Open AccessEffects of acetyl‐L‐carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double‐blind, controlled trial
Author(s) -
Li Sheyu,
Chen Xiang,
Li Qianrui,
Du Juan,
Liu Zhimin,
Peng Yongde,
Xu Mian,
Li Qifu,
Lei Minxiang,
Wang Changjiang,
Zheng Shaoxiong,
Zhang Xiaojuan,
Yu Hongling,
Shi Jinyu,
Tao Shibing,
Feng Ping,
Tian Haoming
Publication year - 2016
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12493
Subject(s) - medicine , methylcobalamin , peripheral neuropathy , randomized controlled trial , diabetic neuropathy , diabetes mellitus , adverse effect , gastroenterology , endocrinology , vitamin b12
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.