Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00154, Rome, Italy.
School of Hygiene and Preventive Medicine, University of Rome Tor Vergata, Rome, Italy.
Health Qual Life Outcomes. 2020 Apr 16;18(1):101. doi: 10.1186/s12955-020-01354-8.
Some recent randomized controlled trials (RCTs) assessed the efficacy and safety of polyunsaturated fatty acids (PUFAs) for the treatment of autism spectrum disorder (ASD). To optimally inform the Italian guideline for the management of ASD in children and adolescents, we reviewed the impact on equity, acceptability and feasibility for developing a pilot recommendation for PUFAs.
We performed a rapid systematic review of observational and experimental studies on PUFAs for children and adolescents with ASD, extracting data on resources required, equity, acceptability, and feasibility of PUFAs. We followed the framework provided by the grading of recommendations assessment, development and evaluation (GRADE) methodology, and we assessed risk of bias and methodological quality of included studies. Results were synthesized both narratively and quantitatively to address clinically relevant questions on equity, acceptability, and feasibility.
We found 14 papers related to equity. PUFAs did not seem to impact equity importantly. We did not find variation in effectiveness across subgroups and in a base case scenario, the cost of a 12 weeks cycle of therapy with 1.155 g/day of PUFAs was €65.51 euro. The acceptability of PUFAs was evaluated in 17 studies, 9 of which were RCTs. PUFAs were widely used among children and adolescents with ASD (18 to 51%), and 50% of parents considered nutritional supplementation as useful. Difficulty in swallowing capsules and bad taste were identified as possible causes of poor compliance, but treatment adherence, when measured in included RCTs, was judged to be good to excellent. Discontinuation due to any cause for PUFAs could not differ from placebo (low certainty of evidence). The feasibility of using PUFAs was assessed in 12 studies. PUFAs were probably sustainable, and no particular critical issue emerged from the feasibility assessment. However, the evidence appeared scarce and indirect.
We found the administration of PUFAs in children and adolescents with ASD to be potentially equitable, acceptable and feasible. These results are limited by the limited number and quality of retrieved documents, and need to be viewed in light of efficacy and safety data to formulate clinical recommendations.
一些最近的随机对照试验(RCT)评估了多不饱和脂肪酸(PUFAs)治疗自闭症谱系障碍(ASD)的疗效和安全性。为了优化为意大利儿童和青少年 ASD 管理指南提供信息,我们审查了在制定 PUFAs 试点推荐方面对公平性、可接受性和可行性的影响。
我们对 PUFAs 治疗 ASD 儿童和青少年的观察性和实验研究进行了快速系统评价,提取了有关所需资源、PUFAs 的公平性、可接受性和可行性的数据。我们遵循了推荐评估、制定和评估(GRADE)方法学的框架,并评估了纳入研究的偏倚风险和方法学质量。结果以叙述性和定量方式进行综合,以解决关于公平性、可接受性和可行性的临床相关问题。
我们发现了 14 篇与公平性相关的论文。PUFAs 似乎并没有重要地影响公平性。我们没有发现有效性在亚组之间存在差异,在基本情况下,每天 1.155g PUFAs 治疗 12 周的治疗费用为 65.51 欧元。PUFAs 的可接受性在 17 项研究中进行了评估,其中 9 项为 RCT。PUFAs 在 ASD 儿童和青少年中广泛使用(18%至 51%),50%的家长认为营养补充有用。吞咽胶囊困难和味道不好被认为是依从性差的可能原因,但在纳入的 RCT 中,治疗依从性被评为良好到极好。由于任何原因停用 PUFAs 与安慰剂无差异(证据确定性低)。PUFAs 的可行性在 12 项研究中进行了评估。PUFAs 可能是可持续的,从可行性评估中没有出现任何特别的关键问题。然而,证据似乎有限且间接。
我们发现,在 ASD 儿童和青少年中使用 PUFAs 具有潜在的公平性、可接受性和可行性。这些结果受到检索文件数量和质量有限的限制,需要结合疗效和安全性数据来制定临床建议。