Investigating placebo effects in irritable bowel syndrome: a novel research design.
Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective. This article summarizes the methodology of an ongoing NIH-funded randomized controlled trial aimed at investigating whether the placebo effect in irritable bowel syndrome (IBS) exists and whether the magnitude of such an effect can be manipulated to vary in a manner analogous to "dose dependence." The trial also uses an innovative combination of quantitative and qualitative methods.
Conboy
Lisa A
LA
Osher Institute, Division for Research and Education in Complementary and Integrative Therapies, Harvard Medical School, 401 Park Drive, Suite 22A, Boston, MA 02115, USA.
Wasserman
Rachel H
RH
Jacobson
Eric E
EE
Davis
Roger B
RB
Legedza
Anna T R
AT
Park
Min
M
Rivers
Andrea L
AL
Morey
Elizabeth B
EB
Nam
Bong Hyun
BH
Lasagna
Louis
L
Kirsch
Irving
I
Lembo
Anthony J
AJ
Kaptchuk
Ted J
TJ
Kerr
Catherine E
CE
D015670:Acupuncture Therapy; D003627:Data Interpretation, Statistical; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D010817:Physician-Patient Relations; D015990:Placebo Effect; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires