Information de reference pour ce titreAccession Number: | 00003135-200402000-00002.
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Author: | Ziegler, D.; Nowak, H. *; Kempler, P. +; Vargha, P. ++; Low, P. A. [S]
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Institution: | German Diabetes Research Institute, Leibriz Institute at the Heinrich Heine University, Dusseldorf, Germany (Ziegler) (*)Department of Biostatistics, VIATRIS GmbH, Frankfurt, Germany +1st Department of Medicine, Semmelweis University, Budapest, Hungary ++Biometric Unit, Semmelweis University, Budapest, Hungary [S]Department of Neurology, Mayo Clinic, Rochester, MN, USA
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Title: | |
Source: | Diabetic Medicine. 21(2):114-121, February 2004.
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Abstract: | Aims: To determine the efficacy and safety of 600 mg of [alpha]-lipoic acid given intravenously over 3 weeks in diabetic patients with symptomatic polyneuropathy.
Methods: We searched the database of VIATRIS GmbH, Frankfurt, Germany, for clinical trials of [alpha]-lipoic acid according to the following prerequisites: randomized, double-masked, placebo-controlled, parallel-group trial using [alpha]-lipoic acid infusions of 600 mg i.v. per day for 3 weeks, except for weekends, in diabetic patients with positive sensory symptoms of polyneuropathy which were scored by the Total Symptom Score (TSS) in the feet on a daily basis. Four trials (ALADIN I, ALADIN III, SYDNEY, NATHAN II) comprised n = 1258 patients ([alpha]-lipoic acid n = 716; placebo n = 542) met these eligibility criteria and were included in a meta-analysis based on the intention-to-treat principle. Primary analysis involved a comparison of the differences in TSS from baseline to the end of i.v. Treatment between the groups treated with [alpha]-lipoic acid or placebo. Secondary analyses included daily changes in TSS, responder rates (>= 50% improvement in TSS), individual TSS components, Neuropathy Impairment Score (NIS), NIS of the lower limbs (NIS-LL), individual NIS-LL components, and the rates of adverse events.
Results: After 3 weeks the relative difference in favour of [alpha]-lipoic acid vs. placebo was 24.1% (13.5, 33.4) (geometric mean with 95% confidence interval) for TSS and 16.0% (5.7, 25.2) for NIS-LL. The responder rates were 52.7% in patients treated with [alpha]-lipoic acid and 36.9% in those on placebo (P < 0.05). On a daily basis there was a continuous increase in the magnitude of TSS improvement in favour of [alpha]-lipoic acid vs. placebo which was noted first after 8 days of treatment. Among the individual components of the TSS, pain, burning, and numbness decreased in favour of [alpha]-lipoic acid compared with placebo, while among the NIS-LL components pin-prick and touch-pressure sensation as well as ankle reflexes were improved in favour of [alpha]-lipoic acid after 3 weeks. The rates of adverse events did not differ between the groups.
Conclusions: The results of this meta-analysis provide evidence that treatment with [alpha]-lipoic acid (600 mg/day i.v.) over 3 weeks is safe and significantly improves both positive neuropathic symptoms and neuropathic deficits to a clinically meaningful degree in diabetic patients with symptomatic polyneuropathy.
(C) 2004 Blackwell Science Ltd.
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Author Keywords: | diabetic polyneuropathy; Total Symptom Score; Neuropathy Impairment Score; [alpha]-lipoic acid; meta-analysis.
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Language: | English.
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Document Type: | Original articles.
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Journal Subset: | Clinical Medicine.
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ISSN: | 0742-3071
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NLM Journal Code: | dme, 8500858
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