Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA and 2294 assigned to placebo. A meta-analysis of extracted data suggested that supplementation with ALA was not associated with an increased risk of any treatment-emergent adverse event (all p > 0.05). ALA supplementation was safe, even in subsets of studies categorized according to smoking habit, cardiovascular disease, presence of diabetes, pregnancy status, neurological disorders, rheumatic affections, severe renal impairment, and status of children/adolescents at baseline.

中文翻译：

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补充α-硫辛酸的安全性评估：随机安慰剂对照临床研究的系统评价和荟萃分析

α-硫辛酸（ALA）是一种天然的短链脂肪酸，近年来作为一种抗氧化剂分子备受关注。然而，最近已经对其安全性提出了一些担忧。为了解决这个问题，我们旨在通过对文献的系统评价和对可用的随机安慰剂对照临床研究的荟萃分析来评估ALA安全性。文献搜索包括截至2020年8月15日的Clarivate数据库所包含的EMBASE，PubMed Medline，SCOPUS，Google Scholar和ISI Web of Science。数据来自71个临床研究，包括155个治疗组，其中包括4749名受试者和2558名受试者ALA和2294分配给安慰剂。p > 0.05）。即使在根据吸烟习惯，心血管疾病，糖尿病的存在，妊娠状况，神经系统疾病，风湿病，严重肾功能不全和基线儿童/青少年状况分类的研究子集中，ALA补充剂也是安全的。