Efficacy and Safety of Chinese Herbal Formula Granules in Treating Chronic Kidney Disease Stage 3: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial.
Jing Zhao, Wei Sun, Jihong Chen, Zhuxing Sun, Dai Chen, Chunhua Cao, Min Yang, Jipei Ma, Ling Wang, Changying Xing, Yan Chen, Meixiao Sheng, Enchao Zhou, Lingdong Xu, Kun Gao, Lihua Liu, Qiong Liu, Lan Yi, Weiming He, Yuanyuan Zhu
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引用次数: 4
Abstract
Background: It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). Chinese medicine herbs are widely applied in TCM therapy. We aimed to evaluate clinical efficacy and safety of Chinese herbal formula granules in patients with CKD stage 3 through a prospective randomized controlled study.
Methods: A total of 343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016. Participants were randomly assigned to a treatment or control group. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules. The duration of intervention was 24 weeks. Primary outcomes were 24-hour proteinuria, serum creatinine, and eGFR, which were measured every 4 weeks.
Results: There was no statistical difference in 24-hour proteinuria between the two groups (0.97 ± 1.14 g/d vs. 0.97 ± 1.25 g/d). Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μmol/L versus 149.12 ± 41.27 μmol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m2 versus 44.46 ± 12.60 ml/min/1.73·m2) than those in the control group (P < 0.05). There was no significant difference between two groups in the incidence of adverse events.
Conclusion: The treatment adopting Chinese herbal formula granules for 24 weeks improved kidney function of patients with CKD stage 3.
期刊介绍：
Evidence-Based Complementary and Alternative Medicine (eCAM) is an international, peer-reviewed journal that seeks to understand the sources and to encourage rigorous research in this new, yet ancient world of complementary and alternative medicine.
The journal seeks to apply scientific rigor to the study of complementary and alternative medicine (CAM) modalities, particularly traditional Asian healing systems. eCAM emphasizes health outcome, while documenting biological mechanisms of action. The journal is devoted to the advancement of science in the field of basic research, clinical studies, methodology or scientific theory in diverse areas of Biomedical Sciences. The journal does not consider articles on homeopathy.
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