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二胺氧化酶(DAO)补充剂可减少二胺氧化酶缺乏的发作性偏头痛患者的头痛:一项随机双盲试验。

Diamine oxidase (DAO) supplement reduces headache in episodic migraine patients with DAO deficiency: A randomized double-blind trial.

机构信息

Department of Neurology, Hospital General de Catalunya, C/ Pere i Pons 1, 08915, Sant Cugat del Vallès, Spain; Department of Basic Sciences, Universitat Internacional de Catalunya, C/ Pere i Pons 1, 08915, Sant Cugat del Vallès, Spain.

Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, School of Pharmacy and Food Sciences, University of Barcelona, Avinguda Prat de la Riba 171, 08921, Santa Coloma de Gramenet, Spain.

出版信息

Clin Nutr. 2019 Feb;38(1):152-158. doi: 10.1016/j.clnu.2018.01.013. Epub 2018 Feb 15.

DOI:10.1016/j.clnu.2018.01.013
PMID:29475774
Abstract

BACKGROUND & AIMS: Histamine intolerance is a disorder in the homeostasis of histamine due to a reduced intestinal degradation of this amine, mainly caused by a deficiency in the enzyme diamine oxidase (DAO). Among histamine related symptoms, headache is one of the most recorded. Current clinical strategies for the treatment of the symptomatology related to this disorder are based on the exclusion of foods with histamine or other bioactive amines and/or exogenous DAO supplementation. The aim of this study was to assess the efficacy of a food supplement consisting of DAO enzyme as a preventive treatment of migraine in patients with DAO deficiency through a randomized double-blind trial.

METHODS

100 patients with confirmed episodic migraine according to current International Headache Society (IHS) criteria and DAO deficiency (levels below 80 HDU/ml) were randomized in two groups. One group received DAO enzyme supplementation and the other received placebo for one month. Clinical outcomes assessed were duration and number of attacks, perception of pain intensity and adverse effects during treatment. The use of triptans was also recorded.

RESULTS

Great variability was found in the duration of migraine attacks reported by placebo and DAO groups. A significant reduction (p = 0.0217) in hours of pain was achieved in patients treated with DAO supplement, with mean durations of 6.14 (±3.06) and 4.76 (±2.68) hours before and after treatment, respectively. A smaller reduction without statistical signification was also observed for this outcome in the placebo group, from 7.53 (±4.24) to 6.68 (±4.42) hours. Only in DAO group, a decrease in the percentage of patients taking triptans was observed. The number of attacks and the scores of pain intensity showed a similar reduction in both groups. No adverse effects were registered in patients treated with DAO enzyme.

CONCLUSIONS

Migrainous patients supplemented with DAO enzyme during one month significantly reduced the duration of their migraine attacks by 1.4 h. No statistically significant reduction was found in placebo group before and after treatment. The reduction of pain hours observed in placebo group (0.9 h) could explain the lack of significant differences between both study groups. One month of DAO supplementation has demonstrated a positive trend in the improvement of migraine but more studies with a longer treatment period are needed to better assess the efficacy of DAO supplementation.

CLINICAL TRIAL REGISTRATION NUMBER

ISRCTN10091019; www.isrctn.org.

摘要

背景与目的

由于肠道对这种胺的降解减少,导致组织胺稳态失调,主要是由于二胺氧化酶(DAO)缺乏,引起组织胺不耐受。在与组织胺相关的症状中,头痛是记录最多的症状之一。目前针对这种疾病相关症状的临床治疗策略是基于排除含有组织胺或其他生物活性胺的食物和/或外源性 DAO 补充。本研究的目的是通过随机双盲试验评估一种由 DAO 酶组成的食品补充剂作为预防 DAO 缺乏症偏头痛的疗效。

方法

根据当前国际头痛协会(IHS)标准和 DAO 缺乏症(水平低于 80 HDU/ml),将 100 例确诊为阵发性偏头痛的患者随机分为两组。一组接受 DAO 酶补充剂治疗,另一组接受安慰剂治疗一个月。评估的临床结果包括发作持续时间和发作次数、疼痛强度感知和治疗期间的不良反应。还记录了曲坦类药物的使用情况。

结果

安慰剂组和 DAO 组报告的偏头痛发作持续时间差异很大。DAO 补充组疼痛时间显著减少(p=0.0217),治疗前后平均持续时间分别为 6.14(±3.06)和 4.76(±2.68)小时。安慰剂组也观察到这一结果的较小但无统计学意义的减少,从 7.53(±4.24)减少到 6.68(±4.42)小时。仅在 DAO 组观察到接受曲坦类药物的患者比例下降。两组的发作次数和疼痛强度评分均有类似的减少。接受 DAO 酶治疗的患者未出现不良反应。

结论

接受 DAO 酶治疗一个月的偏头痛患者偏头痛发作持续时间显著减少 1.4 小时。安慰剂组治疗前后无统计学显著差异。安慰剂组观察到的疼痛时间减少(0.9 小时)可以解释两组之间无显著差异的原因。一个月的 DAO 补充显示偏头痛有改善的积极趋势,但需要更多的、治疗时间更长的研究来更好地评估 DAO 补充的疗效。

临床试验注册号

ISRCTN84432406;www.isrctn.org。

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