背景:在欧洲,含有薄荷油的草药广泛用于肠易激综合征(IBS)患者。在日本,然而,IBS中没有薄荷油的临床证据,它尚未被批准为IBS的药物。因此,我们进行了一项临床研究,以证实薄荷油(ZO-Y60)在日本IBS患者中的疗效和安全性.
方法:这项研究是一个多中心,开放标签,单臂,在日本门诊患者中进行的3期试验,年龄为17-60岁,根据罗马III标准诊断。受试者每天饭前用ZO-Y60口服胶囊治疗三次,四个星期.ZO-Y60的疗效使用患者的整体评估(PtGA)进行评估,IBS症状严重程度评分,大便频率评分,大便形式评分,和医生的全球评估(PGA)。还评估了ZO-Y60的安全性。
结果:69名受试者接受ZO-Y60治疗。在ZO-Y60给药4周期间,PtGA的改善率在第2周为71.6%(48/67),在第4周为85.1%(57/67)。还建议ZO-Y60对任何类型的IBS(便秘的IBS,IBS腹泻,和混合/非亚型IBS)。PGA在第2周的改善率为73.1%(49/67),在第4周的改善率为85.1%(57/67),也证实了ZO-Y60的功效。14名受试者(20.3%)出现不良事件,然而,这些不良事件均未被归类为严重不良事件.
结论:治疗的疗效得到证实,主观症状得到改善,正如以前在日本以外进行的ZO-Y60临床研究所观察到的那样。所有不良反应都是先前已知的,并且是非严重的。这些发现表明薄荷油可能对日本人群有效,并且具有可接受的安全性。
背景:JAPIC临床试验信息编号:JapicCTI-121727https://jrct。尼夫.走吧。jp/en-latest-detail/jRCT1080221685.注册日期:2012-01-10。
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.
CONCLUSIONS: 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.
BACKGROUND: JAPIC Clinical Trials Information number: JapicCTI-121727 https://jrct.niph.go.jp/en-latest-detail/jRCT1080221685 . Registration date: 2012-01-10.