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一组疑似非乳糜泻麸质敏感患者中进行的对照麸质激发试验的效果:一项随机、双盲、安慰剂对照的激发试验。

The effect of a controlled gluten challenge in a group of patients with suspected non-coeliac gluten sensitivity: A randomized, double-blind placebo-controlled challenge.

作者信息

Dale H F, Hatlebakk J G, Hovdenak N, Ystad S O, Lied G A

机构信息

Centre for Nutrition, Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Section of Gastroenterology, Department of Medicine, Haukeland University Hospital, Bergen, Norway.

出版信息

Neurogastroenterol Motil. 2018 Mar 15. doi: 10.1111/nmo.13332.

DOI:10.1111/nmo.13332
PMID:29542844
Abstract

BACKGROUND

Non-coeliac gluten-sensitivity (NCGS) has been proposed as a new entity with unknown prevalence and mechanisms, and there is a need for a standardized procedure to confirm the diagnosis. The objective of this study was to characterize the response to an oral gluten-challenge in patients with a symptom-relief when following a gluten free-diet (GFD).

METHODS

Twenty patients (14F/6M, age range: 21-62 years) with suspected NCGS, without coeliac disease and wheat-allergy, were included while on a gluten-free diet. All patients went through four periods of double-blinded provocation, two with gluten and two with placebo in randomized order. They consumed two muffins a day (11/0 g gluten) for 4 days, followed by a 3-day wash-out. Gastrointestinal symptoms were recorded with questionnaires at baseline and after each provocation. We also investigated whether patients were able to correctly identify periods with gluten-exposure.

KEY RESULTS

Collectively the whole group reported the most severe symptoms after placebo (P = .012). Four out of twenty patients correctly identified the two periods when they received gluten, hence were diagnosed with NCGS. The diagnosed-group tended to show higher symptom scores than the not-diagnosed group both at baseline, after gluten exposure and after placebo, but no clear difference was seen between provocation with gluten and placebo. The not-diagnosed group showed more severe symptoms with placebo than with gluten (P = .029).

CONCLUSIONS AND INFERENCES

The present study showed that the majority of patients with suspected NCGS are not able to identify when challenged with gluten in a double-blind placebo-controlled food challenge, indicating that gluten is not the cause of their symptoms.

摘要

背景

非乳糜泻性麸质敏感(NCGS)被认为是一种新的疾病实体,其患病率和发病机制尚不清楚,因此需要一种标准化程序来确诊。本研究的目的是描述在遵循无麸质饮食(GFD)后症状缓解的患者对口服麸质激发试验的反应。

方法

纳入20例疑似NCGS患者(14例女性/6例男性,年龄范围:21 - 62岁),这些患者无乳糜泻和小麦过敏,且当时正在进行无麸质饮食。所有患者经历四个双盲激发试验阶段,两个阶段给予麸质,两个阶段给予安慰剂,顺序随机。他们每天食用两个松饼(含11/0克麸质),共4天,随后有3天的洗脱期。在基线和每次激发试验后,通过问卷记录胃肠道症状。我们还调查了患者是否能够正确识别麸质暴露阶段。

主要结果

总体而言,整个研究组在服用安慰剂后报告的症状最为严重(P = 0.012)。20例患者中有4例正确识别出他们接受麸质的两个阶段,因此被诊断为NCGS。在基线、麸质暴露后和安慰剂后,诊断组的症状评分往往高于未诊断组,但麸质激发试验和安慰剂激发试验之间没有明显差异。未诊断组服用安慰剂时的症状比服用麸质时更严重(P = 0.029)。

结论与推论

本研究表明,大多数疑似NCGS患者在双盲安慰剂对照食物激发试验中无法识别麸质激发,这表明麸质不是其症状的原因。

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