Effects of Open-label vs Double-blind Treatment in IBS

• Sponsor: Anthony Lembo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02802241
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 340
• Location: 1
• Arms: 4
• Duration (Months): 31
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome; Placebo Effect; Placebos; Peppermint Oil	Drug: placebo; Dietary Supplement: peppermint oil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: Effects of Open-label vs Double-blind Treatment in IBS.
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: open-label placebo	Drug: placebo
Experimental: double-blind placebo	Drug: placebo
Experimental: double-blind peppermint oil	Dietary Supplement: peppermint oil
No Intervention: no additional treatment

Outcome Measures

Primary Outcome Measures

1. Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. [6 weeks]

   Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meet Rome IV diagnostic criteria for IBS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Anthony Lembo
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Aug 17, 2018
• Study Protocol and Statistical Analysis Plan - Jun 15, 2018

More Information

Publications

None provided.

• Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT02802241
• Other Study ID Numbers: 2015P000282; R01AT008573
• First Posted: Jun 16, 2016
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Irritable Bowel Syndrome; Peppermint oil

Study Results

Participant Flow

Arm/Group Title	Open-label Placebo	Double-blind Placebo	Double-blind Peppermint Oil	no Pill Control
Arm/Group Description	placebo	placebo	peppermint oil	control
Period Title: Overall Study
STARTED	97	97	48	98
Planned Analysis	89	86	0	87
COMPLETED	68	71	0	72
NOT COMPLETED	29	26	48	26

Baseline Characteristics

Arm/Group Title	Open-label Placebo	Double-blind Placebo	Double-blind Peppermint Oil	no Pill Control	Total
Arm/Group Description	placebo	placebo	peppermint oil	control	Total of all reporting groups
Overall Participants	96	97	0	98	291
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.2 (17.6)	45.0 (19.2)	41.1 (17.7)	42.0 (18.1)
Sex: Female, Male (Count of Participants)
Female	69 71.9%	71 73.2%	71 Infinity	211 215.3%
Male	27 28.1%	26 26.8%	27 Infinity	80 81.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 NaN	0 0%
Asian	4 4.2%	4 4.1%	9 Infinity	17 17.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 NaN	0 0%
Black or African American	4 4.2%	3 3.1%	5 Infinity	12 12.2%
White	79 82.3%	85 87.6%	78 Infinity	242 246.9%
More than one race	0 0%	0 0%	0 NaN	0 0%
Unknown or Not Reported	9 9.4%	5 5.2%	6 Infinity	20 20.4%
IBS-SSS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	283.6 (61.3)	283.6 (66.7)	278.1 (71.1)	282.1 (67.4)

Outcome Measures

1. Primary Outcome

Title	Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Description	Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Double-blind peppermint oil data was not part of the planned analysis and not reported due to approved submissions with the NIH and FDA.

Arm/Group Title	Open-label Placebo	Double-blind Placebo	Double-blind Peppermint Oil	no Pill Control
Arm/Group Description	placebo	placebo	peppermint oil	control
Measure Participants	96	97	0	98
intention to treat	74.6	94.6	56.4
planned analysis	90.6	100.3	52.3

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	Participants are not at risk for adverse events or mortality since they were not given an active medication. Double-blind peppermint oil data was not collected as part of this study.
Arm/Group Title	Open-label Placebo		Double-blind Placebo		Double-blind Peppermint Oil		no Pill Control
Arm/Group Description	placebo		placebo		peppermint oil		control
All Cause Mortality
	Open-label Placebo		Double-blind Placebo		Double-blind Peppermint Oil		no Pill Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/97 (0%)		0/0 (NaN)		0/98 (0%)
Serious Adverse Events
	Open-label Placebo		Double-blind Placebo		Double-blind Peppermint Oil		no Pill Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/97 (0%)		0/0 (NaN)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Open-label Placebo		Double-blind Placebo		Double-blind Peppermint Oil		no Pill Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/96 (5.2%)		11/97 (11.3%)		0/0 (NaN)		0/98 (0%)
Gastrointestinal disorders
diarrhea	5/96 (5.2%)	5	5/97 (5.2%)	5	0/0 (NaN)	0	0/98 (0%)	0
heartburn	1/96 (1%)	1	6/97 (6.2%)	6	0/0 (NaN)	0	0/98 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.