Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.
Division of Gastroenterology, Mayo Clinic, Jacksonville, Florida, USA.
Clin Transl Gastroenterol. 2019 Apr;10(4):e00021. doi: 10.14309/ctg.0000000000000021.
We conducted a randomized, placebo-controlled trial, which evaluated a novel formulation of caraway oil and L-menthol using microsphere-based site-specific targeting (COLM-SST) vs placebo in patients with functional dyspepsia (FD).
Adult men and women with FD defined by Rome III criteria were recruited. Patients were randomized to COLM-SST (25 mg of caraway oil and 20.75 mg of L-menthol per capsule, at 2 capsules per dose, twice per day) or placebo. Efficacy was measured at 24 hours, 2 weeks, and 4 weeks. Patients were allowed to take concomitant medications for their FD throughout the trial, and rescue medicines were allowed, 48 hours after start of dosing.
Ninety-five patients were enrolled (mean age = 43.4 years; 75.8% women). At 24 hours, the active arm reported a statistically significant reduction in postprandial distress syndrome symptoms (P = 0.039), and a nonsignificant trend toward benefit of epigastric pain syndrome symptoms (P = 0.074). In patients with more severe symptoms, approximately 3 quarters of patients showed substantial global improvement (i.e., clinical global impressions), after 4 weeks of treatment, vs half in the control arm. These differences were statistically significant for patients with epigastric pain syndrome (P = 0.046), and trending toward significance for patients with postprandial distress syndrome (P = 0.091). There was no statistically significant difference between groups for Global Overall Symptom scores for the overall population at 2 and 4 weeks. Treatment emergent adverse events were mild to moderate, and no serious adverse events were reported.
In patients taking their usual medications for FD, COLM-SST provided rapid relief (within 24 hours) and relief of severe FD symptoms. It was safe and well tolerated.
我们进行了一项随机、安慰剂对照试验，评估了一种新型的基于微球的特定部位靶向（COLM-SST）卡萝艾油和 L-薄荷醇配方与安慰剂在功能性消化不良（FD）患者中的疗效。
符合罗马 III 标准的 FD 成年男女患者入组。患者随机分为 COLM-SST（每胶囊含 25 毫克卡萝艾油和 20.75 毫克 L-薄荷醇，每次 2 胶囊，每日 2 次）或安慰剂。在 24 小时、2 周和 4 周时评估疗效。整个试验期间，患者可服用治疗 FD 的伴随药物，允许在开始给药后 48 小时服用急救药物。
共纳入 95 例患者（平均年龄 43.4 岁；75.8%为女性）。在 24 小时时，活性组餐后不适综合征症状显著减轻（P = 0.039），上腹疼痛综合征症状有改善趋势（P = 0.074）。在症状较重的患者中，大约四分之三的患者在治疗 4 周后出现了显著的整体改善（即临床总体印象），而对照组为一半。这些差异在上腹疼痛综合征患者中具有统计学意义（P = 0.046），在餐后不适综合征患者中呈趋势（P = 0.091）。在 2 周和 4 周时，总体人群的总体症状评分，两组间无统计学差异。治疗中出现的不良事件为轻至中度，无严重不良事件报告。
在服用常规 FD 药物的患者中，COLM-SST 可快速缓解（24 小时内）并缓解严重 FD 症状。它是安全且耐受良好的。
