Red Yeast Rice 600 mg by Vitabase

LIKELY EFFECTIVE

• Coronary heart disease (CHD). A diet high in soluble fiber, such as that found in oats, reduces the risk of CHD. Details: Clinical research shows that a diet containing foods high in fiber, such as oats, oat bran, or whole oat flour, reduces the risk of CHD (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the US Food and Drug Administration (FDA) approved a health claim stating that consuming at least 3 grams of soluble fiber per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Hypercholesterolemia. A diet rich in soluble fiber, such as that found in oats, can reduce cholesterol by a moderate amount. Details: Oats, oat bran, and other soluble fibers can modestly reduce total and low-density lipoprotein (LDL) cholesterol when consumed as part of a diet low in saturated fat. Consuming 56-150 grams of whole oat products such as oatmeal and oat bran, containing 3.6-10 grams of soluble fiber daily, can significantly lower total and LDL cholesterol levels. For each gram of soluble fiber consumed, total cholesterol decreases by about 1.4 mg/dL and LDL by about 1.2 mg/dL. Eating 3-10 grams of soluble fiber daily can reduce total cholesterol by about 4-14 mg/dL (4976,4977,5786,5788,5792,5794,5795,8521,107749); however, doses greater than 10 grams daily don't seem to increase effectiveness (5788). Eating three bowls of oatmeal (28 gram servings) daily can decrease total cholesterol by about 5 mg/dL (4972,4973,4974,4975,4976,4977,5786,5788,6188). Oat bran products, such as oat bran muffins and oat bran flakes, may vary in their ability to lower cholesterol, depending on the total soluble fiber content and other dietary variables (6188). Whole oat products might be more effective for lowering LDL and total cholesterol than foods containing oat bran plus soluble fiber (10145).

