Jian Huo1, Li-Sha Liu2, Wen-Yuan Jian1, Jie-Ping Zeng2, Jun-Guo Duan3, Xue-Jing Lu1, Shuo Yin1. 1. College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. 2. Good Clinical Practice Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. 3. College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. duanjgs@126.com.
Abstract
BACKGROUND:Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. OBJECTIVE: To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. METHODS: This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. CONCLUSION: This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).
RCT Entities:
BACKGROUND:Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. OBJECTIVE: To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. METHODS: This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. CONCLUSION: This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).
Authors: Andrew J M Boulton; Arthur I Vinik; Joseph C Arezzo; Vera Bril; Eva L Feldman; Roy Freeman; Rayaz A Malik; Raelene E Maser; Jay M Sosenko; Dan Ziegler Journal: Diabetes Care Date: 2005-04 Impact factor: 19.112
Authors: Suma Vupputuri; Teresa M Kimes; Michael O Calloway; Jennifer B Christian; David Bruhn; Alan A Martin; Gregory A Nichols Journal: J Diabetes Complications Date: 2013-10-07 Impact factor: 2.852
Authors: C P Wilkinson; Frederick L Ferris; Ronald E Klein; Paul P Lee; Carl David Agardh; Matthew Davis; Diana Dills; Anselm Kampik; R Pararajasegaram; Juan T Verdaguer Journal: Ophthalmology Date: 2003-09 Impact factor: 12.079
Authors: Lesley A Inker; Brad C Astor; Chester H Fox; Tamara Isakova; James P Lash; Carmen A Peralta; Manjula Kurella Tamura; Harold I Feldman Journal: Am J Kidney Dis Date: 2014-03-16 Impact factor: 8.860