reduce LDL-C by 20-30% within a short-term use of 1-3 months and 27-31% within a long-term use of 6-12 months, but the risk of abnormal liver function increases to 2.8% after 6 months. It is suggested to take rest for 1 month after taking it for 3 months, and test liver enzymes every 3 months during its long-term use in order not to experience a decline of coenzyme Q10.
1-3 months adaptation period
According to the existing data and research results, the adaptation period of red yeast rice is usually recommended to be 1-3 months. According to the research by the National Institutes of Health of the United States, the tannic acid content in red yeast rice products is usually 2.5-10 mg per tablet, and the taking cycle is once or twice a day. The dose is not more than 20 mg total recommended. Experimental data show that taking it for 1-3 months results in an average 20%-30% decrease in LDL-C, which is 12%-15% higher compared to diet control alone.
The short-term estimated probability of serious side effects of taking red yeast rice is about 2.3%. A randomized double-blind trial of 1,500 patients in France reported that, among those who started within 1 month, 80% of users had a significant reduction in cholesterol levels, and the incidence of side effects was 3.1%. Long-term use of more than 3 months could increase the risk of rhabdomyolysis or abnormal liver function.
Around 15% of RYR products sold in the international market have failed strict quality tests due to, among others, “tartrazine” or mycotoxins in the product that can cause liver toxicity. The US FDA had reported finding in a random inspection in 2020 that almost 10% of the samples had tannic acid content above the standard by over 50%.
An Italian study mentioned that within 1-3 months of an adaptation period, the average LDL-C reduction was as high as 35% for participants who combined with the Mediterranean diet while only 22% of the people who did not adjust their diet. Dietary matching can reduce the incidence of muscle discomfort by about 7%.
The European Society of Cardiology recommends liver function tests every two weeks in the first month of taking red yeast rice, mainly monitoring ALT and AST indicators. Data show that the incidence of abnormal liver function is about 1.5%, more common in people consuming more than 20 mg per day.
Generally, the prices of certified red yeast rice products are between US$30 and US$50 per bottle in the US market. Each bottle contains 60-120 capsules. The daily cost is US$0.5-1 approximately. Compared to this the average monthly price of prescription medicine, Lovastatin is $15-25 dollars.
According to the statement from the American Heart Association, people with diseases such as liver or kidney damage or long term usage of statins have higher risks of medicine interactions while on the consumption of red yeast rice. In a follow-up market survey of 2,000 users, over 85% of users reported that red yeast rice brought about considerable lipid-lowering effects within two months. 73% reported significant improvement in blood lipid indicators. Mild fatigue and stomach discomfort were reported by 12% of the people.
Long-term use of red yeast rice can lead to tannic acid accumulation within the body and thus place an additional metabolic load on the liver. Most doctors recommend suspension of use for one month after 3 months.
6 months and more
One National Heart, Lung, and Blood Institute-funded study showed that when participants were taking 10 mg of tannic acid per day in a red yeast rice supplement, LDL-C was lowered an average 27% after 6 months of use. HDL-C was increased an average 4% for the patients.
A randomized, double-blind, controlled trial in France included 800 subjects and compared long-term therapy with either red yeast rice or placebo. Results demonstrated that after 6 months of continuous use, LDL-C levels in the red yeast rice group had been reduced by 31%, whereas that of the placebo group was decreased only by 3%. Adverse effects were experienced by 4.5% of the subjects in the red yeast rice group.
A 2019 retrospective analysis indicated that the incidence of abnormal liver function in patients who used red yeast rice for a long time was 2.8%, slightly higher compared to short-term users, about 1.5%. Liver function indicators should be monitored regularly by the patients during the 6-month or more period of use.
The average cost of a bottle containing 60 red yeast rice capsules ranges from 30-50 dollars. For a client who consumes two capsules daily, the six months budget goes down to about 180-300 dollars. The prescription statins, such as lovastatin, have an average cost per month of about 25 dollars, amounting to about 150-200 dollars for six months.