POSSIBLY EFFECTIVE

• Diabetes. A diet rich in whole grains, such as oats, may help prevent diabetes or improve blood glucose control in patients with type 1, type 2, or gestational diabetes. Details: Population research shows that for every 16 gram daily serving of whole grains, including oats, there is a 7% to 11% lower risk of developing type 2 diabetes (100622). There is also evidence that consuming oats can decrease blood glucose and insulin levels, as well as lipid levels, in patients with diabetes. The glycemic effects of oats depend on the level of processing of the oat products. Consuming intact oat kernels or thick-cut oats (>0.6 mm) reduces postprandial blood glucose and insulin, but consuming thin-cut, or "quick", oats has no effect (105536). Clinical research shows that consuming oats and oat bran for 4-8 weeks decreases pre-prandial blood glucose, 24-hour plasma glucose, glycated hemoglobin (HbA1c), insulin levels, and low-density lipoprotein (LDL) cholesterol in people with type 2 diabetes (4980,4982,6266,103345). Various doses have been used, including 3 grams of soluble fiber daily, or bread providing 34 grams of total fiber daily (9 grams of soluble fiber) (4961,4980). Additional clinical research in obese adults with type 2 diabetes shows that eating whole grain oats 50-100 grams daily in place of other carbohydrates reduces postprandial blood glucose by 19-27 mg/dL when compared with other carbohydrates in a healthy diet. After 1 year, the groups consuming 50 grams and 100 grams of oats had an additional 0.48% and 0.64% reduction in HbA1c, respectively, when compared with the regular healthy diet group (97520). There is also some evidence that consuming oats 50 grams daily, containing 25 grams of soluble fiber, might be more effective for improving glycemic control and decreasing hyperinsulinemia than the standard moderate fiber diet recommended by the American Diabetes Association (ADA) (6266). Oats have also been evaluated in adolescents with type 1 diabetes. One very small clinical study shows that taking 50 grams of a specific oat product (Betaglucare), providing beta-glucans 6 grams, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with taking only 25 grams of the product daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the duration of hypoglycemia or hyperglycemia between groups (105261). Oats have also been evaluated in patients with gestational diabetes. A randomized, controlled trial shows that taking 30 grams of a specific oat bran product (OAB; Golden Light Cup Company) orally twice daily at lunch and dinner for 4 weeks improves mean fasting blood glucose and two-hour postprandial glucose when compared with a control group. After 4 weeks, the mean fasting blood glucose and 2-hour postprandial glucose in the treatment group were 85 mg/dL and 104 mg/dL, respectively, compared with 93 mg/dL and 117 mg/dL, respectively, in the control group (107751). The validity of this study is limited by the short treatment duration and lack of follow-up.
• Gastric cancer. A diet rich in soluble fiber, such as that found in oats, might reduce the risk of gastric cancer. Details: Observational research has found that consuming a diet that includes cereal fiber, such as oats and oat bran, might reduce the incidence of gastric cancer (10435).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Regular consumption of oats does not seem to reduce the risk of colorectal cancer. Details: Observational research has found that consuming oat bran or oats orally doesn't seem to reduce the risk of colon cancer. Additionally, consuming fiber, including oat-bran fiber, is not associated with a reduction in the risk for recurrence of colorectal adenomas (4820,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical oats for acne, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Anxiety. Although there is interest in using oral oats for anxiety, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Atopic dermatitis (eczema). Topical colloidal oatmeal cream may be beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that applying a cream containing colloidal oatmeal 1% daily for 2 weeks has a moderate effect on the severity of atopic dermatitis when compared with baseline (103344). The validity of this finding is limited by the lack of a comparator group. Other research suggests that colloidal oatmeal may be beneficial when used in combination with topical steroids. Clinical research shows that the benefits obtained from applying an ointment containing fluocinolone 0.025% to the hands for 2 weeks were better maintained in the patients who also used a cream containing colloidal oatmeal 1% during this time period and for an additional 4 weeks when compared with patients using fluocinolone and the cream base without colloidal oatmeal. Quality of life was also improved in the patients using colloidal oatmeal (103340).
• Breast cancer. Observational research suggests that regular oatmeal intake may be associated with reduced mortality from breast cancer. Details: Population research in postmenopausal patients has found that those who have eaten 50 grams of oatmeal daily prior to a breast cancer diagnosis have a 20% reduced risk of all-cause mortality in the 7 years following the diagnosis when compared with patients who have not eaten oatmeal. However, no benefit was seen when post-diagnostic oatmeal intakes were examined (103343).
