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一项针对中重度注意缺陷多动障碍儿童补充欧米伽-3 脂肪酸的双盲安慰剂对照随机试验。

A double-blind placebo-controlled randomised trial of omega-3 supplementation in children with moderate ADHD symptoms.

机构信息

INSERM, CIC1407, 69500, Bron, France.

Laboratoire de Biométrie et Biologie Evolutive, CNRS, UMR 5558, Equipe EME, 69100, Lyon, France.

出版信息

Eur Child Adolesc Psychiatry. 2018 Mar;27(3):377-384. doi: 10.1007/s00787-017-1058-z. Epub 2017 Oct 5.

Abstract

OBJECTIVE

Clinical trials and inconclusive meta-analyses have investigated the effects of omega-3 supplements in children with Attention-Deficit Hyperactivity Disorder (ADHD). We performed a randomised placebo-controlled trial to evaluate the efficacy of omega-3 fatty acids.

METHODS

Children aged 6-15 years with established diagnosis of ADHD were randomised 1:1 to receive either supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or a placebo for 3 months. Psychotropic or omega-3-containing treatments were not authorised during the study. The primary outcome was the change in the Attention-Deficit Hyperactivity Disorder Rating Scale version 4 (ADHD-RS-IV). Other outcomes included safety, lexical level (Alouette test), attention (Test of Attentional Performance for Children-KiTAP), anxiety (48-item Conners Parent Rating Scale-Revised-CPRS-R), and depression (Children's Depression Inventory-CDI).

RESULTS

Between 2009 and 2011, 162 children were included in five French child psychiatry centres. The mean age was 9.90 (SD 2.62) years and 78.4% were boys. The inclusion ADHD-RS-IV at was 37.31 (SD 8.40). The total ADHD-RS-IV score reduction was greater in the placebo group than in the DHA-EPA group: -19 (-26, -12)  % and -9.7 (-16.6, -2.9) %, respectively, p = 0.039. The other components of the Conners score had a similar variation but the differences between groups were not significant. Two patients in the DHA-EPA group and none in the placebo group experienced a severe adverse event (hospitalisation for worsening ADHD symptoms).

CONCLUSION

This study did not show any beneficial effect of omega-3 supplement in children with mild ADHD symptoms.

摘要

目的

临床试验和非结论性荟萃分析已经研究了ω-3 补充剂对注意缺陷多动障碍(ADHD)儿童的影响。我们进行了一项随机安慰剂对照试验,以评估ω-3 脂肪酸的疗效。

方法

6-15 岁确诊为 ADHD 的儿童按 1:1 随机分为两组,分别接受含有二十二碳六烯酸(DHA)和二十碳五烯酸(EPA)的补充剂或安慰剂治疗 3 个月。研究期间不允许使用精神药物或含 ω-3 的治疗方法。主要结局是注意力缺陷多动障碍评定量表第 4 版(ADHD-RS-IV)的变化。其他结局包括安全性、词汇水平(Alouette 测试)、注意力(儿童注意力表现测试-KiTAP)、焦虑(48 项 Conners 父母评定量表修订版-CPRS-R)和抑郁(儿童抑郁量表-CDI)。

结果

2009 年至 2011 年,162 名儿童在法国五家儿童精神病学中心入组。平均年龄为 9.90(SD 2.62)岁,78.4%为男孩。入组时 ADHD-RS-IV 平均为 37.31(SD 8.40)。安慰剂组 ADHD-RS-IV 总分下降大于 DHA-EPA 组:分别为-19(-26,-12)%和-9.7(-16.6,-2.9)%,p=0.039。Conners 评分的其他成分也有类似的变化,但组间差异无统计学意义。DHA-EPA 组有 2 例患者(2.9%)和安慰剂组无患者(0%)发生严重不良事件(因 ADHD 症状加重住院)。

结论

本研究未显示 ω-3 补充剂对轻度 ADHD 症状儿童有任何有益作用。

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