The sensory symptoms of diabetic polyneuropathy are improved with α-lipoic acid

The Sydney trial

Alexander S. Ametov, Alexei Barinov, Peter J Dyck, Robert Hermann, Natalia Kozlova, William J Litchy, Phillip Anson Low, Detlef Nehrdich, Maria Novosadova, Peter C. O'Brien, Miroslav Reljanovic, Rustem Samigullin, Klemens Schuette, Igor Strokov, Hans J. Tritschler, Klaus Wessel, Nikolai Yakhno, Dan Ziegler

Research output: Contribution to journalArticle

269 Citations (Scopus)

Abstract

OBJECTIVE - Because α-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. RESEARCH DESIGN AND 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.

Original languageEnglish (US)
Pages (from-to)770-776
Number of pages7
JournalDiabetes Care
Volume26
Issue number3
DOIs
StatePublished - Mar 1 2003

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Thioctic Acid
Diabetic Neuropathies
Neural Conduction
Placebos
Antioxidants
Safety
Pain
Nerve Degeneration
Hypesthesia
Random Allocation
Nerve Fibers
Double-Blind Method
Signs and Symptoms
Research Design
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

The sensory symptoms of diabetic polyneuropathy are improved with α-lipoic acid : The Sydney trial. / Ametov, Alexander S.; Barinov, Alexei; Dyck, Peter J; Hermann, Robert; Kozlova, Natalia; Litchy, William J; Low, Phillip Anson; Nehrdich, Detlef; Novosadova, Maria; O'Brien, Peter C.; Reljanovic, Miroslav; Samigullin, Rustem; Schuette, Klemens; Strokov, Igor; Tritschler, Hans J.; Wessel, Klaus; Yakhno, Nikolai; Ziegler, Dan.

In: Diabetes Care, Vol. 26, No. 3, 01.03.2003, p. 770-776.

Research output: Contribution to journalArticle

Ametov, AS, Barinov, A, Dyck, PJ, Hermann, R, Kozlova, N, Litchy, WJ, Low, PA, Nehrdich, D, Novosadova, M, O'Brien, PC, Reljanovic, M, Samigullin, R, Schuette, K, Strokov, I, Tritschler, HJ, Wessel, K, Yakhno, N & Ziegler, D 2003, 'The sensory symptoms of diabetic polyneuropathy are improved with α-lipoic acid: The Sydney trial', Diabetes Care, vol. 26, no. 3, pp. 770-776. https://doi.org/10.2337/diacare.26.3.770
Ametov, Alexander S. ; Barinov, Alexei ; Dyck, Peter J ; Hermann, Robert ; Kozlova, Natalia ; Litchy, William J ; Low, Phillip Anson ; Nehrdich, Detlef ; Novosadova, Maria ; O'Brien, Peter C. ; Reljanovic, Miroslav ; Samigullin, Rustem ; Schuette, Klemens ; Strokov, Igor ; Tritschler, Hans J. ; Wessel, Klaus ; Yakhno, Nikolai ; Ziegler, Dan. / The sensory symptoms of diabetic polyneuropathy are improved with α-lipoic acid : The Sydney trial. In: Diabetes Care. 2003 ; Vol. 26, No. 3. pp. 770-776.
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AU - Hermann, Robert

AU - Kozlova, Natalia

AU - Litchy, William J

AU - Low, Phillip Anson

AU - Nehrdich, Detlef

AU - Novosadova, Maria

AU - O'Brien, Peter C.

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AU - Samigullin, Rustem

AU - Schuette, Klemens

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N2 - OBJECTIVE - Because α-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. RESEARCH DESIGN AND 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.

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