Treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine: a randomized, double-blind, single-simulated, multi-center clinical trial

Abstract

Objective This study aimed to assess the clinical efficacy and safety of the treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine. Methods The study was a prospective, randomized, double-blind, 2∶1 basic-control, multi-center clinical trial, with 120 patients recruited from 7 hospitals in China. The test group was administered with traditional Chinese medicine (TCM) particles on the base of prednisone and cyclophosphamide treatment for 3 months, while the control group was administered with placebo using the same method. The 24-hour urinary protein, serum albumin, serum creatinine, TCM syndrome score and adverse reactions were monitored timely. SPSS 20.0 software was used for data analysis. Results At 3 months, the total effective rate was 89.39% and 63.64% for the test and the control, respectively, the difference of which was of statistical significance (χ2=7.824, P=0.005). The total effective rate of TCM syndromes was 93.94% and 72.73% for the test and the control, respectively, the difference of which was also of statistical significance (χ2=6.918, P=0.009). The incidence of Cushing′s syndrome, digestive tract reactions, and infections in the test group were lower than in the control group, the difference of which was of statistical significance (χ2=7.666, P=0.006; χ2=5.088, P=0.024; χ2=5.227, P=0.022). Conclusion Treatment with integrated traditional Chinese and western medicine effectively improved the clinical efficacy of refractory nephrotic syndrome, improved the clinical symptoms, and reduced the side effects of immunosuppressive agents. Key words: Treatment with integrated traditional Chinese and western medicine; Refractory nephrotic syndrom; Clinical trial