title: Effects of Chinese herbal medicine Yiqi Huaju Qingli Formula in metabolic syndrome patients with microalbuminuria: a randomized placebo-controlled trial.
abstract: BACKGROUND
  Microalbuminuria (MAU) is a key component of metabolic syndrome (MetS) and is an early sign of diabetic nephropathy as well. Although routine Western medicine treatments are given to MetS patients to control high blood pressure, hyperglycemia and dyslipidemia, some patients still experience progressive renal lesions and it is necessary to modify and improve the treatment strategy for MetS patients.
  
  
  OBJECTIVE
  To investigate the efficacy of Yiqi Huaju Qingli Herb Formula, a compound traditional Chinese herbal medicine, in MetS patients with MAU when it is combined with routine Western medicine treatment.
  
  
  METHODS
  Sixty patients with MetS were randomized into the Chinese herbal formula group (CHF, Yiqi Huaju Qingli formula treatment in combination with Western medicine) and control group (placebo in combination with Western medicine). All treatments were administered for 12 weeks.
  
  
  METHODS
  Urinary microalbumin (MA), urinary albumin-to-creatinine ratio (UACR), 24-hour total urine protein (24-hTP), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2-hPPG), glycosylated hemoglobin (HbA1c), homeostasis model assessment for insulin resistance (HOMA-IR), blood lipid profile and blood pressure were observed.
  
  
  RESULTS
  Compared with the control group, CHF treatment significantly decreased BMI (P<0.05), WC (P<0.01) and WHR (P<0.01). Both groups had significant decreases in FPG, 2-hPPG, HbA1c, HOMA-IR, MA, and UACR, with CHF treatment showing better effects on these parameters compared with the control treatment (P<0.05). Both treatments significantly reduced the levels of total cholesterol, low-density lipoprotein cholesterol and triacylglycerol (TAG), and a greater reduction in TAG was observed with CHF treatment (P<0.05). The level of high-density lipoprotein cholesterol did not change in the control group after treatment (P>0.05), whereas it significantly increased with CHF treatment (P<0.01). Compared with before the treatment, significant decreases in systolic blood pressure, diastolic blood pressure and mean arterial blood pressure were observed in both groups (P<0.01). However, there was no significant difference between the two groups (P>0.05).
  
  
  CONCLUSIONS
  Combined treatment of Yiqi Huaju Qingli Formula and Western medicine significantly alleviated MAU, which may correlate with the improvement of insulin sensitivity and glucose and lipid metabolism. TRIAL REGISTRATION IDENTIFIER: This trial was registered in the Chinese Clinical Trial Registry with the identifier ChiCTR-TRC-11001633.
authors.affiliation: Institute of Integrative Medicine, Fudan University, Shanghai, China.
authors.forename: Tian-zhan
authors.initials: TZ
authors.lastname: Wang
authors.forename: Yu
authors.initials: Y
authors.lastname: Chen
authors.forename: Yan-ming
authors.initials: YM
authors.lastname: He
authors.forename: Xiao-dong
authors.initials: XD
authors.lastname: Fu
authors.forename: Yi
authors.initials: Y
authors.lastname: Wang
authors.forename: Yan-qiu
authors.initials: YQ
authors.lastname: Xu
authors.forename: Hong-jie
authors.initials: HJ
authors.lastname: Yang
authors.forename: Hong-li
authors.initials: HL
authors.lastname: Xue
authors.forename: Yi
authors.initials: Y
authors.lastname: Liu
authors.forename: Xiao-tao
authors.initials: XT
authors.lastname: Feng
authors.forename: Teng
authors.initials: T
authors.lastname: Zhang
authors.forename: Wen-jian
authors.initials: WJ
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D001786:Blood Glucose / Q000378:metabolism; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D004365:Drugs, Chinese Herbal; D006442:Glycated Hemoglobin; D008055:Lipids