Chien-Ying Lee1,2,3, Min-Chien Yu3,4, Wu-Tsun Perng5, Chun-Che Lin1,6, Ming-Yung Lee7, Ya-Lan Chang2,3, Ya-Yun Lai8, Yi-Ching Lee2,3, Yu-Hsiang Kuan2,3, James Cheng-Chung Wei1,9, Hung-Che Shih10,11,12. 1. Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China. 2. Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China. 3. Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China. 4. Department of Integrated Chinese and Western Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China. 5. Department of Recreation Sport & Health Promotion, National Pingtung University of Science and Technology, Taiwan, 91201, China. 6. Division of Hepatogastroenterology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China. 7. Department of Statistics and Informatics Science, Providence University, Taiwan, 43301, China. 8. Department of Applied Cosmetology, National Tainan Junior College of Nursing, China, Taiwan, 700. 9. Department of Internal Medicine, Chung Shan Medical University Hospital; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan, 40201, China. 10. Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw. 11. Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw. 12. Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw.
Abstract
OBJECTIVE: To observe the effect of combining red yeast rice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies. METHODS: A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeast rice + L. casei) or the control group (red yeast rice + placebo). One red yeast rice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8. RESULTS: At week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeast rice can signifificantly reduce LDL-C, total cholesterol and triglyceride. CONCLUSION: The combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.
RCT Entities:
OBJECTIVE: To observe the effect of combining red yeastrice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies. METHODS: A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeastrice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeastrice + L. casei) or the control group (red yeastrice + placebo). One red yeastrice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8. RESULTS: At week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeastrice can signifificantly reduce LDL-C, total cholesterol and triglyceride. CONCLUSION: The combination of red yeastrice and L. casei did not have an additional effect on lipid profifiles.
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