title: Use of beat-to-beat cardiovascular variability data to determine the validity of sham therapy as the placebo control in osteopathic manipulative medicine research.
abstract: Osteopathic manipulative medicine researchers often use sham therapy as the placebo control during clinical trials. Optimally, the sham therapy should be a hands-on procedure that is perceptually indistinguishable from osteopathic manipulative treatment, does not create an effect on its own, and is not a treatment intervention. However, the sham therapy itself may often influence the outcome. The use of cardiovascular variability (eg, beat-to-beat heart rate variability) as a surrogate for the autonomic nervous system is one objective method by which to identify such an effect. By monitoring cardiovascular variability, investigators can assess autonomic nervous system activity as a response to the sham therapy and quickly determine whether or not the selected sham therapy is a true placebo control. The authors provide evidence for assessment of beat-to-beat heart rate variability as one method for assuring objectivity of sham therapy as a placebo control in osteopathic manipulative medicine research.
authors.affiliation: From the Marian University College of Osteopathic Medicine in Indianapolis, Indiana chenley@marian.edu.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Henley
authors.affiliation: From the Marian University College of Osteopathic Medicine in Indianapolis, Indiana.
authors.forename: Thad E
authors.initials: TE
authors.lastname: Wilson
mesh_terms: D035843:Biomedical Research; D006339:Heart Rate; D006801:Humans; D026301:Manipulation, Osteopathic; D010919:Placebos; D012107:Research Design
chemical_list: D010919:Placebos