title: Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial.
abstract: BACKGROUND
  Diabetic nephropathy (DN) is the most common cause of end-stage renal failure. Although angiotensin II receptor blockers (ARBs) can be used to attenuate proteinuria in DN patients, their efficacy remains limited. This clinical trial aimed to evaluate the efficacy of Tripterygium wilfordii Hook F (TwHF) extract in the treatment of type 2 diabetes mellitus (DM)-induced nephropathy.
  
  
  METHODS
  A total of 65 DN patients with proteinuria levels ≥ 2.5 g/24 h and serum creatinine levels<3 mg/dl were enrolled in this six-month, prospective, randomized, controlled study. The patients were randomized into treatment groups that received either 120 mg of TwHF extract per day for three months, followed by 60 mg per day for three more months, or 160 mg of valsartan daily for six months. The urinary protein and estimated glomerular filtration (eGFR) level were measured at one, three, and six months after the commencement of treatment. The primary measure of treatment efficacy was a reduction in the 24-h urine protein level between baseline and the end of the study, and the secondary measure of treatment efficacy was a reduction in the eGFR value.
  
  
  RESULTS
  At the end of the treatment period, the mean urine protein level in the TwHF group was dramatically decreased (4.99 ± 2.25 g/24 h vs 2.99 ± 1.81 g/24 h, p< 0.01), with decreases at one, three, and six months of 32.9%, 38.8%, and 34.3%, respectively. In contrast, the proteinuria in the valsartan group was not significantly attenuated, and the decreases in urine protein levels at treatment months one, three, and six were 1.05%, 10.1%, and -11.7%, respectively. The mean decrease in eGFR in the valsartan group was greater than that in the TwHF group (26.4% vs. 13.7%, respectively; p =0.067).
  
  
  CONCLUSIONS
  TwHF extract can reduce the urine protein level of DN patients and represents a novel, potentially effective, and safe drug for the treatment of DN patients with proteinuria.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00518362.
authors.forename: Yongchun
authors.initials: Y
authors.lastname: Ge
authors.forename: Honglang
authors.initials: H
authors.lastname: Xie
authors.forename: Shijun
authors.initials: S
authors.lastname: Li
authors.forename: Bo
authors.initials: B
authors.lastname: Jin
authors.forename: Jinhua
authors.initials: J
authors.lastname: Hou
authors.forename: Haitao
authors.initials: H
authors.lastname: Zhang
authors.forename: Mingjun
authors.initials: M
authors.lastname: Shi
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Liu
mesh_terms: D000328:Adult; D000368:Aged; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000503:physiopathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013777:Tetrazoles / Q000627:therapeutic use; D016896:Treatment Outcome; D029757:Tripterygium / Q000737:chemistry*; D014633:Valine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D010936:Plant Extracts; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine