Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
12
|
| pubmed:dateCreated |
1996-9-24
|
| pubmed:abstractText |
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.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Dec
|
| pubmed:issn |
0012-186X
|
| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
38
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
1425-33
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:8786016-Adolescent,
pubmed-meshheading:8786016-Adult,
pubmed-meshheading:8786016-Aged,
pubmed-meshheading:8786016-Antioxidants,
pubmed-meshheading:8786016-Blood Pressure,
pubmed-meshheading:8786016-Diabetes Mellitus, Type 2,
pubmed-meshheading:8786016-Diabetic Neuropathies,
pubmed-meshheading:8786016-Double-Blind Method,
pubmed-meshheading:8786016-Female,
pubmed-meshheading:8786016-Humans,
pubmed-meshheading:8786016-Infusions, Intravenous,
pubmed-meshheading:8786016-Male,
pubmed-meshheading:8786016-Middle Aged,
pubmed-meshheading:8786016-Pain Measurement,
pubmed-meshheading:8786016-Placebos,
pubmed-meshheading:8786016-Thioctic Acid,
pubmed-meshheading:8786016-Time Factors,
pubmed-meshheading:8786016-Treatment Outcome
|
| pubmed:year |
1995
|
| pubmed:articleTitle |
Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant alpha-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study).
|
| pubmed:affiliation |
Diabetes-Forschungsinstitut an der Heinrich-Heine-Universität, Düsseldorf, Germany.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study
|