A three-year study in Japan demonstrated that subjects taking red yeast rice for a longer period with improved diet had a significantly higher reduction in cholesterol levels, 35%, compared with 20% for those who did not change their diet. The EFSA advised in its 2020 report that long-term users should have a health check-up every three months.
In the market survey of 3,000 users, more than 70% of long-term users believed that red yeast rice could continue to help them keep their cholesterol levels stable. 10% of users reported mild fatigue after taking it for more than six months, while another 5% reported muscle aches.
Combination use of red yeast rice with lovastatin can produce drug interactions that elevate the chance of abnormal liver function to 7.5%, studies show. According to the American Heart Association, “15% of patients using red yeast rice over a 6-month period demonstrated a reduction in coenzyme Q10 level greater than 20%.”.
Usage of 3 months followed by stopping for a month
This study proposes that continuous intake for 3 months should be followed by an intermittent break for 1 month to avert side effects. According to the clinical data, within 3 months, the tannic acid in red yeast rice manifests the most paramount lipid-lowering effect. One NIH-funded study found that 10 mg of tannic acid daily for 3 months could lower LDL-C by an average of 27%. Long-term continuous use can lead to a rise in liver enzyme levels, and a 1-month rest period can reduce the burden on the liver.
A European study followed 1,200 patients, and within one year, it was observed that the average cholesterol level of those who adopted the “3 months of use + 1 month of rest” program dropped 22%, versus only 18% for participants in the rest-free control group. The side effects in the intermittent group reached only 3.2% compared to the continuous group with 6.8%.
A biological metabolic study showed that the half-life of tannic acid within the liver was approximately 12 hours and it might cause an accumulation with the metabolites during long-term intake. Residual metabolites of tannins can be thoroughly removed in one month with rest.
The data indicated that the tannic acid content of most of the red yeast rice products was between 2.5 and 10 mg; for users who take 10 mg daily, their taking a one-month break will avoid the risk of overdose.
In the market survey of 2,000 users of red yeast rice, more than 85% of users who followed the “3 months of use + 1 month of rest” plan felt that the effect was significant and the side effects were controllable. Of those who continued taking it for over 6 months, about 12% had mild muscle pain or fatigue.
Indeed, within the Italian study, patients getting red yeast rice for 3 months along with a Mediterranean diet experienced a reduction of 30% in LDL-C, but among patients not changing their diet, LDL-C was reduced by 22%. Continuation of a healthy diet can avoid rebounding in cholesterol levels during a 1-month washout period.
Data show that the metabolism of tannic acid in red yeast rice is slow in patients over 65 years old, and continuous use can easily cause side effects. Incidence can be reduced effectively through intermittent rest from 4.5% to 2.1% to abnormal liver function.
Taking a bottle costing $30 for example, a bottle can be taken for 30 days; the cost is $90 for 3 months, and it is free during the 1-month rest. This, in comparison with the continuous use plan, reduces the annual expenditure by the user by about 25%. Some studies have also indicated that following 1 year of intermittent use, over 70% of the patients are able to sustain the intake of lower cholesterol through diet and exercise, hence reducing long-term reliance on red yeast rice.
Continuous use within 1 year
In a study funded by the American Heart Association, continuous use of red yeast rice over 12 months resulted in an average reduction in LDL-C of 30%. The daily dose of tannic acid taken by the study group was 10 mg, with only 5% of the patients exhibiting mild muscle soreness. The overall use within 1 year was safe and controllable.
A multicenter clinical trial in France followed up with 1,200 patients with high cholesterol and found the average total cholesterol of patients who used red yeast rice continuously for one year to be decreased by 22%. In the meantime, HDL-C had increased by an average
of 5% within that period.
A Japanese study compared the long-term use data between young and elderly people, and came to a conclusion that in those above 65 years of age, the LDL-C reduction was 25% within one year, while that in those less than 45 years of age was 32%. A German study showed that, over a period of one year, patients who consumed 5-10 mg tannic acid per day did not exhibit liver function abnormalities; however, approximately 8% of patients taking more than 20 mg/day had elevated ALT or AST.
