Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Other: Sugar pill
- Registration Number
- NCT01010191
- Lead Sponsor
- Harvard University Faculty of Medicine
- Brief Summary
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Irritable bowel syndrome.
- Any signs of organic bowel disease such as rectal bleeding.
- No other major illnesses.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cellulose pill Sugar pill The active intervention is a sugar pill.
- Primary Outcome Measures
Name Time Method IBS Global Improvement Scale 3 weeks
- Secondary Outcome Measures
Name Time Method IBS Adequate Relief 3 weeks IBS quality of life (QoL) 3 weeks IBS Symptom Severity Scale 3 weeks
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States