The Efficacy of Alpha-Lipoic Acid and B Vitamins in the Management of Diabetic Patients with Symptomatic Distal Symmetric Polyneuropathy: A Randomized Controlled Trial

BackgroundDistal symmetric polyneuropathy (DSPN) is a microvascular complication of diabetes that significantly impairs quality of life. However, effective treatment of symptomatic DSPN remains a challenge. This study investigates the efficacy of a fixed-dose combination of alpha lipoic acid (ALA) and B vitamins in treating type 2 diabetes mellitus(T2DM) patients with symptomatic DSPN. MethodsA double-blind, randomized, placebo-controlled trial was conducted, enrolling 80 T2DM with DSPN into two groups. The intervention group received a fixed dose combination of ALA and B vitamins (n= 40), and the control group received a placebo (n=40). The efficacy was determined by using a total symptoms score (TSS), neuropathy symptom score (NSS) and neuropathy disability score (NDS) at baseline, 6 weeks, and 12 weeks. Safety profile [renal function test (RFT) and liver function test (LFT)] was measured at baseline and 12 weeks. ResultsA total of 80 respondents who initially participated in the study, 74 completed the 12-week treatment period; 38 in the intervention group and 36 in the placebo group. Per-protocol analyses revealed the intervention group demonstrated a significant reduction in TSS mean scores from baseline (6.92{+/-}2.76) to 6 weeks (3.51{+/-}2.57) and 12 weeks (2.45{+/-}1.92). Specifically, the mean score of TSS components in the intervention group, stabbing pain, paraesthesia, and numbness, was significantly decreased. Similarly, NSS mean score in the intervention group was significantly reduced from baseline (7.50 {+/-} 1.16) to 6 weeks (5.29 {+/-} 2.47) and 12 weeks (4.11 {+/-} 2.44). NDS mean score in the intervention group also significantly reduced from 8.37 {+/-} 1.58 at baseline to 7.08 {+/-} 1.99 at 12 weeks. No significant changes were observed in safety parameters (RFT, LFT) after 12 weeks of treatment. ConclusionThe 12-week oral treatment with a fixed-dose combination of ALA and B vitamins is effective in treating symptomatic DSPN and safe. Trial registration: ClinicalTrials.gov (NCT06568185).