α-lipoic acid in the treatment of diabetic polyneuropathy in Germany: Current evidence from clinical trials

Experimental and Clinical Endocrinology and Diabetes

Volumn 107, Issue 7, 1999, Pages 421-430

  Ziegler, Dan ^a   Reljanovic, M ^c   Mehnert, H ^b   Gries, F A ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b INSTITUT FÜR DIABETESFORSCHUNG   (Germany)

^c NONE

Author keywords

Clinical trials; Diabetic polyneuropathy; Pathogenesis; Treatment; lipoic acid

Indexed keywords

THIOCTIC ACID;

ARTICLE; AUTONOMIC NEUROPATHY; CLINICAL PRACTICE; CLINICAL TRIAL; DIABETIC NEUROPATHY; DRUG EFFICACY; DRUG SAFETY; GERMANY; HEART RATE VARIABILITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; META ANALYSIS; METHODOLOGY; MOTOR NERVE CONDUCTION; ORAL DRUG ADMINISTRATION; OUTCOMES RESEARCH; POLYNEUROPATHY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SAMPLE; SENSORY NERVE CONDUCTION; SIDE EFFECT;

EID: 0032702870     PISSN: 09477349     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0029-1212132     Document Type: Article

References (67)

1. Altman DG, Bland JM. Absence of evidence is not evidence of absence. Br Med J 311: 485, 1995
2. Apfel SC, Kessler JA, Adornato BT, Litchy WJ, Sanders C, Rask CA, the NGF Study Group: Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. Neurology 51: 695-702, 1998
3. Baynes JW. Role of oxidative stress in development of complications in diabetes. Diabetes 40: 405-412, 1991
4. Benbow SJ, Wallymahmed ME, MacFarlane IA. Diabetic peripheral neuropathy and quality of life. Q J Med 91: 733-737, 1998
5. Bierhaus A, Chevion S, Chevion M, Hofmann M, Quehenberger P, Illmer T, Luther T, Berentshtein E, Tritschler H, Mueller M, Wahl P, Ziegler R, Nawroth PP. Advanced glycation end product-induced activation of NF-κB is suppressed by α-lipoic acid in cultured endothelial cells. Diabetes 46: 1481-1490, 1997.
6. Bock E, Schneeweiss J: Ein Beitrag zur Therapie der Neuropathia diabetica. Münchner Med. Wochenschrift: 43: 1911-1912, 1959
7. Borcea V, Nourooz-Zadeh J, Wolff SP, Zumbach M, Hofmann M, Ulrich H, Wahl P, Ziegler R, Tritschler H, Halliwell B, and Nawroth PP: α-Lipoic acid decreases oxidative stress meassures in patients with diabetes mellitus. Free Radicals in Biology and Medicine, 1999, in press
8. Boulton AJM, Scarpello JHB, Armstrong WD, Ward JD. The natural history of painful diabetic neuropathy - a 4-year study. Postgrad Med J 59: 556-559, 1983
9. Boyko EJ, Ahroni JH, Smith DG, Davignon D: Increased mortality associated with diabetic ulcer. Diabetic Med 13: 967-972, 1996
10. Cameron NE, Cotter MA, Horrobin DH, Tritschler HJ. Effects of α-lipoic acid on neurovascular function in diabetic rats: interaction with essential fatty acids. Diabetologia 41: 390-399, 1998
11. Cameron NE, Cotter MA: Metabolic and vascular factors in the pathogenesis of diabetic neuropathy. Diabetes 46, Suppl 2: S31-S37, 1997
12. Cavaliere D, Scorpiglione N, Belfiglio M, Carinci F, Cubasso D, Labbrozzi D, Mari E, Massi Benedetti M, Pontano C, Tognoni G, Nicolucci A: Quality assessment of randomised clinical trials on medical treatment of diabetic neuropathy. Diab Nutr Metab 7: 287-294, 1994
13. Dyck PJ, Davies JL, Litchy WJ, O'Brien PC: Longitudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort. Neurology 49: 229-239, 1997
14. Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton III LJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: The Rochester Diabetic Neuropathy Study. Neurology 43: 817-824, 1993
