Abstract |
Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α- lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd; n = 16) or to ALA withdrawal (n = 17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p < 0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p < 0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier: NCT02439879.
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Authors | Hector Garcia-Alcala, Celia Isabel Santos Vichido, Silverio Islas Macedo, Christelle Nathalie Genestier-Tamborero, Marissa Minutti-Palacios, Omara Hirales Tamez, Carlos García, Dan Ziegler |
Journal | Journal of diabetes research
(J Diabetes Res)
Vol. 2015
Pg. 189857
( 2015)
ISSN: 2314-6753 [Electronic] England |
PMID | 26345602
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics
- Antioxidants
- Thioctic Acid
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Analgesics
(administration & dosage)
- Antioxidants
(therapeutic use)
- Diabetes Mellitus, Type 2
(drug therapy)
- Diabetic Neuropathies
(physiopathology)
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Polyneuropathies
(drug therapy)
- Symptom Assessment
- Thioctic Acid
(administration & dosage, therapeutic use)
- Treatment Outcome
- Young Adult
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