Evaluation of Alpha-Lipoic Acid and B Vitamins on Quality of Life and Metabolic Parameters Among Diabetic Patients with Symptomatic Distal Symmetric Polyneuropathy: A Randomized Controlled Trial

Background: Distal symmetric polyneuropathy (DSPN) is a debilitating diabetic complication that impairs Quality of Life (QoL). Objective: This study evaluated the effects of Alpha Lipoic Acid (ALA) plus B vitamins on QoL and metabolic parameters in diabetic patients with symptomatic DSPN. Methods: In this randomized, double-blind, placebo-controlled trial, 80 patients were allocated to receive either oral ALA plus B vitamins, i.e., Bionerv® (n =40) (intervention group) or placebo (n = 40) for 12 weeks. QoL, Body Mass Index (BMI), and Blood Pressure (BP) were assessed at baseline, 6 weeks, and 12 weeks. QoL was measured using the Revised Diabetes Quality of Life Questionnaire (Rv-DQoL), where higher scores indicate poorer QoL. Metabolic parameters (glycated haemoglobin (HbA1c), fasting blood sugar (FBS), fasting lipid profile (FLP)) were assessed at baseline and 12 weeks. Results: In the intervention group, the mean Rv-DQoL score decreased significantly in withingroup analysis from 29.50 ± 5.25 at baseline to 24.37 ± 3.43 at week 12 [F(2,156)=55.16; P<0.001]. However, between-group differences were not significant (P=0.151). Blood pressure also declined significantly within the intervention group (P<0.05), but no significant differences were observed between the placebo and intervention groups (P>0.05). Metabolic parameters (HbA1c, FBS, FLP, BMI) showed no significant changes between intervention and control groups (P>0.05). Conclusion: Twelve weeks of treatment with ALA and B vitamins resulted in an improvement in QoL and BP among DSPN patients. However, these changes did not reach statistical significance compared with placebo, and no alterations in metabolic parameters were observed. Trial registration: ClinicalTrials.gov (NCT06568185).