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.

Highlights

  • Chronic kidney disease (CKD) stands for a health threat around the world

  • Patients in the treatment group received Chinese medicine herbs plus basic care, while those in the control group were treated with placebo plus basic care. e study was conducted in 9 centers across Jiangsu Province in China, including Affiliated Hospital of Nanjing University of Chinese Medicine, Wuxi People’s Hospital, Changzhou traditional Chinese medicine (TCM) Hospital, Taizhou Hospital of TCM, the First People’s Hospital of Changzhou, Wuxi Hospital of TCM, Xuzhou No

  • Recruited male and female patients were diagnosed with primary CKD and aged 18–75 years, with estimated glomerular filtration rate ≥ 30 ml/ min/1.73 m2 and

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Summary

Introduction

Chronic kidney disease (CKD) stands for a health threat around the world. Its prevalence is between 8% and 16% across regions and locates at around 11% among developed nations such as America and Australia [1]. CKD prevalence among middle-age and elderly people achieves 11.5%, and merely, 8.7% of these cases are diagnosed while 4.7% experience proper treatments [3]. Some subtypes of this disease would evolve into end-stage renal disease (ESRD), leading to the implementation of kidney replacement. It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). 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. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules.

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