• Burns. Although there is interest in using topical oats for burns, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral oats for CFS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Cognitive function. It is unclear if oral oats are beneficial in healthy adults with mild memory impairment. Details: Preliminary clinical research in healthy middle-aged adults with self-reported memory decline shows that consuming a specific wild green-oats extract (Neuravena, Frutarom) 800 mg as a single dose improves overall speed, but not overall accuracy, of cognitive performance when compared with placebo. However, a higher dose of 1600 mg was ineffective (97519).
• Dry skin. It is unclear if applying lotion containing colloidal oat extract improves dry skin to a greater extent than other lotion products. Details: Preliminary clinical research shows that applying a lotion containing colloidal oat extract (Aveeno Active Naturals Skin Relief 24Hr Moisturizing Lotion, Johnson & Johnson) twice daily for 2 weeks improves itchiness, cracking, scaling, dryness, and roughness when compared to baseline in females with dry skin (91458). Additional preliminary clinical research shows that applying a colloidal oatmeal lotion to the legs twice daily for three weeks reduces skin dryness and improves skin integrity when compared to baseline in adults with dry skin (97518). The validity of these findings is limited by the lack of a comparator group.
• Exercise-induced muscle soreness. It is unclear if oral oats are beneficial for exercise-induced muscle soreness. Details: A small clinical trial shows that eating two cookies containing oat flour 60 grams daily for 8 weeks reduces muscle soreness 48 or 72 hours after downhill running when compared with baseline (103341).
• Fat redistribution syndrome. It is unclear if oral oats are beneficial for fat redistribution syndrome. Details: Consumption of a high fiber diet, including oats, with adequate energy and protein might prevent fat deposition in patients with HIV. A one-gram increase in total dietary fiber may decrease the risk of fat deposition by 7% (12517).
• Gallbladder disease. Although there is interest in using oral oats for gallbladder disease, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Hypertension. It is unclear if oral oats are beneficial for hypertension. Details: Observational research has found that consumption of oats as oatmeal or oat cereal does not seem to reduce diastolic blood pressure (DBP) or systolic blood pressure (SBP) in males with minor elevations in blood pressure (2956). A randomized, controlled trial in patients with stage 1 hypertension receiving dietary guidance shows that taking 30 grams of oat bran, providing 8.9 grams of dietary fiber, once daily with breakfast or in between meals for 3 months improves various blood pressure measures when compared with dietary guidance alone. After 3 months of treatment, 24-hour maximum SBP and DBP decreased by 14 mmHg and 11 mmHg, respectively, and office SBP and DBP decreased by 15 mmHg and 10 mmHg, respectively. Oat consumption may also have impacted antihypertensive medication use. Two patients in the control group increased doses of antihypertensive medications, whereas 6 patients in the treatment group decreased doses and 1 patient discontinued use (107750). The effect of oral oat bran on patients with stage 2 hypertension or pre-hypertension is unknown.
• Irritable bowel syndrome (IBS). Although there is interest in using oral oats for IBS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Metabolic syndrome. Limited research suggests that oats may not be beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that adding oat bran 40 grams daily for 6 weeks to a low-calorie diet does not reduce the incidence of metabolic syndrome. Oat bran also does not improve body weight, blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, or blood glucose levels when compared with a low-calorie diet alone in patients with metabolic syndrome (103342).
• Osteoarthritis. Although there is interest in using oral oats for osteoarthritis, there is insufficient reliable information about the clinical effects of oats for this condition.
• Pruritus. Applying oat lotion topically may improve some types of pruritus. Details: Preliminary clinical research shows that applying an oat lotion (Espanol) twice daily for up to 2 weeks can decrease itching intensity by about 20% when compared to baseline in patients with pruritus associated with chronic kidney disease (uremic pruritus). This decrease is similar to the effects of applying vinegar 5% solution or taking hydroxyzine 10 mg orally. However, applying the oat lotion does not appear to decrease the frequency of itching (91457).
• Psoriasis. Although there is interest in using topical oats for psoriasis, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Rheumatoid arthritis (RA). Although there is interest in using oral oats for RA, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Stroke. It is unclear if oral oats are beneficial for reducing the risk of stroke. Details: Population research suggests that consuming oatmeal for breakfast once weekly might reduce the incidence of stroke by a small amount when compared with consuming white bread or eggs for breakfast (103337).
• Ulcerative colitis. Oral oats have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific oat-based product (Profermin, Nordisk Rebalance) containing fermented oat flour, Lactobacillus plantarum, barley malt flour, and lecithin, 250 mL orally twice daily for 8 weeks, reduces disease activity and increases remission in about two-fold more patients with relapsing ulcerative colitis, when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).
• Wound healing. Although there is interest in using topical oats for wound healing, there is insufficient reliable information about the clinical effects of oats for this purpose. More evidence is needed to rate oats for these uses.

(Read more about OATS)

LIKELY EFFECTIVE

• Hyperlipidemia. Most research shows that red yeast rice supplements lower lipid levels in patients with high cholesterol. This effect is likely due to the monacolin K (lovastatin) content of red yeast rice products. Details: Clinical research shows that taking certain red yeast rice products 1-5 grams daily for up to 24 weeks can lower total cholesterol by up to 23% and low-density lipoprotein (LDL) cholesterol by up to 34% when compared with placebo or control. Some of these products include Cholestin (Pharmanex), Xuezhikang (WBL Peking University Biotech Co, Ltd.) , Red Yeast Rice (Sylvan Bioproducts), and HypoCol (AsiaPharm Biotech) (2624,6988,16836,17089,70491,70509,95666,107951). Meta-analyses of clinical studies, which include some of these studies, show that taking red yeast rice 100-4800 mg daily for up to 4.5 years reduces LDL cholesterol by about 21-29 mg/dL and triglycerides by 20-27 mg/dL, and increases high-density lipoprotein (HDL) cholesterol by about 3 mg/dL, when compared with placebo. These meta-analyses included various patient populations, including those with hyperlipidemia, cardiovascular disease, or hypertension (103310,110583,110584). These and other red yeast rice products provide up to 10-20 mg daily of monacolin K, which is identical to the drug lovastatin (95666). The United States Food and Drug Administration (FDA) considers red yeast rice products that contain statins to be illegal, unapproved drugs (6610). In Germany, red yeast rice products with a daily monacolin K (lovastatin) dose greater than 5 mg are classified as drugs (98822). Health Canada allows red yeast rice products containing only trace amounts of lovastatin (i.e. 1 mg or less daily) to be marked as natural health products (110586). The European Union limits the amount of monacolin K (lovastatin) content to less than 3 mg daily in red yeast rice products (110587). However, the amount of monacolin K in products is not always clearly stated on the label. While some red yeast rice products available in the US contain little or no statin constituents, many still contain significant concentrations of statins. One analysis shows that that some of these products can contain up to 5 mg of statins per tablet (95903). It is not known whether red yeast rice products that contain a lower concentration of statins can significantly reduce cholesterol levels in patients with hyperlipidemia. Accordingly, the recommendations from various clinical societies differ regarding red yeast rice. While the American College of Cardiology/American Heart Association guidelines do not mention red yeast rice, the European Society of Cardiology recommends against its use (110588,110589). The International Lipid Expert Panel suggests consideration of red yeast rice for certain patients for primary cardiovascular prevention, including those who are statin-intolerant or unwilling to take a statin, but recommends against use of red yeast rice for secondary cardiovascular prevention (110585). Some studies have also evaluated combination products containing red yeast rice, such as Limicol (Laboratoire Lescuyer), Armolipid Plus (Rottapharm S.p.A.), and Prelipid Prevention Meds, Inc. Taking these products for 4-24 weeks seems to modestly reduce total and LDL cholesterol levels in patients with dyslipidemia (18110,34262,89451,89452,89454,92142,95663). One of these products (Armolipid Plus, Rottapharm S.p.A.), containing red yeast rice, berberine, policosanol, and other ingredients, which has been studied in over 12 clinical trials in patients with hypercholesterolemia, modestly reduces total and LDL cholesterol and triglyceride levels, and improves HDL cholesterol, when compared with baseline or placebo (34283,89438,92142,107952). This product has also been shown to further lower lipid levels when added to low-dose statin or ezetimibe therapy in patients with coronary heart disease and a history of percutaneous intervention (97232,97233). Another combination product (DIF1STAT) containing monacolin K 2.5-2.9 mg, niacin 27 mg, and unknown doses of olive oil extract, green tea extract, and various B vitamins decreases total and LDL cholesterol when compared with placebo (107953).

POSSIBLY EFFECTIVE

• HIV/AIDS-related dyslipidemia. Oral red yeast rice seems to reduce lipid levels in patients with dyslipidemia due to HIV. Details: A very small clinical study in adults with dyslipidemia due to HIV shows that taking red yeast rice (Cholestin) 1.2 grams twice daily for 8 weeks seems to reduce total and low-density lipoprotein cholesterol when compared with placebo (9475).
• Myocardial infarction (MI). Oral red yeast rice seems to reduce recurrence of non-fatal MI in some patients. Details: A meta-analysis of 4 clinical trials in over 10,000 individuals with a previous MI shows that taking red yeast rice 1.2 grams in two divided doses daily for 4 or 4.5 years reduces the incidence of nonfatal MI by 58%, revascularization by 42%, and sudden death by 29% when compared with placebo; however, there was no effect on the incidence of fatal MI (103310). All clinical trials used a specific red yeast rice extract (Xuezhikang, WBL Peking University Biotech Co, Ltd.) (70508,70513,70520,103310). Furthermore, all of the available research has been conducted in China; it is unclear if these benefits can be extrapolated to other geographic locations.

