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在刺激性肠综合征中评估对低FODMAP饮食的"反应":我们应该报告更难的初级终点吗?

Thomas Edward Conley¹, Miles Parkes², Stephen Moss²

¹University of Liverpool Institute of Integrative Biology, Liverpool, UK; Liverpool University Hospitals NHS Foundation Trust, Department of Gastroenterology, Liverpool, UK.

Clinical nutrition (Edinburgh, Scotland)

|April 5, 2024

概括

低FODMAP饮食 (LFD) 广泛用于IBS,但其临床试验反应指标需要更新. 与药物试验相比,目前的方法缺乏严格性,可能会夸大LFD的有效性.

科学领域:

胃肠病学胃肠病学
饮食疗法饮食疗法
临床试验方法论临床试验方法论

背景情况:

低FODMAP饮食 (LFD) 是刺激性肠综合征 (IBS) 管理的基石.
对比组的挑战和高响应率质疑目前的LFD试验结果评估.
现有的LFD试验响应措施落后于制药研究中使用的严格终点.

研究的目的:

评估当前临床响应测量在IBS低FODMAP饮食试验中的适当性.
倡导重新考虑在研究环境中对LFD临床反应的定义和评估.

主要方法:

进行了长达十年的低FODMAP饮食 (LFD) 临床试验文献综述.
专注于确定和分析用于初级临床终点的响应指标.

主要成果:

50点的IBS-SSS三角值是LFD试验中最常见的响应指标.
没有一个LFD试验采用了药物试验所规定的严格的初级临床终点.
多样化的反应指标,包括二元结果和特异性症状变化,缺乏明确的临床意义,使患者和临床医生的期望复杂化.

结论:

需要重新评估LFD试验中的"反应".
采用更强大的临床终点对于准确衡量症状改善与LFD苛刻的性质至关重要.

关键词:

刺激性肠综合征是什么意思低FODMAP饮食是一种低FODMAP饮食.响应响应响应响应

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