title: The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial.
abstract: OBJECTIVE
  Because alpha-lipoic acid (ALA), a potent antioxidant, prevents or improves nerve conduction attributes, endoneurial blood flow, and nerve (Na(+) K(+) ATPase activity in experimental diabetes and in humans and may improve positive neuropathic sensory symptoms, in this report we further assess the safety and efficacy of ALA on the Total Symptom Score (TSS), a measure of positive neuropathic sensory symptoms.
  
  
  METHODS
  Metabolically stable diabetic patients with symptomatic (stage 2) diabetic sensorimotor polyneuropathy (DSPN) were randomized to a parallel, double-blind study of ALA (600 mg) (n = 60) or placebo (n = 60) infused daily intravenously for 5 days/week for 14 treatments. The primary end point was change of the sum score of daily assessments of severity and duration of TSS. Secondary end points were sum scores of neuropathy signs (NIS), symptoms (NSC), attributes of nerve conduction, quantitative sensation tests (QSTs), and an autonomic test.
  
  
  RESULTS
  At randomization, the groups were not significantly different by the criteria of metabolic control or neuropathic end points. After 14 treatments, the TSS of the ALA group had improved from baseline by an average of 5.7 points and the placebo group by an average of 1.8 points (P < 0.001). Statistically significant improvement from baseline of the ALA, as compared with the placebo group, was also found for each item of the TSS (lancinating and burning pain, asleep numbness and prickling), NIS, one attribute of nerve conduction, and global assessment of efficacy.
  
  
  CONCLUSIONS
  Intravenous racemic ALA, a potent antioxidant, rapidly and to a significant and meaningful degree, improved such positive neuropathic sensory symptoms as pain and several other neuropathic end points. This improvement of symptoms was attributed to improved nerve pathophysiology, not to increased nerve fiber degeneration. Because of its safety profile and its effect on positive neuropathic sensory symptoms and other neuropathic end points, this drug appears to be a useful ancillary treatment for the symptoms of diabetic polyneuropathy.
authors.affiliation: Russian Medical Academy for Advanced Studies, Moscow, Russia.
authors.forename: Alexander S
authors.initials: AS
authors.lastname: Ametov
authors.forename: Alexei
authors.initials: A
authors.lastname: Barinov
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Dyck
authors.forename: Robert
authors.initials: R
authors.lastname: Hermann
authors.forename: Natalia
authors.initials: N
authors.lastname: Kozlova
authors.forename: William J
authors.initials: WJ
authors.lastname: Litchy
authors.forename: Phillip A
authors.initials: PA
authors.lastname: Low
authors.forename: Detlef
authors.initials: D
authors.lastname: Nehrdich
authors.forename: Maria
authors.initials: M
authors.lastname: Novosadova
authors.forename: Peter C
authors.initials: PC
authors.lastname: O'Brien
authors.forename: Miroslav
authors.initials: M
authors.lastname: Reljanovic
authors.forename: Rustem
authors.initials: R
authors.lastname: Samigullin
authors.forename: Klemens
authors.initials: K
authors.lastname: Schuette
authors.forename: Igor
authors.initials: I
authors.lastname: Strokov
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Tritschler
authors.forename: Klaus
authors.initials: K
authors.lastname: Wessel
authors.forename: Nikolai
authors.initials: N
authors.lastname: Yakhno
authors.forename: Dan
authors.initials: D
authors.lastname: Ziegler
mesh_terms: D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D003929:Diabetic Neuropathies / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction; D009475:Neurons, Afferent / Q000502:physiology; D008063:Thioctic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D008063:Thioctic Acid