High-quality tannic acid does not have a huge variation in content. Normally, it should be within ±3% deviation rate. From the users’ feedback, one can infer that most of the users take the red yeast rice for one year without problem. Over 3,000 users who participated in a questionnaire reported over 85% significantly improved in their cholesterol condition. Only 8% have had some minor side effects.
An Italian study recorded a 35% drop in cholesterol levels, compared to an 18% drop for participants who did not make any changes to their diet, over one year of use. Based on a product that costs $30 per bottle of 60 capsules, the monthly cost is about $30, and the annual cost is about $360. A US study, it was found that among those patients who used it continuously for a year, 10% of them showed coenzyme Q10 more than 25% drop.
Continuous use for more than 1 year
A two-year randomized controlled study showed that among patients who took red yeast rice continuously, low-density lipoprotein cholesterol dropped by an average of 28%, and high-density lipoprotein cholesterol increased by an average of 6%. Only 4.2% of the study group took 10 mg of tannic acid per day, and experienced mild muscle aches.
Another study on long-term use looked at data from more than 1,500 patients. On average, total cholesterol levels fell by 22% after 18 months of treatment with red yeast rice. Even as high as 96% of the liver function indicators, such as ALT and AST, remained within the normal range.
A Japanese study demonstrated that the overall LDL-C reduction, after 1.5 years of red yeast rice therapy, was 25% for patients over 65 years and 32% for those under 45 years of age. During a 2020 market spot check by the U.S. Food and Drug Administration, it was found that 15% of red yeast rice products were unstable. Consumers are led to choose between GMP and USP-certified brands. In addition, the usually allowed rate of deviation of concentration of tannin is within ±5%.
One French study followed the case of 1,200 long-term users of red yeast rice and reported that 6.5% of users for more than 2 years had developed muscle ache, while the proportion of users within 1 year was only 3.2%. The study recommends that long-term users check their creatine kinase, or CK, levels every 3 months.
An Italian study that put patients on red yeast rice for two years revealed that those who followed a Mediterranean diet showed a 12% greater reduction in cholesterol compared with those who did not change their diet. The product costs about $30 per bottle of 60 capsules, and at a dose of 2 capsules daily, the monthly cost is about $30. The total cost is about $360 for one year and $720 for two years.
A US study found that for patients who used red yeast rice for more than one year, 12% of patients saw a drop in coenzyme Q10 levels of over 20%. In a survey covering 3,000 users, over 80% of users believed that red yeast rice was helpful for maintaining stable cholesterol levels within two years.
Changes after stopping for 1-3 months
In a study of 500 patients, after cessation of red yeast rice for 3 months, LDL-C increased on average about 8% after 1 month of stopping. Total cholesterol was still 15% lower than before taking it.
One French clinical trial followed up for 2 months in patients who had stopped using red yeast rice and found that about 70% of patients had stable or only slightly increased cholesterol levels, with 10% of the patients having a significant rebound. For those who had better dietary control, the rebound rate was less than 5%.
One US-based monitoring of liver function changes in 300 patients recorded a 12% reduction of ALT and AST levels within one month of discontinuation of red yeast rice, mainly within the first 4-6 weeks.
In a feedback survey of long-term users, approximately 15% of users reported that muscle soreness improved significantly within 2-3 weeks after stopping. The incidence of fatigue dropped from 8% before stopping to 2% after stopping.
A study in Italy also found that subjects who took the red yeast rice preparation after 3 months of washout had a cholesterol reduction rate not significantly different from first-time users, with an average LDL-C reduction of 25%. It has been observed that on a sample of 1,200 patients with a diet low in fat and cholesterol, during the wash-out period, the increase in total cholesterol of red yeast rice consumers was only 5%-8% compared with an up to 18% increase without dietary restriction.
A study indicated that, on the average, patients’ coenzyme Q10 level increased by 10% following a stoppage of the red yeast rice after 1 month. A cessation of red yeast rice for 1 to 3 months would create very significant cost savings of medication. Using the price of $30 per bottle, with one bottle consumed every month; three months’ cessation from this medication would yield a savings of approximately $90.
