Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Randomized Controlled Trial|
- IBS Global Improvement Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- IBS Adequate Relief [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- IBS quality of life (QoL) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- IBS Symptom Severity Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Cellulose pill
The active intervention is a sugar pill.
|Other: Sugar pill|
No Intervention: No treatment
The control arm is wait list control
Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.