Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies
Federica Fogacci,
Manfredi Rizzo,
Christoffer Krogager,
Cormac Kennedy,
Coralie M.G. Georges,
Tamara Knežević,
Evangelos Liberopoulos,
Alexandre Vallée,
Pablo Pérez-Martínez,
Eliane F.E. Wenstedt,
Agnė Šatrauskienė,
Michal Vrablík,
Arrigo F.G. Cicero
Affiliations
Federica Fogacci
Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, Sant’Orsola-Malpighi University Hospital, 40138 Bologna, Italy
Manfredi Rizzo
Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), School of Medicine, University of Palermo, 90127 Palermo, Italy
Christoffer Krogager
Department of Endocrinology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
Cormac Kennedy
Department of Pharmacology and Therapeutics, Trinity College Dublin and St James Hospital, Dublin 8, Ireland
Coralie M.G. Georges
Department of Cardiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, 1200 Brussels, Belgium
Tamara Knežević
Department of Nephrology, Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, 10 000 Zagreb, Croatia
Evangelos Liberopoulos
Faculty of Medicine, School of Health Sciences, University of Ioannina, 451 10 Ioannina, Greece
Alexandre Vallée
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Paris-Descartes University, 75004 Paris, France
Pablo Pérez-Martínez
CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28007 Madrid, Spain
Eliane F.E. Wenstedt
Amsterdam UMC—University of Amsterdam, 1100 DD Amsterdam, The Netherlands
Agnė Šatrauskienė
Faculty of Medicine, Vilnius University, LT-03101 Vilnius, Lithuania
Michal Vrablík
Third Department of Internal Medicine, First Medical Faculty, Charles University, 128 08 Prague 2, Czech Republic
Arrigo F.G. Cicero
Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, Sant’Orsola-Malpighi University Hospital, 40138 Bologna, Italy
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.
