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Gastroenterology. 2019 Aug 27. pii: S0016-5085(19)41246-8. doi: 10.1053/j.gastro.2019.08.026. [Epub ahead of print]

Efficacy and Safety of Peppermint Oil in a Randomized Double-blind Trial of Patients With Irritable Bowel Syndrome.

Author information

1
Division of Gastroenterology and Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: z.weerts@maastrichtuniversity.nl.
2
Division of Gastroenterology and Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.
3
Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands; Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands.
4
Department of Gastroenterology, Alrijne Zorggroep, Leiden, The Netherlands.
5
Department of Methodology and Statistics, CAPHRI, Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands.
6
Unit of Pharmacotherapy -Epidemiology and -Economics, University of Groningen, Groningen Research Institute of Pharmacy, The Netherlands.
7
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen Research Institute of Pharmacy, The Netherlands.
8
Department of Family Medicine, CAPHRI Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands.
9
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
10
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
11
Department of Clinical and Experimental Medicine, Translational Research Center for Gastrointestinal Diseases (TARGID), University of Leuven, Leuven, Belgium.
12
Department of Gastroenterology and Hepatology, Medical Center Leeuwarden. Leeuwarden, the Netherlands.

Abstract

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); 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 Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared to 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 peppermint oil and placebo groups: 29/62 patients in the small intestinal-release peppermint oil group had a response (46.8%, P=.170 vs placebo), 26/63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P=.385 vs placebo), and 22/64 patients in the placebo group had a response (34.4%). We did not find differences among 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 FDA/EMA 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 no: NCT02716285.

KEYWORDS:

PERSUADE study; RCT; functional gastrointestinal disorder; treatment

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