title: Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial.
abstract: BACKGROUND
  Abelmoschus manihot, a single medicament of traditional Chinese medicine, has been widely used to treat kidney disease. This is the first randomized controlled clinical trial to assess its efficacy and safety in patients with primary glomerular disease.
  
  
  METHODS
  Prospective, open-label, multicenter, randomized, controlled, clinical trial.
  
  
  METHODS
  From May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study.
  
  
  METHODS
  A manihot in the form of a huangkui capsule, 2.5 g, 3 times per day; losartan potassium, 50mg/d; or combined treatment, a huangkui capsule at 2.5 g 3 times per day, was combined with losartan potassium, 50mg/d. The duration of intervention was 24 weeks.
  
  
  METHODS
  The primary outcome was change in 24-hour proteinuria from baseline after treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after treatment was a secondary outcome. The 24-hour proteinuria was measured every 4 weeks and eGFR was measured at 0, 4, 12, and 24 weeks.
  
  
  RESULTS
  Mean baseline urine protein excretion was 1,045, 1,084, and 1,073 mg/d in the A manihot, losartan, and combined groups, respectively, and mean eGFR was 108, 106, and 106 mL/min/1.73 m2, respectively. After 24 weeks of treatment, mean changes in proteinuria were protein excretion of -508, -376, and -545 mg/d, respectively (P=0.003 for A manihot vs losartan and P<0.001 for the combined treatment vs losartan). Mean eGFR did not change significantly. The incidence of adverse reactions was not different among the 3 groups (P>0.05), and there were no severe adverse events in any group.
  
  
  CONCLUSIONS
  Results cannot be generalized to those with nephrotic syndrome or reduced eGFR.
  
  
  CONCLUSIONS
  A manihot is a promising therapy for patients with primary kidney disease (chronic kidney disease stages 1-2) with moderate proteinuria.
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease 2011DAV00088, Chinese PLA General Hospital, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease 2011DAV00088, Chinese PLA General Hospital, Beijing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Li
authors.affiliation: Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu, China.
authors.forename: Chang-ying
authors.initials: CY
authors.lastname: Xing
authors.affiliation: Department of Nephrology, The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
authors.forename: Jiu-yang
authors.initials: JY
authors.lastname: Zhao
authors.affiliation: Department of Nephrology, Daping Hospital, The Third Military Medical University, Chongqing, China.
authors.forename: Ya-ni
authors.initials: YN
authors.lastname: He
authors.affiliation: Department of Nephrology, Second Affiliated Hospital of Lanzhou University, Lanzhou, China.
authors.forename: Jian-qin
authors.initials: JQ
authors.lastname: Wang
authors.affiliation: Department of Nephrology, First Affiliated Hospital of Third Military Medical University of PLA, Chongqing, China.
authors.forename: Xiong-fei
authors.initials: XF
authors.lastname: Wu
authors.affiliation: Department of Nephrology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Zhang-suo
authors.initials: ZS
authors.lastname: Liu
authors.affiliation: Department of Nephrology, Jinan General Hospital of PLA, Jinan, Shandong, China.
authors.forename: Ai-ping
authors.initials: AP
authors.lastname: Zhang
authors.affiliation: Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
authors.forename: Hong-li
authors.initials: HL
authors.lastname: Lin
authors.affiliation: Division of Nephrology, Zhongshan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Xiao-qiang
authors.initials: XQ
authors.lastname: Ding
authors.affiliation: Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
authors.forename: Ai-ping
authors.initials: AP
authors.lastname: Yin
authors.affiliation: Department of Nephrology, Third Affiliated Hospital of Third Military Medical University of PLA, Chongqing, China.
authors.forename: Fa-huan
authors.initials: FH
authors.lastname: Yuan
authors.affiliation: Department of Nephrology, Huaxi Hospital of Sichuan University, Chengdu, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Fu
authors.affiliation: Department of Nephrology, Second Affiliated Hospital of Anhui Medical University, Hefei, China.
authors.forename: Li
authors.initials: L
authors.lastname: Hao
authors.affiliation: Department of Nephropathy, The Second Hospital of Jilin University, Changchun, Jilin, China.
authors.forename: Li-ning
authors.initials: LN
authors.lastname: Miao
authors.affiliation: Department of Nephrology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
authors.forename: Ru-juan
authors.initials: RJ
authors.lastname: Xie
authors.affiliation: Department of Nephrology, Shandong Provincial Hospital, Jinan, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Nephrology, PLA Navy General Hospital, Beijing, China.
authors.forename: Chun-hua
authors.initials: CH
authors.lastname: Zhou
authors.affiliation: Department of Nephrology, Second Affiliated Hospital of Shandong University, Jinan, China.
authors.forename: Guang-ju
authors.initials: GJ
authors.lastname: Guan
authors.affiliation: Department of Nephrology, Qilu Hospital of Shandong, Jinan, China.
authors.forename: Zhao
authors.initials: Z
authors.lastname: Hu
authors.affiliation: Department of Nephrology, General Hospital of Tianjin Medical University, Tianjin, China.
authors.forename: Shan
authors.initials: S
authors.lastname: Lin
authors.affiliation: Department of Nephrology, Dalian Central Hospital, Dalian, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Chang
authors.affiliation: Department of Nephrology, Drum Tower Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: Miao
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Department of Nephrology, Shuguang Hospital of Shanghai Traditional Chinese Medicine University, Shanghai, China.
authors.forename: Li-qun
authors.initials: LQ
authors.lastname: He
authors.affiliation: Division of Nephrology, Kidney Institute of PLA, Changzheng Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Chang-lin
authors.initials: CL
authors.lastname: Mei
authors.affiliation: Department of Nephrology, Sichuan Provincial People's Hospital, Chengdu, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Nephrology, State Key Laboratory of Kidney Disease 2011DAV00088, Chinese PLA General Hospital, Beijing, China. Electronic address: xmchen301@126.com.
authors.forename: Xiangmei
authors.initials: X
authors.lastname: Chen
mesh_terms: D028483:Abelmoschus; D000328:Adult; D001706:Biopsy; D002681:China; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects / Q000502:physiology; D005921:Glomerulonephritis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D019808:Losartan / Q000627:therapeutic use; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D019808:Losartan
keywords: Abelmoschus manihot; Primary glomerular disease; clinical trial; estimated glomerular filtration rate (eGFR); huangkui capsule; proteinuria; traditional Chinese medicine