on many other chronic diseases. Bottom line, positive messages and thoughts are not as effective as proven drug therapies currently available to improve lung function in people with poorly controlled asthma. Clinicians' conversations with study participants can drastically impact a study's results and should be carefully considered."

This study was funded by the American Lung Association and the National Heart, Lung and Blood Institute, a component of the National Institutes of Health.

The ACRC Network is an American Lung Association sponsored research program that conducts large scale clinical trials with the mission of advancing the care and treatment of people with asthma. The network, with a central data coordinating center and 20 clinical centers located across the country, is the largest of its kind. By placing its clinical centers around the country, the ACRC Network is able to enroll large numbers of patients for clinical trials, thus ensuring relevant research findings can be interpreted with the highest level of scientific authority.

Abstact: Randomized trial of the effect of drug presentation on asthma outcomes: The American Lung Association Asthma Clinical Research Centers

Background: Information that enhances expectations about drug effectiveness improves the response to placebos for pain.  Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit.

Objective: The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit.

Methods: A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups.  Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages or montelukast with neutral messages) or to usual care.  Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked.  The enhanced message aimed to increase expectation of benefit from the drug.  The primary outcome was mean change in daily peak flow over 4 weeks.  Secondary outcomes included lung function and asthma symptom control.

Results: Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups.  Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline differences.  Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect.

Conclusions: Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function.  However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

Norman H. Edelman, MD, disclosed stock ownership with Johnson & Johnson.

About the American Lung Association: Now in its second century, the American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease. With your generous support, the American Lung Association is "Fighting for Air" through research, education and advocacy. For more information about the American Lung Association, a Charity Navigator Four Star Charity and holder of the Better Business Bureau Wise Giving Guide Seal, or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872) or visit www.lung.org