title: Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial.
abstract: OBJECTIVE
  To assess the efficacy and safety of acetyl-L-carnitine (ALC) on diabetic peripheral neuropathy compared with methylcobalamin (MC).
  
  
  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.
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Sheyu
authors.initials: S
authors.lastname: Li
authors.affiliation: Laboratory of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xiang
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Qianrui
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Juan
authors.initials: J
authors.lastname: Du
authors.affiliation: Department of Endocrinology, Changzheng Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Department of Endocrinology and Metabolism, Shanghai First People's Hospital, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Yongde
authors.initials: Y
authors.lastname: Peng
authors.affiliation: Department of Endocrine and Metabolic Diseases, The Second Affiliated Hospital of Kunming Medical College, Kunming, China.
authors.forename: Mian
authors.initials: M
authors.lastname: Xu
authors.affiliation: Department of Endocrinology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.
authors.forename: Qifu
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Xiangya Hospital of Central South University, Changsha, China.
authors.forename: Minxiang
authors.initials: M
authors.lastname: Lei
authors.affiliation: Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
authors.forename: Changjiang
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Endocrinology and Metabolism, The Second Hospital of Tianjin Medical University, Tianjin, China.
authors.forename: Shaoxiong
authors.initials: S
authors.lastname: Zheng
authors.affiliation: Laboratory of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xiaojuan
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Hongling
authors.initials: H
authors.lastname: Yu
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Jinyu
authors.initials: J
authors.lastname: Shi
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Shibing
authors.initials: S
authors.lastname: Tao
authors.affiliation: Statistics Department of GCP Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Feng
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Haoming
authors.initials: H
authors.lastname: Tian
mesh_terms: D000108:Acetylcarnitine / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction / Q000187:drug effects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014805:Vitamin B 12 / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000108:Acetylcarnitine; C019476:mecobalamin; D014805:Vitamin B 12
keywords: Acetyl-L-carnitine; Diabetic peripheral neuropathy; Methylcobalamin