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Open AccessArticle

Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies

Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, Sant’Orsola-Malpighi University Hospital, 40138 Bologna, Italy
Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), School of Medicine, University of Palermo, 90127 Palermo, Italy
Department of Endocrinology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
Department of Pharmacology and Therapeutics, Trinity College Dublin and St James Hospital, Dublin 8, Ireland
Department of Cardiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, 1200 Brussels, Belgium
Department of Nephrology, Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, 10 000 Zagreb, Croatia
Faculty of Medicine, School of Health Sciences, University of Ioannina, 451 10 Ioannina, Greece
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Paris-Descartes University, 75004 Paris, France
CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28007 Madrid, Spain
Lipids and Atherosclerosis Unit, Department of Internal Medicine, Reina Sofia University Hospital, 14004 Cordoba, Spain
Maimonides Biomedical Research Institute of Cordoba (IMIBIC), 14004 Cordoba, Spain
Department of Medicine (Medicine, Dermatology and Otorhinolaryngology), University of Cordoba, 14004 Cordoba, Spain
Amsterdam UMC—University of Amsterdam, 1100 DD Amsterdam, The Netherlands
Faculty of Medicine, Vilnius University, LT-03101 Vilnius, Lithuania
Vilnius University Hospital Santariškių Klinikos, LT-08661 Vilnius, Lithuania
Third Department of Internal Medicine, First Medical Faculty, Charles University, 128 08 Prague 2, Czech Republic
Author to whom correspondence should be addressed.
Antioxidants 2020, 9(10), 1011;
Received: 19 September 2020 / Revised: 10 October 2020 / Accepted: 15 October 2020 / Published: 19 October 2020
(This article belongs to the Special Issue Role of Natural Antioxidants on Neuroprotection and Neuroinflammation)
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. View Full-Text
Keywords: α-lipoic acid; thioctic acid; dietary supplement; safety; meta-analysis α-lipoic acid; thioctic acid; dietary supplement; safety; meta-analysis
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Fogacci, F.; Rizzo, M.; Krogager, C.; Kennedy, C.; Georges, C.M.; Knežević, T.; Liberopoulos, E.; Vallée, A.; Pérez-Martínez, P.; Wenstedt, E.F.; Šatrauskienė, A.; Vrablík, M.; Cicero, A.F. Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. Antioxidants 2020, 9, 1011.

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