机构：[1]Department of Endocrinology, Guangdong Provincial Hospital of ChineseMedicine, Guangzhou, China[2]Department of Neurology, The SecondAffiliated Hospital & Yuying Children’s Hospital of Wenzhou MedicalUniversity, Wenzhou, China[3]School of Second Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China[4]Department ofEndocrinology, The Affiliated Hospital of Liaoning University of TraditionalChinese Medicine, Shenyang, Liaoning, China[5]Department ofEndocrinology, Beijing University of Chinese Medicine Affiliated DongzhimenHospital, Beijing, China[6]Department of Geriatric, Luoyang NO.1 Hospital ofTraditional Chinese Medicine, Luoyang, China[7]Department ofEndocrinology, The First Affiliated Hospital of Anhui University of ChineseMedicine, Hefei 230031, China[8]Department of Endocrinology, LiuyangHospital of Chinese Medicine, Changsha, China[9]Department ofEndocrinology, The First Affiliated Hospital of Guiyang College of TraditionalChinese Medicine, Guiyang, China[10]Department of Endocrinology, HainanProvincial Hospital of Traditional Chinese Medicine, Haikou, China
Background: As a common complication of diabetes, the incidence of diabetic peripheral neuropathy (DPN) is 60-70% worldwide. DPN is a major risk factor for diabetic foot, which may lead to foot ulceration and even amputation. The treatment of DPN remains challenging. Our preliminary study demonstrated that the external application of Tangbi Waixi (TW) decoction to the lower extremities relieved clinical symptoms and improved nerve conduction velocity in DPN patients. The aim of this study was to verify the efficacy of TW among DPN patients and evaluate the herb mixture's safety using rigorous methodological designs. Methods/design: This study is a multicenter, double-blind, randomized controlled trial. A total of 640 DPN patients will be recruited and randomized to receive a foot bath with either the TW decoction or control drug. Participants will be assessed at baseline and 12 and 24 weeks after treatment. The primary outcome was the change of the Toronto Clinical Scoring System (TCSS). Secondary outcomes were nerve conduction velocity, blood glucose, blood lipids, serum inflammatory cytokines, and the European Quality of Life Five-Dimension Scale (EQ-5D) and TCM symptom scores. Discussion: This multicenter, prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of foot bath treatment with TW decoction. Positive results would provide a novel treatment regimen for DPN patients.
基金：
Chinese Government, Ministry of Science and Technology of the People's Republic of China through the National Science and Technology Support Program [2015BAI04B09]; State Administration of Traditional Chinese Medicine
第一作者机构：[1]Department of Endocrinology, Guangdong Provincial Hospital of ChineseMedicine, Guangzhou, China
通讯作者：
推荐引用方式(GB/T 7714)：
Guanjie Fan,Haoyue Huang,Yuping Lin,et al.Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial[J].TRIALS.2018,19:doi:10.1186/s13063-018-2856-4.
APA：
Guanjie Fan,Haoyue Huang,Yuping Lin,Guoqing Zheng,Xianyu Tang...&Xiaotang Qiu.(2018).Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial.TRIALS,19,
MLA：
Guanjie Fan,et al."Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial".TRIALS 19.(2018)
