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.

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.

• Authors: Li Zhang, Ping Li, Chang-ying Xing, Jiu-yang Zhao, Ya-ni He, Jian-qin Wang, Xiong-fei Wu, Zhang-suo Liu, Ai-ping Zhang, Hong-li Lin, Xiao-qiang Ding, Ai-ping Yin, Fa-huan Yuan, Ping Fu, Li Hao, Li-ning Miao, Ru-juan Xie, Rong Wang, Chun-hua Zhou, Guang-ju Guan, Zhao Hu, Shan Lin, Ming Chang, Miao Zhang, Li-qun He, Chang-lin Mei, Li Wang, Xiangmei Chen
• Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation (Am J Kidney Dis) Vol. 64 Issue 1 Pg. 57-65 (Jul 2014) ISSN: 1523-6838 [Electronic] United States
• PMID: 24631042 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Drugs, Chinese Herbal
• Losartan

Topics

• Abelmoschus
• Adult
• Biopsy
• China
• Drug Therapy, Combination
• Drugs, Chinese Herbal (adverse effects, pharmacology, therapeutic use)
• Female
• Glomerular Filtration Rate (drug effects, physiology)
• Glomerulonephritis (drug therapy, physiopathology)
• Humans
• Kidney (drug effects, pathology, physiopathology)
• Losartan (therapeutic use)
• Male
• Medicine, Chinese Traditional
• Middle Aged
• Prospective Studies
• Renal Insufficiency, Chronic (drug therapy, physiopathology)
• Treatment Outcome