Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant ?-lipoic acid: A 3-week multicentre randomized controlled trial (ALADIN Study)
Open accessAbstract
Anti-oxidant treatment has been shown to prevent nerve dysfunction in experimental diabetes mellitus, thus providing a rationale of potential therapeutic value for diabetic patients. The effects of the anti-oxidant alpha-lipoic acid (thioctic acid) were studied in a 3-week multicentre, randomized, double-blind placebo-controlled trial (Alpha-Lipoic Acid in Diabetic Neuropathy; ALADIN) in 328 non-insulin-dependent diabetic patients with symptomatic peripheral neuropathy who were randomly assigned to treatment with intravenous infusion of alpha-lipoic acid using three doses (1200, 600, or 100 mg ALA) or placebo (PLAC). Neuropathic symptoms (pain, burning, paraesthesiae, and numbness) were scored at baseline and at each visit (days 2-5, 8-12, and 15-19) prior to infusion. In addition, the Hamburg Pain Adjective List, a multidimensional specific pain questionnaire, and the Neuropathy Symptom and Disability Scores were assessed at baseline and day 19. According to the protocol 260 (65/63/66/66) patients completed the study. The total symptom score in the feet decreased from baseline to day 19 by -4.5 +/- 3.7 (-58.6%) points (mean +/- SD) in ALA 1200, -5.0 +/- 4.1 (-63.5%) points in ALA 600, -3.3 +/- 2.8 (-43.2%) points in ALA 100, and -2.6 +/- 3.2 (-38.4%) points in PLAC (ALA 1200 vs PLAC: p = 0.003; ALA 600 vs PLAC: p < 0.001). The response rates after 19 days, defined as an improvement in the total symptom score of at least 30%, were 70.8% in ALA 1200, 82.5% in ALA 600, 65.2% in ALA 100, and 57.6% in PLAC (ALA 600 vs PLAC; p = 0.002). The total scale of the Pain Adjective List was significantly reduced in ALA 1200 and ALA 600 as compared with PLAC after 19 days (both p < 0.01). The rates of adverse events were 32.6% in ALA 1200, 18.2% in ALA 600, 13.6% in ALA 100, and 20.7% in PLAC. These findings substantiate that intravenous treatment with alpha-lipoic acid using a dose of 600 mg/day over 3 weeks is superior to placebo in reducing symptoms of diabetic peripheral neuropathy, without causing significant adverse reactions.
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In human studies, intravenous α-lipoic acid improved diabetic peripheral neuropathy.
“In human studies, α-lipoic acid has been administered intravenously and improved diabetic peripheral neuropathy (352).”
From Mitochondrial Dysfunction in Diabetes: From Molecular Mechanisms to Functional Significance and Therapeutic Opportunities (2010) · cites this paper as [352]
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- Authors
- Ziegler, D., Hanefeld, M., Ruhnau, K. J., Mei\ner, H. P., Lobisch, M., Sch�tte, K., Gries, F. A., & The ALADIN Study Group
- Affiliations
- Deutsches Diabetes-Zentrum e.V. (DE)
- ORCID
- Ziegler, D.
- Venue
- Diabetologia
- Published
- 1995-12
- Volume
- 38
- Issue
- 12
- Pages
- 1425-1433
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W2886334118
- Cited by
- 525
- References
- 45
- Citations by year
- 2026: 11 · 2025: 13 · 2024: 13 · 2023: 12 · 2022: 11 · 2021: 21 · 2020: 24 · 2019: 9 · 2018: 13 · 2017: 15 · 2016: 16 · 2015: 11 · 2014: 23 · 2013: 22 · 2012: 20
- FWCI
- 5.32
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Biochemical Acid Research Studies
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Aldose Reductase and Taurine
- Keywords
- alpha-lipoic acid, diabetic peripheral neuropathy, antioxidant therapy, neuropathic pain, type 2 diabetes, intravenous infusion, analgesia, dose-response relationship, treatment response rate, placebo comparison
- MeSH terms
- Adolescent, Adult, Aged, Antioxidants, Blood Pressure, Diabetes Mellitus, Type 2, Diabetic Neuropathies, Double-Blind Method, Female, Humans, Infusions, Intravenous, Thioctic Acid, Male, Middle Aged, Pain Measurement, Placebos, Time Factors, Treatment Outcome
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