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Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading.

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.
AuthorsHector Garcia-Alcala, Celia Isabel Santos Vichido, Silverio Islas Macedo, Christelle Nathalie Genestier-Tamborero, Marissa Minutti-Palacios, Omara Hirales Tamez, Carlos García, Dan Ziegler
JournalJournal of diabetes research (J Diabetes Res) Vol. 2015 Pg. 189857 ( 2015) ISSN: 2314-6753 [Electronic] England
PMID26345602 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Analgesics
  • Antioxidants
  • Thioctic Acid
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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