肠易激综合征(IBS)影响全球9,2%的人口,并给医疗保健系统带来相当大的负担。大多数治疗IBS的药物,包括痉挛,泻药,和止泻药,具有低功效。尚未开发用于IBS的有效和安全的治疗性治疗。
这项研究评估了含有标准化薄荷醇的食品补充剂的有效性和安全性,柠檬烯,和姜辣素在患有IBS或IBS/功能性消化不良(FD)的人类参与者中。
双盲,随机化,安慰剂对照试验。
我们将56例IBS或IBS/FD患者随机分为干预组(第1组)或对照组(第2组),给予补充或安慰剂。分别,除了标准治疗方案30d。在研究期间进行了3次门诊就诊。每次就诊时使用7×7问卷测量症状严重程度。基于16SrRNA基因测序,在第1次和第3次访问时评估肠道微生物群的定性和定量组成。
在第1次就诊时(治疗前),两组的7×7问卷总分中位数均在中度疾病范围内,组间无差异(p=0.1)。在第2次访问时,总的7×7分降低为轻度疾病,组间无差异(p=0.4)。在第3次访问时,第1组的总分表示临界疾病,第2组的总分表示轻度疾病(p=0.009)。尽管我们观察到各组之间肠道微生物群的一些变化,我们没有发现任何有统计学意义的变化.
含有标准化薄荷醇的食品补充剂,柠檬烯,姜辣素含量增加了IBS和FD患者标准治疗的疗效。使用补充剂没有引起任何明显的副作用。
ClinicalTrials.gov标识符:NCT04484467。
Irritable bowel syndrome (IBS) affects 9,2% of the global population and places a considerable burden on healthcare systems. Most medications for treating IBS, including spasmolytics, laxatives, and antidiarrheals, have low efficacy. Effective and safe therapeutic treatments have yet to be developed for IBS.
This
study assessed the efficacy and safety of a food supplement containing standardized menthol,
limonene, and gingerol in human participants with IBS or IBS/functional dyspepsia (FD).
A double-blind, randomized, placebo-controlled
trial.
We randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d. Three outpatient visits were conducted during the
study. Symptom severity was measured at each visit using a 7×7 questionnaire. Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing.
At visit 1 (before treatment), the median total 7×7 questionnaire score was in the moderately ill range for both groups, with no difference between the groups (p = 0.1). At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4). At visit 3, the total score for group 1 indicated borderline illness and for group 2 remained indicated mild illness (p = 0.009). Even though we observed some variations in gut microbiota between the groups, we did not find any statistically significant changes.
The food supplement with standardized menthol,
limonene, and gingerol content increased the efficacy of standard therapy in IBS and FD patients. The use of the supplement did not cause any obvious side effects.
ClinicalTrials.gov Identifier: NCT04484467.