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Abstract

Grant Number:	5R01AT001414-04
Project Title:	Enhancing the Placebo Effect in Irritable Bowel Syndrome

PI Information:	Name	Email	Title
	KAPTCHUK, TED J.	ted_kaptchuk@hms.harvard.edu	ASSISTANT PROFESSOR OF MEDICINE

Abstract: DESCRIPTION (provided by applicant): This grant continues our ongoing research on how placebo effects can be enhanced and provides crucial data on the placebo effect's scientific validity and clinical significance. Our model uses Irritable Bowel Syndrome (IBS) to study the placebo effects elicited by different patient-practitioner contexts. In phase one, 260 patients will be randomized to a 3 week three arm RCT comparing: 1. sham needle treatment (a validated sham acupuncture placebo device) given in the context of a patient-practitioner interaction 'augmented' with positive cognitive, emotional and symbolic interactions, 2. identical sham given within a 'limited' contextual interaction, 3. a no treatment control. The primary question tested is whether the 'nonspecific' effects across the two sham device arms and the no treatment arm behave monotonically in a manner analogous to 'dose dependence' i.e. is 'augmented' arm > 'limited arm' > wait-list natural history. This trial also allows us to answer whether 1. the placebo effect in IBS can be enhanced, i.e., does an 'augmented' placebo intervention elicit a greater placebo effect than a 'limited' placebo intervention and 2. whether the 'limited' placebo intervention elicits a greater placebo effect than natural history arm with any 'non-specific' effects attendant to being in a no-treatment control. To maintain ethical norms, phase two will continue the same context, but sham acupuncture will seamlessly be switched to verum acupuncture to explore acupuncture's efficacy in IBS. In addition, a second parallel qualitative study will follow 27 additional patients (whose outcome data will be excluded from the larger study's analysis) through the same three arms; the study will use interviews to explore the relationships between patients' interpretations and understandings (what anthropologists call 'meaning') of IBS, and their responses to placebo and verum treatment.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
behavioral medicine, human therapy evaluation, irritable bowel syndrome, placebo, social psychology
acupuncture /acupressure, clinical trial phase I, clinical trial phase II, cognition, dosage, emotion, functional ability, interdisciplinary collaboration, outcomes research, patient care personnel relations, psychometrics, psychosomatic disorder
alternative medicine, behavioral /social science research tag, clinical research, human subject, patient oriented research, psychological test

Institution:	HARVARD UNIVERSITY (MEDICAL SCHOOL)
	MEDICAL SCHOOL CAMPUS
	BOSTON, MA 02115
Fiscal Year:	2006
Department:	MEDICINE
Project Start:	01-APR-2003
Project End:	31-DEC-2008
ICD:	NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE
IRG:	ZRG1

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