Is red yeast rice capsule beneficial for treating dyslipidemia amongst statin-intolerant patients, as compared to placebo?
Date of publication of the randomized clinical trial: June 2009
Design
Randomized controlled trial (RCT).
Participants
59 patients (mean age: 60.5 years in red yeast rice group, 61.5 years in placebo group, male%: 35%) with known hypercholesterolemia and had discontinued at least 1 statin because of myalgias, with resolution of muscle pain when the medication was discontinued. Patients who had received statin or red yeast rice in the month before random assignment were excluded.
Intervention
Three 600 mg capsules of red yeast rice administrated orally with a frequency of twice daily for 24 weeks.
Comparator
Comparison: Red yeast rice capsule versus placebo with identical appearance.
Major Outcomes
Outcome 1: Mean percentage change in low-density lipoprotein cholesterol level (%) from baseline to week 12;
Outcome 2: Mean percentage change in total cholesterol level (%) from baseline to week 12;
Outcome 3: Mean percentage change in triglyceride level (%) from baseline to week 12.
Settings
This trial was conducted in an outpatient setting.
Comparison    Red yeast rice capsule versus placebo
Main Results
Compared to placebo, red yeast rice capsule showed significant improvement on the following outcomes: low-density lipoprotein cholesterol level (difference in mean % change: 21.6, 95% CI: -29.4 to -13.8), total cholesterol level (difference in mean % change: -16.7, 95% CI: -23.4 to -10.3) and triglyceride level (mean % change difference: -20.0, 95 %CI: -38.9 to -1.1).
Comparison: Red yeast rice capsule versus placebo amongst statin-intolerant patients with dyslipidemia
Outcomes (unit) No. of studies (Total no. of participants) Mean % of change (SD) /No. of participants Heterogeneity test (I2) Difference in mean % change (95%CI) Overall quality of evidence*
Intervention Comparator
1 (%) 1 (59) -27.3 (16.4) /29 -5.7 (13.3) /30 Not applicable because there is only 1 study. -21.6 (-29.4 to -13.8) High
2 (%) 1 (59) -21.4 (12.3) /29 -4.7 (12.2) /30 Not applicable because there is only 1 study. -16.7 (-23.4 to -10.3) High
3 (%) 1 (59) -11.8 (33.2) /29 8.2(39.3) /30 Not applicable because there is only 1 study. -20.0 (-38.9 to -1.1) High
Key: CI = confidence interval; SD = standard deviation.
Comparison    Red yeast rice capsule versus placebo
Main Results
Compared to placebo, red yeast rice capsule showed significant improvement on the following outcomes: low-density lipoprotein cholesterol level (difference in mean % change: 21.6, 95% CI: -29.4 to -13.8), total cholesterol level (difference in mean % change: -16.7, 95% CI: -23.4 to -10.3) and triglyceride level (mean % change difference: -20.0, 95 %CI: -38.9 to -1.1).
Comparison: Red yeast rice capsule versus placebo amongst statin-intolerant patients with dyslipidemia
Outcomes (unit) 1 (%) 2 (%) 3 (%)
No. of studies (Total no. of participants) 1 (59) 1 (59) 1 (59)
Mean % of change (SD) /No. of participants Intervention -27.3 (16.4) /29 -21.4 (12.3) /29 -11.8 (33.2) /29
Comparator -5.7 (13.3) /30 -4.7 (12.2) /30 8.2(39.3) /30
Difference in mean % change (95%CI) -21.6 (-29.4 to -13.8) -16.7 (-23.4 to -10.3) -20.0 (-38.9 to -1.1)
Overall quality of evidence* High High High
Key: CI = confidence interval; SD = standard deviation.
Conclusion
Benefits
Compared to placebo, red yeast rice capsule showed beneficial effect on reducing low-density lipoprotein cholesterol level, total cholesterol level and triglyceride level amongst statin-intolerant dyslipidemia patients. For all outcomes, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect.
Harms
No adverse event was reported in this study.
Link to Original Article
http://www.ncbi.nlm.nih.gov/pubmed/19528562
The synopsis is based on the following article:
Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):830-9, W147-9.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.