Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial

Introduction: Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and...

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Autores principales:	Cristina Esposito, Emanuele Ugo Garzarella, Cristina Santarcangelo, Alessandro Di Minno, Marco Dacrema, Roberto Sacchi, Gaetano Piccinocchi, Roberto Piccinocchi, Maria Daglia
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Alpha-lipoic acid Idiopathic pain Food supplement Safety Efficacy Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/60801cb3d096463699e3c8ae39776fd7
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spelling	oai:doaj.org-article:60801cb3d096463699e3c8ae39776fd72021-11-14T04:29:27ZSafety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial0753-332210.1016/j.biopha.2021.112308https://doaj.org/article/60801cb3d096463699e3c8ae39776fd72021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S0753332221010921https://doaj.org/toc/0753-3322Introduction: Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and efficacy in the reduction of different forms of idiopathic pain. Methods: Two-hundred and ten normoglycemic adults suffering from idiopathic pain (i.e. 57 subjects with primitive neuropathic pain, 141 subjects with arthralgia with unknown etiology, and 12 subjects with idiopathic myalgia) were randomized to receive placebo, 400 mg/day, or 800 mg/day of ALA. Participants underwent two visits (at baseline = t0, and after 2 months = t1) in which two validated questionaries for pain (numerical rating scale [NRS] and visual analogue scale [VAS]) were collected; fasting blood glucose assessment, adverse effects, and renal and hepatic toxicity were also monitored. Results: At t1, none of subjects treated with ALA reported a decreased glycemia or adverse effects. The treated subjects showed a significant reduction in NRS (p < 0.001) while the placebo group did not show any NRS reduction (p = 0.86). Similar results were also obtained for VAS. Statistical analysis aimed at detecting possible differences in NRS and VAS scores among treatment groups based on the source of pain did not reveal any significant effect. Conclusions: Since the management of idiopathic pain is challenging for physicians, the use of ALA food supplements could be a feasible option, based on its safety and efficacy compared to commonly-used analgesic drugs.Cristina EspositoEmanuele Ugo GarzarellaCristina SantarcangeloAlessandro Di MinnoMarco DacremaRoberto SacchiGaetano PiccinocchiRoberto PiccinocchiMaria DagliaElsevierarticleAlpha-lipoic acidIdiopathic painFood supplementSafetyEfficacyTherapeutics. PharmacologyRM1-950ENBiomedicine & Pharmacotherapy, Vol 144, Iss , Pp 112308- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Alpha-lipoic acid Idiopathic pain Food supplement Safety Efficacy Therapeutics. Pharmacology RM1-950
spellingShingle	Alpha-lipoic acid Idiopathic pain Food supplement Safety Efficacy Therapeutics. Pharmacology RM1-950 Cristina Esposito Emanuele Ugo Garzarella Cristina Santarcangelo Alessandro Di Minno Marco Dacrema Roberto Sacchi Gaetano Piccinocchi Roberto Piccinocchi Maria Daglia Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
description	Introduction: Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and efficacy in the reduction of different forms of idiopathic pain. Methods: Two-hundred and ten normoglycemic adults suffering from idiopathic pain (i.e. 57 subjects with primitive neuropathic pain, 141 subjects with arthralgia with unknown etiology, and 12 subjects with idiopathic myalgia) were randomized to receive placebo, 400 mg/day, or 800 mg/day of ALA. Participants underwent two visits (at baseline = t0, and after 2 months = t1) in which two validated questionaries for pain (numerical rating scale [NRS] and visual analogue scale [VAS]) were collected; fasting blood glucose assessment, adverse effects, and renal and hepatic toxicity were also monitored. Results: At t1, none of subjects treated with ALA reported a decreased glycemia or adverse effects. The treated subjects showed a significant reduction in NRS (p < 0.001) while the placebo group did not show any NRS reduction (p = 0.86). Similar results were also obtained for VAS. Statistical analysis aimed at detecting possible differences in NRS and VAS scores among treatment groups based on the source of pain did not reveal any significant effect. Conclusions: Since the management of idiopathic pain is challenging for physicians, the use of ALA food supplements could be a feasible option, based on its safety and efficacy compared to commonly-used analgesic drugs.
format	article
author	Cristina Esposito Emanuele Ugo Garzarella Cristina Santarcangelo Alessandro Di Minno Marco Dacrema Roberto Sacchi Gaetano Piccinocchi Roberto Piccinocchi Maria Daglia
author_facet	Cristina Esposito Emanuele Ugo Garzarella Cristina Santarcangelo Alessandro Di Minno Marco Dacrema Roberto Sacchi Gaetano Piccinocchi Roberto Piccinocchi Maria Daglia
author_sort	Cristina Esposito
title	Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
title_short	Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
title_full	Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
title_fullStr	Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
title_full_unstemmed	Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial
title_sort	safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: a monocentric, randomized, double-blind, placebo-controlled clinical trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/60801cb3d096463699e3c8ae39776fd7
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Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial

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