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Repeatability and effect of blinding of fructose breath tests in patients with functional gastrointestinal disorders

机译:功能性胃肠道疾病患者果糖呼吸试验的可重复性和效果

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Abstract Background Breath tests are used as measures of sugar intolerance or malabsorption in patients with functional gastrointestinal disorders (FGID), although the repeatability or anticipatory bias have not been adequately studied. We examined the repeatability and anticipatory bias during fructose breath testing using a nocebo‐controlled, randomized, cross‐over, and double‐blind study design. Methods Gastrointestinal symptoms and breath concentrations of hydrogen and methane were documented during breath tests with fructose (given open twice and blinded once), water (blind neutral nocebo) and a cyclamate/saccharine sweetener (blind sweet nocebo) on 5?days in patients with FGID. Repeatability of fructose breath tests (16 patients) and differences between open and blinded substrate groups (31 patients) was assessed using thresholds for intolerance and malabsorption, and areas‐under‐the‐curve (AUC) of symptoms and breath gas concentrations. Key Results Fructose breath tests showed moderate repeatability for intolerance status (absolute agreement 87%, kappa 0.72), but limited repeatability for malabsorber status (absolute agreement 53%, kappa 0.05). Repeatability of AUCs of GI symptoms, hydrogen and methane breath concentrations was moderate (intraclass correlation coefficients 0.70, 0.57, and 0.57, respectively). There were no significant differences between open and blinded fructose breath tests in intolerance or malabsorber status, or in AUCs of GI symptoms, hydrogen and methane concentrations. Conclusions & Inferences Fructose breath tests showed moderate repeatability for intolerance status and for AUCs of symptoms and gas concentrations, lying within the range of accepted gastrointestinal sensory and transit tests. Repeatability for malabsorption status was inadequate and requires revisiting. The fructose breath test can be used unblinded in FGID.
机译:摘要背景呼吸试验用作功能性胃肠障碍患者(FGID)的糖不耐受或吸收不耐受的措施,尽管尚未得到充分研究重复性或预期偏差。我们在使用Nocebo-Control,随机的,交叉和双盲研究设计期间检查了果糖呼吸测试期间的可重复性和预期偏差。方法胃肠道和甲烷的胃肠症状和呼吸浓度被记录在呼吸试验期间用果糖(露天两次和致盲一次),水(盲中Nocebo)和循环酸盐/糖精甜味剂(盲甜蜜的NOCEBO)在5?天内FGID。使用阈值和呼吸气体浓度的区域和呼吸气体浓度的区域,评估果糖呼吸试验(16名患者)和开放和盲底族基团组(31例患者)之间的可重复性和开放和盲的底物组(31例)之间的差异。关键结果果糖呼吸试验表现出适度的不耐受状态可重复性(绝对协议87%,kappa 0.72),但对于马拉布机构的可重复性有限(绝对协议53%,Kappa 0.05)。 GI症状,氢气和甲烷呼吸浓度的AUCS的可重复性(分别分别为0.70,0.57和0.57)中等(腹积相关系数0.70,0.57和0.57)。不耐受或马拉布化学者状态或胃肠杆菌,氢气和甲烷浓度的AUC,在不耐受性果糖呼吸测试之间没有显着差异。结论&推论果糖呼吸试验显示不耐受状态和症状和气体浓度的适度可重复性,呈现在接受的胃肠道感官和过境试验范围内。恶臭状态的可重复性不足,需要重新审视。果糖呼吸试验可以在FGID中未粘连。

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