POSSIBLY INEFFECTIVE

• Hypertension. Adding oral red yeast rice to antihypertensive medications does not seem to further lower blood pressure. Details: Small clinical studies in patients with hypertension with or without a history of myocardial infarction shows that taking a specific red yeast rice extract (Xuezhikang, WBL Peking University Biotech Co, Ltd.) 1200 mg daily for up to 2 years, along with antihypertensive drugs such as nifedipine and valsartan, does not further reduce blood pressure when compared with using antihypertensive drugs alone (70519,70521,70526,70530).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. It is unclear if oral red yeast rice is beneficial for reducing atherosclerotic plaque. Details: A meta-analysis of 20 mostly low-to-moderate quality clinical studies that included 2217 patients with atherosclerosis shows that taking red yeast rice alone or with other statins improves markers of carotid atherosclerosis and modestly reduces blood lipid levels when compared with placebo, usual care, or statins. Studies were with specific red yeast rice products Xuezhikang (WBL Peking University Biotech Co, Ltd) or Zhibitai at daily doses up to 1800 mg or 960 mg, respectively, for 3-12 months (110582). The validity of the findings from this meta-analysis is limited by the heterogeneity of the included studies. Furthermore, all of these studies were conducted in China; it is unclear if these benefits can be extrapolated to other geographic locations.
• Cancer. It is unclear if oral red yeast rice is beneficial for reducing cancer mortality. Details: Clinical research in Chinese adults with a history of heart attack shows that taking red yeast rice extract (Xuezhikang, WBL Peking University Biotech Co, Ltd.) 1.2 grams daily for an average of 4.5 years decreases the risk of cancer mortality by 22% to 56% when compared with placebo (70513,70520). However, it is not clear if red yeast rice reduces the risk of cancer development or recurrence.
• Coronary heart disease (CHD). Although there is interest in using oral red yeast rice for CHD, there is insufficient reliable information about the clinical effects of red yeast rice for this condition.
• Diabetes. Although there is interest in using oral red yeast rice for diabetes, there is insufficient reliable information about the clinical effects of red yeast rice for this condition.
• Liver cancer. It is unclear if red yeast rice lowers the risk of developing liver cancer. Details: In a large population study conducted in Taiwan, people who consumed a specific red yeast rice product (LipoCol Forte) 600 mg (equivalent to about 6 mg of lovastatin) twice daily for at least one year had a 9% lower risk of developing liver cancer than people who had not taken red yeast rice. The risk of developing liver cancer continued to decrease with ongoing use of the supplement, with the lowest rate seen after 6 years of follow-up (112090).
• Metabolic syndrome. It is unclear if oral red yeast rice is beneficial in patients with metabolic syndrome. Details: A meta-analysis of mostly small, low-to-moderate quality studies in adults with metabolic syndrome suggests that taking red yeast rice modestly reduces glycated hemoglobin (HbA1c), fasting glucose, and lipid levels, and improves markers of insulin resistance, when compared with placebo, usual care, or other lipid-lowering treatments. Most studies were short-term and used a specific red yeast rice product (Xuezhikang, WBL Peking University Biotech Co, Ltd.) at an unknown dose (110580¬). The validity of the findings from this meta-analysis is limited by the heterogeneity of the included studies. Furthermore, the included studies were conducted in China; it is unclear if these benefits can be extrapolated to other geographic locations. Red rice yeast has also been evaluated in combination with other ingredients. A small clinical study in adults with metabolic syndrome shows that taking a specific combination product (Liposcudil Plus, Piam Farmaceutici SPA) containing monacolin K 10 mg and coenzyme Q10 30 mg once daily for 2 months, in conjunction with a Mediterranean diet, seems to modestly decrease blood pressure and lipid levels when compared with following the diet alone (98821). Clinical research in patients with metabolic syndrome and left ventricular hypertrophy shows that taking a specific product (Armolipid Plus, Rottapharm Madaus Spa) containing red yeast rice extract 200 mg, berberine 500 mg, and policosanol 10 mg daily for 6 months improves lipid profile and reduces left ventricular mass (LVM) when compared with placebo. LVM reduction occurred in 57% of patients taking the product, compared with 28% of those taking placebo (103311). It is unclear if any of these benefits are due to red yeast rice, other ingredients, or the combinations.
• Nonalcoholic fatty liver disease (NAFLD). Although there is interest in using oral red yeast rice for NAFLD, there is insufficient reliable information about the clinical effects of red yeast rice for this condition.
• Overall mortality. It is unclear if oral red yeast rice reduces mortality. Details: A meta-analysis of 2 moderate quality studies that included 3295 adults suggests that taking a specific red yeast rice product (Xuezhikang, WBL Peking University Biotech Co, Ltd.) at an unknown dose for up to 4-4.5 years reduces mortality by 38% when compared with placebo. This analysis also suggests red yeast rice reduces the incidence of major adverse cardiovascular events (MACE) by 46% when compared with placebo or routine care (110580). The validity of the findings from this meta-analysis is limited by the heterogeneity of the included patients. Furthermore, the included studies were conducted in China; it is unclear if these benefits can be extrapolated to other geographic locations.
• Postoperative recovery. It is unclear if oral red yeast rice is beneficial for recovery after surgery. Details: Observational research in Taiwanese patients has found that taking red yeast rice prior to major inpatient surgery is associated with lower odds of postoperative bleeding, pneumonia, stroke, and mortality, as well as a shorter hospital stay, when compared with a control group (100246).
• Stroke. It is unclear if oral red yeast rice reduces the risk of stroke. Details: Observational research in Taiwanese adults without a prior stroke suggests that taking a specific red yeast rice product (LipoCol Forte) is associated with a 35% reduction in the risk of stroke when compared with patients who did not take red yeast rice (110581). However, it is unclear if these results are due to red yeast rice or other factors, since patients who took red yeast rice were less likely to have comorbidities such as hypertension, diabetes, or ischemic heart disease. More evidence is needed to rate red yeast for these uses.

