Li Zhang1, Ping Li1, Chang-ying Xing2, Jiu-yang Zhao3, Ya-ni He4, Jian-qin Wang5, Xiong-fei Wu6, Zhang-suo Liu7, Ai-ping Zhang8, Hong-li Lin9, Xiao-qiang Ding10, Ai-ping Yin11, Fa-huan Yuan12, Ping Fu13, Li Hao14, Li-ning Miao15, Ru-juan Xie16, Rong Wang17, Chun-hua Zhou18, Guang-ju Guan19, Zhao Hu20, Shan Lin21, Ming Chang22, Miao Zhang23, Li-qun He24, Chang-lin Mei25, Li Wang26, Xiangmei Chen27. 1. Department of Nephrology, State Key Laboratory of Kidney Disease 2011DAV00088, Chinese PLA General Hospital, Beijing, China. 2. Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu, China. 3. Department of Nephrology, The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China. 4. Department of Nephrology, Daping Hospital, The Third Military Medical University, Chongqing, China. 5. Department of Nephrology, Second Affiliated Hospital of Lanzhou University, Lanzhou, China. 6. Department of Nephrology, First Affiliated Hospital of Third Military Medical University of PLA, Chongqing, China. 7. Department of Nephrology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. 8. Department of Nephrology, Jinan General Hospital of PLA, Jinan, Shandong, China. 9. Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China. 10. Division of Nephrology, Zhongshan Hospital, Shanghai Medical College, Fudan University, Shanghai, China. 11. Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 12. Department of Nephrology, Third Affiliated Hospital of Third Military Medical University of PLA, Chongqing, China. 13. Department of Nephrology, Huaxi Hospital of Sichuan University, Chengdu, China. 14. Department of Nephrology, Second Affiliated Hospital of Anhui Medical University, Hefei, China. 15. Department of Nephropathy, The Second Hospital of Jilin University, Changchun, Jilin, China. 16. Department of Nephrology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China. 17. Department of Nephrology, Shandong Provincial Hospital, Jinan, China. 18. Department of Nephrology, PLA Navy General Hospital, Beijing, China. 19. Department of Nephrology, Second Affiliated Hospital of Shandong University, Jinan, China. 20. Department of Nephrology, Qilu Hospital of Shandong, Jinan, China. 21. Department of Nephrology, General Hospital of Tianjin Medical University, Tianjin, China. 22. Department of Nephrology, Dalian Central Hospital, Dalian, China. 23. Department of Nephrology, Drum Tower Hospital of Nanjing Medical University, Nanjing, China. 24. Department of Nephrology, Shuguang Hospital of Shanghai Traditional Chinese Medicine University, Shanghai, China. 25. Division of Nephrology, Kidney Institute of PLA, Changzheng Hospital, Second Military Medical University, Shanghai, China. 26. Department of Nephrology, Sichuan Provincial People's Hospital, Chengdu, China. 27. Department of Nephrology, State Key Laboratory of Kidney Disease 2011DAV00088, Chinese PLA General Hospital, Beijing, China. Electronic address: xmchen301@126.com.
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. STUDY DESIGN: Prospective, open-label, multicenter, randomized, controlled, clinical trial. SETTING & PARTICIPANTS: From May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study. INTERVENTIONS: 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. OUTCOMES & MEASUREMENTS: 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. LIMITATIONS: 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.
RCT Entities:
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. STUDY DESIGN: Prospective, open-label, multicenter, randomized, controlled, clinical trial. SETTING & PARTICIPANTS: From May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study. INTERVENTIONS: 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. OUTCOMES & MEASUREMENTS: 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. LIMITATIONS: 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.