Multi-center Randomized Control Study on the Effects of Syndrome Differentiated Traditional Chinese MedicineTherapy on CKD 1-2 with Chronic Nephritis Proteinuria

Objective To determine the effects of Syndrome Differentiated Chinese Medicine (TCM) Therapy on (CKD) 1-2 stage chronic kidney disease with proteinuria. Methods A prospective randomized control study was undertaken in 11 centers. A total of 396 chronic nephritis patients were divided into a treatment group (n=297) and a control group (n=99). Their TCM syndrome was classified as “Qi and Yin Deficiency of spleen and kidney” or “Qi and Yang Deficiency of spleen and kidney”, with accompanying syndromes showing as “water and dampness”, “damp-heat”, and “blood stasis”. Patients in the treatment group took a dose of Chinese medicine daily in response to their syndromes, while the controls took 50 mg/d losartan. The course of treatment was 24 weeks. Changes of 24-hour urinary protein excretion and glomerular filtration rate (eGFR) before and after treatments （4, 8, 12, 16, 20, 24weeks）, as well as clinical efficacy （after 4, 16, 24 weeks treatments） weremeasured. Results 361 patients were included in the final program participants comply analysis (PPS). Patients in the treatment group showed gradual decreased 24-hour urinary protein excretion, whereas the controls remained unchanged. Significant differences in 24-hour urinary protein excretion appeared between the experimental and control group at week 20 and 24 （P <0.05）. eGFR decreased in all of the patients after treatments （P =0.001 4）. At three follow-up points, patients in the treatment group had higher eGFR than the controls, but without statistical significance （P >0.05）. Significant differences in clinical remission rate, marked effect rate and total effective rate were observed between the treatment and control groups at week 24 （P <0.001）. Conclusion Syndrome differentiated TCM therapy can reduce the level of proteinuria in CKD 1-2 nephritis patients, promoting clinical effectiveness and protecting renal functions.