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J Diabetes Investig. 2016 Sep;7(5):777-85. doi: 10.1111/jdi.12493. Epub 2016 Mar 28.

Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial.

Author information

1
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
2
Laboratory of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
3
Department of Endocrinology, Changzheng Hospital, Second Military Medical University, Shanghai, China.
4
Department of Endocrinology and Metabolism, Shanghai First People's Hospital, Shanghai Jiaotong University, Shanghai, China.
5
Department of Endocrine and Metabolic Diseases, The Second Affiliated Hospital of Kunming Medical College, Kunming, China.
6
Department of Endocrinology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.
7
Department of Endocrinology, Xiangya Hospital of Central South University, Changsha, China.
8
Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
9
Department of Endocrinology and Metabolism, The Second Hospital of Tianjin Medical University, Tianjin, China.
10
Statistics Department of GCP Center, West China Hospital, Sichuan University, Chengdu, China.

Abstract

AIMS/INTRODUCTION:

To assess the efficacy and safety of acetyl-L-carnitine (ALC) on diabetic peripheral neuropathy compared with methylcobalamin (MC).

MATERIALS AND METHODS:

This was a multicenter, randomized, parallel-group, double-blind, double-dummy, positive-controlled, non-inferior phase II clinical trial. Diabetic patients with abnormal nerve conduction test results were randomized in a 1:1 ratio to receive oral ALC 500 mg t.i.d. or MC 0.5 mg t.i.d. for 24 weeks. The neuropathy symptom score, neuropathy disability score and neurophysiological parameters were measured during follow up.

RESULTS:

A total of 232 patients were randomized (ALC n = 117, MC n = 115), 88% of which completed the trial. At week 24, patients from both groups had significant reductions in both neuropathy symptom score and neuropathy disability score with no significant difference between two groups (neuropathy symptom score reduction: ALC vs MC 2.35 ± 2.23, P < 0.0001 vs 2.11 ± 2.48, P < 0.0001, intergroup P = 0.38; neuropathy disability score reduction ALC vs MC 1.66 ± 1.90, P < 0.0001 vs 1.35 ± 1.65, P < 0.0001, intergroup P = 0.23). Neurophysiological parameters were also improved in both groups. No significant difference was found between groups in the development of adverse events.

CONCLUSIONS:

ALC is as effective as MC in improving clinical symptoms and neurophysiological parameters for patients with diabetic peripheral neuropathy over a 24-week period with good tolerance.

KEYWORDS:

Acetyl-L-carnitine; Diabetic peripheral neuropathy; Methylcobalamin

PMID:
27180954
PMCID:
PMC5009142
DOI:
10.1111/jdi.12493
[Indexed for MEDLINE]
Free PMC Article

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