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Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.
Gastroenterology. 2020 01; 158(1):123-136.G

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), 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.

Authors+Show Affiliations

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.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.Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands; Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands.Department of Gastroenterology, Alrijne Zorggroep, Leiden, The Netherlands.Department of Methodology and Statistics, CAPHRI, Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands.Unit of Pharmacotherapy, Epidemiology, and Economics, University of Groningen, Groningen Research Institute of Pharmacy, The Netherlands.Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen Research Institute of Pharmacy, The Netherlands.Department of Family Medicine, CAPHRI Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht, The Netherlands.Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.Department of Clinical and Experimental Medicine, Translational Research Center for Gastrointestinal Diseases (TARGID), University of Leuven, Leuven, Belgium.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.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.Department of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.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.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.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31470006

Citation

Weerts, Zsa Zsa R M., et al. "Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome." Gastroenterology, vol. 158, no. 1, 2020, pp. 123-136.
Weerts ZZRM, Masclee AAM, Witteman BJM, et al. Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. Gastroenterology. 2020;158(1):123-136.
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. (2020). Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. Gastroenterology, 158(1), 123-136. https://doi.org/10.1053/j.gastro.2019.08.026
Weerts ZZRM, et al. Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. Gastroenterology. 2020;158(1):123-136. PubMed PMID: 31470006.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. AU - Weerts,Zsa Zsa R M, AU - Masclee,Ad A M, AU - Witteman,Ben J M, AU - Clemens,Cees H M, AU - Winkens,Bjorn, AU - Brouwers,Jacobus R B J, AU - Frijlink,Henderik W, AU - Muris,Jean W M, AU - De Wit,Niek J, AU - Essers,Brigitte A B, AU - Tack,Jan, AU - Snijkers,Johanna T W, AU - Bours,Andrea M H, AU - de Ruiter-van der Ploeg,Annieke S, AU - Jonkers,Daisy M A E, AU - Keszthelyi,Daniel, Y1 - 2019/08/27/ PY - 2019/05/18/received PY - 2019/08/05/revised PY - 2019/08/14/accepted PY - 2019/8/31/pubmed PY - 2020/2/15/medline PY - 2019/8/31/entrez KW - Functional Gastrointestinal Disorder KW - PERSUADE Study KW - RCT KW - Treatment SP - 123 EP - 136 JF - Gastroenterology JO - Gastroenterology VL - 158 IS - 1 N2 - 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/31470006/Efficacy_and_Safety_of_Peppermint_Oil_in_a_Randomized_Double_Blind_Trial_of_Patients_With_Irritable_Bowel_Syndrome_ DB - PRIME DP - Unbound Medicine ER -