15. Dyck P.J., O'Brien PC., Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy. Diabetes Care 12: 649-652, 1989
16. Dyck PJ, Sherman WR, Hallcher LM, Service FJ, O'Brien PC, Grina LA, Palumbo PJ, Swanson CJ. Human diabetic endoneurial sorbitol, fructose, and myo-inositol related to sural nerve morphometry. Ann Neurol 8: 590-596, 1980
17. Forsblom CM, Sane T, Groop P-H, Tötterman KJ, Kallio M, Saloranta C, Laasonen L, Summanen P, Lepäntalo M, Laatikainen L, Matikainen E, Teppo A-M, Koskimies S, Groop L. Risk factors for mortality in Type 2 (non-insulin-dependent) diabetes: evidence of a role for neuropathy and a protective effect of HLA-DR4. Diabetologia 41: 1253-1262, 1998
18. Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: survey of two sets of "negative" trials. In: Bailar JC, Mosteller F (eds.). Medical uses of statistics, pp. 357-373, NEJM Books, Boston, 1992
19. Garrett NE, Malcangio M, Dewhurst M, Tomlinson DR. α-Lipoic acid corrects neuropeptide deficits in diabetic rats via induction of trophic support. Neurosci Lett 222: 191-194, 1997
20. Greene DA, Cao X, van Huysen C, Obrosova IG. Effects of DL-α-lipoic acid (LA) on diabetic nerve function, bioenergetics, and antioxidative defense. Diabetes 47, Suppl 1: A136
21. Hermann R, Gleiter CH, Niebch G, Ruus P, Wildgrube HJ, Nowak H. α-Liponsaure (Thioctsäure) - Aktueller Stand zur enantiose-lektiven Pharmakokinetik bei Gesunden und Diabetikern. Diab Stoffw 5, Suppl 3: 5-11, 1996
22. Hofmann MA, Schiekofer S, Isermann B, Kanitz M, Henkels M, Joswig M, Treusch A, Morcos M, Weiss T, Borcea V, Abdel Khalek AKM, Amiral J, Tritschler H, Ritz E, Wahl P, Ziegler R, Bierhaus A, Nawroth PP: Peripheral blood mononuclear cells isolated from patients with diabetic nephropathy show increased activation of the oxidative-stress sensitive transcription factor NF-KB. Diabetologia 42: 222-232, 1999
23. Horrobin DF: Essential fatty acids in the management of impaired nerve function in diabetes. Diabetes 46, Suppl 2: S90-S93, 1997
24. Hounsom L, Horrobin DF, Tritschler H, Corder R, Tomlinson DR: A lipoic acid-gamma linolenic acid conjugate is effective against multiple indices of experimental diabetic neuropathy. Diabetologia 41: 839-843, 1998
25. Jack A, Cotter MA, Cameron NE. Antioxidant treatment effects on defective endothelium-derived hyperpolarizing factor and relaxation in the mesenteric vasculature of diabetic rats. Diabetes 47, Suppl 1: A54, 1998
26. Jacob S, Henriksen EJ, Tritschler HJ, Augustin HJ, Dietze GJ: Improvement of insulin-stimulated glucose-disposal in type 2 diabetes after repeated parenteral administration of thioctic acid. Exp Clin Endocrinol Diabetes 104: 284-288, 1996
27. Jacob S, Henriksen EJ, Tritschler HJ, Clancy DE, Simon I, Schiemann A, Ulrich H, Jung WI, Dietze GJ, Augustin HJ: α-lipoic acid enhances glucose-disposal in patients with type II diabetes. Arzneimittel-Forschung / Drug research 45: 872-874, 1995.
28. Keegan A, Cotter MA, Cameron NE. Effects of diabetes and treatment with the antioxidant α-lipoic acid on endothelial and neurogenic responses of corpus cavernosum function in rats. Diabetologia 42: 343-350, 1999
29. Kennedy WR, Navarro X, Goetz FC, Sutherland DER, Najarian JS. Effects of pancreatic transplantation on diabetic neuropathy. N Engl J Med 322: 1031-1037, 1990
