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Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial.
Diabetes Care 2006; 29(11):2365-70DC

Abstract

OBJECTIVE

The aim of this trial was to evaluate the effects of alpha-lipoic acid (ALA) on positive sensory symptoms and neuropathic deficits in diabetic patients with distal symmetric polyneuropathy (DSP).

RESEARCH DESIGN AND METHODS

In this multicenter, randomized, double-blind, placebo-controlled trial, 181 diabetic patients in Russia and Israel received once-daily oral doses of 600 mg (n = 45) (ALA600), 1,200 mg (n = 47) (ALA1200), and 1,800 mg (ALA1800) of ALA (n = 46) or placebo (n = 43) for 5 weeks after a 1-week placebo run-in period. The primary outcome measure was the change from baseline of the Total Symptom Score (TSS), including stabbing pain, burning pain, paresthesia, and asleep numbness of the feet. Secondary end points included individual symptoms of TSS, Neuropathy Symptoms and Change (NSC) score, Neuropathy Impairment Score (NIS), and patients' global assessment of efficacy.

RESULTS

Mean TSS did not differ significantly at baseline among the treatment groups and on average decreased by 4.9 points (51%) in ALA600, 4.5 (48%) in ALA1200, and 4.7 (52%) in ALA1800 compared with 2.9 points (32%) in the placebo group (all P < 0.05 vs. placebo). The corresponding response rates (>/=50% reduction in TSS) were 62, 50, 56, and 26%, respectively. Significant improvements favoring all three ALA groups were also noted for stabbing and burning pain, the NSC score, and the patients' global assessment of efficacy. The NIS was numerically reduced. Safety analysis showed a dose-dependent increase in nausea, vomiting, and vertigo.

CONCLUSIONS

Oral treatment with ALA for 5 weeks improved neuropathic symptoms and deficits in patients with DSP. An oral dose of 600 mg once daily appears to provide the optimum risk-to-benefit ratio.

Authors+Show Affiliations

FRCPE, Deutsche Diabetes-Klinik, Deutsches Diabetes-Zentrum, Leibniz-Institut an der Heinrich-Heine-Universität, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany. dan.ziegler@ddz.uni-duesseldorf.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17065669

Citation

Ziegler, Dan, et al. "Oral Treatment With Alpha-lipoic Acid Improves Symptomatic Diabetic Polyneuropathy: the SYDNEY 2 Trial." Diabetes Care, vol. 29, no. 11, 2006, pp. 2365-70.
Ziegler D, Ametov A, Barinov A, et al. Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. Diabetes Care. 2006;29(11):2365-70.
Ziegler, D., Ametov, A., Barinov, A., Dyck, P. J., Gurieva, I., Low, P. A., ... Samigullin, R. (2006). Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. Diabetes Care, 29(11), pp. 2365-70.
Ziegler D, et al. Oral Treatment With Alpha-lipoic Acid Improves Symptomatic Diabetic Polyneuropathy: the SYDNEY 2 Trial. Diabetes Care. 2006;29(11):2365-70. PubMed PMID: 17065669.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. AU - Ziegler,Dan, AU - Ametov,Alexander, AU - Barinov,Alexey, AU - Dyck,Peter J, AU - Gurieva,Irina, AU - Low,Phillip A, AU - Munzel,Ullrich, AU - Yakhno,Nikolai, AU - Raz,Itamar, AU - Novosadova,Maria, AU - Maus,Joachim, AU - Samigullin,Rustem, PY - 2006/10/27/pubmed PY - 2006/12/16/medline PY - 2006/10/27/entrez SP - 2365 EP - 70 JF - Diabetes care JO - Diabetes Care VL - 29 IS - 11 N2 - OBJECTIVE: The aim of this trial was to evaluate the effects of alpha-lipoic acid (ALA) on positive sensory symptoms and neuropathic deficits in diabetic patients with distal symmetric polyneuropathy (DSP). RESEARCH DESIGN AND METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, 181 diabetic patients in Russia and Israel received once-daily oral doses of 600 mg (n = 45) (ALA600), 1,200 mg (n = 47) (ALA1200), and 1,800 mg (ALA1800) of ALA (n = 46) or placebo (n = 43) for 5 weeks after a 1-week placebo run-in period. The primary outcome measure was the change from baseline of the Total Symptom Score (TSS), including stabbing pain, burning pain, paresthesia, and asleep numbness of the feet. Secondary end points included individual symptoms of TSS, Neuropathy Symptoms and Change (NSC) score, Neuropathy Impairment Score (NIS), and patients' global assessment of efficacy. RESULTS: Mean TSS did not differ significantly at baseline among the treatment groups and on average decreased by 4.9 points (51%) in ALA600, 4.5 (48%) in ALA1200, and 4.7 (52%) in ALA1800 compared with 2.9 points (32%) in the placebo group (all P < 0.05 vs. placebo). The corresponding response rates (>/=50% reduction in TSS) were 62, 50, 56, and 26%, respectively. Significant improvements favoring all three ALA groups were also noted for stabbing and burning pain, the NSC score, and the patients' global assessment of efficacy. The NIS was numerically reduced. Safety analysis showed a dose-dependent increase in nausea, vomiting, and vertigo. CONCLUSIONS: Oral treatment with ALA for 5 weeks improved neuropathic symptoms and deficits in patients with DSP. An oral dose of 600 mg once daily appears to provide the optimum risk-to-benefit ratio. SN - 0149-5992 UR - https://www.unboundmedicine.com/medline/citation/17065669/Oral_treatment_with_alpha_lipoic_acid_improves_symptomatic_diabetic_polyneuropathy:_the_SYDNEY_2_trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=17065669 DB - PRIME DP - Unbound Medicine ER -