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-value <0.001]. However, between-group differences were not significant (p-value =0.151). Blood pressure also declined significantly within the intervention group (p-value <0.05), but no significant differences were observed between the placebo and intervention groups (p-value >0.05). Metabolic parameters (HbA1c, FBS, FLP, BMI) showed no significant changes between intervention and control groups (p-value >0.05).

DISCUSSION: Twelve-week treatment with ALA plus B vitamins resulted in improvements 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. The short duration and small sample size may have limited the detectability of effects.