30. Kihara M, Low PA. Impaired vasoreactivity to nitric oxide in experimental diabetic neuropathy. Experimental Neurology 132: 180-185, 1995
31. Klein W: Die Behandlung der neuropathia diabetica mit oraler Gabe von Liponsäure. Münchner Med Wochenschrift 22: 957-958, 1972
32. Konrad T, Vicini P, Kusterer K, Höflich A, Assadkhani A. Böhles HJ, Sewell A, Tritschler HJ, Cobelli C, Usadel KH: α-Lipoic acid treatment decreases serum lactate and pyruvate concentrations and improves glucose effectiveness in lean and obese patients with Type 2 diabetes. Diabetes Care 22: 280-287, 1999
33. Low PA, Nickander KK, Tritschler HJ: The roles of oxidative stress and antioxidant treatment in experimental diabetic neuropathy. Diabetes 46, Suppl 2: S38-S42, 1997
34. Low PA, Yao J.K., Kishi Y., Tritschler HJ, Schmelzer JD, Zollmann PJ and Nickander KK: Peripheral nerve energy metabolism in experimental diabetes. Neurosci Res Commun 21: 49-56, 1997
35. Malik RA, Williamson S, Abbott C, Carrington AL, Iübal J, Schady W, Boulton AJM. Effect of angiotensin-converting-enzyme (ACE) inhibitor trandolapril on human diabetic neuropathy: randomized double-blind controlled trial. Lancet 352: 1978-1981, 1998
36. Nagamatsu M, Nickander KK, Schmelzer JD, Raya A, Wittrock DA, Tritschler HT, Low PA. Lipoic acid improves nerve blood flow, reduces oxidative stress and improves distal nerve conduction in experimental diabetic neuropathy. Diabetes Care 18: 1160-1167, 1995
37. Navarro X, Kennedy WR, Aeppli D, Sutherland DER: Neuropathy and mortality in diabetes: influence of pancreas transplantation. Muscle Nerve 19: 1009-1016, 1996
38. Nickander KK, McPhee BR, Low PA, Tritschler H: Alpha-lipoic acid: antioxidant potency against lipid peroxidation of neural tissues in vitro and implications for diabetic neuropathy. Free Rad Biol Med 21: 631-639, 1996
39. Nicolucci A, Carinci F, Cavaliere D, Scorpiglione N, Belfiglio M, Labbrozzi D, Mari E, Massi Benedetti M, Tognoni G, Liberati A: A meta-analysis of trials on aldose reductase inhibitors in diabetic peripheral neuropathy. Diabetic Med 13: 1017-1026, 1996a
40. Nicolucci A, Carinci F, Graepel JG, Hohman TC, Ferris F, Lachin JM: The efficacy of tolrestat in the treatment of diabetic peripheral neuropathy. A meta-analysis of individual patient data. Diabetes Care 19: 1091-1096, 1996b
41. Obrosova I, Cao X, Greene DA, Stevens MJ. Diabetes-induced changes in lens antioxidant status, glucose utilization and energy metabolism: effect of DL-α-lipoic acid. Diabetologia 41: 1442-1450, 1998.
42. Peripheral Nerve Society. Diabetic polyneuropathy in controlled clinical trials: consensus report of the Peripheral Nerve Society. Ann Neurol 38: 478-482, 1995
43. Pfeifer MA, Schumer MP, Gelber DA: Aldose reductase inhibitors: the end of an era or the need for different trial designs? Diabetes 46, Suppl2: S82-S89, 1997
44. Pfeifer MA, Schumer MP: Clinical trials of diabetic neuropathy: past, present, and future. Diabetes 44: 1355-1361, 1995
45. Pringle M, Churchill R. Randomized controlled trials in general practice. Br Med J 311: 1382-1383, 1995
46. Rathmann W, Haastert B, Delling B, Gries FA, Giani G: Postmarketing surveillance of adverse drug reactions: a correlation study approach using multiple data sources. Pharmaepiemiology and Drug Safety 7: 51-57, 1998
