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

Harvard University Faculty of Medicine

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01010191

M16986

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Irritable bowel syndrome.

Exclusion criteria

• Any signs of organic bowel disease such as rectal bleeding.
• No other major illnesses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Cellulose pill

Experimental group

Description:

The active intervention is a sugar pill.

Treatment:

Other: Sugar pill

No treatment

No Intervention group

Description:

The control arm is wait list control