title: The effectiveness and safety of a danshen-containing Chinese herbal medicine for diabetic retinopathy: a randomized, double-blind, placebo-controlled multicenter clinical trial.
abstract: BACKGROUND
  Salvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR).
  
  
  OBJECTIVE
  The present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR).
  
  
  METHODS
  223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters.
  
  
  CONCLUSIONS
  At 24 weeks, for the FFA, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed.
  
  
  CONCLUSIONS
  DR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy.
authors: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors: Fengmei
authors: F
authors: Lian
authors: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors: Lie
authors: L
authors: Wu
authors: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors: Jiaxing
authors: J
authors: Tian
authors: China-Japan Friendship Hospital, Beijing 100029, China.
authors: Ming
authors: M
authors: Jin
authors: Tasly Pharmaceutical Co., Tianjin 300410, China.
authors: Shuiping
authors: S
authors: Zhou
authors: Tasly Pharmaceutical Co., Tianjin 300410, China.
authors: Min
authors: M
authors: Zhao
authors: The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun 130021, China.
authors: Lijuan
authors: L
authors: Wei
authors: The Affiliated Hospital to Chengdu University of Chinese Medicine, Chengdu 610032, China.
authors: Yanlin
authors: Y
authors: Zheng
authors: Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210005, China.
authors: Yuliang
authors: Y
authors: Wang
authors: The Affiliated Union Hospital to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430022, China.
authors: Mingchang
authors: M
authors: Zhang
authors: First Affiliated Hospital of Third Military Medical University, Chongqing 400038, China.
authors: Wei
authors: W
authors: Qin
authors: Wuxi Number 2 People׳s Hospital, Wuxi 214002, China.
authors: Zhifeng
authors: Z
authors: Wu
authors: Tang Center for Herbal Medicine Research, Pritzker School of Medicine, University of Chicago, IL 60037, USA. Electronic address: cyuan@dacc.uchicago.edu.
authors: Chun-Su
authors: CS
authors: Yuan
authors: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. Electronic address: xiaolintong66@sina.com.
authors: Xiaolin
authors: X
authors: Tong
mesh_terms: D000368:Aged; D001892:Camphanes; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009887:Ophthalmoscopy; D053723:Panax notoginseng; D012039:Regional Blood Flow / Q000187:drug effects; D012171:Retinal Vessels / Q000502:physiology; D027561:Salvia miltiorrhiza; D016896:Treatment Outcome
chemical_list: D001892:Camphanes; D004365:Drugs, Chinese Herbal; D007004:Hypoglycemic Agents; C000604051:danshen dripping pill
keywords: Diabetic retinopathy; Fluorescence fundus angiography (FFA); Fundoscopic examination; Glycosylated hemoglobin (HbA1c); Panax notoginseng; Salvia miltiorrhiza