47. Reljanovic M, Reichel C, Rett K, Lobisch M, Schütte K, Möller W, Tritschler HJ, Mehnert H, and the ALADIN II Study group: Treatment of diabetic peripheral neuropathy with the antioxidant thioctic acid (α-lipoic acid). A two-year multicenter randomized double blind placebo controlled trial (ALADIN II). Free Rad Res 1999 (in press)
48. Ruhnau K-J, Meissner HP, Finn JR, Lobisch M, Schütte K, Nehrdich D, Tritschler HJ, Mehnert H, Ziegler D. Effects of 3-week oral treatment with the antioxidant thioctic acid (α-lipoic acid) in symptomatic diabetic polyneuropathy. Diabetic Med (in press)
49. Schreiber FK: Zur Behandlung der Neuropathia diabetica. Dtsch Med Wschr 86: 531-536, 1961
50. Strödter D, Lehmann E, Lehmann U, Tritschler H-J, Bretzel RG, Federlin K. The influence of thioctic acid on metabolism and function of the diabetic heart. Diabetes Res Clin Pract 29: 19-26, 1995
51. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329: 977-986, 1993
52. Thomas PK. Painful diabetic neuropathy: mechanisms and treatment. Diab Nutr Metab 7: 359-368, 1994
53. Tomlinson DR, Fernyhough P, Diemel LT: Role of neurotrophins in diabetic neuropathy and treatment with nerve growth factors. Diabetes 46, Suppl 2: S43-S49, 1997
54. Tütüncü NB, Bayraktar M, Varli K. reversal of defective nerve conduction with vitamin E supplementation in Type 2 diabetes. Diabetes Care 21: 1915-1918, 1998
55. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352: 837-853, 1998
56. Watkins PJ. The natural history of the diabetic neuropathies. Q J Med 77, 1209-1218, 1990
57. Young MJ, Boulton AJM, Macleod AF, Williams DRR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia 36: 150-154, 1993
58. Young RJ, Ewing DJ, Clarke BF: Chronic and remitting painful diabetic neuropathy. Diabetes Care 11: 34-40, 1988
59. Ziegler D, Dannehl K, Wiefels K, Gries FA. Differential effects of near-normoglycaemia for 4 years on somatic nerve dysfunction and heart rate variation in Type 1 diabetic patients. Diabetic Med 9: 622-629, 1992
60. Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R, the ALADIN III Study group: Treatment of symptomatic diabetic polyneuropathy with the antioxidant (-lipoic acid. A 7-month multicenter randomized controlled trial (ALADIN III Study). Diabetes Care 22: 1296-1301, 1999
61. Ziegler D, Hanefeld M, Ruhnau KJ, Meissner HP, Lobisch M, Schütte K, Nehrdich D, Dannehl K, Gries FA, the ALADIN Study Group: Treatment of symptomatic diabetic peripheral neuropathy with the antioxidant α-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia 38: 1425-1433, 1995
62. 1 bei der diabetischen Neuropathie. Diab Stoffw 2: 443-448, 1993
63. Ziegler D, Schatz H, Conrad F, Gries FA, Ulrich H, Reichel G, the DEKAN Study Group: Effects of treatment with the antioxidant α-lipoic acid on cardiac autonomic neuropathy in NIDDM patients. A 4-month randomized controlled multicenter trial (DEKAN Study). Diabetes Care 20: 369-373, 1997
64. Ziegler D. Diabetic cardiovascular autonomic neuropathy: prognosis, diagnosis and treatment. Diab Metab Rev 10: 339-383, 1994
65. Ziegler D. Pharmacological treatment of painful diabetic neuropathy. In: Veves A (ed.) Contemporary Endocrinology: Clinical Management of Diabetic Neuropathy. pp147-169, Humana Press Inc., Totowa, NJ, 1998
66. Ziegler D. The design of clinical trials for treatment of diabetic neuropathy. Neurosci Res Commun 21: 83 -91, 1997
67. Ziegler D: Diagnosis, staging and epidemiology of diabetic peripheral neuropathy. Diab Nutr Metab 7: 342-348, 1994