Zhang Yuehong, Jin De, Duan Yingying, Hao Rui, Chen Keyu, Yu Tongyue, Lian Fengmei, Tong Xiaolin
Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2021 May 20;12:676503. doi: 10.3389/fphar.2021.676503. eCollection 2021.
Diabetic peripheral neuropathy (DPN) characterized by nerve damage is a common and disabling chronic microvascular complication in patients with type 2 diabetic mellitus (T2DM), affecting at least half of patients diagnosed with T2DM. Unfortunately, the current treatment for DPN is not ideal. Traditional Chinese medicine (TCM), with a unique theoretical system, has made outstanding contributions in the treatment of T2DM and related complications. Mudan granule, a Chinese patent medicine, has been previously validated that could ameliorate the symptoms, promote nerve tissue repair, increase nerve conduction velocity (NCV) in patients with DPN. However, the previous studies are of variable quality, which limits the clinical application of Mudan granule. Therefore, we designed a double-blind, randomized, placebo-controlled, parallel-arm, multi-center trial to estimate the safety and efficacy of Mudan granule in conjunction with methylcobalamin in individuals suffering from type 2 diabetic peripheral neuropathy. This work is conducted as a 14-center, double-blind, randomized, placebo-controlled, parallel-arm trial. In all, 402 subjects (aged 30-70 years) will be recruited and randomized in a 1:1 ratio to an intervention group ( = 201; Mudan granule + methylcobalamin) and a control group ( = 201; placebo + methylcobalamin). Treatment is administered in 24 weeks cycles without any treatment interruption between cycles. Michigan Diabetic Neuropathy Score (MDNS) as the primary outcome will be evaluated at baseline, 12 weeks during the intervention period, and after 24 weeks of the intervention. Adverse events and safety assessments will be also documented. The analysis of all data will be carried out based on a predefined statistical analysis plan. The outcomes from this study will offer important evidence regarding the safety and efficacy that Mudan granule can be used as an alternative and complementary therapeutic intervention in patients with type 2 diabetic peripheral neuropathy. Registered at https://clinicaltrials.gov/. Trial registration number: NCT04711980. Registered January 2021.
糖尿病周围神经病变（DPN）以神经损伤为特征，是2型糖尿病（T2DM）患者常见的致残性慢性微血管并发症，影响至少一半的T2DM确诊患者。不幸的是，目前DPN的治疗并不理想。中医拥有独特的理论体系，在T2DM及其相关并发症的治疗方面做出了杰出贡献。牡丹颗粒是一种中成药，此前已证实其可改善DPN患者的症状、促进神经组织修复、提高神经传导速度（NCV）。然而，以往的研究质量参差不齐，这限制了牡丹颗粒的临床应用。因此，我们设计了一项双盲、随机、安慰剂对照、平行组、多中心试验，以评估牡丹颗粒联合甲钴胺对2型糖尿病周围神经病变患者的安全性和有效性。 这项工作作为一项14中心、双盲、随机、安慰剂对照、平行组试验进行。总共将招募402名受试者（年龄30 - 70岁），并按1:1的比例随机分为干预组（n = 201；牡丹颗粒 + 甲钴胺）和对照组（n = 201；安慰剂 + 甲钴胺）。治疗以24周为周期进行，周期之间不中断任何治疗。密歇根糖尿病神经病变评分（MDNS）作为主要结局指标，将在基线、干预期的12周以及干预24周后进行评估。不良事件和安全性评估也将记录在案。所有数据的分析将根据预先定义的统计分析计划进行。 本研究的结果将为牡丹颗粒可作为2型糖尿病周围神经病变患者的替代和补充治疗干预措施的安全性和有效性提供重要证据。 在https://clinicaltrials.gov/注册。试验注册号：NCT04711980。2021年1月注册。
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