Short-term use (1-3 months)
It is safe to take red yeast rice in the short term of 1-3 months, which multiple studies support. In one study, researchers had participants take 1200 mg of red yeast rice supplements daily for 6 weeks and found that their LDL-C decreased by an average of 28%.
It was observed that high-risk subjects for dyslipidemia had a reduction in cardiovascular disease risk by 15% in the short run. 1.8% of the participants in the study developed mild muscle discomfort, which reminds us to use it with caution and monitor health indicators regularly.
The lovastatin content of red yeast rice products sold in the market ranges from less than 0.1 mg per gram to more than 10 mg, and this inconsistency may lead to significant differences in efficacy and safety. As a result of the analysis of economic data, the market price of red yeast rice generally ranges between US$15 and US$40 per bottle; each bottle contains 60 to 90 capsules, with a monthly expenditure of about US$20-30 based on the recommended daily dose.
A 2021 study showed that around 6% of the users reported stomach discomfort, another 4% reported muscle soreness, and the proportion of serious side effects was less than 1%. In the short term, it is recommended that the daily intake of lovastatin be controlled below 10 mg in order to avoid abnormal liver function or muscle damage caused by excessive intake.
In the Japanese market, in 2018, more than 300,000 bottles of red yeast rice products had been recalled because of high concentrations of citric acid. It says that the maximum allowable content of lovastatin should not exceed 10 mg, and detailed ingredient analysis reports need to be provided by manufacturers.
Statistics show that, over the past five years, the global red yeast rice health supplement market has seen an average annual growth rate of 8.4%, and the market scale is likely to reach US$1 billion by 2025. Certain studies have shown that 15%-20% of patients with high cholesterol are poorly responsive to lovastatin products and may be in need of higher dosage or additional combination therapy.
Medium-term use (3-6 months)
Medium-term therapy of red yeast rice may be safe and effective in some subjects for 3-6 months, but safety and effectiveness differ among individuals and should be assessed in combination with clinical data and specific usage. A 2018 study followed 400 subjects with hypercholesterolemia over 6 months.
Patients with a daily intake of 1200 mg of red yeast rice showed an average reduction of low-density lipoprotein cholesterol by 25.3% and total cholesterol by 18.4%. Most participants gradually stabilized at approximately 3 months, but some patients’ cholesterol levels continued slowly to further decrease with further use.
One of the large-scale analyses conducted in 2021 showed that in about 9% of users, mild muscle soreness was reported after 3 months of use, while within 6 months, this proportion increased to 12%. In another 4% of users, gastrointestinal discomfort was reported.
A multicenter study of 800 patients received red yeast rice for 3 months and then had a statistically significant lipid-lowering effect but in the succeeding 3 months, the decline in LDL-C tended to be flat, and the average decline fell from 27% initially to 16%.
Priced at an average for common, over-the-counter red yeast rice capsule products available, 60 capsules cost between US$20 and US$30, and at a rate of 2 capsules per day, that comes to US$1 or US$30 per month and totals about US$180 for 6 months.
The randomised controlled comparison was done in this study for the two-dose response for 600 and 1200 mg. These effects were achieved because the high dose reduced LDL-C by 28%, and a low dose had only been reduced by 18%.
Statistic data show that the annual growth rate of the sales of the red yeast rice preparations is 8.4%, and by 2025, the world market size is expected to break through US$1.2 billion. Nearly 30% of the products of red yeast rice in the European market have not clearly marked the content of lovastatin, and high concentrations of citric acid are even detected.
A 2020 study showed that supplementation with red yeast rice for 6 months decreased arteriosclerosis indicators in patients at high risk for cardiovascular disease by 12%. It also lowered the blood levels of some inflammatory markers, such as C-reactive protein, by about 15%.
Clinical studies have demonstrated that red yeast rice lowers cholesterol in diabetic patients with high cholesterol, but at least 7% of patients have seen their blood sugar fluctuate over a period of 3 to 6 months.
Long-term use (6 months-1 year)
Red yeast rice use over the long term (6 months to 1 year) may have some efficacy in the management of the blood lipid levels, but such use also may carry potential risks and uncertainties. In one study, 2,000 high-cholesterol patients were treated for 12 months with 1,200 mg a day of red yeast rice; this resulted in a reduction of their LDL cholesterol by an average of 22%, with an HDL (“good”) cholesterol increase of about 5% over a year.
In the study, 12% of participants reported muscle aches and fatigue of varying degrees between 6-12 months. A 2020 meta-analysis reported that in more than 10% of long-term users, liver function showed mild abnormalities, especially ALT and AST.
