Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

Summary

Patients with diabetic neuropathy and total symptoms score(TSS) \>7 points were invited to this open multicenter study. Patients were free of pain medications and severe diabetic complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a decrease \>3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and the frequency of use of rescue medications. Physicians were free to manage glucose to maintain Hba1c close to the ADA target (HbA1c \<7%).

Timeline

Start

2009-12

Primary completion

2010-12

Completion

2010-12

Publications

• Background Papanas N, Ziegler D. Efficacy of alpha-lipoic acid in diabetic neuropathy. Expert Opin Pharmacother. 2014 Dec;15(18):2721-31. doi: 10.1517/14656566.2014.972935. Epub 2014 Nov 10.
• Results Ziegler D, Papanas N, Vinik AI, Shaw JE. Epidemiology of polyneuropathy in diabetes and prediabetes. Handb Clin Neurol. 2014;126:3-22. doi: 10.1016/B978-0-444-53480-4.00001-1.
• Results Brownrigg JR, de Lusignan S, McGovern A, Hughes C, Thompson MM, Ray KK, Hinchliffe RJ. Peripheral neuropathy and the risk of cardiovascular events in type 2 diabetes mellitus. Heart. 2014 Dec;100(23):1837-43. doi: 10.1136/heartjnl-2014-305657. Epub 2014 Aug 5.
• Results Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
• Results Ziegler D, Buchholz S, Sohr C, Nourooz-Zadeh J, Roden M. Oxidative stress predicts progression of peripheral and cardiac autonomic nerve dysfunction over 6 years in diabetic patients. Acta Diabetol. 2015 Feb;52(1):65-72. doi: 10.1007/s00592-014-0601-3. Epub 2014 Jun 5.
• Results Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schutte K, Dyck PJ. Efficacy and safety of antioxidant treatment with alpha-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.
• Garcia-Alcala H, Santos Vichido CI, Islas Macedo S, Genestier-Tamborero CN, Minutti-Palacios M, Hirales Tamez O, Garcia C, Ziegler D. Treatment with alpha-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading. J Diabetes Res. 2015;2015:189857. doi: 10.1155/2015/189857. Epub 2015 Aug 4.

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