Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

source extracted confidence: high 2026-04-09
#administration-oral #diabetes-mellitus-type-2 #diabetic-neuropathies #double-blind-method #female

Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

El-Nahas et al., 2020 | Endocr Metab Immune Disord Drug Targets | Rct

Citation

El-Nahas Mamdouh R, Elkannishy Ghada, ... El-Sehrawy Amr A. Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study. Endocr Metab Immune Disord Drug Targets. 2020;20(9):1531-1534. doi:10.2174/1871530320666200506081407

Abstract

BACKGROUND: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN. METHODS: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment. RESULTS: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment. CONCLUSION: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

Key Findings

Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population dpn
Sample Size 100
Age Range See abstract
Condition See abstract

MeSH Terms

  • Administration, Oral
  • Diabetes Mellitus, Type 2
  • Diabetic Neuropathies
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Thioctic Acid
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: ALA-diabetes

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09