Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma
Top Cited Papers
- 14 July 2011
- journal article
- research article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 365 (2), 119-126
- https://doi.org/10.1056/nejmoa1103319
Abstract
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. 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 (FEV1) was measured, and patients' self-reported improvement ratings were recorded. Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P1 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; ClinicalTrials.gov number, NCT01143688.)Keywords
This publication has 25 references indexed in Scilit:
- Placebo studies and ritual theory: a comparative analysis of Navajo, acupuncture and biomedical healingPhilosophical Transactions Of The Royal Society B-Biological Sciences, 2011
- Biological, clinical, and ethical advances of placebo effectsThe Lancet, 2010
- Randomized trial of the effect of drug presentation on asthma outcomes: The American Lung Association Asthma Clinical Research CentersJournal of Allergy and Clinical Immunology, 2009
- The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trialsAnnals Of The Rheumatic Diseases, 2008
- Ted KaptchukNature Reviews Drug Discovery, 2008
- PrefaceJournal of Allergy and Clinical Immunology, 2007
- Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma–Summary Report 2007Journal of Allergy and Clinical Immunology, 2007
- Chemosensitivity and Perception of Dyspnea in Patients with a History of Near-Fatal AsthmaNew England Journal of Medicine, 1994
- Clinical applications of visual analogue scales: a critical reviewPsychological Medicine, 1988
- Placebo responses: An experimental study of psychophysiological processes in asthmatic volunteersBritish Journal of Clinical Psychology, 1986