Division of Gastroenterology-Hepatology, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
United European Gastroenterol J. 2021 Nov;9(9):997-1006. doi: 10.1002/ueg2.12134. Epub 2021 Sep 1.
Irritable Bowel Syndrome (IBS) is a prevalent, chronic gastrointestinal disorder that imposes a substantial socioeconomic burden. Peppermint oil is a frequently used treatment for IBS, but evidence about cost-effectiveness is lacking.
We aimed to assess cost-effectiveness of small-intestinal release peppermint oil versus placebo in IBS patients.
In a multicenter randomized placebo-controlled trial, cost-effectiveness was evaluated from a societal perspective. The incremental cost-effectiveness ratios (ICERs) were expressed as (1) incremental costs per Quality Adjusted Life Years (QALY), and (2) incremental costs per successfully treated patient, that is per abdominal pain responder (according to FDA definitions), both after an eight-week treatment period with placebo versus peppermint oil. Cost-utility and uncertainty were estimated using non-parametric bootstrapping. Sensitivity analyses were performed.
The analysis comprised 126 patients (N = 64 placebo, N = 62 small-intestinal release peppermint oil). Peppermint oil was a dominant treatment compared to placebo in 46% of bootstrap replications. Peppermint oil was also more effective but at higher cost in 31% of replications. The net-benefit acceptability curve showed that peppermint oil has a 56% probability of being cost-effective at a conservative willingness-to-pay threshold of €10.000/QALY. Peppermint oil was also a dominant treatment per additional successfully treated patient according to FDA definitions, that is in 51% of replications. In this case, the acceptability curve showed an 89% probability of being cost-effective.
In patients with IBS, small-intestinal release peppermint oil appears to be a cost-effective treatment although there is uncertainty surrounding the ICER. When using abdominal pain responder as outcome measure for the ICER, peppermint oil has a high probability of being cost-effective. The use of peppermint oil, which is a low-cost treatment, can be justified by the modest QALY gains and slightly higher proportion of abdominal pain responders. More research and long-term data are necessary to confirm the cost-effectiveness of peppermint oil. NCT02716285.
肠易激综合征（IBS）是一种普遍存在的慢性胃肠道疾病，给社会带来了巨大的经济负担。薄荷油是治疗 IBS 的常用药物，但缺乏关于成本效益的证据。
评估小肠释放薄荷油治疗 IBS 的成本效益。
在一项多中心随机安慰剂对照试验中，从社会角度评估了成本效益。增量成本效益比（ICER）表示为：（1）每增加一个质量调整生命年（QALY）的增量成本；（2）每增加一个成功治疗的患者的增量成本，即根据 FDA 定义的腹痛应答者（根据 FDA 定义的腹痛应答者），治疗期结束后 8 周安慰剂与薄荷油之间的增量成本。使用非参数自举法估算成本效用和不确定性。进行了敏感性分析。
该分析包括 126 名患者（N = 64 名安慰剂，N = 62 名小肠释放薄荷油）。在 46%的自举复制中，薄荷油相对于安慰剂是一种主导治疗。在 31%的复制中，薄荷油也更有效，但成本更高。净效益接受曲线表明，薄荷油在保守的 10000 欧元/QALY 的支付意愿阈值下，有 56%的可能性具有成本效益。根据 FDA 的定义，薄荷油每增加一个成功治疗的患者，也是一种主导治疗，即 51%的复制。在这种情况下，接受曲线显示出 89%的成本效益可能性。
在 IBS 患者中，小肠释放薄荷油似乎是一种具有成本效益的治疗方法，尽管 ICER 存在不确定性。当使用腹痛应答者作为 ICER 的结果测量时，薄荷油具有很高的成本效益可能性。使用薄荷油这种低成本的治疗方法，可以通过适度的 QALY 收益和略高的腹痛应答者比例来证明其合理性。需要更多的研究和长期数据来证实薄荷油的成本效益。NCT02716285。
