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The antioxidant [alpha]-lipoic acid administered over 3 weeks at a dose of 600 mg/day reduces symptomatic polyneuropathy in over 700 patients with diabetes.
"We saw significant improvements in subjects and feel quite optimistic about the potential therapeutic use of this agent," said Dan Zeigler, MD, a clinical researcher at Heinrich Heine University, in Dusseldorf, Germany.
Dr. Zeigler and colleagues conducted a meta-analysis of research from the database of VIATRIS GmbH & Co., a pharmaceutical company based in Frankfurt, Germany, to determine the efficacy and safety of [alpha]-lipoic acid in diabetic patients with symptomatic polyneuropathy. All of the data came from randomized, double-masked, placebo-controlled, parallel-group trials using [alpha]-lipoic acid infusion.
Four trials (ALADINI, ALADIN III, SYDNEY, NATHAN II) involved 716 patients treated with [alpha]-lipoic acid and 542 treated with placebo. The researchers analyzed the data for comparative differences in Total Symptom Score (TSS) and in its individual components, as well as for comparative differences in Neuropathy Impairment Score of the lower limbs (NIS-LL).
After 3 weeks, alpha-lipoic acid had a 24.1% improvement over placebo (geometric mean with 95% confidence interval) for TSS and 16.0% for NIS (both P<0.05).
Response rates were 52.7% in patients treated with [alpha]-lipoic acid and 36.9% in those on placebo (P<0.05).
Among individual components of the TSS, pain, burning, and numbness decreased to a greater extent with [alpha]-lipoic acid compared with placebo. On the NIS-LL, alpha-lipoic acid had a better results pinprick and touch-pressure sensation and ankle reflex scores than placebo (all P<0.05).
The rates of adverse events did not differ between the groups.
The investigators concluded that treatment with [alpha]-lipoic acid is safe and, "significantly improves both neuropathic symptoms and deficits to a clinically meaningful degree in diabetic patients with symptomatic polyneuropathy."
Reported at the American Diabetes Association 63rd Annual Meeting.
[Study title: Treatment of Symptomatic Diabetic Polyneuropathy with the Antioxidant [alpha]-Lipoic Acid: A Meta-Analysis. Abstract 850-P]===========================
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