A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms
A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms
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DOI：
10.1007/s10620-015-3858-7
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发表时间：
2016-02-01
影响因子：
3.1
通讯作者：
Shah, Syed M.
中科院分区：
文献类型：
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作者：
Cash, Brooks D.;Epstein, Michael S.;Shah, Syed M.
薄荷油(PO)已经显示出作为IBS治疗的前景，但先前的试验已经证明了不同的疗效和耐受性结果。为了评价一种新的PO制剂在IBS-M和IBS-D患者的小肠缓释的有效性和耐受性。这是一项为期4周的随机、双盲、安慰剂对照临床试验，在符合罗马III IBS-M或IBS-D标准的患者中，每天3次使用PO或相同的安慰剂。主要终点是治疗4周后IBS总症状评分(TISS)与基线的变化。72名患者(平均年龄40.7岁，女性75%，白人77.8%)被随机分为PO组(n=35)和安慰剂组(n=37)。在4周时，PO与TISS较基线下降40%(平均变化-1.16，SD+/-A 0.807)相关，优于安慰剂观察到的24.3%(平均变化-0.7，SD+/-A 0.737)(P=0.0246)。服药后24 h，PO组TISS下降19.6%(平均变化-0.55，SD+/-A 0.613)，也明显大于安慰剂组(-10.3%，平均变化-0.27，SD+/-A 0.342)(P=0.0092)。在试验结束时，与安慰剂相比，PO组的患者在多种个人胃肠道症状以及严重或无法忍受的症状方面都有更大的改善。PO耐受性良好，不良事件很少。一种新的PO制剂设计为在小肠内缓释，是一种安全、有效的治疗方法，能够迅速缓解IBS症状。
Peppermint oil (PO) has shown promise as an IBS therapy, but previous trials have demonstrated variable efficacy and tolerability results.To evaluate the efficacy and tolerability of a novel formulation of PO designed for sustained release in the small intestine in patients with IBS-M and IBS-D.This is a 4-week, randomized, double-blind, placebo-controlled clinical trial of PO or identical placebo 3 times daily in patients fulfilling Rome III criteria for IBS-M or IBS-D. The primary endpoint was the change from baseline in the Total IBS Symptom Score (TISS) after 4 weeks of treatment.Seventy-two patients (mean age 40.7 years, 75 % female, 77.8 % white) were randomized to PO (n = 35) or placebo (n = 37). At 4 weeks, PO was associated with a 40 % reduction in the TISS from baseline (mean change -1.16, SD +/- A 0.807), superior to the 24.3 % decrease (mean change -0.70, SD +/- A 0.737) observed with placebo (P = 0.0246). The decrease in the TISS of 19.6 % (mean change -0.55, SD +/- A 0.613) in the PO group at 24 h was also significantly larger than placebo (-10.3 %, mean change -0.27, SD +/- A 0.342) (P = 0.0092). At trial completion, patients in the PO group experienced greater improvement in multiple individual gastrointestinal symptoms as well as in severe or unbearable symptoms, compared to placebo. PO was well tolerated with few adverse events.A novel PO formulation designed for sustained release in the small intestine is a safe, effective treatment capable of providing rapid relief of IBS symptoms.