Mamdouh R El-Nahas1, Ghada Elkannishy2, Hala Abdelhafez2, Enas T Elkhamisy2, Amr A El-Sehrawy2.
Abstract
BACKGROUND: Alpha-lipoic acid (ALA) was tried in 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 treatment of patients with DPN.
METHODS: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinics 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. In 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 resultsregarding 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. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.
RCT Entities:
BACKGROUND: Alpha-lipoic acid (ALA) was tried in 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 treatment of patients with DPN.
METHODS: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinics 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. In 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 resultsregarding 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. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.
Entities:
Keywords:
alpha lipoic acid; diabetes mellitus; diabetic neuropathy; painful neuropathy; peripheral neuropathy; thioctic acid
Year: 2020
PMID： 32370731 DOI： 10.2174/1871530320666200506081407
Source DB: PubMed Journal: Endocr Metab Immune Disord Drug Targets ISSN： 1871-5303 Impact factor: 2.895