Efficacy of complex pathogenic therapy of diabetic distal neuropathy in patients with type 2 diabetes mellitus

Aim. To study the influence of combined therapy on carbohydrate and lipid metabolism and neurological status in patients with type 2 diabetes mellitus (DM) and diabetic neuropathy (DN).

Materials and methods. Seventy-eight patients with type 2 DM and DN were examined. The first group included 58 patients who were prescribed alpha-lipoic acid drugs (Octolipen, Thioctacid, Thiogamma and Berlithion) at 600 mg/day dropwise as antihyperglycemic therapy and B group vitamins (combilipen and milgamma) at 2 mL/day with further oral intake of octolipen, thioctacid HR and berlithion at 600 mg/day and liposoluble formulations, such as combilipen tabs, milgamma compositum or benfogamma, for 12 weeks. The second group included 20 patients with type 2 DM and DN who received antihyperglycemic therapy. All of the patients were comparable in age, DM status, DN duration, body mass index and concomitant diseases. The third group (control) included 18 healthy individuals. The efficacy of therapy was determined by assessing HbA1c dynamics, glycaemic control, lipid spectrum and sensorimotor symptoms under the TSS and NIS-LL scales; measuring pain levels with the McGill Pain Questionnaire and visual analogue scale (VAS); and performing stimulation electroneuromyography of n. tibialis and n. peroneus to analyse M-wave characteristics, nerve conduction velocity (NCV) and residual latency (RL). All analyses were performed before the administration of combined therapy and at the completion of the 12-week treatment.

Results. Comparative analysis of the combined therapy of patients with type 2 DM and DN demonstrated an improvement in positive neurological symptomatology according to the TSS scale and reduced negative symptoms according to the NIS-LL scales as well as reductions in neuropathy symptoms according to the McGill Pain Questionnaire and trends toward M-wave growth with reduced RL and increased NCV. Furthermore, individual-targeted glycaemic control (HbA1c < 7.5%) was achieved of 78% with consistent reduction in the atherogenicity index. Correlation analysis determined an average direct link between the HbA1c level and negative neurologic manifestations on the NIS-LL scale (r = 0.42, p = 0.027) and an inverse link between the McGill Pain Questionnaire score and NCV (r = -0.36, p = 0.019).

Conclusions. The complex diagnostics of neurological changes (TSS, NIS-LL, McGill and VAS scales) allows the assessment of the severity of distal DN after combined therapy with alpha-lipoic acid drugs (600 mg) and liposoluble forms of B group vitamins. These methods are also recommended for use in outpatient settings for the early detection and prevention of the diabetic foot development.

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