Po-Jen Hsiao1, Kao-Shin Lin2, Chih-Chien Chiu3, Hsueh-Wen Chen4, Jing-Shu Huang4, Sen-Yeong Kao5, Yuh-Feng Lin6, Jin-Shuen Chen7. 1. Division of Nephrology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Division of Nephrology, Department of Internal Medicine, Taoyuan Armed Forces General Hospital, Taiwan. 2. Department of Chinese Medicine, Tri-Service General Hospital, Taipei, Taiwan. 3. Division of Nephrology, Department of Internal Medicine, Taoyuan Armed Forces General Hospital, Taiwan. 4. Division of Nephrology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. 5. School of Public Health, National Defense Medical Center, Taipei, Taiwan. 6. Division of Nephrology, Department of Medicine, Shuang Ho Hospital, New Taipei, Taiwan. 7. Division of Nephrology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: dgschen@mail.ndmctsgh.edu.tw.
Abstract
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. Crown
RCT Entities:
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 HDpatients. Further larger clinical trial of long-term treatment with R-S-Y-R-T is necessary for evaluating treatment use. Crown