Generic placeholder image

Endocrine, Metabolic & Immune Disorders - Drug Targets

Editor-in-Chief

ISSN (Print): 1871-5303
ISSN (Online): 2212-3873

General Research Article

Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

Author(s): Mamdouh R. El-Nahas, Ghada Elkannishy, Hala Abdelhafez, Enas T. Elkhamisy and Amr A. El-Sehrawy*

Volume 20 , Issue 9 , 2020

Page: [1531 - 1534] Pages: 4

DOI: 10.2174/1871530320666200506081407

Price: $65

Abstract

Background: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN.

Methods: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment.

Results: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment.

Conclusion: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

Keywords: Alpha-lipoic acid, diabetes mellitus, peripheral neuropathy, thioctic acid, diabetic neuropathy, painful neuropathy.

Graphical Abstract
[1]
Pasnoor, M.; Dimachkie, M.M.; Kluding, P.; Barohn, R.J. Diabetic neuropathy part 1: Overview and symmetric phenotypes. Neurol. Clin., 2013, 31(2), 425-445.
[http://dx.doi.org/10.1016/j.ncl.2013.02.004] [PMID: 23642717]
[2]
Galer, B.S.; Gianas, A.; Jensen, M.P. Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life. Diabetes Res. Clin. Pract., 2000, 47(2), 123-128.
[http://dx.doi.org/10.1016/S0168-8227(99)00112-6] [PMID: 10670912]
[3]
Gordois, A.; Scuffham, P.; Shearer, A.; Oglesby, A.; Tobian, J.A. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care, 2003, 26(6), 1790-1795.
[http://dx.doi.org/10.2337/diacare.26.6.1790] [PMID: 12766111]
[4]
Iqbal, Z.; Azmi, S.; Yadav, R.; Ferdousi, M.; Kumar, M.; Cuthbertson, D.J.; Lim, J.; Malik, R.A.; Alam, U. Diabetic peripheral neuropathy: Epidemiology, diagnosis, and pharmacotherapy. Clin. Ther., 2018, 40(6), 828-849.
[http://dx.doi.org/10.1016/j.clinthera.2018.04.001] [PMID: 29709457]
[5]
Javed, S.; Alam, U.; Malik, R.A. Treating diabetic neuropathy: present strategies and emerging solutions. Rev. Diabet. Stud., 2015, 12(1-2), 63-83.
[http://dx.doi.org/10.1900/RDS.2015.12.63] [PMID: 26676662]
[6]
Ziegler, D. Thioctic acid for patients with symptomatic diabetic polyneuropathy: A critical review. Treat. Endocrinol., 2004, 3(3), 173-189.
[http://dx.doi.org/10.2165/00024677-200403030-00005] [PMID: 16026113]
[7]
Ziegler, D.; Hanefeld, M.; Ruhnau, K.J.; Meissner, H.P.; Lobisch, M.; Schütte, K.; Gries, F.A. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia, 1995, 38(12), 1425-1433.
[http://dx.doi.org/10.1007/BF00400603] [PMID: 8786016]
[8]
Ziegler, D.; Hanefeld, M.; Ruhnau, K.J.; Hasche, H.; Lobisch, M.; Schütte, K.; Kerum, G.; Malessa, R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. Diabetes Care, 1999, 22(8), 1296-1301.
[http://dx.doi.org/10.2337/diacare.22.8.1296] [PMID: 10480774]
[9]
Ametov, A.S.; Barinov, A.; Dyck, P.J.; Hermann, R.; Kozlova, N.; Litchy, W.J.; Low, P.A.; Nehrdich, D.; Novosadova, M.; O’Brien, P.C.; Reljanovic, M.; Samigullin, R.; Schuette, K.; Strokov, I.; Tritschler, H.J.; Wessel, K.; Yakhno, N.; Ziegler, D. SYDNEY Trial Study Group. The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. Diabetes Care, 2003, 26(3), 770-776.
