title: No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.
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.
  
  
  CONCLUSIONS
  The combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.
authors.affiliation: Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China.|Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.|Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China.
authors.forename: Chien-Ying
authors.initials: CY
authors.lastname: Lee
authors.affiliation: Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China.|Department of Integrated Chinese and Western Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.
authors.forename: Min-Chien
authors.initials: MC
authors.lastname: Yu
authors.affiliation: Department of Recreation Sport & Health Promotion, National Pingtung University of Science and Technology, Taiwan, 91201, China.
authors.forename: Wu-Tsun
authors.initials: WT
authors.lastname: Perng
authors.affiliation: Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China.|Division of Hepatogastroenterology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.
authors.forename: Chun-Che
authors.initials: CC
authors.lastname: Lin
authors.affiliation: Department of Statistics and Informatics Science, Providence University, Taiwan, 43301, China.
authors.forename: Ming-Yung
authors.initials: MY
authors.lastname: Lee
authors.affiliation: Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.|Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China.
authors.forename: Ya-Lan
authors.initials: YL
authors.lastname: Chang
authors.affiliation: Department of Applied Cosmetology, National Tainan Junior College of Nursing, China, Taiwan, 700.
authors.forename: Ya-Yun
authors.initials: YY
authors.lastname: Lai
authors.affiliation: Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.|Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China.
authors.forename: Yi-Ching
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China.|Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China.
authors.forename: Yu-Hsiang
authors.initials: YH
authors.lastname: Kuan
authors.affiliation: Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China.|Department of Internal Medicine, Chung Shan Medical University Hospital; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan, 40201, China.
authors.forename: James Cheng-Chung
authors.initials: JC
authors.lastname: Wei
authors.affiliation: Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw.|Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw.|Department of Pharmacology, Chung Shan Medical University, Taichung, Taiwan, 40201, China. shj525@csmu.edu.tw.
authors.forename: Hung-Che
authors.initials: HC
authors.lastname: Shih
mesh_terms: D001688:Biological Products / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002784:Cholesterol / Q000097:blood*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003131:Combined Modality Therapy; D003710:Demography; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood* / Q000503:physiopathology / Q000628:therapy*; D000960:Hypolipidemic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D007780:Lacticaseibacillus casei / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000097:blood
chemical_list: D001688:Biological Products; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D014280:Triglycerides; C117343:red yeast rice; D002784:Cholesterol
keywords: Lactobacillus casei; low-density lipoprotein cholesterol; randomized controlled trial; red yeast rice