ArticleBioPsychoSocial medicine2024
Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study.
Article in BioPsychoSocial medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Systematic Review and Meta-Analysis: Plant-Based Therapy for Irritable Bowel Syndrome.Phytotherapy research : PTR · 2026Pooled it
- The Potential of Complementary and Alternative Therapies in Improving Diarrhea-Predominant Irritable Bowel Syndrome: Strategies for Long-Term Efficacy.Digestive diseases and sciences · 2026Review
- Plant-Derived Treatments for IBS: Clinical Outcomes, Mechanistic Insights, and Their Position in International Guidelines.Nutrients · 2026Review
- Natural Remedies for Irritable Bowel Syndrome: A Comprehensive Review of Herbal-Based Therapies.International journal of molecular sciences · 2025Review
- Advanced multidimensional quality evaluation of encapsulated peppermint oil products in various formulas.Journal of natural medicines · 2025Article
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Europe, an herbal medicine containing peppermint oil is widely used in patients with irritable bowel syndrome (IBS). In Japan, however, no clinical evidence for peppermint oil in IBS has been established, and it has not been approved as a drug for IBS. Accordingly, we conducted a clinical study to confirm the efficacy and safety of peppermint oil (ZO-Y60) in Japanese patients with IBS.
methodsThe study was a multi-center, open-label, single-arm, phase 3 trial in Japanese outpatients with IBS aged 17-60 years and diagnosed according to the Rome III criteria. The subjects were treated with an oral capsule of ZO-Y60 three times a day before meals, for four weeks. The efficacy of ZO-Y60 was evaluated using the patient's global assessment (PtGA), IBS symptom severity score, stool frequency score, stool form score, and physician's global assessment (PGA). The safety of ZO-Y60 was also assessed.
resultsSixty-nine subjects were treated with ZO-Y60. During the four-week administration of ZO-Y60, the improvement rate of the PtGA was 71.6% (48/67) in week 2 and 85.1% (57/67) in week 4. It was also suggested that ZO-Y60 is effective against any type of IBS (IBS with constipation, IBS with diarrhea, and mixed/unsubtyped IBS). The improvement rate of the PGA was 73.1% (49/67) in week 2 and 85.1% (57/67) in week 4, also confirming the efficacy of ZO-Y60. Adverse events were observed in 14 subjects (20.3%), however, none of these adverse events were categorized as serious.
conclusionThe efficacy of treatment was confirmed, subjective symptoms were improved, as was observed in previous clinical studies of ZO-Y60 conducted outside of Japan. All adverse reactions were previously known and were non-serious. These findings suggest that peppermint oil may be effective in the Japanese population and that it has an acceptable safety profile.
trial registrationJAPIC Clinical Trials Information number: JapicCTI-121727 https://jrct.niph.go.jp/en-latest-detail/jRCT1080221685 . Registration date: 2012-01-10.
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