Recent randomized controlled trials (RCTs) claimed PUFAs to be effective for autism spectrum disorder (ASD) but international guidelines have not considered yet this body of evidence. Our aim was to assess the effectiveness of PUFAs in children and adolescents with ASD, for the Italian national guidelines on the management of ASD in children and adolescents. We performed a systematic review and meta-analysis of RCTs comparing PUFAs versus placebo or a healthy diet for the treatment of ASD in children and adolescents. The outcomes considered were deemed by the guideline panel to be highly relevant to children and adolescents with ASD and to their caregivers. The outcomes included hyperactivity, quality of sleep, self-harm, aggression, irritability, anxiety, attention, adaptive functioning, social interaction, restricted and repetitive interests and behavior, communication, hyperactivity and disruptive behaviors coexistent with core symptoms. The risk of bias of the included studies was assessed with the Cochrane tool, and the rating of the confidence in the effect estimates according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We included 9 studies with 405 participants. The strength of evidence ranged from low to very low. Six studies included preschoolers and school-age children, three studies included both children and adolescents. The majority of participants were males (83.8%), with a mean age of 6.7 years. PUFAs were superior compared to placebo in reducing anxiety in individuals with ASD (SMD -1.01, 95% CI − 1.86 to − 0.17; very low certainty of evidence). Moreover, PUFAs worsened quality of sleep compared to a healthy diet (SMD 1.11, 95% CI 0.21 to 2.00; very low certainty of evidence). PUFAs were not better than placebo in reducing aggression, hyperactivity, adaptive functioning, irritability, restricted and repetitive interests and behaviors and communication. Effects on some critical outcomes such as sleep, self-harm and disruptive behavior are currently unknown. The main limitations were the small number of participants included in the RCTs and the dosage which varied greatly (from 200 mg/day to 1540 mg/day), making it difficult to address causal inference. PUFAs did not show evidence of effect in children and adolescents with ASD and the certainty of evidence as measured with the GRADE was low to very low. Further research is needed on this topic because the available evidence is inconclusive.

中文翻译：

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多不饱和脂肪酸对患有自闭症谱系障碍的儿童和青少年的患者重要结果的影响：系统评价。


最近的随机对照试验 (RCT) 声称多不饱和脂肪酸对自闭症谱系障碍 (ASD) 有效，但国际指南尚未考虑这一证据。我们的目的是根据意大利国家儿童和青少年自闭症谱系障碍管理指南，评估多不饱和脂肪酸对患有自闭症谱系障碍的儿童和青少年的有效性。我们对 RCT 进行了系统回顾和荟萃分析，比较 PUFA 与安慰剂或健康饮食治疗儿童和青少年 ASD 的效果。指南小组认为所考虑的结果与患有自闭症谱系障碍的儿童和青少年及其照顾者高度相关。结果包括多动、睡眠质量、自残、攻击性、烦躁、焦虑、注意力、适应性功能、社交互动、受限和重复的兴趣和行为、沟通、多动以及与核心症状共存的破坏性行为。使用 Cochrane 工具评估纳入研究的偏倚风险，并根据建议评估、制定和评价分级 (GRADE) 方法对效果估计的置信度进行评级。我们纳入了 9 项研究，共有 405 名参与者。证据强度从低到极低不等。六项研究包括学龄前儿童和学龄儿童，三项研究包括儿童和青少年。大多数参与者是男性（83.8%），平均年龄为 6.7 岁。与安慰剂相比，PUFA 在减少自闭症谱系障碍患者的焦虑方面优于安慰剂（SMD -1.01，95% CI - 1.86 至 - 0.17；证据质量非常低）。此外，与健康饮食相比，PUFA 会恶化睡眠质量（SMD 1.11，95% CI 0.21 至 2.00；证据质量非常低）。 多不饱和脂肪酸在减少攻击性、多动症、适应性功能、易怒、受限和重复的兴趣、行为和沟通方面并不比安慰剂更好。对睡眠、自残和破坏性行为等一些关键结果的影响目前尚不清楚。主要局限性是随机对照试验的参与者数量较少，且剂量变化很大（从 200 毫克/天到 1540 毫克/天），因此很难进行因果推断。多不饱和脂肪酸没有显示出对患有自闭症谱系障碍的儿童和青少年有效的证据，并且用 GRADE 衡量的证据质量很低到非常低。由于现有证据尚无定论，因此需要对此主题进行进一步研究。