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Lee, Min, and Han: The Comparison of Efficacy with α-lipoic Acid Treatment Methods in Diabetic Polyneuropathy
Original Article
The Journal of Korean Diabetes Association

The Journal of Korean Diabetes Association 2006; 30(2): 112-121.

Published online: 31 March 2006

DOI: https://doi.org/10.4093/jkda.2006.30.2.112

The Comparison of Efficacy with α-lipoic Acid Treatment Methods in Diabetic Polyneuropathy

Hyejin Lee, Kyung Wan Min1, Kyung Ah Han1

Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.

1Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.

Received 17 June 2005       Accepted 17 March 2006

Copyright © 2006 Korean Diabetes Association

Abstract

Background

Diabetic neuropathy represents a major health problem, as it is responsible for substantial morbidity, increased mortality, and impaired quality of life. Antioxidant treatment has been shown to prevent nerve dysfunction, providing a rationale for a potential therapeutic value in diabetic patients. The safety and efficacy of α-lipoic acid (ALA) given intravenously were proved in many studies, but the oral treatment remains to be established. Therefore we compare the efficacy and safety of ALA given intravenously followed by oral treatment and given only orally.

Methods

45 outpatients were randomly assigned to sequential treatment with ALA intravenously for 2 weeks, followed by orally for 10 weeks (group 1, n = 21); ALA orally for 12 weeks (group 2, n = 24). The primary end point was change of the sum score of severity and duration of total symptom score (TSS). HbA1c and safety parameters were determined at baseline and after 12 weeks.

Results

The TSS was significantly decreased from baseline to 2 week and 12 week in both groups. But no significant differences between the two groups were noted at 2 week and 12 week. There were no significant changes in HbA1c and safety parameters between baseline and 12 week. The rate of adverse events were 47.6% in group 1 and 12.5% in group 2.

Conclusion

We conclude that both methods of ALA treatment are effective to improve the symptoms of diabetic polyneuropathy, and the safety was probably superior in oral treatment method.

Keywords: Diabetic neuropathy, α-lipoic acid

Figures and Tables

Fig. 1
TSS trend according to the treatment of α-lipoic acid. TSS: total symptom score.
jkda-30-112-g001
Fig. 2
Changes in the TSS from baseline to 2 weeks and 12 weeks.
*P < 0.05
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Table 1
Symptoms* and Scoring† of the TSS
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*pain, burning, paresthesia, numbness.

†scoring: total score 0-14.64.

TSS: total symptom score.

Table 2
Basal Clinical Characteristics
jkda-30-112-i002

BMI: body mass index, WC: waist circumference, SBP: systolic blood pressure, DBP: diastolic blood pressure.

Table 3
Laboratory Characteristics
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FPG: fasting plasma glucose, TC: total cholesterol, TG: triglyceride, HDL-C: HDL cholesterol, NCV: nerve conduction velocity, PPN: peripheral polyneuropathy.

Table 4
Changes in TSS after 2 Weeks and 12 Weeks
jkda-30-112-i004

TSS: total symptom score

Table 5
Baseline Nerve Conduction Velocity
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Table 6
Nerve Conduction Velocity from Baseline to 12 Week in Group 1
jkda-30-112-i006
Table 7
Nerve Conduction Velocity from Baseline to 12 Week in Group 2
jkda-30-112-i007
Table 8
Characteristics of Adverse Events
jkda-30-112-i008

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