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

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#biological-products #blood-pressure #cholesterol #cholesterol-hdl #cholesterol-ldl

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

Lee et al., 2017 | Chin J Integr Med | Rct

Citation

Lee Chien-Ying, Yu Min-Chien, ... Shih Hung-Che. 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. Chin J Integr Med. 2017-Aug;23(8):581-588. doi:10.1007/s11655-016-2530-1

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.

Key Findings

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

Outcomes Measured

  • diastolic blood pressure

Population

Field Value
Population primary hyperlipidemia
Sample Size See abstract
Age Range See abstract
Condition See abstract

MeSH Terms

  • Biological Products
  • Blood Pressure
  • Cholesterol
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Combined Modality Therapy
  • Demography
  • Double-Blind Method
  • Endpoint Determination
  • Female
  • Humans
  • Hyperlipidemias
  • Hypolipidemic Agents
  • Lacticaseibacillus casei
  • Male
  • Middle Aged
  • Triglycerides

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: red-yeast-rice

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09