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Journal of Integrative Medicine ›› 2021, Vol. 19 ›› Issue (2): 111-119.doi: 10.1016/j.joim.2021.01.009

• Original Chinical Research • Previous Articles     Next Articles

Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial

Jie Wua, Shu-wei Duana, Hong-tao Yangb, Yue-yi Dengc, Wei Li d, Ya-ni He e, Zhao-hui Nif, Yong-li Zhang, Shan Linh, Zhi-yong Guoi, Jun Zhuj, Jing-ai Fang k, Xu-sheng Liul, Li-hua Wangm, Rong Wangn, Nian-song Wango, Xiao-hong Chengp, Li-qun Heq, Ping Luor, Shi-ren Suns, Ji-feng Sunt, Ai-ping Yinu, Geng-ru Jiangv, Hong-yu Chenw, Wen-hu Liux, Hong-li Liny, Meng Liangz, Lu Maaa, Ming Chenab, Li-qun Songac, Jian Chenad, Qing Zhuae, Chang-ying Xingaf, Yun Liag, Ji-ning Gaoah, Rong-shan Liai, Ying Liaj, Hao Zhangak, Ying Lual, Qiao-ling Zhouam, Jun-zhou Fuan, Qiang Heao, Guang-yan Caia, Xiang-mei Chenaa   

  1. a Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases
    (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China
    b Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300192, China
    c Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    d Department of Nephrology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan 250011, Shandong Province, China
    e Department of Nephrology, Daping Hospital, Army Medical University, Chongqing 400042, China
    f Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China
    g Department of Nephrology, Guang’anmen Hospital, China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China
    h Department of Nephrology, Tianjin Medical University General Hospital, Tianjin 300052, China
    i Department of Nephrology, Changhai Hospital of Shanghai, Naval Medical University, Shanghai 200433, China
    j Department of Nephrology, West China Hospital, Chengdu 610083, Sichuan Province, China
    k Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China
    l Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, Guangdong Province, China
    mDepartment of Nephrology, Shanxi Medical University Second Affiliated Hospital, Taiyuan 030001, Shanxi Province, China
    n Department of Nephrology, Shandong Provincial Hospital, Jinan 250021, Shandong Province, China
    o Department of Nephrology and Rheumatology, Affiliated Sixth People’s Hospital, Shanghai Jiao Tong University, Shanghai 200233, China
    p Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an 710003, Shaanxi Province, China
    q Department of Nephrology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
    r Department of Nephrology, Jilin University Second Hospital, Changchun 130041, Jilin Province, China
    s Department of Nephrology, Xijing Hospital, Air Force Military Medical University, Xi’an 710032, Shaanxi Province, China
    t Department of Nephrology, Tangdu Hospital, Air Force Military Medical University, Xi’an 710038, Shaanxi Province, China
    u Department of Nephrology, the First Affiliated Hospital of Xi’an Jiao Tong University, Xi’an 710061, Shaanxi Province, China
    v Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
    wDepartment of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou 310007, Zhejiang Province, China
    x Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
    y Department of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning Province, China
    z Department of Nephrology, the 174th Hospital of the People’s Liberation Army, Xiamen 361003, Fujian Province, China
    aa Department of Nephrology, 281th Hospital of Chinese People’s Liberation Army, Qinhuangdao 066100, Hebei Province, China
    ab Department of Nephrology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
    ac Department of Nephrology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, Heilongjiang Province, China
    ad Department of Nephrology, 900th Hospital of the Joint Logistics Team of the Chinese People’s Liberation Army, Fuzhou 350001, Fujian Province, China
    ae Department of Nephrology, Henan Provincial People’s Hospital, Zhengzhou 450003, Henan Province, China
    af Department of Nephrology, Jiangsu Province Hospital, Nanjing 210029, Jiangsu Province, China
    ag Department of Nephrology, Jiangxi Provincial People’s Hospital, Nanchang 330006, Jiangxi Province, China
    ah Department of Nephrology, Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan 030001, Shanxi Province, China
    ai Department of Nephrology, Shanxi Provincial People’s Hospital, Taiyuan 030012, Shanxi Province, China
    aj Department of Nephrology, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
    ak Department of Nephrology, the Third Xiangya Hospital of Central South University, Changsha 410000, Hunan Province, China
    al Department of Nephrology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province, China
    am Department of Nephrology, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China
    an Department of Nephrology, Guangzhou First People’s Hospital, Guangzhou 510180, Guangdong Province, China
    ao Department of Nephrology, Zhejiang Provincial People’s Hospital, Hangzhou 310014, Zhejiang Province, China
  • Received:2020-08-24 Accepted:2020-12-24 Online:2021-03-12 Published:2021-03-26

Background
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.

Objective
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.

Design, setting, participants and intervention
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18–70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m2, and 24-hour proteinuria level of 0.5–3.0 g, were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups: SYKFT, losartan potassium 50 mg or 100 mg, SYKFT plus losartan potassium 50 mg or 100 mg.

Main outcome measures
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.

Results
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (= 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.

Conclusion
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.

Trial registration number
NCT02063100 on ClinicalTrials.gov.

Key words: Herbal medicine, Chinese, Shenyankangfu Tablet, Primary glomerulonephritis, Randomized controlled trial, Double blind, Double dummy

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