Abstract

Distal symmetric painful diabetic neuropathy is the most frequent clinical form of diabetic neuropathy. The condition appears as a result of alteration of the structure and function of nervous fibres as a consequence of hyperglycaemia. Hyperglycaemia determines the metabolism of glucose on alterative pathways and generates increased oxidative stress, mechanisms that cause an accelerated apoptosis of the neurons and a high intensity of lipid peroxidation. Pathogenic treatment of diabetic neuropathy includes limited options, two of them are: Benfotiamine (inhibits the metabolism of glucose on hexosamine pathway, reducing the formation of advanced glycosylation end products) and alpha-lipoic acid (has a scavenger effect on free radical species). The study included 120 patients with distal symmetric painful diabetic neuropathy randomized in 3 treatment groups. We evaluated the effect of oral administration for 8 weeks of Benfotiamine in a dosage of 300mg/day in monotherapy, of alpha-lipoic acid in a dosage of 600 mg/day in monotherapy, respectively of both -in combined therapy - on the parameters that are used to determine the severity of distal symmetric painful diabetic neuropathy: Diabetic Neuropathy Symptoms score, Neuropathy Disability Score and the intensity of lower limb pain on the visual analogue pain scale. All the three therapies were effective with a statistically significant improvement of these parameters, but the combined therapy with alpha-lipoic acid and Benfotiamine was superior to the monotherapy with alpha-lipoic acid or Benfotiamine.

Highlights

  • Distal symmetric painful diabetic neuropathy is the most frequent clinical form of diabetic neuropathy

  • Hyperglycaemia determines the metabolism of glucose on alterative pathways and generates increased oxidative stress, mechanisms that cause an accelerated apoptosis of the neurons and a high intensity of lipid peroxidation

  • We evaluated the effect of oral administration for 8 weeks of Benfotiamine in a dosage of 300mg/day in monotherapy, of alpha-lipoic acid in a dosage of 600 mg/day in monotherapy, respectively of both -in combined therapy - on the parameters that are used to determine the severity of distal symmetric painful diabetic neuropathy: Diabetic Neuropathy Symptoms score, Neuropathy Disability Score and the intensity of lower limb pain on the visual analogue pain scale

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Summary

Introduction

Distal symmetric painful diabetic neuropathy is the most frequent clinical form of diabetic neuropathy. Distal symmetric painful diabetic neuropathy (DSPDN) is the most frequent clinical form of diabetic neuropathy and it represents a chronic, symmetric dysfunction of the long peripheral nerve fibres of the lower limbs. Hyperglycaemia represents the most important factor in the pathogenesis of diabetic neuropathy [3-7] and is the main cause of the physio-pathological mechanisms that determine the appearance of diabetic neuropathy: increased influx on the polyol pathway, accumulation of glycosylation end products, increased influx on the hexosamine pathway, activation of protein-kinase C and oxidative stress [9].The excess of glucose metabolized on the polyol pathway leads to a decrease in NADPH concentration and as a consequence of glutathione concentration, this way glutathione antioxidant activity is diminished.

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