(Read more about RED YEAST RICE)

LIKELY SAFE ...when used orally and appropriately in food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).

POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).

(Read more about OATS)

POSSIBLY SAFE ...when used orally and appropriately. Red yeast rice 1.2 grams daily has been used with apparent safety in clinical studies for up to 4.5 years (512,2624,6988,6995,6996,17089,18110,70508,70513) (70520,70525,70530,95664,95666). However, red yeast rice products can contain an HMG-CoA reductase inhibitor identical to lovastatin, and can cause the same side effects as this drug. It is recommended that people taking red yeast rice products be monitored for the same hepatic and muscle-related adverse effects that are seen with lovastatin (98822).

PREGNANCY: LIKELY UNSAFE
when used orally. The red yeast rice constituent, lovastatin, has induced fetal skeletal malformations in animals (2619). The US Food and Drug Administration (FDA) recommends that most patients discontinue statin therapy during pregnancy due to the risks to the fetus; however, in certain high-risk patients, a prescription statin may be continued during pregnancy (107954).

LACTATION:
Insufficient reliable information available; avoid using. The US FDA recommends against breastfeeding while taking statins (107954).

(Read more about RED YEAST RICE)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.  Details Consuming oats can decrease blood glucose in patients with diabetes (4980,4982,6266,103345). In those who require insulin, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Concomitant use of oats and insulin might increase the risk of hypoglycemia.  Details In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

(Read more about OATS)

CYCLOSPORINE (Neoral, Sandimmune) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking red yeast rice in combination with cyclosporine might increase the risk of myopathy.  Details Red yeast rice contains varying levels of the statin drug lovastatin (9587,15017). Cyclosporine has been reported to increase plasma levels of lovastatin by 5- to 20-fold, resulting in reports of myopathy and rhabdomyolysis (104951).

