PMID- 10499773
OWN - NLM
STAT- MEDLINE
DCOM- 19991101
LR  - 20221207
IS  - 1071-5762 (Print)
IS  - 1029-2470 (Linking)
VI  - 31
IP  - 3
DP  - 1999 Sep
TI  - Treatment of diabetic polyneuropathy with the antioxidant thioctic acid 
      (alpha-lipoic acid): a two year multicenter randomized double-blind 
      placebo-controlled trial (ALADIN II). Alpha Lipoic Acid in Diabetic Neuropathy.
PG  - 171-9
AB  - Short-term trials with the antioxidant thioctic acid (TA) appear to improve 
      neuropathic symptoms in diabetic patients, but the long-term response remains to 
      be established. Therefore, Type 1 and Type 2 diabetic patients with symptomatic 
      polyneuropathy were randomly assigned to three treatment regimens: (1) 2 x 600(mg 
      of TA (TA 1200), (2) 600)mg of TA plus placebo (PLA) (TA 600) or (3) placebo and 
      placebo (PLA). A trometamol salt solution of TA of 1200 or 600 mg or PLA was 
      intravenously administered once daily for five consecutive days before enrolling 
      the patients in the oral treatment phase. The study was prospective, 
      PLA-controlled, randomized, double-blind and conducted for two years. Severity of 
      diabetic neuropathy was assessed by the Neuropathy Disability Score (NDS) and 
      electrophysiological attributes of the sural (sensory nerve conduction velocity 
      (SNCV), sensory nerve action potential (SNAP)) and the tibial (motor nerve 
      conduction velocity (MNCV), motor nerve distal latency (MNDL)) nerve. Statistical 
      analysis was performed after independent reviewers excluded all patients with 
      highly variable data allowing a final analysis of 65 patients (TA 1200: n = 18, 
      TA 600: n = 27; PLA: n = 20). At baseline no significant differences were noted 
      between the groups regarding the demographic variables and peripheral nerve 
      function parameters for these 65 patients. Statistically significant changes 
      after 24 months between TA and PLA were observed (mean +/- SD) for sural SNCV: 
      +3.8 +/- 4.2 m/s in TA 1200, +3.0+/-3.0m/s in TA 600, -0.1+/-4.8m/s in PLA (p < 
      0.05 for TA 1200 and TA 600 vs. PLA); sural SNAP: +0.6+/-2.5 microV in TA 1200, 
      +0.3+/-1.4 microV in TA 600, -0.7 +/- 1.5 microV in PLA (p = 0.076 for TA 1200 
      vs. PLA and p < 0.05 for TA 600 vs. PLA), and in tibial MNCV: +/- 1.2 +/- 3.8 m/s 
      in TA 1200, -0.3 +/- 5.2 m/s in TA 600, 1.5 +/- 2.9 m/s in PLA (p < 0.05 for TA 
      1200 vs. PLA). No significant differences between the groups after 24 months were 
      noted regarding the tibial MNDL and the NDS. We conclude that in a subgroup of 
      patients after exclusion of patients with excessive test variability throughout 
      the trial, TA appeared to have a beneficial effect on several attributes of nerve 
      conduction.
FAU - Reljanovic, M
AU  - Reljanovic M
AD  - University of Clinic for Diabetes, Endocrinology and Metabolic Diseases Vuk 
      Vrhovac, Medical faculty, University of Zagreb, Coratia.
FAU - Reichel, G
AU  - Reichel G
FAU - Rett, K
AU  - Rett K
FAU - Lobisch, M
AU  - Lobisch M
FAU - Schuette, K
AU  - Schuette K
FAU - Moller, W
AU  - Moller W
FAU - Tritschler, H J
AU  - Tritschler HJ
FAU - Mehnert, H
AU  - Mehnert H
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Free Radic Res
JT  - Free radical research
JID - 9423872
RN  - 0 (Antioxidants)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Placebos)
RN  - 73Y7P0K73Y (Thioctic Acid)
SB  - IM
MH  - Action Potentials/drug effects
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antioxidants/*administration & dosage/adverse effects
MH  - Diabetes Mellitus, Type 1/complications/metabolism
MH  - Diabetes Mellitus, Type 2/complications/metabolism
MH  - Diabetic Neuropathies/complications/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Middle Aged
MH  - Neural Conduction/drug effects
MH  - Peripheral Nervous System Diseases/complications/*drug therapy/physiopathology
MH  - Placebos
MH  - Prospective Studies
MH  - Sural Nerve/physiopathology
MH  - Thioctic Acid/*administration & dosage/adverse effects
MH  - Tibial Nerve/physiopathology
EDAT- 1999/09/28 00:00
MHDA- 1999/09/28 00:01
CRDT- 1999/09/28 00:00
PHST- 1999/09/28 00:00 [pubmed]
PHST- 1999/09/28 00:01 [medline]
PHST- 1999/09/28 00:00 [entrez]
AID - 10.1080/10715769900300721 [doi]
PST - ppublish
SO  - Free Radic Res. 1999 Sep;31(3):171-9. doi: 10.1080/10715769900300721.