Efficacy and tolerability of alpha-lipoic acid and B vitamins in the management of diabetic patients with symptomatic distal symmetric polyneuropathy: A randomized-placebo controlled trial
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Che Nur Ain Che Abdullah 1 , Noraini Mohamad 2 3 * , Nani Draman 1 3 , Zainab Mat Yudin 2 3 , Wan Muhamad Amir W Ahmad 2 , Ritzzaleena Rosli Mohd Rosli 1 3 , Chee Yong Chuan 4 , Najib Majdi Yaacob 5
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1 Department of Family Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, MALAYSIA2 Medical and Basic Dental Sciences Unit, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, MALAYSIA3 Outpatient Family Health Clinic, Universiti Sains Malaysia Specialist Hospital, Kelantan, Malaysia4 Neurology Unit, Department of Internal Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, MALAYSIA5 Biostatistics and Research Methodology Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, MALAYSIA* Corresponding Author

Abstract

Background: Distal symmetric polyneuropathy (DSPN) is a microvascular complication of type 2 diabetes mellitus (T2DM) that significantly impairs quality of life. However, effective treatment remains a challenge. This study evaluates the efficacy and tolerability of a fixed-dose combination of alpha-lipoic acid (ALA) and B vitamins in T2DM patients with symptomatic DSPN.
Methods: A single-center, randomized, double-blind, placebo-controlled trial enrolled 80 T2DM patients with DSPN into two groups. The intervention group (n = 40) received two tablets daily of ALA (300 mg), vitamin B12 (500 mcg), B6 (8 mg), and B1 (39 mg), i.e., Bionerv®, and the control group (n = 40) received a placebo in the same dosage for 12 weeks from June to December 2024. Efficacy was assessed using the total symptom score (TSS) and neuropathy symptom score (NSS) at baseline, 6 weeks, and 12 weeks, while the neuropathy disability score (NDS) and safety parameters, including renal function tests (RFT) and liver function tests (LFT), were measured at baseline and at week 12.
Results: The intervention group showed a significant reduction in TSS mean (M) score from baseline (6.72 ± 2.82) to weeks 6 (3.53 ± 2.50) and 12 (2.49 ± 1.88), compared to the placebo group, with a significant improvement in stabbing pain, paranesthesia, and numbness. NSS M score also decreased significantly in the intervention group from 7.45  ±  1.15 at baseline to 4.18  ±  2.39 in week 12. The NDS M score in the intervention group significantly decreased from 8.28 ± 1.63 at baseline to 7.11 ± 1.95 in 12 weeks, but the between-group difference was not significant (p =  0.057). There are no significant changes in RFT and LFT after 12 weeks of treatment.
Conclusion: The 12-week oral treatment with a fixed-dose combination of ALA and B vitamins is effective in reducing symptoms of DSPN with a favorable safety profile.

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Article Type: Original Article

ELECTRON J GEN MED, Volume 23, Issue 3, June 2026, Article No: em740

https://doi.org/10.29333/ejgm/18705

Publication date: 04 Jun 2026

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