CYTOCHROME P450 3A4 (CYP3A4) INHIBITORS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, drugs that inhibit the CYP3A4 enzymes might increase levels of lovastatin from red yeast rice.  Details Red yeast rice contains varying levels of the statin drug lovastatin, which is metabolized by CYP3A4 (104951). Combining red yeast rice with CYP3A4 inhibitors might increase serum levels of lovastatin from red yeast rice.

GEMFIBROZIL (Lopid) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking red yeast rice in combination with gemfibrozil might increase the risk of rhabdomyolysis.  Details Red yeast rice contains varying levels of the statin drug lovastatin (9587,15017). Gemfibrozil has been reported to increase the risk of rhabdomyolysis when used in combination with lovastatin (104951).

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use might increase the risk of liver damage.  Details Red yeast rice contains varying levels of the drug lovastatin. Lovastatin can cause liver damage in some people (104951). Some clinical research suggests that supplements containing red yeast rice might increase liver enzyme levels in some, but not all, participants (42692,70491). Cases of acute hepatitis have been associated with red yeast rice (16654,54477). Combining it with hepatotoxic drugs might further increase this risk.

HMG-CoA REDUCTASE INHIBITORS ("Statins") Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking red yeast rice with other statins might increase the risk of potential adverse effects.  Details Red yeast rice contains varying levels of the statin drug lovastatin and might result in supratherapeutic levels when used with other statins. Based on evaluation of data from the US Food and Drug Administration's adverse event reporting system (FAERS), it is recommended that red yeast rice products be avoided in people taking prescription statins (98822).

NIACIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking red yeast rice in combination with high-dose niacin might increase the risk of rhabdomyolysis.  Details Red yeast rice contains varying levels of the statin drug lovastatin and has been linked to reports of myopathy (9587,15017). Niacin has been reported to increase the risk of rhabdomyolysis when used in combination with lovastatin (104951).

(Read more about RED YEAST RICE)

General ...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.

Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).

Gastrointestinal ...When consumed orally, oats provide fiber. Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).

(Read more about OATS)

General ...Orally, red yeast rice seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, dizziness, flatulence, headache, heartburn, myopathy, and nausea.
Serious Adverse Effects (Rare):
Orally: There have been reports of hepatotoxicity and rhabdomyolysis, likely related to the lovastatin content of red yeast rice. Contaminated red yeast rice might cause renal toxicity.

Cardiovascular ...Orally, red yeast rice used in combination with other natural ingredients, such as green tea extract and policosanol, has been associated with a case of chest pain and a case of tachycardia requiring hospitalization, in post marketing surveillance (94001).

Dermatologic ...Orally, red yeast rice has been rarely associated with mild cases of pruritus and rash in clinical trials and post marketing surveillance (70531,94001,95664). Two cases of alopecia were reported in patients taking red yeast rice in clinical research (17089).

Gastrointestinal ...Orally, red yeast rice has been associated with mild adverse effects including abdominal discomfort, bloating, heartburn, flatulence, diarrhea or loose stools, nausea, vomiting, abdominal distention or pain, and reduced appetite, in clinical trials and post marketing surveillance (2624,6988,16836,70556,94001,95664). Taking red yeast rice with food may reduce the risk of heartburn, gas, and abdominal discomfort.

Genitourinary ...Orally, red yeast rice has been associated with rare reports of erectile dysfunction (70520). In one case report, a 39-year-old male developed erectile dysfunction after taking red yeast rice for one week. The dysfunction resolved after discontinuation of red yeast rice (98822).
A case of cystitis has been reported in a patient taking a specific combination product (Limicol, Laboratoire Lescuyer) containing red yeast rice extract, sugar cane extract, dry artichoke leaf extract, dry garlic extract, pine bark extract, vitamin E, riboflavin, and inositol hexanicotinate (89451). However, it is unclear if this event was associated with red yeast rice or other ingredients in the supplement.

