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.
Conclusions:
Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and
tolerable.
The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)
