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Purpose <p>Diabetic neuropathy is an important complication of diabetes. Restless Leg Syndrome (RLS) has been reported to be more common in patients with neuropathy. Peripheral nerve damage and oxidative stress plays a crucial role in the pathophysiology of both diabetic neuropathy and RLS. Alpha-lipoic acid (ALA) as an antioxidant is used in the treatment of peripheral neuropathy, but its effects on RLS have not been adequately investigated. A safe, efficient, and cost-effective treatment with minimal side effects in long-term use in the treatment of RLS is still sought. To our knowledge, this is the first study in the literature to evaluate the potential effect of ALA treatment on RLS symptoms in patients with diabetic neuropathy.</p> Methods <p>A total of 162 patients aged 35–80 years who had been on 600&#xa0;mg/day oral alpha-lipoic acid (ALA) treatment for diabetic neuropathy for three months were invited to the observational study. A total of 65 volunteer patients who met the inclusion criteria were evaluated for RLS. They were categorized into two groups, patients with no RLS (Group 1, <i>n</i> = 36) and those diagnosed with RLS (Group 2, <i>n</i> = 29). RLS symptom severity in patients with RLS was compared before and after treatment to determine the effect of ALA. All statistical analyses were performed using SPSS version 27 (IBM Corp., Armonk, NY, USA) between the groups. A p-value &lt; 0.05 was considered statistically significant for all analyses.</p> Results <p>In this study, the mean symptom severity score in patients with RLS was 19.38 ± 3.99 before treatment, and it was found to decrease to 12.66 ± 6.41 after ALA treatment (<i>p</i> &lt; 0.001). A mean 6.72 ± 4.65-point decrease was observed in RLS symptoms (with a 95% confidence interval (CI) of 4.955 to 8.493). Statistical analysis revealed that ALA treatment yielded a highly significant improvement in RLS severity (t = 7.785, df = 28, <i>p</i> &lt; 0.001), indicating a robust therapeutic effect. It was found that patients with HbA1c ≤ 8.45%, LDL ≥ 126.5&#xa0;mg/dL, ferritin ≥ 163.5 ng/mL, and albumin ≥ 4.15&#xa0;g/dL values benefited more from ALA treatment. The Total Score calculated using these parameters was found to be a highly effective tool for identifying patients likely to respond favorably to ALA treatment (Using a cutoff of ≥ 2.5, the total score achieved 93.3% sensitivity and 71.4% specificity).</p> Conclusion <p>ALA treatment has been shown to be more effective in RLS, especially in patients with good glycemic control and certain biochemical parameters. In addition, a scoring system can be used to determine the candidates most likely to benefit from ALA treatment among patients with diabetic neuropathy and comorbid RLS and to guide personalized treatment strategies for RLS management. The gold standard treatment for RLS remains unsolved. Since this is the first study in the literature addressing this issue and is a potential agent in terms of providing future treatment opportunities for RLS, it may shed light on future studies. In order to clearly determine the causality of these data, it is necessary to support the data with strong evidence in randomized controlled studies to be conducted in a larger population in the future.</p>

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Alpha-Lipoic acid in the management of restless legs syndrome in patients with diabetic neuropathy: A possible novel therapeutic approach

  • 期刊论文

  • 发表日期：

    2025年10月13日

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  • Duygu Tutan,
  • Jan Ulfberg,
  • Ülkem Şen Uzeli,
  • Tuba Kayır,
  • Ayşe Erdoğan Kaya,
  • Nilay Bektas Akpinar,
  • Handan Bilgin,
  • Mehmet Berksun Tutan

摘要

Purpose

Diabetic neuropathy is an important complication of diabetes. Restless Leg Syndrome (RLS) has been reported to be more common in patients with neuropathy. Peripheral nerve damage and oxidative stress plays a crucial role in the pathophysiology of both diabetic neuropathy and RLS. Alpha-lipoic acid (ALA) as an antioxidant is used in the treatment of peripheral neuropathy, but its effects on RLS have not been adequately investigated. A safe, efficient, and cost-effective treatment with minimal side effects in long-term use in the treatment of RLS is still sought. To our knowledge, this is the first study in the literature to evaluate the potential effect of ALA treatment on RLS symptoms in patients with diabetic neuropathy.

Methods

A total of 162 patients aged 35–80 years who had been on 600 mg/day oral alpha-lipoic acid (ALA) treatment for diabetic neuropathy for three months were invited to the observational study. A total of 65 volunteer patients who met the inclusion criteria were evaluated for RLS. They were categorized into two groups, patients with no RLS (Group 1, n = 36) and those diagnosed with RLS (Group 2, n = 29). RLS symptom severity in patients with RLS was compared before and after treatment to determine the effect of ALA. All statistical analyses were performed using SPSS version 27 (IBM Corp., Armonk, NY, USA) between the groups. A p-value < 0.05 was considered statistically significant for all analyses.

Results

In this study, the mean symptom severity score in patients with RLS was 19.38 ± 3.99 before treatment, and it was found to decrease to 12.66 ± 6.41 after ALA treatment (p < 0.001). A mean 6.72 ± 4.65-point decrease was observed in RLS symptoms (with a 95% confidence interval (CI) of 4.955 to 8.493). Statistical analysis revealed that ALA treatment yielded a highly significant improvement in RLS severity (t = 7.785, df = 28, p < 0.001), indicating a robust therapeutic effect. It was found that patients with HbA1c ≤ 8.45%, LDL ≥ 126.5 mg/dL, ferritin ≥ 163.5 ng/mL, and albumin ≥ 4.15 g/dL values benefited more from ALA treatment. The Total Score calculated using these parameters was found to be a highly effective tool for identifying patients likely to respond favorably to ALA treatment (Using a cutoff of ≥ 2.5, the total score achieved 93.3% sensitivity and 71.4% specificity).

Conclusion

ALA treatment has been shown to be more effective in RLS, especially in patients with good glycemic control and certain biochemical parameters. In addition, a scoring system can be used to determine the candidates most likely to benefit from ALA treatment among patients with diabetic neuropathy and comorbid RLS and to guide personalized treatment strategies for RLS management. The gold standard treatment for RLS remains unsolved. Since this is the first study in the literature addressing this issue and is a potential agent in terms of providing future treatment opportunities for RLS, it may shed light on future studies. In order to clearly determine the causality of these data, it is necessary to support the data with strong evidence in randomized controlled studies to be conducted in a larger population in the future.