Objective： Animal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effect...Objective： Animal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial. Methods： This was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group （30 patients） and the placebo group （30 patients）, for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol （LDL-C） at 8 weeks. The secondary endpoints included total cholesterol （TC） and triglycerides （TG）. Results： Our results revealed no statistically significant differences in LDL-C and TC between the two groups. Despite the lack of a statistically significant difference in the level of TG between the two groups, a declining trend was noted. A significant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline （P=0.048）. The incidence of stomach discomfort, gastroesophageal reflux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other significant adverse events were found. Conclusions： It is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary.展开更多
基金Chung Shan Medical University Hospital for its sponsorship that contributed to the completion of this study
文摘Objective： Animal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial. Methods： This was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group （30 patients） and the placebo group （30 patients）, for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol （LDL-C） at 8 weeks. The secondary endpoints included total cholesterol （TC） and triglycerides （TG）. Results： Our results revealed no statistically significant differences in LDL-C and TC between the two groups. Despite the lack of a statistically significant difference in the level of TG between the two groups, a declining trend was noted. A significant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline （P=0.048）. The incidence of stomach discomfort, gastroesophageal reflux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other significant adverse events were found. Conclusions： It is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary.
