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[Efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy].

Abstract

OBJECTIVE

To evaluate the efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy with regards to sensory symptoms and nerve conduction velocity.

METHODS

A total of 236 diabetics with symptomatic polyneuropathy were enrolled into this 5-center, randomized, double-blind and placebo-controlled study of α-lipoic acid 1800 mg daily (n = 117) or matching placebo (n = 119) for 12 weeks. The primary outcome was total symptom score (TSS). Secondary end points included nerve conduction velocity, individual symptom score, HbA1c and safety parameters. The above parameters were reviewed and recorded at zero point and after treatment for 2, 4, 8, 12 weeks separately.

RESULTS

73.27% patients with symptomatic polyneuropathy improved after treatment with α-lipoic acid for 12 weeks versus 18.27% with placebo. TSS declined by 2.6 ± 2.3 with α-lipoic acid. And it was more than 0.7 ± 1.4 versus placebo (P < 0.05). TSS decreased quickly after treatment with α-lipoic acid for 2 weeks (P < 0.05). And it was better than placebo. Individual symptom scores of pain, extremity numbness, burning sensation or resting abnormal sensations were significantly diminished as compared to those before treatment and placebo group (all P < 0.05). Nerve conduction velocity had no change. HbA1c further decreased at the end of trial after α-lipoic acid treatment (P < 0.05). The incidence rates of adverse effects were 25.4% vs 11.8% in the treatment and control groups. The major manifestation was burning sensation from throat to stomach (12.7%).

CONCLUSION

Oral treatment with high-dose α-lipoic acid for 12 weeks may improve symptoms in patients with diabetic polyneuropathy. Dose of 600 mg thrice daily for 2 weeks has marked effects with a reasonable safety.

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  • Authors+Show Affiliations

    ,

    Ruijin Hospital, Jiaotong University School of Medicine, Yuanyang Subdivision, Shanghai 200025, China.

    , , , , , , ,

    Source

    Zhonghua yi xue za zhi 90:35 2010 Sep 21 pg 2473-6

    MeSH

    Aged
    Antioxidants
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Peripheral Nervous System Diseases
    Thioctic Acid

    Pub Type(s)

    English Abstract
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    chi

    PubMed ID

    21092474

    Citation

    Gu, Xue-ming, et al. "[Efficacy and Safety of High-dose Α-lipoic Acid in the Treatment of Diabetic Polyneuropathy]." Zhonghua Yi Xue Za Zhi, vol. 90, no. 35, 2010, pp. 2473-6.
    Gu XM, Zhang SS, Wu JC, et al. [Efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy]. Zhonghua Yi Xue Za Zhi. 2010;90(35):2473-6.
    Gu, X. M., Zhang, S. S., Wu, J. C., Tang, Z. Y., Lu, Z. Q., Li, H., ... Ning, G. (2010). [Efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy]. Zhonghua Yi Xue Za Zhi, 90(35), pp. 2473-6.
    Gu XM, et al. [Efficacy and Safety of High-dose Α-lipoic Acid in the Treatment of Diabetic Polyneuropathy]. Zhonghua Yi Xue Za Zhi. 2010 Sep 21;90(35):2473-6. PubMed PMID: 21092474.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - [Efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy]. AU - Gu,Xue-ming, AU - Zhang,Shan-shan, AU - Wu,Jing-cheng, AU - Tang,Zheng-yi, AU - Lu,Zhi-qiang, AU - Li,Hui, AU - Liu,Chao, AU - Chen,Li, AU - Ning,Guang, PY - 2010/11/25/entrez PY - 2010/11/26/pubmed PY - 2011/7/29/medline SP - 2473 EP - 6 JF - Zhonghua yi xue za zhi JO - Zhonghua Yi Xue Za Zhi VL - 90 IS - 35 N2 - OBJECTIVE: To evaluate the efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy with regards to sensory symptoms and nerve conduction velocity. METHODS: A total of 236 diabetics with symptomatic polyneuropathy were enrolled into this 5-center, randomized, double-blind and placebo-controlled study of α-lipoic acid 1800 mg daily (n = 117) or matching placebo (n = 119) for 12 weeks. The primary outcome was total symptom score (TSS). Secondary end points included nerve conduction velocity, individual symptom score, HbA1c and safety parameters. The above parameters were reviewed and recorded at zero point and after treatment for 2, 4, 8, 12 weeks separately. RESULTS: 73.27% patients with symptomatic polyneuropathy improved after treatment with α-lipoic acid for 12 weeks versus 18.27% with placebo. TSS declined by 2.6 ± 2.3 with α-lipoic acid. And it was more than 0.7 ± 1.4 versus placebo (P < 0.05). TSS decreased quickly after treatment with α-lipoic acid for 2 weeks (P < 0.05). And it was better than placebo. Individual symptom scores of pain, extremity numbness, burning sensation or resting abnormal sensations were significantly diminished as compared to those before treatment and placebo group (all P < 0.05). Nerve conduction velocity had no change. HbA1c further decreased at the end of trial after α-lipoic acid treatment (P < 0.05). The incidence rates of adverse effects were 25.4% vs 11.8% in the treatment and control groups. The major manifestation was burning sensation from throat to stomach (12.7%). CONCLUSION: Oral treatment with high-dose α-lipoic acid for 12 weeks may improve symptoms in patients with diabetic polyneuropathy. Dose of 600 mg thrice daily for 2 weeks has marked effects with a reasonable safety. SN - 0376-2491 UR - https://www.unboundmedicine.com/medline/citation/21092474/[Efficacy_and_safety_of_high_dose_α_lipoic_acid_in_the_treatment_of_diabetic_polyneuropathy]_ L2 - http://journal.yiigle.com/LinkIn.do?linkin_type=pubmed&amp;issn=0376-2491&amp;year=2010&amp;vol=90&amp;issue=35&amp;fpage=2473 DB - PRIME DP - Unbound Medicine ER -