[http://dx.doi.org/10.2337/diacare.26.3.770] [PMID: 12610036]
[10]
Ziegler, D.; Low, P.A.; Litchy, W.J.; Boulton, A.J.; Vinik, A.I.; Freeman, R.; Samigullin, R.; Tritschler, H.; Munzel, U.; Maus, J.; Schütte, K.; Dyck, P.J. Efficacy and safety of antioxidant treatment with α-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care, 2011, 34(9), 2054-2060.
[http://dx.doi.org/10.2337/dc11-0503] [PMID: 21775755]
[11]
Ruhnau, K.J.; Meissner, H.P.; Finn, J.R.; Reljanovic, M.; Lobisch, M.; Schütte, K.; Nehrdich, D.; Tritschler, H.J.; Mehnert, H.; Ziegler, D. Effects of 3-week oral treatment with the antioxidant thioctic acid (alpha-lipoic acid) in symptomatic diabetic polyneuropathy. Diabet. Med., 1999, 16(12), 1040-1043.
[http://dx.doi.org/10.1046/j.1464-5491.1999.00190.x] [PMID: 10656234]
[12]
Ziegler, D.; Ametov, A.; Barinov, A.; Dyck, P.J.; Gurieva, I.; Low, P.A.; Munzel, U.; Yakhno, N.; Raz, I.; Novosadova, M.; Maus, J.; Samigullin, R. Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. Diabetes Care, 2006, 29(11), 2365-2370.
[http://dx.doi.org/10.2337/dc06-1216] [PMID: 17065669]
[13]
Dyck, P.J.; Sherman, W.R.; Hallcher, L.M.; Service, F.J.; O’Brien, P.C.; Grina, L.A.; Palumbo, P.J.; Swanson, C.J. Human diabetic endoneurial sorbitol, fructose, and myo-inositol related to sural nerve morphometry. Ann. Neurol., 1980, 8(6), 590-596.
[http://dx.doi.org/10.1002/ana.410080608] [PMID: 7212646]
[14]
England, J.D.; Gronseth, G.S.; Franklin, G.; Miller, R.G.; Asbury, A.K.; Carter, G.T.; Cohen, J.A.; Fisher, M.A.; Howard, J.F.; Kinsella, L.J.; Latov, N.; Lewis, R.A.; Low, P.A.; Sumner, A.J. American academy of neurology; American association of electrodiagnostic medicine; American academy of physical medicine and rehabilitation. Distal symmetric polyneuropathy: A definition for clinical research: Report of the American academy of neurology, the American association of electrodiagnostic medicine, and the American academy of physical medicine and rehabilitation. Neurology, 2005, 64(2), 199-207.
[http://dx.doi.org/10.1212/01.WNL.0000149522.32823.EA] [PMID: 15668414]
[15]
Tankova, T.; Cherninkova, S.; Koev, D. Treatment for diabetic mononeuropathy with alpha-lipoic acid. Int. J. Clin. Pract., 2005, 59(6), 645-650.
[http://dx.doi.org/10.1111/j.1742-1241.2005.00452.x] [PMID: 15924591]
[16]
Bureković, A.; Terzić, M.; Alajbegović, S.; Vukojević, Z.; Hadzić, N. The role of alpha-lipoic acid in diabetic polyneuropathy treatment. Bosn. J. Basic Med. Sci., 2008, 8(4), 341-345.
[http://dx.doi.org/10.17305/bjbms.2008.2894] [PMID: 19125705]
[17]
Mijnhout, G.S.; Kollen, B.J.; Alkhalaf, A.; Kleefstra, N.; Bilo, H.J. Alpha lipoic Acid for symptomatic peripheral neuropathy in patients with diabetes: A meta-analysis of randomized controlled trials. Int. J. Endocrinol., 2012, 2012456279
[http://dx.doi.org/10.1155/2012/456279] [PMID: 22331979]
[18]
Ibrahimpasic, K. Alpha lipoic acid and glycaemic control in diabetic neuropathies at type 2 diabetes treatment. Med. Arh., 2013, 67(1), 7-9.
[http://dx.doi.org/10.5455/medarh.2013.67.7-9] [PMID: 23678828]

Rights & Permissions Print Export Cite as
© 2022 Bentham Science Publishers | Privacy Policy