Treatment of symptomatic diabetic polyneuropathy with the antioxidant α-lipoic acid: A 7-month multicenter randomized controlled trial (ALADIN III study)

Diabetes Care

Volumn 22, Issue 8, 1999, Pages 1296-1301

  Ziegler, Dan ^a   Hanefeld, Markolf ^b   Ruhnau, Klaus Jürgen ^c   Hasche, Helmut ^d   Lobisch, Michael ^e   Schütte, Klemens ^e   Kerum, Gorazd ^f   Malessa, Rolf ^g  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^c Diabetologische Schwerpunktpraxen   (Germany)

^d ASTA Medica AG ^*  (Germany)

^e ASTA MEDICA AG   (Germany)

^f UNIVERSITY OF FREIBURG   (Germany)

^g Klin F Neurol Klin Neurophysiol   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIOXIDANT; HEMOGLOBIN A1C; THIOCTIC ACID;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DISEASE COURSE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; OUTCOMES RESEARCH; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM;

ADMINISTRATION, ORAL; ANTIOXIDANTS; DIABETES MELLITUS, TYPE 2; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; THIOCTIC ACID; TREATMENT OUTCOME;

EID: 0032788081     PISSN: 01495992     EISSN: None     Source Type: Journal    
DOI: 10.2337/diacare.22.8.1296     Document Type: Article

References (30)

1. Ziegler D: Diagnosis, staging and epidemiology of diabetic peripheral neuropathy. Diabetes Nutr Metab 7:342-348, 1994
2. Navarro X, Kennedy WR, Aeppli D, Sutherland DER: Neuropathy and mortality in diabetes: influence of pancreas transplantation. Muscle Nerve 19:1009-1016, 1996
3. Boyko EJ, Ahroni JH, Smith DG, Davignon D: Increased mortality associated with diabetic ulcer. Diabet Med 13:967-972, 1996
4. 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
5. 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. Lancet 352:837-853, 1998
6. Pfeifer MA, Schumer MP: Clinical trials of diabetic neuropathy: past, present, and future. Diabetes 44:1355-1361, 1995
7. 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
8. 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. Diabet Med 9:622-629, 1992
9. Cameron NE, Cotter MA: Metabolic and vascular factors in the pathogenesis of diabetic neuropathy. Diabetes 46 (Suppl. 2): S31-S37, 1997
10. 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
11. Pfeifer MA, Schumer MP, Gelber DA: Aldose reductase inhibitors: the end of an era or the need for different trial designs? Diabetes 46 (Suppl. 2):S82-S89, 1997
12. Horrobin DF: Essential fatty acids in the management of impaired nerve function in diabetes. Diabetes 46 (Suppl. 2):S90-S93, 1997
13. 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
14. Apfel SC, Kessler JA, Adomato BT, Utchy 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
15. 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. Diabet Med 13:1017-1026, 1996
16. 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. Diabetes Nutr Metab 7:287-294, 1994
17. Ziegler D: The design of clinical trials for treatment of diabetic neuropathy. Neurosci Res Commun 21:631-639, 1997
18. 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, 1996
19. Nagamatsu M, Nickander KK, Schmelzer JD, Raya A, Wittrock DA, Tritschler H, 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
20. 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
21. 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
22. 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
23. 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
24. 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
25. Ziegler D, Schatz H, Conrad F, Gnes 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
26. National Diabetes Data Group: Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 28:1039-1057, 1979
27. 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
28. 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
29. Peripheral Nerve Society: Diabetic polyneuropathy in controlled clinical trials: consensus report of the Peripheral Nerve Society. Ann Neural 38:478-482, 1995
30. Young MJ, Breddy JL, Veves A, Boulton AJM: The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds: a prospective study. Diabetes Care 17:557-560, 1994