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.

Cristina Esposito, Emanuele Ugo Garzarella, Cristina Santarcangelo, Alessandro Di Minno, Marco Dacrema, Roberto Sacchi, Gaetano Piccinocchi, Roberto Piccinocchi, Maria Daglia

Journal: Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie 2022;144():112308

PMID: 34649217

Plain Language Summary

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The management of pain with no apparent cause, or idiopathic pain, is a real challenge. In the absence of any underlying disease that is treatable, idiopathic pain is usually addressed by relieving symptomatic pain with medication. Whereby these medications can be fast and effective, they can have limited benefits and, in some cases, considerable side effects. Alpha-lipoic acid (ALA) is a food supplement and naturally occurring compound in humans, animals and plants. Previous research suggested that it is effective in managing diabetic nerve pain. As reactive oxygen species and antioxidants appear to play a role in pain regulation, the antioxidant and anti-inflammatory activities of ALA are of interest here. In addition, ALA has a strong safety record. This study sought to investigate the safety and effectiveness of ALA in non-diabetic individuals who were diagnosed with idiopathic pain. 210 male and female subjects, from age 18-75, who were non-diabetic and on no pain medication were randomly assigned to receive either a placebo or 400 mg/day or 800 mg/day of ALA over a course of two months. The pain was tracked with two pain scoring questionnaires, whilst blood samples were monitored for adverse effects, including blood sugar, kidney and liver markers. The ALA intervention group showed a significant reduction in both pain scores compared to placebo. Treated subjects showed a marginal decrease in blood sugars of no clinical significance and no other adverse effects were reported. The authors concluded that ALA as a food supplement has suitable potential for the management of idiopathic pain. And given its safety and efficacy compared to commonly used pain medication it could be of interest in clinical application.

Abstract

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.

Copyright © 2021 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

Address: Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.; Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; CEINGE-Biotecnologie Avanzate, Via Gaetano Salvatore 486, 80145 Naples, Italy.; Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.; Comegen S.c.S., Società Cooperativa Sociale di Medici di Medicina Generale, Viale Maria Bakunin, 41, 80125 Naples, Italy.; Level 1 Medical Director Anaesthesia and Resuscitation A. U. O. Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138 Naples, Italy.; Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, 212013 Zhenjiang, China. Electronic address: [email protected].
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