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Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome
Open accessAbstract
Background & aims Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil.Methods We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events.Results Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005).Conclusions In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.
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Metadata
- Authors
- Weerts, Z. Z. R. M., Masclee, A. A. M., Witteman, B. J. M., Clemens, C. H. M., Winkens, B., Brouwers, J. R. B. J., Frijlink, H. W., Muris, J. W. M., De Wit, N. J., Essers, B. A. B., Tack, J., Snijkers, J. T. W., Bours, A. M. H., de Ruiter-van der Ploeg, A. S., Jonkers, D. M. A. E., & Keszthelyi, D.
- Affiliations
- Maastricht University Medical Centre (NL)
- Ziekenhuis Gelderse Vallei (NL)
- Alrijne Ziekenhuis (NL)
- University of Groningen (NL)
- KU Leuven (BE)
- Corresponding author
- Weerts, Zsa Zsa R.M.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2020-01
- Volume
- 158
- Issue
- 1
- Pages
- 123-136
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2970993597
- Cited by
- 137
- References
- 43
- Citations by year
- 2026: 17 · 2025: 18 · 2024: 17 · 2023: 18 · 2022: 18 · 2021: 31 · 2020: 16
- FWCI
- 15.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (acceptedVersion, other-oa)
- Socio-Environmental Systems Modeling (acceptedVersion)
- Lirias (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Takeda Pharmaceutical Company
- Janssen Pharmaceuticals
- AstraZeneca
- ZonMw (35:1965–1978, 836031017)
- Kyowa Hakko Kirin
- Shire
- Allergan
- Shionogi
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Health and Development
- Keywords
- peppermint oil, irritable bowel syndrome, abdominal pain, symptom relief, adverse events, placebo comparison, IBS symptom severity, Rome IV criteria
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Analgesics, Capsules, Double-Blind Method, Female, Humans, Intestinal Mucosa, Male, Middle Aged, Netherlands, Pain Measurement, Plant Oils, Severity of Illness Index, Abdominal Pain, Treatment Outcome, Mentha piperita, Irritable Bowel Syndrome, Young Adult
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