Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study
Abstract Background In 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 conducte...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | BioPsychoSocial Medicine |
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| Online Access: | https://doi.org/10.1186/s13030-024-00302-y |
| _version_ | 1797274199368138752 |
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| author | Kei Matsueda Shin Fukudo Masayuki Ogishima Yuki Naito Soichiro Nakamura |
| author_facet | Kei Matsueda Shin Fukudo Masayuki Ogishima Yuki Naito Soichiro Nakamura |
| author_sort | Kei Matsueda |
| collection | DOAJ |
| description | Abstract Background In 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. Methods The 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. Results Sixty-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. Conclusion The 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 registration JAPIC Clinical Trials Information number: JapicCTI-121727 https://jrct.niph.go.jp/en-latest-detail/jRCT1080221685 . Registration date: 2012–01-10. |
| first_indexed | 2024-03-07T14:54:58Z |
| format | Article |
| id | doaj.art-e24e46f6cac943169e1433e6fed1ca06 |
| institution | Directory Open Access Journal |
| issn | 1751-0759 |
| language | English |
| last_indexed | 2024-03-07T14:54:58Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BioPsychoSocial Medicine |
| spelling | doaj.art-e24e46f6cac943169e1433e6fed1ca062024-03-05T19:30:33ZengBMCBioPsychoSocial Medicine1751-07592024-02-0118111310.1186/s13030-024-00302-yEfficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm studyKei Matsueda0Shin Fukudo1Masayuki Ogishima2Yuki Naito3Soichiro Nakamura4Sakura Life ClinicDepartment of Behavioral Medicine, Tohoku University Graduate School of MedicineZeria Pharmaceutical Co., Ltd.Zeria Pharmaceutical Co., Ltd.Zeria Pharmaceutical Co., Ltd.Abstract Background In 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. Methods The 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. Results Sixty-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. Conclusion The 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 registration JAPIC Clinical Trials Information number: JapicCTI-121727 https://jrct.niph.go.jp/en-latest-detail/jRCT1080221685 . Registration date: 2012–01-10.https://doi.org/10.1186/s13030-024-00302-yClinical trialHerbal medicineIrritable bowel syndromeJapanese patientsPeppermint oilRome III criteria |
| spellingShingle | Kei Matsueda Shin Fukudo Masayuki Ogishima Yuki Naito Soichiro Nakamura Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study BioPsychoSocial Medicine Clinical trial Herbal medicine Irritable bowel syndrome Japanese patients Peppermint oil Rome III criteria |
| title | Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study |
| title_full | Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study |
| title_fullStr | Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study |
| title_full_unstemmed | Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study |
| title_short | Efficacy and safety of peppermint oil for the treatment in Japanese patients with irritable bowel syndrome: a prospective, open-label, and single-arm study |
| title_sort | efficacy and safety of peppermint oil for the treatment in japanese patients with irritable bowel syndrome a prospective open label and single arm study |
| topic | Clinical trial Herbal medicine Irritable bowel syndrome Japanese patients Peppermint oil Rome III criteria |
| url | https://doi.org/10.1186/s13030-024-00302-y |
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