For example, a 60-count bottle of red yeast rice supplements currently costs about $20 to $40. A typical dosage is 2 capsules daily, which would amount to about $30 a month and $360 a year. By contrast, the average prescription statin costs well over $1,000 annually.
One observational study over a period of 12 months demonstrated that while patients indeed had a significant drop in cholesterol within the first 6 months, during the next 6 months, further declines in LDL levels stabilized or, in other words, basically stagnated, and some even experienced a slight rebound.
In one of the studies comprising 500 patients, more than 30% of the subjects showed mild discomfort symptoms after taking red yeast rice for 12 months: 10% reported bloating, 7% reported decreased appetite, and 13% showed muscle fatigue.
There are reports of improved cardiovascular outcomes where a study among Europeans indicated a 17% lower incidence in cardiovascular events with the use of red yeast rice for 1 year when compared to the blank group. It was indicated through an adverse drug reaction report, abnormal liver functions were recorded over 5 percent of its use in a prolonged period of intake, combined in particular with anti-biotics or immunosuppressants.
A 2021 study indicated that after the long-term use of red yeast rice, the incidence of muscle soreness in elderly people over 65 was as high as 18%, which was significantly higher than that among young people. More than 20 percent of 120 analyzed red yeast rice products available in the U.S. market had excessive levels of citric acid amide, a fungal toxin capable of seriously damaging kidneys and the liver.
**Preventive use (take 1-2 months a year)
One study published in 2020 concluded that individuals at risk of high cholesterol who took the supplement of red yeast rice for 2 months out of the year saw an average reduction of 18% in LDL-C and a 12% decrease in total cholesterol levels.
In the experiment involving 500 persons, aside from the diet, supplements of red yeast rice were taken for 8 weeks per year. Resulting from this was that the improvement in blood lipids was decidedly superior to the control group, which had to depend on diet alone. The total cholesterol level of the experimental group was reduced on average by 15%, while in the control group, the reduction was 8% only. The HDL in the experimental group was increased by 5% to show possible improvement in blood lipids over all due to red yeast rice.
Using the common health supplement of red yeast rice, for example, a single bottle containing 60 capsules costs in the range of $20-$40, while taking 2 capsules daily for 2 months costs in the range of $40-$80. In one observation, only 2% of 1,000 users reported stomach discomfort and 1% reported mild muscle aches, which usually resolved quickly after stopping use.
In one study among high-risk patients for cardiovascular disease, it was found that regular use of red yeast rice over 2 months every year led to a reduction in the incidence of cardiovascular events within 2 years by 10%. The authors think that this effect could be related to the anti-inflammatory action of red yeast rice because during its use, the CRP level fell sharply by 13% in the participants.
In one market survey, 15% of the red yeast rice products were contaminated with an excess amount of citric acid amide, which is a fungal toxin potentially nephro- and hepatotoxic. One RCT documented a decrease in LDL-C in people with mild high cholesterol, with an absolute reduction between 10 and 25, with a median of 18 percent following red yeast rice, taken for a duration of 8 weeks.
It has been shown that 600 mg daily is well tolerated and effective in most patients with mild dyslipidemia. Adverse effects are less than 1% for lower doses of the medication. Studies reveal that 1-2 months a year of routine red yeast rice supplementation can help 35% of healthy adults maintain good blood lipid indicators.
Use as needed (when short-term indicators are abnormal)
One 2019 study reported that in patients receiving 1200 mg per day of red yeast rice, the mean LDL-C was reduced by 19% after 4 weeks, whereas HDL-C slightly increased by about 3%.
A study of 200 participants showed that taking 600 mg of red yeast rice daily reduced blood lipid levels by 10%-15% after 2 weeks, while patients taking 1200 mg daily saw a decrease of 18%-25%. However, high doses may bring mild discomfort, such as muscle soreness, which occurred in 5% of the high-dose group and only 2% of the low-dose group.
In the observation of 400 users for a period of 4 weeks, only 1.5% reported stomach discomfort and 0.8% reported mild headache; these disappeared quickly after its intake was stopped.
One study showed that 800 mg per day of red yeast rice on a high-fat diet led to a 14% reduction in total cholesterol levels within 4 weeks. This decline went further to 21% for those in the experimental group who took it while changing their diet.
Taking for example a bottle of 60 red yeast rice capsules, to ingest 2 capsules daily costs about $1 to $1.5, while a month’s total for using it as needed is about $30 to $45. It means that the small-scale trial that has shown around 70% of the users can bring about a considerable reduction in the levels of blood lipids over a very short term, about within 4 weeks; still, about 20% show weak responses against red yeast rice effects.
