Use of traditional Chinese medicine (Ren Shen Yang Rong Tang) against microinflammation in hemodialysis patients: An open-label trial

Background: Complementary and alternative medicine such as traditional Chinese medicine (TCM) is now frequently used combined with Western medicine for treatment in chronic kidney disease (CKD). Objective: We designed an open-label trial to investigate the safety and potential therapeutic effects of Ren Shen Yang Rong Tang (R-S-Y-R-T) in hemodialysis (HD) patients. Methods: The experimental group was treated with additional R-S-Y-R-T combined with routine western medicine, while the control group was treated only with routine western medicine. The duration of study was 6 months. Primary outcomes were to evaluate the changes in serum hematocrit and albumin levels. Secondary outcomes including blood inflammatory markers (c-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]) were checked. Finally we also followed up the change of quality of life (QOL) in our subjects. Results: Sixty nine respondents were enrolled in this trial. Finally a total of 59 patients (27 R-S-Y-R-T group, 32 control group) completed the 6-month follow-up. Primary outcomes showed no significant statistical change of hematocrit in either 2 group (P>. 0.05). But the R-S-Y-R-T group had a statistical increase in serum albumin (P < 0.05). Secondary outcomes were that both TNF-α (p = 0.003) and IL-6 (p = 0.001) showed evident decrease in the R-S-Y-R-T group. CRP was identified without statistical difference in both groups (p = 0.226). The R-S-Y-R-T group also had a significant improvement in QOL (P < 0.05). Conclusions: Our study suggests that R-S-Y-R-T could decrease chronic inflammation and increase the life quality in HD patients. Further larger clinical trial of long-term treatment with R-S-Y-R-T is necessary for evaluating treatment use.