Hepatic ...Orally, red yeast rice preparations have been linked to case reports of hepatotoxicity, including increased liver enzymes and acute hepatitis (16654,54477,94001,95664,98822,112644). Since red yeast rice often contains significant concentrations of the statin-like monacolin constituents, including lovastatin, it has the potential to cause similar side effects, including elevated liver enzymes. Clinical trials have shown that red yeast rice intake is associated with mild increases in levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which suggests possible liver damage (42692,70491,70513,70531,70547,107952). A case report describes a 62-year-old female who developed mixed hepatocellular and cholestatic hepatitis while taking red yeast rice. Signs and symptoms included fever, dark colored urine, weight loss, hyperbilirubinemia, and elevated ALT levels, all of which resolved after stopping red yeast rice (112089). A small study in various patient populations shows that taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing red yeast rice, berberine, policosanol, and other ingredients modestly increases levels of ALT, but not AST (107953). Clinical reviews of red yeast rice products show the risk of liver injury is comparable to the placebo or active control group, including pravastatin or lovastatin, when taken for up to 24 weeks (95664,95666).

Immunologic ...In one case report, a 58-year-old male presented with complaints of chronic dysphagia from eosinophilic esophagitis 12 months after starting an oral red yeast rice supplement (Artechol) containing monacolin K. Eosinophilic esophagitis resolved after cessation of red yeast rice (104465).
Inhalation of red yeast rice powder has resulted in one case of anaphylaxis (6997).

Musculoskeletal ...Orally, red yeast rice preparations have been linked to cases of myalgia, muscle spasm, rhabdomyolysis, and myopathy (9587,15017,16654,16834,16836,17089,70475,94001,95664,98822)(103311,112644,112645). Also, elevated creatine kinase levels up to 10 times normal, suggesting muscle injury and inflammation, have been reported in clinical and post-marketing research reports (6988,9587,15017,42692,70530,70567,94001,95664). The risk of muscle injury with red yeast rice seems to be similar to that with statins. In a small 3-month clinical trial in patients with previous statin intolerance, the rate of therapy discontinuation due to myalgia was similar between patients taking a specific red yeast rice product (Red Yeast Rice, Sylvan Bioproducts) 2400 mg twice daily (containing a daily dose of about 10 mg lovastatin) and patients taking pravastatin 20 mg twice daily (17089). However, in one case report, a 53-year-old patient experienced myalgia after 4 months of taking a red yeast rice product containing 4-8 mg lovastatin. Another case report describes a 50-year-old female who developed generalized myalgias and rhabdomyolysis, with elevated creatine phosphokinase, lactate dehydrogenase, and myoglobin levels, while taking red yeast rice (112306). The risk of myopathy seems to depend on the specific red yeast rice formulation and dose used (95903).

Neurologic/CNS ...Orally, red yeast rice has been associated with dizziness, headache, fatigue, and tingling in the extremities (6988,16836,17089,18110,94001). A case of peripheral neuropathy occurred in a 60-year-old male with a gastrointestinal tumor who was taking imatinib 400 mg daily along with red yeast rice for 3 years (89453). Three months after cessation of red yeast rice, symptoms resolved.

Ocular/Otic ...Orally, red yeast rice in combination with policosanol has been associated with one post-marketing report of hazy vision (94001).

Renal ...Orally, red yeast rice contaminated with citrinin may cause renal toxicity. Analyses of red yeast rice products have found that about one-third to two-thirds of these products contain citrinin (9588,17501,95666). Citrinin is a nephrotoxin that results from incorrect rice fermentation processes (9588,17501,70543). In vitro and in animal research, citrinin has been reported to cause kidney damage (70482,70542,70540).

Other ...Orally, red yeast rice has been associated with rare cases of edema (70508,70520,70525).

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