title: Active albuterol or placebo, sham acupuncture, or no intervention in asthma.
abstract: BACKGROUND
  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. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma.
  
  
  METHODS
  In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients' self-reported improvement ratings were recorded.
  
  
  RESULTS
  Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients' reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001).
  
  
  CONCLUSIONS
  Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.).
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA. mwechsler@partners.org
authors.forename: Michael E
authors.initials: ME
authors.lastname: Wechsler
authors.forename: John M
authors.initials: JM
authors.lastname: Kelley
authors.forename: Ingrid O E
authors.initials: IO
authors.lastname: Boyd
authors.forename: Stefanie
authors.initials: S
authors.lastname: Dutile
authors.forename: Gautham
authors.initials: G
authors.lastname: Marigowda
authors.forename: Irving
authors.initials: I
authors.lastname: Kirsch
authors.forename: Elliot
authors.initials: E
authors.lastname: Israel
authors.forename: Ted J
authors.initials: TJ
authors.lastname: Kaptchuk
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D000420:Albuterol / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D001993:Bronchodilator Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D059026:Diagnostic Self Evaluation; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D010865:Pilot Projects; D015990:Placebo Effect; D010919:Placebos / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D001993:Bronchodilator Agents; D010919:Placebos; D000420:Albuterol