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

Hector Garcia-Alcala, Celia Isabel Santos Vichido, Silverio Islas Macedo, Christelle Nathalie Genestier-Tamborero, Marissa Minutti-Palacios, Omara Hirales Tamez, Carlos García, Dan Ziegler, Hector Garcia-Alcala, Celia Isabel Santos Vichido, Silverio Islas Macedo, Christelle Nathalie Genestier-Tamborero, Marissa Minutti-Palacios, Omara Hirales Tamez, Carlos García, Dan Ziegler

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.

Figures

Figure 1
Figure 1
Total Symptom Score (TSS) during the first 4 weeks of treatment with α-lipoic acid (600 mg tid) in responders (n = 33, solid circles) and nonresponders (n = 4, open circles). Values are mean ± SEM; ∗p < 0.05 versus baseline.
Figure 2
Figure 2
Total Symptom Score (TSS) from 4 to 20 weeks in patients who received α-lipoic acid (600 mg qd; n = 16, solid squares) compared to those in whom α-lipoic acid was withdrawn (n = 17, open squares). Values are mean ± SEM; ∗p < 0.05 versus week 4.
Figure 3
Figure 3
Individual components of the Total Symptom Score (TSS) from 4 to 20 weeks in patients who received α-lipoic acid (600 mg qd; n = 16, solid squares) compared to those in whom α-lipoic acid was withdrawn (n = 17, open squares). Values are mean ± SEM; ∗p < 0.05 versus week 4.
Figure 4
Figure 4
Total Symptom Score (TSS) at weeks 8–20 in participants who received α-lipoic acid (a) and those in whom α-lipoic acid was withdrawn (b) separately for subgroups which received analgesic rescue medication (black bars) and those who did not (white bars). Numbers in bars represent n. Values are mean ± SEM.

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Source: PubMed

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