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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.

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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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Russian Medical Academy for Advanced Studies, Moscow, Russia.

    , , , , , , , , , , , , , , , , ,

    Source

    Diabetes care 26:3 2003 Mar pg 770-6

    MeSH

    Aged
    Antioxidants
    Diabetic Neuropathies
    Female
    Humans
    Injections, Intravenous
    Male
    Middle Aged
    Neural Conduction
    Neurons, Afferent
    Thioctic Acid
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    12610036

    Citation

    Ametov, Alexander S., et al. "The Sensory Symptoms of Diabetic Polyneuropathy Are Improved With Alpha-lipoic Acid: the SYDNEY Trial." Diabetes Care, vol. 26, no. 3, 2003, pp. 770-6.
    Ametov AS, Barinov A, Dyck PJ, et al. The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. Diabetes Care. 2003;26(3):770-6.
    Ametov, A. S., Barinov, A., Dyck, P. J., Hermann, R., Kozlova, N., Litchy, W. J., ... Ziegler, D. (2003). The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. Diabetes Care, 26(3), pp. 770-6.
    Ametov AS, et al. The Sensory Symptoms of Diabetic Polyneuropathy Are Improved With Alpha-lipoic Acid: the SYDNEY Trial. Diabetes Care. 2003;26(3):770-6. PubMed PMID: 12610036.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. AU - Ametov,Alexander S, AU - Barinov,Alexei, AU - Dyck,Peter J, AU - Hermann,Robert, AU - Kozlova,Natalia, AU - Litchy,William J, AU - Low,Phillip A, AU - Nehrdich,Detlef, AU - Novosadova,Maria, AU - O'Brien,Peter C, AU - Reljanovic,Miroslav, AU - Samigullin,Rustem, AU - Schuette,Klemens, AU - Strokov,Igor, AU - Tritschler,Hans J, AU - Wessel,Klaus, AU - Yakhno,Nikolai, AU - Ziegler,Dan, AU - ,, PY - 2003/3/1/pubmed PY - 2003/9/13/medline PY - 2003/3/1/entrez KW - Non-programmatic SP - 770 EP - 6 JF - Diabetes care JO - Diabetes Care VL - 26 IS - 3 N2 - 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. 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. SN - 0149-5992 UR - https://www.unboundmedicine.com/medline/citation/12610036/The_sensory_symptoms_of_diabetic_polyneuropathy_are_improved_with_alpha_lipoic_acid:_the_SYDNEY_trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=12610036 DB - PRIME DP - Unbound Medicine ER -