Abstract: Objective To evaluate the clinical efficacy of syndrome differentiation-based treatment with traditional Chinese
medicine (TCM) versus losartan therapy in addition to basic treatment for management of proteinuria in patients with chronic
kidney disease. Methods This multicenter, randomized, and case-controlled clinical trial was conducted among 81 consecutive
patients meeting the inclusion criteria. The patients were randomized consecutively to receive TCM treatments according to
the syndrome patterns in TCM (spleen and kidney Qi and Yin deficiency, and spleen and kidney Qi and Yang deficiency, n=60)
or oral losartan therapy (50 mg/day, n=21) in addition to the basic treatments. All the patients were followed up for 24 weeks to
observe the clinical effects. Results The patients in TCM group showed a significantly higher overall response rate (93.33%)
than those in losartan group (76.20%, P<0.05). The TCM score in the two groups were all decreased at week 24 as compared
with baseline (P<0.01 or P<0.05). The TCM scores in both groups decreased significantly after the treatments as compared with
the baseline scores (P<0.05). After a 8-week-long treatment, Scr, eGFR and Cys-C, U-Pro/24 h, and MA/Cr all decreased
significantly in TCM group (P<0.05) but showed no significant changes in losartan group (P>0.05). Conclusion Syndrome
differentiation-based TCM treatment in addition to basic treatments can produce satisfactory therapeutic effects on proteinuria
in patients with chronic kidney disease by improving the clinical symptoms, reducing TCM symptom scores and proteinuria,
and protecting the renal functions.