Cash Brooks D, Epstein Michael S, Shah Syed M
Division of Gastroenterology, University of South Alabama, 6000 University Commons, 75 University Blvd, S, Mobile, AL, 36688, USA.
Digestive Disorders Associates, 621 Ridgely Ave, #201, Annapolis, MD, 21401, USA.
Dig Dis Sci. 2016 Feb;61(2):560-71. doi: 10.1007/s10620-015-3858-7. Epub 2015 Aug 29.
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 ± 0.807), superior to the 24.3 % decrease (mean change -0.70, SD ± 0.737) observed with placebo (P = 0.0246). The decrease in the TISS of 19.6 % (mean change -0.55, SD ± 0.613) in the PO group at 24 h was also significantly larger than placebo (-10.3 %, mean change -0.27, SD ± 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.
薄荷油（PO）已显示出作为肠易激综合征（IBS）治疗方法的潜力，但先前的试验表明其疗效和耐受性结果存在差异。
评估一种专为在小肠中持续释放而设计的新型薄荷油制剂对腹泻型肠易激综合征（IBS-D）和混合型肠易激综合征（IBS-M）患者的疗效和耐受性。
这是一项为期4周的随机、双盲、安慰剂对照临床试验，符合IBS-M或IBS-D罗马III标准的患者每日3次服用薄荷油或相同的安慰剂。主要终点是治疗4周后肠易激综合征总症状评分（TISS）相对于基线的变化。
72名患者（平均年龄40.7岁，75%为女性，77.8%为白人）被随机分为薄荷油组（n = 35）或安慰剂组（n = 37）。4周时，薄荷油组的TISS较基线降低了40%（平均变化-1.16，标准差±0.807），优于安慰剂组观察到的24.3%的降低（平均变化-0.70, 标准差±0.737）（P = 0.0246）。薄荷油组在24小时时TISS降低19.6%（平均变化-0.55，标准差±0.613）也显著大于安慰剂组（-10.3%，平均变化-0.27，标准差±0.342）（P = 0.0092）。在试验结束时，与安慰剂组相比，薄荷油组患者在多个个体胃肠道症状以及严重或难以忍受的症状方面有更大改善。薄荷油耐受性良好，不良事件较少。
一种专为在小肠中持续释放而设计的新型薄荷油制剂是一种安全、有效的治疗方法，能够快速缓解肠易激综合征症状。
