Irritable Bowel Syndrome, Placebo Effect, Placebos, Peppermint Oil
Conditions
Brief summary
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Interventions
DRUGplacebo
DIETARY_SUPPLEMENTpeppermint oil
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet Rome IV diagnostic criteria for IBS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label Placebo placebo | 89 |
| Double-blind Placebo placebo | 87 |
| no Pill Control control | 86 |
| Double-blind Peppermint Oil peppermint oil | 46 |
| Total | 308 |
Baseline characteristics
| Characteristic | Open-label Placebo | Total | Double-blind Peppermint Oil | no Pill Control | Double-blind Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 17.6 | 42.0 years STANDARD_DEVIATION 18.1 | 41.0 years STANDARD_DEVIATION 17.4 | 40.0 years STANDARD_DEVIATION 17.7 | 43.8 years STANDARD_DEVIATION 19.2 |
| IBS-SSS | 286.0 units on a scale STANDARD_DEVIATION 62 | 282.1 units on a scale STANDARD_DEVIATION 67.4 | 283.5 units on a scale STANDARD_DEVIATION 71.7 | 274.4 units on a scale STANDARD_DEVIATION 71.1 | 285.8 units on a scale STANDARD_DEVIATION 69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 18 Participants | 2 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 15 Participants | 3 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 20 Participants | 0 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 73 Participants | 255 Participants | 41 Participants | 66 Participants | 75 Participants |
| Sex: Female, Male Female | 63 Participants | 224 Participants | 34 Participants | 63 Participants | 64 Participants |
| Sex: Female, Male Male | 26 Participants | 84 Participants | 12 Participants | 23 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 97 | 0 / 0 | 0 / 98 |
| other Total, other adverse events | 5 / 96 | 11 / 97 | 0 / 0 | 0 / 98 |
| serious Total, serious adverse events | 0 / 96 | 0 / 97 | 0 / 0 | 0 / 98 |
Outcome results
Primary
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Time frame: 6 weeks
Population: Double-blind peppermint oil data was not part of the planned analysis. While the data was collected, the results were analyzed with a modified intention to treat which differs from the primary analysis of intention to treat. The outcome results data are not an accurate comparision.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Open-label Placebo | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | intention to treat | 74.6 score on a scale |
| Open-label Placebo | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | planned analysis | 90.6 score on a scale |
| Double-blind Placebo | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | planned analysis | 100.3 score on a scale |
| Double-blind Placebo | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | intention to treat | 94.6 score on a scale |
| no Pill Control | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | intention to treat | 56.4 score on a scale |
| no Pill Control | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | planned analysis | 52.3 score on a scale |
| Double-blind Peppermint Oil | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | intention to treat | 90.8 score on a scale |
| Double-blind Peppermint Oil | Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. | planned analysis | 90.8 score on a scale |