Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:
NCT01010191
First received: November 5, 2009
Last updated: June 21, 2011
Last verified: June 2011

November 5, 2009
June 21, 2011
July 2008
April 2010   (final data collection date for primary outcome measure)
IBS Global Improvement Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010191 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Pilot Randomized Controlled Trial

Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Irritable Bowel Syndrome
Other: Sugar pill
  • Experimental: Cellulose pill
    The active intervention is a sugar pill.
    Intervention: Other: Sugar pill
  • No Intervention: No treatment
    The control arm is wait list control
Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Irritable bowel syndrome.

Exclusion Criteria:

  • Any signs of organic bowel disease such as rectal bleeding.
  • No other major illnesses.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010191
M16986
No
Ted Kaptchuk, Harvard Medical School
Harvard University Faculty of Medicine
Beth Israel Deaconess Medical Center
Not Provided
Harvard University Faculty of Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP